Eli Lilly

Biomarkers

• RET fusion or mutation7
• KRAS G12C5
• IDH1/2 mutation3
• PIK3CA activating mutation2
• FGFR3 alteration (mutation or fusion)2
• EGFR exon 19 deletion / L858R1
• KRAS G12D1

Drugs in these trials

Targeted, immune and antibody-drug-conjugate therapies named in the company's active biomarker-selected trials (including other companies' drugs used in combination).

selpercatinib 7pembrolizumab 6olomorasib 4abemaciclib 4cetuximab 4durvalumab 2anastrozole 2letrozole 2fulvestrant 2erlotinib 2LY3410738 2STX-478 1ribociclib 1palbociclib 1cabozantinib 1vandetanib 1ramucirumab 1gefitinib 1osimertinib 1enfortumab vedotin 1

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months, according to the sponsor.

• 2027-02 A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy Phase 2 · IDH1/2 mutation
• 2027-04 Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C) Phase 1/2 · KRAS G12C

Trials

22 of 36 trials shown

1. A Study of Selpercatinib (LY3527723) in Participants With Rearranged During Transfection (RET)-Altered Cancers in India

   Not yet recruiting Phase 4 Eli Lilly Started 2026Primary completion 2029-10 NCT07822880

   selpercatinib FDA EU

   Participants with one of the following RET-altered cancers:

   RET fusion or mutationThyroid Neoplasms, Carcinoma, Non-Small-Cell Lung

2. Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

   Recruiting Phase 3 Eli Lilly Started 2025Primary completion 2029-05 NCT06890598

   olomorasibpembrolizumabdurvalumab

   Must have disease with evidence of KRAS G12C mutation.

   KRAS G12CCarcinoma, Non-Small-Cell Lung

3. A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

   Recruiting Phase 3 Eli Lilly Started 2025Primary completion 2029-05 NCT07174336

   STX-478ribociclibpalbociclib FDA EUabemaciclibanastrozoleletrozoleExemestanefulvestrant FDA EU

   Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.

   PIK3CA activating mutationBreast Neoplasms, Neoplasm Metastasis

4. A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

   Recruiting Phase 3 Eli Lilly Started 2023Primary completion 2027-11 NCT06119581

   olomorasibpembrolizumabcisplatincarboplatinpemetrexed

   Must have disease with evidence of KRAS G12C mutation.

   KRAS G12CCarcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

5. A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)

   Active, not recruiting Phase 3 Eli Lilly Started 2021Primary completion 2026-01 NCT04819100

   selpercatinib FDA EU

   Must have an activating RET gene fusion in tumor based on polymerase chain reaction (PCR), next generation sequencing (NGS), or a…

   RET fusion or mutationCarcinoma, Non-Small-Cell Lung

6. A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer

   Active, not recruiting Phase 3 Eli Lilly Started 2020Primary completion 2023-05 NCT04211337

   selpercatinib FDA EUcabozantinibvandetanib

   A defined/acceptable RET gene alteration identified in a tumor, germline deoxyribonucleic acid (DNA) or blood sample.

   RET fusion or mutationMedullary Thyroid Cancer

7. A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

   Active, not recruiting Phase 3 Eli Lilly Started 2020Primary completion 2023-05 NCT04194944

   selpercatinib FDA EUcarboplatincisplatinpemetrexedpembrolizumab

   A RET gene fusion in tumor and/or blood from a qualified laboratory.

   RET fusion or mutationNon-Small Cell Lung Cancer

8. A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

   Active, not recruiting Phase 3 Eli Lilly Started 2015Primary completion 2019-01 NCT02411448

   ramucirumab FDA EUerlotinib FDA EUgefitinib FDA EUosimertinib FDA EU

   …h erlotinib based on documented evidence of tumor harboring an activating EGFR mutation \[exon 19 deletion or exon 21 (L858R) substitution mutation\].

   EGFR exon 19 deletion / L858RMetastatic Non-Small Cell Lung Cancer

9. A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer

   Active, not recruiting Phase 3 Eli Lilly Started 2014Primary completion 2017-09 NCT02152631

   abemacicliberlotinib

   A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer

   KRAS G12CKRAS G12DNon Small Cell Lung 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 Study of Vepugratinib (LY3866288) in Adults With Non-Muscle Invasive Bladder Cancer and Upper Tract Urothelial Cancer

    Not yet recruiting Phase 2 Eli Lilly Started 2026Primary completion 2028-07 NCT07827612

    Vepugratinib

    Have a documented qualifying fibroblast growth factor receptor 3 protein (FGFR3) mutation or fusion

    FGFR3 alteration (mutation or fusion)Urinary Bladder Neoplasms, Urologic Neoplasms, Receptor, Fibroblast Growth Factor, Type 3

12. A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy

    Active, not recruiting Phase 2 Eli Lilly Started 2024Primary completion 2027-02 NCT06413706

    abemaciclibtemozolomide

    IDH-mutant diffuse glioma with homozygous cyclin- dependent kinase inhibitor 2A/B (CDKN2A/B) deletio…

    IDH1/2 mutationGlioma

13. 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

14. A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation

    Active, not recruiting Phase 2 Eli Lilly Started 2020Primary completion 2021-03 NCT04280081

    selpercatinib FDA EU

    Evidence of a RET gene alteration in tumor and/or blood.

    RET fusion or mutationSolid Tumor, Medullary Thyroid Cancer

15. A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

    Active, not recruiting Phase 1/2 Eli Lilly Started 2019Primary completion 2024-11 NCT03899792

    selpercatinib FDA EU

    Evidence of an activating RET gene alteration in the tumor and/or blood

    RET fusion or mutationMedullary Thyroid Cancer, Infantile Myofibromatosis, Infantile Fibrosarcoma, Papillary Thyroid Cancer

16. A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)

    Active, not recruiting Phase 1/2 Eli Lilly Started 2017Primary completion 2025-02 NCT03157128

    selpercatinib FDA EU

    A RET gene alteration is not required initially.

    RET fusion or mutationNon-Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Any Solid Tumor

17. 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

18. 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

19. FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3

    Recruiting Phase 1 Eli Lilly Started 2023Primary completion 2027-06 NCT05614739

    Vepugratinibpembrolizumabenfortumab vedotintrastuzumab deruxtecanmidazolamDigoxinRosuvastatin

    …, C1, D1, and D2: Locally advanced or metastatic solid tumor malignancy with a qualifying FGFR3 alteration.

    FGFR3 alteration (mutation or fusion)Urinary Bladder Neoplasms, Neoplasm Metastasis, Ureteral Neoplasms

20. A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

    Active, not recruiting Phase 1 Eli Lilly Started 2022Primary completion 2025-04 NCT05307705

    LOXO-783fulvestrant FDA EUimlunestrantabemaciclibanastrozoleletrozolepaclitaxel

    … H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)

    PIK3CA activating mutationBreast Cancer

21. Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations

    Active, not recruiting Phase 1 Eli Lilly Started 2020Primary completion 2023-07 NCT04603001

    LY3410738venetoclaxazacitidine

    Advanced IDH mutant hematologic malignancy including:

    IDH1/2 mutationAcute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), Myeloproliferative Neoplasms (MPNs)

22. Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

    Active, not recruiting Phase 1 Eli Lilly Started 2020Primary completion 2023-07 NCT04521686

    LY3410738gemcitabinecisplatindurvalumab

    Evidence of IDH1 R132 mutation (any solid tumor) or circulating tumor DNA IDH2 R140 or IDH2 R172 mutation (chol…

    IDH1/2 mutationCholangiocarcinoma, Chondrosarcoma, Glioma, Any Solid Tumor

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