cetuximab

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

Biomarkers

Sponsors

Industry sponsors leading active biomarker-selected trials of cetuximab.

1. MSD (Merck & Co.) 7
2. Bristol Myers Squibb 5
3. Pfizer 5
4. Eli Lilly 4
5. Genfleet Therapeutics 3
6. Verastem 3
7. Roche 2
8. Revolution Medicines 2
9. PAQ Therapeutics 2
10. Incyte 2
11. Quanta Therapeutics 2
12. D3 Bio 1

Trials

83 of 146 trials shown

1. A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)

   Recruiting Phase 3 MSD (Merck & Co.) Started 2025Primary completion 2029-03 NCT06997497

   calderasiboxaliplatinleucovorinfluorouracilcetuximabbevacizumab

   Demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation

   KRAS G12CColon Adenocarcinoma, Rectal Adenocarcinoma

2. Continuation of Cetuximab Beyond First-Line Progression in Metastatic Colorectal Cancer

   Recruiting Phase 3 University of Campania Luigi Vanvitelli Started 2025Primary completion 2030-10 NCT07389265

   cetuximab FDA EUbevacizumabFOLFOXleucovorinfluorouraciloxaliplatinFOLFIRIirinotecan

   RAS (NRAS and KRAS exon 2,3 and 4), BRAFV600E, PIK3CA, EGFR ECD wild-type and HER2 not amplified in liquid biopsy at the time of screen…

   BRAF V600EMetastatic Colorectal Cancer (mCRC)

3. Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer

   Active, not recruiting Phase 2/3 Alliance for Clinical Trials in Oncology Started 2023Primary completion 2034-06 NCT05710406

   encorafenib FDA EUcetuximab FDA EU

   BRAF V600E mutation

   BRAF V600EColon Adenocarcinoma, Microsatellite Stable Colon Carcinoma, Stage IIB Colon Cancer AJCC v8, Stage IIC Colon Cancer AJCC v8

4. Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

   Recruiting Phase 3 Shanghai Kechow Pharma Started 2023Primary completion 2026-12 NCT06008119

   vemurafenib FDA EUbevacizumabcetuximab FDA EU

   Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

   BRAF V600EColorectal Cancer Metastatic

5. Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)

   Active, not recruiting Phase 3 MSD (Merck & Co.) Started 2022Primary completion 2028-09 NCT05239741

   pembrolizumab FDA EUoxaliplatinleucovorinfluorouracilirinotecanbevacizumabcetuximab

   …ersus Chemotherapy in Chinese Participants With Stage IV Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer (MK-3475-C66)

   MSI-H / dMMRColorectal Neoplasms

6. Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

   Active, not recruiting Phase 3 Bristol Myers Squibb Started 2021Primary completion 2026-01 NCT04793958

   adagrasib FDA EUcetuximabmFOLFOX6FOLFIRI

   Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.

   KRAS G12CAdvanced Colorectal Cancer, Metastatic Colorectal Cancer

7. A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

   Active, not recruiting Phase 3 Pfizer Started 2020Primary completion 2025-03 NCT04607421

   encorafenib FDA EUcetuximab FDA EUoxaliplatinirinotecanleucovorinfluorouracilcapecitabinebevacizumab

   Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation

   BRAF V600ENeoplasms

8. Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer

   Active, not recruiting Phase 3 Massachusetts General Hospital Started 2020Primary completion 2026-12 NCT03803553

   FOLFIRIleucovorinfluorouracilirinotecannivolumab FDA EUencorafenibbinimetinibcetuximabtrastuzumabpertuzumab

   Presence of deficient (d) DNA mismatch repair (dMMR) may be assessed by IHC for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of…

   MSI-H / dMMRMetastatic Colon Cancer, Stage III Colon Cancer

9. A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

   Active, not recruiting Phase 3 Bristol Myers Squibb Started 2019Primary completion 2024-08 NCT04008030

   ipilimumab FDA EUoxaliplatinleucovorinfluorouracilirinotecanbevacizumabcetuximabnivolumab FDA EU

   Known tumor microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice

   MSI-H / dMMRMetastatic Colorectal Cancer

10. A Study of Olomorasib (LY3537982) in Participants With Advanced Colorectal Cancer and a KRAS G12C Mutation

    Not yet recruiting Phase 2 Eli Lilly Started 2026Primary completion 2028-11 NCT07814417

    olomorasibcetuximaboxaliplatinleucovorinfluorouracil

    Must have disease with evidence of KRAS G12C mutation

    KRAS G12CColorectal Neoplasms

11. A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)

    Recruiting Phase 1/2 MSD (Merck & Co.) Started 2026Primary completion 2029-08 NCT07286149

    calderasibpatritumab deruxtecansacituzumab tirumotecancetuximabRescue Medications

    …of Kirsten rat sarcoma viral oncogene (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations

    KRAS G12CKRAS G12DLung Neoplasm Malignant

12. Neoadjuvant Treatment of Fulzerasib Plus Cetuximab N01 in KRAS G12C Mutated Locally Advanced Colorectal Cancer With or Without Resectable Metastases

    Recruiting Phase 2 Zhejiang University Started 2026Primary completion 2028-12 NCT07581912

    fulzerasibcetuximab

    PMMR/MSS, KRAS G12C mutation, and both NRAS and BRAF wild-type

    KRAS G12CColorectal Cancer, KRAS G12C Mutant Advanced Solid Tumors, Fulzerasib, Cetuximab N01

13. Efficacy of Tunlametinib in Combination With Anti-EGFR Monoclonal Antibody in Patients With RAS-Mutated Advanced Gastrointestinal Malignancies

    Not yet recruiting Phase 2 Chinese PLA General Hospital Started 2026Primary completion 2027-10 NCT07446270

    cetuximabPancreatic cancer: Tunlametinib +Nimotuzumab

    Genetic testing demonstrating RAS mutation;

    KRAS G12CKRAS G12DTreatment for Advanced Colorectal Cancer, Treatment for Advanced Pancreatic Cancer

14. A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation

    Recruiting Phase 1/2 Genfleet Therapeutics Started 2026Primary completion 2027-11 NCT07678593

    GFH276cetuximabnab-paclitaxelgemcitabinefluorouracilleucovorinirinotecanoxaliplatin

    …cally or cytologically confirmed locally advanced or metastatic solid tumor and PDAC with RAS mutation or KRAS amplification

    KRAS G12CKRAS G12DAdvanced Solid Tumors Cancer, Pancreatic Ductal Adenocarcinoma, RAS Mutation

15. Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors

    Not yet recruiting Phase 1/2 BOE Technology Group Started 2026Primary completion 2028-04 NCT07551778

    NK CellspemetrexedcetuximabbevacizumabcapecitabineNK cells + PD-(L)1 inhibitor + VEGF inhibitor as first-line maintenance therapy

    …: EGFR sensitive mutations, ALK gene rearrangements, ROS1 mutations, BRAF 600E mutations, KRAS mutations);

    KRAS G12CKRAS G12DNSCLC (Advanced Non-small Cell Lung Cancer), Colorectal Cancer, Advanced Solid Tumors, Advanced Hepatocellular Carcinoma (HCC)

16. Tunlametinib Combination Therapy in KRAS-Mutated Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer

    Not yet recruiting Phase 2 Sun Yat-sen University Started 2026Primary completion 2028-05 NCT07463677

    cetuximabfulzerasib

    Positive for KRAS driver gene mutations (including: KRAS G12C and KRAS non-G12C).

    KRAS G12CKRAS G12DLung Cancer (NSCLC)

17. Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors

    Recruiting Phase 1/2 Revolution Medicines Started 2026Primary completion 2029-05 NCT07397338

    daraxonrasibelironrasibzoldonrasibivonescimabcarboplatincisplatinpemetrexedcetuximab

    …ogically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS.

    KRAS G12CKRAS G12DAdvanced Solid Tumors, Metastatic Solid Tumors, Non-small Cell Lung Cancer (NSCLC), NSCLC

18. A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer

    Recruiting Phase 2 Verastem Started 2026Primary completion 2027-06 NCT07659795

    VS-7375cetuximabpanitumumabmFOLFOX6

    Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)

    KRAS G12DColorectal Cancer

19. GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer

    Not yet recruiting Phase 2 Genfleet Therapeutics Started 2026Primary completion 2027-04 NCT07554859

    VS-7375cetuximabpemetrexed

    Have a written report confirming KRAS G12D mutation positive.

    KRAS G12DNSCLC (Advanced Non-small Cell Lung Cancer)

20. A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer

    Recruiting Phase 2 Verastem Started 2026Primary completion 2027-06 NCT07644559

    VS-7375cetuximabpanitumumab

    Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)

    KRAS G12DPancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS

21. A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer

    Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2026Primary completion 2027-12 NCT07506109

    ipilimumabsintilimabcetuximab FDA EUdabrafenib FDA EU

    Documented microsatellite stable (MSS) and BRAF V600E mutation by prior genomic testing.

    BRAF V600EBRAF V600E, Colorectal Cancer, Sintilimab, MSS (Microsatellite Stable)

22. A Single-Arm, Phase II, Multicenter Clinical Study of Neoadjuvant Encorafenib Plus Cetuximab N01 and mFOLFOX6 in Patients With Locally Advanced BRAF V600E-Mutant Colorectal Cancer With or Without Resectable Metastases

    Recruiting Phase 2 Zhejiang University Started 2026Primary completion 2029-12 NCT07789210

    encorafenib FDA EUcetuximab FDA EUmFOLFOX6

    PMMR/MSS, BRAF V600E mutation, and both NRAS and KRAS wild-type;

    BRAF V600EColorectal Cancer, BRAF V600E Mutation Positive, Encorafenib, Cetuximab N01

23. HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in BRAF V600-Mutant Metastatic Colorectal Cancer

    Recruiting Phase 1/2 Haisco Pharmaceutical Group Started 2026Primary completion 2029-09 NCT07790510

    HSK42360cetuximab FDA EUmFOLFOX6oxaliplatinleucovorinfluorouracilFOLFIRIirinotecan

    … (limited to PCR or NGS-based assays) must be provided prior to enrollment to demonstrate BRAF V600 mutation positivity;

    BRAF V600EMetastatic Colorectal Cancer (CRC)

24. IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation

    Recruiting Phase 2 Guangdong Association of Clinical Trials Started 2025Primary completion 2027-09 NCT07198841

    fulzerasibcetuximab

    Documented KRAS G12C mutation confirmed by a written report from a certified laboratory.

    KRAS G12CLung Cancer (Non-Small Cell)

25. Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC

    Not yet recruiting Phase 2 Sun Yat-sen University Started 2025Primary completion 2028-10 NCT07294261

    garsorasibbenmelstobartanlotinibcetuximab

    Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC

    KRAS G12CLocal Advanced or Metastatic NSCLC

26. KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)

    Recruiting Phase 2 MSD (Merck & Co.) Started 2025Primary completion 2029-11 NCT07252739

    calderasibpembrolizumabcetuximabsacituzumab tirumotecanRescue medication

    …cid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutations

    KRAS G12CMalignant Neoplasm

27. The Efficacy and Safety of IBI351, Cetuximab β Combined With FOLFIRI as First-line /IBI351, Cetuximab β as Second-line in the Treatment of KRAS G12C-mutated Metastatic Colorectal Cancer

    Enrolling by invitation Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine Started 2025Primary completion 2027-05 NCT06959589

    fulzerasibcetuximabFOLFIRI

    There is a written test report proving the presence of KRASG12C mutation: PCR method or NGS method detection clearly indicates KRASG12C mutation 4.

    KRAS G12CColorectal Cancer Metastatic, KRAS G12C Mutation

28. A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

    Recruiting Phase 2 MSD (Merck & Co.) Started 2025Primary completion 2032-04 NCT07209111

    calderasibcetuximab

    Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation

    KRAS G12CNeoplasm Malignant

29. A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

    Recruiting Phase 1/2 Bristol Myers Squibb Started 2025Primary completion 2028-10 NCT07223047

    BMS-986523gemcitabinenab-paclitaxelcetuximabpembrolizumab

    …etastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification).

    KRAS G12CKRAS G12DAdvanced Solid Malignancies, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC)

30. A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors

    Recruiting Phase 1/2 Verastem Started 2025Primary completion 2028-12 NCT07020221

    VS-7375cetuximabcarboplatinpemetrexedpembrolizumabgemcitabinenab-paclitaxeldefactinibmidazolamRepaglinide

    …cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation.

    KRAS G12DPancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer, Colorectal Cancer, Solid Tumor, Adult

31. A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation

    Recruiting Phase 1/2 Genfleet Therapeutics Started 2025Primary completion 2027-07 NCT07259590

    VS-7375cetuximabpaclitaxelgemcitabine

    …or cytologically confirmed locally advanced unresectable or metastatic solid tumors, with KRAS G12D mutation.

    KRAS G12DAdvanced Solid Tumors Cancer, PDAC, CRC (Colorectal Cancer)

32. Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer

    Recruiting Phase 2 Fudan University Started 2025Primary completion 2026-12 NCT06763029

    irinotecancetuximab FDA EU

    For BRAF V600E mutated patients with MSI-H, first-line immunotherapy with PD-1 or PD-L1 is required;

    BRAF V600EMSI-H / dMMRColorectal Cancer Metastatic

33. A Study of Irinotecan With Dabrafenib Plus Trametinib and Anti-EGFR in the Second Line of Therapy in People With Metastatic Colorectal Cancer

    Active, not recruiting Phase 2 Blokhin's Russian Cancer Research Center Started 2025Primary completion 2027-11 NCT06967155

    dabrafenib FDA EUtrametinib FDA EUcetuximab FDA EUoxaliplatinirinotecanleucovorinfluorouracil

    …nib and Trametinib, Anti-EGFR in the Second Line of Treatment of Patients With Metastatic BRAF V600E- Mutated Colorectal Cancer.

    BRAF V600ENeoplasms

34. A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer

    Recruiting Phase 2 Blokhin's Russian Cancer Research Center Started 2025Primary completion 2027-11 NCT06978400

    mFOLFOX6dabrafenib FDA EUcetuximab FDA EUpanitumumab

    Histologically confirmed colorectal adenocarcinoma that contains MSS and BRAF V600E mutation

    BRAF V600ENeoplasms

35. A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations

    Recruiting Phase 1/2 M.D. Anderson Cancer Center Started 2024Primary completion 2029-03 NCT06412198

    cetuximabcemiplimabadagrasib FDA EU

    …y confirmed diagnosis of advanced/metastatic microsatellite stable colorectal cancer with KRASG12C mutation with 1+ prior line(s) of therapy

    KRAS G12CMetastatic Colorectal Cancer, KRAS G12C Mutations

36. Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

    Recruiting Phase 1/2 Revolution Medicines Started 2024Primary completion 2028-09 NCT06445062

    daraxonrasibmFOLFOX6bevacizumabmFOLFIRINOXcetuximabgemcitabinenab-paclitaxelzoldonrasibFOLFIRI

    …reatic carcinoma or poorly differentiated pancreatic carcinoma with metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unre…

    KRAS G12CKRAS G12DColorectal Cancer, CRC, Pancreatic Ductal Adenocarcinoma, PDAC

37. A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

    Active, not recruiting Phase 1/2 Jiangsu Hengrui Started 2024Primary completion 2025-12 NCT06385678

    HRS-4642adebrelimabSHR-9839pemetrexedcisplatincarboplatincetuximab

    With unresectable locally advanced or metastatic solid tumors harbouring with KRAS G12D mutation confirmed by central laboratory testing.

    KRAS G12DAdvanced KRAS G12D Mutant Solid Tumors

38. Combination Therapy for BRAF-V600E Metastatic CRCm

    Recruiting Phase 2 Vall d'Hebron Institute of Oncology Started 2024Primary completion 2027-05 NCT06411600

    encorafenib FDA EUcetuximab FDA EUbevacizumab

    Presence of BRAF V600E mutation in tumor tissue previously determined according to the guidelines of each center…

    BRAF V600EMetastatic Colorectal Cancer

39. Irinotecan Hydrochloride Liposome Injection (Ⅱ) Combined with Fluorouracil, Folinic Acid, Vermofenib and Cetuximab in First-line Treatment of BRAFV600E Mutated Advanced Colorectal Cancer

    Recruiting Phase 2 Shanghai Changzheng Hospital Started 2024Primary completion 2026-08 NCT06603376

    FOLFIRIvemurafenib FDA EUcetuximab FDA EUbevacizumab

    Patients with BRAFV600E mutation confirmed by tissue or blood testing.

    BRAF V600EStatus may be outdated, last updated 2024-09-19Colorectal Carcinoma

40. Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC

    Active, not recruiting Phase 2 Gruppo Oncologico del Nord-Ovest Started 2024Primary completion 2026-05 NCT06578559

    cetuximab FDA EUencorafenib FDA EU

    Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC

    BRAF V600EMSI-H / dMMRColorectal Cancer

41. Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab.

    Recruiting Phase 2 Fondazione Policlinico Universitario Agostino Gemelli IRCCS Started 2024Primary completion 2025-12 NCT06640166

    encorafenib FDA EUcetuximab FDA EUFOLFIRI

    presence of BRAF V600E mutation in tumor tissue (primary CRC and/or related metastasis) as previously determined…

    BRAF V600EColorectal Carcinoma, Colorectal Neoplasms, Colorectal Tumor, Colorectal Adenocarcinoma

42. Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study

    Recruiting Phase 2 Sun Yat-sen University Started 2024Primary completion 2026-07 NCT06547203

    cetuximab FDA EUtoripalimabirinotecan

    …ested as RAS/BRAF V600E wild-type and negative ultraselected for mutations including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions.

    BRAF V600EALK fusionRET fusion or mutationNTRK1/2/3 fusionStatus may be outdated, last updated 2024-08-09Colorectal Cancer Metastatic

43. Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies

    Recruiting Phase 1/2 Institut de Recherches Internationales Servier Started 2023Primary completion 2028-06 NCT05786924

    S241656FOLFOX6/FOLFOX7FOLFIRIcetuximabpanitumumab FDAgemcitabinenab-paclitaxel

    Part 2A4: Advanced/metastatic NSCLC with a KRAS G12C mutation

    KRAS G12CBRAF V600ENon-small Cell Lung Cancer, Histiocytic Neoplasm, Histiocytosis, BRAF Gene Mutation

44. Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA

    Recruiting Phase 2 Fudan University Started 2023Primary completion 2028-09 NCT06440902

    cetuximab

    Metastatic colorectal cancer with tissue RAS mutation-type;

    KRAS G12CKRAS G12DStatus may be outdated, last updated 2024-06-04Colorectal Cancer Metastatic

45. Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer

    Recruiting Phase 2 Federation Francophone de Cancerologie Digestive Started 2023Primary completion 2026-12 NCT05706779

    encorafenib FDA EUcetuximab FDA EU

    …m (supra-peritoneal) considered operable and histologically confirmed, localised, mutated BRAF V600E determined in a biopsy specimen and resectable after CT-scan assessment.

    BRAF V600EColorectal Cancer, BRAF V600E Mutation Positive

46. A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

    Recruiting Phase 1/2 D3 Bio Started 2022Primary completion 2027-04 NCT05410145

    D3S-001pembrolizumabcisplatincarboplatinpemetrexedcetuximab

    Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.

    KRAS G12CKRAS P.G12C

47. JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation

    Active, not recruiting Phase 1/2 Allist Pharmaceuticals Started 2022Primary completion 2025-04 NCT05194995

    glecirasibcetuximab

    … colorectal cancer, advanced small intestinal cancer and advanced appendiceal cancer with KRAS p.G12C mutation

    KRAS G12CAdvanced Colorectal Cancer, Small Intestinal Cancer, Appendiceal Cancer

48. Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2022Primary completion 2026-02 NCT05308446

    cetuximab FDA EUencorafenib FDA EUnivolumab

    Participants must have BRAF\^V600E mutated colorectal cancer as tested in a Clinical Laboratory Improvement Act (CLIA)-certi…

    BRAF V600EMSI-H / dMMRMetastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage III Colon Cancer AJCC v8, Stage III Rectal Cancer AJCC v8

49. A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer

    Active, not recruiting Phase 2 Pfizer Started 2022Primary completion 2026-06 NCT05217446

    encorafenib FDA EUcetuximab FDA EUpembrolizumab

    Locally confirmed BRAF V600E mutation in tumor tissue or blood

    BRAF V600EMSI-H / dMMRMetastatic Colorectal Cancer

50. A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors

    Recruiting Phase 1/2 Sanofi Started 2022Primary completion 2027-01 NCT05584670

    SAR445877cetuximabADG126bevacizumabnivolumab FDA EUipilimumab FDA EU

    HCC, colorectal cancer (MSI-H/dMMR), malignant pleural mesothelioma or esophageal squamous cell carcinoma (ESCC). and f…

    MSI-H / dMMRSolid Tumor

51. Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

    Active, not recruiting Phase 1/2 Eli Lilly Started 2021Primary completion 2027-04 NCT04956640

    olomorasibpembrolizumabcetuximabpemetrexedcisplatincarboplatin

    Patients must have disease with evidence of KRAS G12C mutation in tumor tissue or circulating tumor deoxyribonucleic acid (DNA).

    KRAS G12CCarcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms

52. Study to Evaluate D-1553 in Subjects With Solid Tumors

    Active, not recruiting Phase 1/2 InventisBio Started 2020Primary completion 2024-04 NCT04585035

    garsorasibpembrolizumabcetuximab

    Subject has KRasG12C mutation in tumor tissue or other bio-specimens containing cancer cells or DNA.

    KRAS G12CSolid Tumor, Adult, NSCLC, CRC

53. Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

    Active, not recruiting Phase 1/2 Bristol Myers Squibb Started 2019Primary completion 2026-06 NCT03785249

    adagrasib FDA EUpembrolizumabcetuximabafatinib

    Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation

    KRAS G12CAdvanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease

54. Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer

    Active, not recruiting Phase 1/2 M.D. Anderson Cancer Center Started 2019Primary completion 2027-12 NCT04017650

    cetuximab FDA EUencorafenib FDA EUnivolumab

    Confirmation of BRAFV600E tumor as detected by a CLIA-certified laboratory.

    BRAF V600EBRAF NP_004324.2:p.V600E, Metastatic Colon Adenocarcinoma, Metastatic Microsatellite Stable Colorectal Carcinoma, Metastatic Rectal Adenocarcinoma

55. A Phase 1 Dose Escalation and Dose Expansion Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation

    Recruiting Phase 1 Kestrel Therapeutics Started 2026Primary completion 2028-04 NCT07458347

    KST-6051gemcitabinenab-paclitaxelcetuximabpembrolizumabmFOLFOX6FOLFIRIpemetrexedcarboplatin

    Documentation of KRAS mutation prior to the first dose of trial drug(s).

    KRAS G12CKRAS G12DKRAS-mutant Non-small Cell Lung Cancer (NSCLC), KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC), KRAS-mutant Colorectal Cancer (CRC), Other KRAS-mutant Solid Tumors

56. A Study to Learn More About How Safe BAY 3771249 is and How Well it Works in People With Advanced or Metastatic Colorectal Cancer That Has a KRAS G12D Mutation

    Recruiting Phase 1 Bayer Started 2026Primary completion 2029-07 NCT07535112

    BAY 3771249cetuximab

    KRAS G12D mutated solid tumor

    KRAS G12DAdvanced/Metastatic Colorectal Adenocarcinoma

57. A First-in-Human Study Investigating BG-85738 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors With Rat Sarcoma Virus (RAS) Mutations

    Recruiting Phase 1 BeOne Medicines (BeiGene) Started 2026Primary completion 2028-09 NCT07746141

    BG-85738tislelizumabcetuximab

    Participants must have evidence of a RAS mutation defined as a nonsynonymous mutation in Kirsten rat sarcoma viral oncogene homolog (KRAS),…

    KRAS G12DRAS Mutation, Advanced Solid Tumor, Metastatic Solid Tumor

58. A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors

    Not yet recruiting Phase 1 Pfizer Started 2026Primary completion 2030-03 NCT07897721

    PF-08165784fulvestrant FDA EUAtirmociclibcetuximabletrozole

    Phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) mutation

    PIK3CA activating mutationAdvanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma

59. BBO-11818 in Adult Subjects With KRAS Mutant Cancer

    Recruiting Phase 1 BridgeBio Oncology Therapeutics Started 2025Primary completion 2027-08 NCT06917079

    BBO-11818pembrolizumabcisplatincarboplatinpemetrexedcetuximabmFOLFOX6BBO-10203mFOLFIRINOXgemcitabinenab-paclitaxel

    …ced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation

    KRAS G12CKRAS G12DNon-Small Cell Lung Cancer, NSCLC, PDAC - Pancreatic Ductal Adenocarcinoma, CRC (Colorectal Cancer)

60. A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

    Recruiting Phase 1 Bristol Myers Squibb Started 2025Primary completion 2027-10 NCT06764771

    BMS-986488adagrasib FDA EUcetuximabnivolumab

    i) Part 1B: solid tumors with KRAS G12C mutation.

    KRAS G12CAdvanced Malignant Tumors

61. A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

    Recruiting Phase 1 Kumquat Biosciences Started 2025Primary completion 2029-06 NCT06720987

    KQB365cetuximabKQB198

    …ith KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.

    KRAS G12CKRAS G12C Mutation, KRAS G12S Mutation, Solid Tumor Malignancies, CRC (Colorectal Cancer)

62. A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)

    Recruiting Phase 1 MSD (Merck & Co.) Started 2025Primary completion 2030-12 NCT07247110

    MK-4716pembrolizumabcetuximab

    …716 + Cetuximab: Must demonstrate presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration

    KRAS G12CKRAS G12DMalignant Neoplasm

63. A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations

    Recruiting Phase 1 Alterome Therapeutics Started 2025Primary completion 2029-05 NCT06835569

    ALTA3263cetuximabmFOLFOX6pembrolizumabpemetrexedcisplatincarboplatinmFOLFIRINOXGnPmidazolam

    Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Impro…

    KRAS G12CKRAS G12DCancer, PDAC - Pancreatic Ductal Adenocarcinoma, NSCLC (Non-small Cell Lung Cancer), CRC (Colorectal Cancer)

64. A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors

    Recruiting Phase 1 PAQ Therapeutics Started 2025Primary completion 2028-10 NCT07300150

    PT0511cetuximab

    A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors

    KRAS G12CKRAS G12DColorectal Cancer, Pancreatic Cancer, Non-Small Cell Lung Cancer, Solid Tumor

65. Study of AUBE00 in Patients With Solid Tumors

    Recruiting Phase 1 Roche Started 2025Primary completion 2029-12 NCT07030959

    AUBE00cetuximab

    Patients with Kirsten rat sarcoma (KRAS) alteration confirmed by local tests or central laboratory test (Details are defined for each part)

    KRAS G12CKRAS G12DSolid Tumors

66. TLN-372 in Advanced KRAS Mutant Solid Tumors

    Recruiting Phase 1 Treeline Biosciences Started 2025Primary completion 2031-12 NCT07204340

    TLN-372cetuximabpembrolizumab

    Patients must have locally advanced or metastatic KRAS mutant solid tumors.

    KRAS G12CKRAS G12DKRAS Mutant Solid Tumors

67. A Study to Evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

    Active, not recruiting Phase 1 Incyte Started 2025Primary completion 2027-03 NCT06818812

    INCB186748cetuximabGEMNabPmFOLFIRINOX

    Locally advanced or metastatic solid tumor with KRAS G12D mutation.

    KRAS G12DSolid Tumors

68. Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small Lung Cell Cancer

    Not yet recruiting Phase 1 Jonathan Riess Started 2024Primary completion 2025-01 NCT06067776

    cetuximabosimertinib FDA EUtucatinib

    NSCLC must harbor at least one of the following EGFR activating mutations: Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q, Exon 20 S768I.

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-10-05Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

69. A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

    Active, not recruiting Phase 1 Eli Lilly Started 2024Primary completion 2030-01 NCT06607185

    LY4066434.cetuximabnab-paclitaxelgemcitabineoxaliplatinleucovorinirinotecanfluorouracilcarboplatincisplatinpemetrexedpembrolizumab

    Have evidence of KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor DNA

    KRAS G12CKRAS G12DPancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumor

70. MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

    Active, not recruiting Phase 1 Eli Lilly Started 2024Primary completion 2028-03 NCT06586515

    LY3962673cetuximabgemcitabinenab-paclitaxeloxaliplatinleucovorinirinotecanfluorouracil

    Have evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA

    KRAS G12DPancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer

71. A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

    Recruiting Phase 1 Incyte Started 2024Primary completion 2027-01 NCT06179160

    INCB161734cetuximabretifanlimabGEMNabPmFOLFIRINOXFOLFOXFOLFIRIINCA33890

    Locally advanced or metastatic solid tumor with KRAS G12D mutation.

    KRAS G12DSolid Tumors

72. A Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors

    Recruiting Phase 1 PAQ Therapeutics Started 2024Primary completion 2026-12 NCT06797336

    PT0253Chemotherapy Combination 1Chemotherapy Combination 2Chemotherapy Combination 3cetuximab

    …rticipant has a pathologically documented, locally advanced or metastatic malignancy with KRAS p.G12D mutation identified through molecular testing using a Clinical Laboratory Improvement Ame…

    KRAS G12DSolid Tumor

73. QTX3046 in Patients With KRAS G12D Mutations

    Active, not recruiting Phase 1 Quanta Therapeutics Started 2024Primary completion 2027-07 NCT06428500

    QTX3046cetuximab

    Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutations identified through molecular testing (NGS- or PCR-based) with a Clinical Labora…

    KRAS G12DAdvanced Solid Tumor

74. QTX3034 in Patients With KRAS G12D Mutation

    Recruiting Phase 1 Quanta Therapeutics Started 2024Primary completion 2027-04 NCT06227377

    QTX3034cetuximab

    Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laborat…

    KRAS G12DSolid Tumors

75. A Study to Learn About the Study Medicine PF-07934040 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Genetic Mutation.

    Active, not recruiting Phase 1 Pfizer Started 2024Primary completion 2026-10 NCT06447662

    PF-07934040gemcitabinenab-paclitaxelcetuximabfluorouraciloxaliplatinleucovorinbevacizumabpembrolizumabpemetrexedcisplatinpaclitaxel

    Documentation of mutated KRAS gene

    KRAS G12DCarcinoma, Pancreatic Ductal, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung

76. Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy

    Recruiting Phase 1 M.D. Anderson Cancer Center Started 2024Primary completion 2028-03 NCT05985954

    cetuximab FDA EUulixertinibencorafenib FDA EU

    BRAF expansion Cohort: BRAF V600E mutation must be present

    BRAF V600EMetastatic Colorectal Cancer

77. Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer

    Recruiting Phase 1 National Cancer Institute (NCI) Started 2024Primary completion 2027-01 NCT06102902

    ZEN-3694cetuximab FDA EUencorafenib FDA EU

    …confirmed and radiographically measurable metastatic colorectal adenocarcinoma with known BRAF V600E mutation, confirmed in a Clinical Laboratory Improvement Amendments (CLIA) certified labo…

    BRAF V600EMetastatic Colorectal Adenocarcinoma, Recurrent Colorectal Adenocarcinoma, Refractory Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8

78. Phase I Trial of Adagrasib (MRTX849) in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer

    Active, not recruiting Phase 1 M.D. Anderson Cancer Center Started 2023Primary completion 2027-09 NCT05722327

    adagrasib FDA EUirinotecancetuximab

    Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with KRASG12C mutation.

    KRAS G12CColon Cancer, Colorectal Cancer

79. Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation

    Recruiting Phase 1 Innovent Biologics Started 2022Primary completion 2025-05 NCT05504278

    fulzerasibcetuximabpemetrexedcarboplatinsintilimabcisplatin

    Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation

    KRAS G12CAdvanced Non-Small Cell Lung Cancer

80. A Study of ASP3082 in Adults With Advanced Solid Tumors

    Recruiting Phase 1 Astellas Started 2022Primary completion 2028-12 NCT05382559

    setidegrasibcetuximableucovorinoxaliplatinfluorouracilirinotecannab-paclitaxelgemcitabinedocetaxelpembrolizumabcisplatincarboplatin

    … lung cancer (NSCLC) (Note: for Cohort H only, the tumor must be non-squamous NSCLC) with KRAS G12D mutation and

    KRAS G12DSolid Tumor

81. A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.

    Active, not recruiting Phase 1 Pfizer Started 2022Primary completion 2027-08 NCT05355701

    claturafenibbinimetinib FDA EUcetuximab FDA EUmidazolamfluorouracilleucovorinoxaliplatin

    Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required.

    BRAF V600EMelanoma, Non-Small-Cell Lung Cancer, Thyroid Cancer, Glioma

82. A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

    Recruiting Phase 1 MSD (Merck & Co.) Started 2021Primary completion 2030-02 NCT05067283

    calderasibpembrolizumabcarboplatinpemetrexedcetuximaboxaliplatinleucovorinfluorouracil

    …e or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease

    KRAS G12CKRAS G12DAdvanced Solid Tumors

83. A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

    Active, not recruiting Phase 1 Roche Started 2020Primary completion 2027-12 NCT04449874

    divarasibatezolizumabcetuximabbevacizumaberlotinibGDC-1971inavolisib

    Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.

    KRAS G12CNon-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumors

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