EGFR TKI (2nd generation) · small molecule
afatinib
12 active trials across 10 of our biomarkers, targeting EGFR/HER2. 2 active approvals for a biomarker on marked.bio.
Also known as BIBW 2992, Gilotrif, Giotrif.
Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.
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.
| Therapy | Biomarker | Tumour | United States | European Union |
|---|---|---|---|---|
afatinib
|
EGFR exon 19 deletion / L858R | NSCLC | Approved 2013 | Approved 2013 |
In the US label
LUX-Lung 3
vs pemetrexed + cisplatin, 230 vs 115 patients Serious side effects 29%Stopped for side effects 14% Trial details and side effects
In the EU product information
LUX-Lung 3
vs pemetrexed + cisplatin, 230 vs 115 patients Trial details and side effects
|
||||
Biomarkers
| Biomarker | Active trials | All trials | Furthest active phase |
|---|---|---|---|
| EGFR exon 19 deletion / L858R | 6 | 46 | Phase 3 |
| KRAS G12C | 2 | 3 | Phase 1/2 |
| FGFR2 fusion or rearrangement | 1 | 1 | Phase 1 |
| FGFR3 alteration (mutation or fusion) | 1 | 1 | Phase 1 |
| HER2 (ERBB2) activating mutation | 1 | 4 | Phase 2 |
| HER2-low / ultralow (IHC 1+ or 2+/ISH-) | 1 | 1 | Phase 1/2 |
| MSI-H / dMMR | 1 | 1 | Phase 2 |
| EGFR exon 20 insertion | 0 | 3 | – |
| KRAS G12D | 0 | 1 | – |
| NRG1 fusion | 0 | 3 | – |
Sponsors
Industry sponsors leading active biomarker-selected trials of afatinib.
- Chia Tai Tianqing (Sino Biopharm) 1
- Bristol Myers Squibb 1
- Amgen 1
Trials
12 of 59 trials shown
-
EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study
afatinib FDA EUdacomitinib FDA EUosimertinib FDA EU
EGFR-mutation in tumor (in cases where tumor tissue is not available for mutation analysis, circulating…
EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer
-
FHND9041 Versus Afatinib for Non-small Cell Lung Cancer
FHND9041afatinib FDA EU
…nce of a confirmed EGFR-positive gene mutation sensitive to EGFR-TKI treatment, including exon 19 deletion or L858R mutation.
EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
-
Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
gefitinib FDA EUerlotinib FDA EUafatinib FDA EUosimertinib FDA EU
Positive EGFR mutations are diagenesis.
EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer, EGFR Gene Mutation, EGFR-TKI Resistant Mutation
-
Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer
trastuzumab deruxtecan FDA EUafatinib
HER2-low (HER2 1+, HER2 2+ (SISH negative))
HER2-low / ultralow (IHC 1+ or 2+/ISH-)Stomach Neoplasm
-
Primary Tumor Resection With EGFR TKI for Stage IV NSCLC
afatinib FDA EU
Patients must have one of the following:NSCLC which harbors EGFR exon 19 deletion or L858R mutation.
EGFR exon 19 deletion / L858RNSCLC Stage IV
-
Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
adagrasib FDA EUpembrolizumabcetuximabafatinib
Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
KRAS G12CAdvanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease
-
Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A)
afatinib FDA EU
Activating mutations of EGFR (del 19, L858R) OR
EGFR exon 19 deletion / L858RAdvanced Lymphoma, Advanced Malignant Solid Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm
-
Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B)
Patient's tumor must have activating HER2 mutation, as determined via the MATCH Master Protocol
HER2 (ERBB2) activating mutationAdvanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma
-
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
adavosertibafatinibbinimetinibcapivasertibcopanlisibcrizotinibdabrafenibDasatinibdefactiniberdafitinibfexagratinibipatasertib
…candidate for Z1M based on local Clinical Laboratory Improvement Act (CLIA) assessment of mismatch repair deficiency (MMRd) by immunohistochemistry (IHC) or microsatellite instability (MSI) status by polyme…
MSI-H / dMMRAdvanced Lymphoma, Advanced Malignant Solid Neoplasm, Bladder Carcinoma, Breast Carcinoma
-
Afatinib With CT and RT for EGFR-Mutant NSCLC
afatinib FDA EUcisplatinpemetrexed
Have lung cancer harboring an EGFR mutation
EGFR exon 19 deletion / L858RLung Cancer
-
Pemigatinib + Afatinib in Advanced Refractory Solid Tumors
FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions on …
FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementAdvanced Solid Tumor, Unresectable Solid Tumor, Metastatic Solid Tumor, Cholangiocarcinoma
-
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
sotorasib FDA EUtrametinibvociprotafibafatinibpembrolizumabpanitumumab FDAcarboplatinpemetrexeddocetaxelpaclitaxelatezolizumabpalbociclib
Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requireme…
KRAS G12CAdvanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation
-
To Evaluate the Efficacy of Afatinib in the Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer With NRG1 Fusion
Locally advanced or metastatic non-small cell lung cancer with NRG1 fusion detected by DNA or RNA-based next-generation sequencing (NGS) technology in tumor tissue …
NRG1 fusionNRG1-fused Non-small Cell Lung Cancer
-
Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)
afatinib FDA EU
Evidence of common EGFR activating mutations (Del 19 and/or L858R)
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung, ErbB Receptors
-
Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older
afatinib FDA EU
Evidence of common EGFR mutation (Del 19 and/or L858R)
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung, ErbB Receptors
-
Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
afatinib FDA EU
…ly Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harbouring an EGFR Mutation (Del19 or L858R) Who Have Failed First-line Treatment With Platinum-based Chemotherapy
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung
-
S1403, Afatinib Dimaleate With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung Cancer
Patients must have documented presence of an EGFR exon 19 deltion or exon 21 (L858R) substitution mutation
EGFR exon 19 deletion / L858RRecurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer
-
Afatinib in Patients With Non Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations
afatinib FDA EU
Epidermal Growth Factor Receptor (EGFR) mutation-positive results per the institution's testing methodology
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung
-
An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
afatinib FDA EU
Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution's testing methodology.
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung
-
Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
afatinib FDA EU
presence of Epidermal Growth Factor Receptor (EGFR) mutations in tumor biopsy
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung
-
BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)
gemcitabinecisplatinafatinib FDA EU
…ine Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung, Adenocarcinoma
-
BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
pemetrexedafatinib FDA EUcisplatin
…ine Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung, Adenocarcinoma
-
Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers
afatinibenzalutamideabirateronezenocutuzumab FDA
…histologically confirmed locally advanced, unresectable, or metastatic NSCLC harboring an NRG1 gene fusion detected by DNA- or RNA-based next generation sequencing in a tumor sample or in plasma-c…
NRG1 fusionNSCLC Harboring NRG1 Fusion, Metastatic Castration-resistant Prostate Cancer
-
Afatinib in Advanced NRG1-Rearranged Malignancies
Progressive metastatic or locally advanced NRG1-Rearranged Malignancy as determined by investigator
NRG1 fusionMetastatic and Locally Advanced NRG1-rearranged Malignancies
-
Neoadjuvant Afatinib Therapy for Potentially Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma
afatinib FDA EU
Neoadjuvant Afatinib Therapy for Potentially Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma
EGFR exon 19 deletion / L858RLung Adenocarcinoma Stage III, EGFR Gene Mutation
-
Neoadjuvant Afatinib Combination With Chemotherapy for Stage Ⅱa-Ⅲb NSCLC With EGFR Activating Mutation
afatinib FDA EUpemetrexedgemcitabinecisplatincarboplatin
Neoadjuvant Afatinib Combination With Chemotherapy for Stage Ⅱa-Ⅲb NSCLC With EGFR Activating Mutation
EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer, Surgery, EGFR Activating Mutation, Chemotherapy
-
Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer
…gically or cytologically confirmed stage IV non-small cell lung cancer, harboring an EGFR exon 20 insertion mutation.
EGFR exon 20 insertionCarcinoma, Non-Small-Cell Lung
-
An Explorative Study of Afatinib in the Treatment of Advanced Cancer Carrying an EGFR, a HER2 or a HER3 Mutation
afatinib FDA EUpaclitaxel
Women and men with locally advanced or metastatic cancers harboring either an activating EGFR mutation or a HER2 mutation or a HER3 mutation
EGFR exon 19 deletion / L858RHER2 (ERBB2) activating mutationCancers Harbouring an EGFR Mutation, (Excluding Non-squamous Non- Small Cell Lung Cancer, a Registered Indication), a HER2 Mutation or a HER3 Mutation
-
Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA
afatinib FDA EU
Activating EGFR mutation (G719X, exon 19 deletion, L858R, L861Q) detected from circulating DNA
EGFR exon 19 deletion / L858RLung Neoplasms, EGFR Gene Mutation
-
Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer
EGFR mutation (exon 19 deletion, L858R mutation, G719X , L861Q or S768I mutations or exon 19 insertion)
EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
-
Deciphering Afatinib Response and Resistance With INtratumour Heterogeneity
afatinib FDA EU
Patients must have tumours harbouring a sensitising EGFR mutation or HER2 mutation in at least one biopsy at recurrence, or region of the primary sample.
EGFR exon 19 deletion / L858RHER2 (ERBB2) activating mutationNon-small Cell Lung Cancer
-
Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.
afatinib FDA EU
Resectable EGFR Mutant NSCLC With (or Without) Afatinib as Neoadjuvant Treatment; REMNANT an Exploratory Study o…
EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
-
First Line Bio-immunotherapy With Thymosin Alpha 1 in Patients With Sensitizing EGFR Mutation Positive Non Small Cell Lung Cancer Who Are Taking Standard of Care Therapy
Thymalfasin (Thymosin alpha 1, Ta1)afatinib FDA EUgefitinib FDA EUerlotinib FDA EU
First Line Bio-immunotherapy With Thymosin Alpha 1 in Patients With Sensitizing EGFR Mutation Positive Non Small Cell Lung Cancer Who Are Taking Standard of Care Therapy
EGFR exon 19 deletion / L858REGFR Mutation Positive Non Small Cell Lung Cancer
-
Afatinib in NSCLC With HER2 Mutation
afatinibpaclitaxel
Tumor tissue with HER2 mutations as confirmed by AmoyDx® HER2 Mutation Detection Kit
HER2 (ERBB2) activating mutationCarcinoma, Non-Small-Cell Lung
-
Maintaining ERBB Blockade in EGFR-mutated Lung Cancer
afatinib FDA EUpemetrexed
Documented somatic EGFR mutation as determined by medically accepted assay technology
EGFR exon 19 deletion / L858RNon-small-cell Lung Cancer With Somatic EGFR Mutations
-
Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer
afatinibselumetinibdocetaxel
Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer
KRAS G12CKRAS G12DColorectal Neoplasms, Gastrointestinal Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung
-
Afatinib Plus Nimotuzumb for NSCLC
afatinib FDA EU
Presence of EGFR sensitizing mutations (L858R mutation in exon 21 or exon 19 deletion) or response by RECIST on prior gefitinib or erlotinib or stable disease on prior gefitin…
EGFR exon 19 deletion / L858RNSCLC
-
An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
afatinib FDA EU
EGFR mutation or six months or longer benefit from EGFR TKIs
EGFR exon 19 deletion / L858RNSCLC
-
Afatinib vs Erlotinib as 2nd TKI After Failure to 1st TKI and Chemotherapy for Metastatic NSCLC
afatinib FDA EUerlotinib FDA EU
Patients with stage IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer who were previously responsive to one line of EGFR tyrosine ki…
EGFR exon 19 deletion / L858RLung Cancer
-
Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation
afatinib FDA EU
Pathologically confirmed diagnosis of non-small cell lung cancer with EGFR mutation
EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
-
Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients
afatinib FDA EU
L858R, exon 19 deletions, exon 20 insertions, T790M, list is not exhaustive), and WHO PS 0-3 Or No tissue suitabl…
EGFR exon 19 deletion / L858REGFR exon 20 insertionCarcinoma, Non-Small-Cell Lung
-
Treatment With BIBW 2992, Irreversible Inhibitor of EGFR and HER-2 in Non-small Cell Lung Cancer
afatinib FDA EU
…ll Cell Lung Cancer in Advanced Stage, Which Have Progressed to Chemotherapy. Analysis of Mutations in EGFR and Number of Copies of HER-2
EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer, EGFR, HER-2
-
LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung
afatinib FDA EUgefitinib FDA EU
Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.
EGFR exon 19 deletion / L858RLung Neoplasms
-
Phase II Trial of BIBW 2992 (Afatinib) in Genetically Pre-screened Cancers With EGFR and/or HER2 Gene Amplification.
afatinib FDA EU
… and/or HER2 gene amplification by FISH testing or patients with tumors that harbor known activating EGFR mutations.
EGFR exon 19 deletion / L858RNeoplasms
-
LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations
afatinib FDA EU
LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung
-
Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer
…cally or cytologically confirmed, locally advanced or metastatic NSCLC, harboring an EGFR exon 20 insertion mutation. ( non-irradiable, non-operable);
EGFR exon 20 insertionLocally Advanced or Metastatic Non-Small Cell Lung Cancer
-
Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma
afatinib FDA EUTalcum powder
Non-small cell lung cancer with positive mutation of EGFR verified
EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
-
An Autologous NK/CIK Cell Product (PB101) in Combination With EGFR-TKI for Treating Lung Cancer
gefitinib FDA EUerlotinib FDA EUafatinib FDA EUosimertinib FDA EU
EGFR sensitizing mutation must be detected in tumor tissue.
EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer
-
Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC
afatinib FDA EU
Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC
EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer, Leptomeningeal Disease, Central Nervous System Metastases
-
Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer
afatinib FDA EUnecitumumab
…cytologically-confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is EGFR mutation positive
EGFR exon 19 deletion / L858RNon-Small Cell Lung Carcinoma
-
Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib
afatinib FDA EUpembrolizumab
…vanced or metastatic/recurrent non-small cell lung cancer with EGFR activating mutations (exon 19 del, exon 21 L858R, L861Q, G718X)
EGFR exon 19 deletion / L858RRecurrent Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
-
Xentuzumab (BI 836845) Plus Afatinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)
Xentuzumabafatinib FDA EU
Activating EGFR mutation (exon 19 deletion, L858R, G719X, L861X)
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung
-
Phase I Trial of Afatinib (BIBW 2992) and Dasatinib in Non-small Cell Lung Cancer (NSCLC)
Dasatinib - 1Aafatinib FDA EUDasatinib - 1B
…h of the following: A tumor which harbors an activating Epidermal Growth Factor Receptor (EGFR) - mutation
EGFR exon 19 deletion / L858RLung Cancer, Non-small Cell Lung Cancer (NSCLC)
-
Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation
afatinib FDA EUcisplatincarboplatinpemetrexed
Documentation of a sensitizing EGFR mutation
EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer
-
Trial of BIBW 2992 (Afatinib) + Cetuximab in Non-Small Cell Lung Cancer
…ctor Receptor (EGFR) -mutation known to be associated with drug sensitivity (i.e., G719X, exon 19 deletion, L858R, L861Q) from previous tumor biopsy or surgery.
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung
-
Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib
afatinib FDA EUSirolimus (rapamycin)
are EGFR mutation-positive or
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung
-
Metformin Plus TKI Use in Patients With Non-Small Cell Lung Carcinoma
metforminerlotinib FDA EUafatinib FDA EUgefitinib FDA EU
NSCLC EGFR mutation-positive
EGFR exon 19 deletion / L858RNon-Small Cell Adenocarcinoma, Tyrosine Kinase Mutation, EGFR Gene Mutation
-
Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis
gefitinib FDA EUerlotinib FDA EUafatinib FDA EU
Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6.
EGFR exon 19 deletion / L858REGFR Mutation Positive Non-small Cell Lung Cancer
-
Understanding Mechanisms of Acquired Resistance to BIBW2992
afatinib FDA EU
A somatic mutation in epidermal growth factor receptor (EGFR) must be present as documented by a CLIA-certified laboratory
EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer, EGFR Mutations
No trials match these filters.