Gilotrif

(Afatinib)

ApprovedSmall molecule

Afatinib is used to treat certain types of lung cancer, particularly non-small cell lung cancer with specific genetic mutations. It works by blocking proteins that help cancer cells grow.[2] Gilotrif is currently approved and in use across 17 indications[4].[1]

Gilotrif is one of 365 small molecule programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Approved.

Indications

125

Total Trials

Active Trials

364

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Esophageal Squamous Cell CarcinomaRecruiting

Gallbladder CarcinomaRecruiting

Non-Small Cell Squamous Lung CarcinomaActive, not recruiting

Gastric CancerRecruiting

Head and Neck Squamous Cell CarcinomaRecruiting

Advanced Solid TumorsActive, not recruiting

NSCLCActive, not recruiting

HNSCCActive, not recruiting

Advanced CancerCompleted

Advanced LymphomaActive, not recruiting

Esophageal Squamous Cell CarcinomaPhase 2

Recruiting

Gallbladder CarcinomaPhase 2

Recruiting

Non-Small Cell Squamous Lung CarcinomaPreclinical

Active, not recruiting

Gastric CancerPhase 2

Recruiting

Head and Neck Squamous Cell CarcinomaPhase 3

Recruiting

Advanced Solid TumorsPhase 1

Active, not recruiting

NSCLCPhase 2

Active, not recruiting

HNSCCPreclinical

Active, not recruiting

Advanced CancerPhase 2

Completed

Advanced LymphomaPhase 2

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

286 competitors in Advanced Solid Tumors

#DrugCompanyPhaseTrials

Gilotrif

Boehringer Ingelheim

Approved

2 2

Keytruda

Merck & Co.

Phase 2

47 3

Paraplatin

AAvyxa

Phase 2

31 4

Erbitux

IImclone

Phase 2

14 5

Sutent

Pfizer

Phase 2

3 6

Afinitor

Novartis

Phase 2

3 7

Libtayo

Regeneron

Phase 2

3 8

Myrbetriq

Astellas

Phase 2

1 9

Tarceva

OOSI Pharmaceuticals

Phase 2

6 10

Tuoyi

CCoherus Oncology, Inc.

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Recruiting

Gastric Cancer

NCT06085755

Phase 2Recruiting

Advanced NSCLC

NCT06062823

Post-ApprovalActive, not recruiting

Efficacy and Safety

NCT04413201

PreclinicalActive, not recruiting

Advanced Cancer

NCT03785249

Q1 2027

Phase 2Active, not recruiting

Advanced Lymphoma

NCT06385483

Q2 2027

PreclinicalActive, not recruiting

HNSCC

NCT07010120

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer12 trials

Phase II Study of Afatinib Plus Bevacizumab in the Treatment Epidermal Growth Factor Receptor (EGFR) Exon G719X, S768I, and L861Q Mutation Metastatic Non-Small Cell Lung Cancer

Unknown status·QQingdao Central Hospital·Phase 2·NCT05267288·30 enrolled

Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer

Unknown status·TThe Netherlands Cancer Institute·Phase 1/2·NCT02450656·320 enrolled

The Study Observes How Long Patients With Non-small Cell Lung Cancer (NSCLC) Benefit From Treatment With Epidermal Growth Factor Tyrosine Kinase Inhibitor (EGFR-TKI) When Given Either for Uncommon Mutations or for Common Mutations in the Sequence Afatinib Followed by Osimertinib

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT04179890·462 enrolled

Show 9 more trials

A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

Completed· Pfizer logo

Pfizer··NCT05834348·5,279 enrolled

The Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients With Advanced EGFR Mutation-positive Non-small Cell Lung Cancer Treated With Afatinib

Completed·HHellenic Cooperative Oncology Group··NCT04640870·59 enrolled

Expanded Access Study of Afatinib in Treatment-naive or Chemotherapy Pre-treated Patients With Non-small Cell Lung Cancer (NSCLC)

Approved for marketing· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT01931306

FHND9041 Versus Afatinib for Non-small Cell Lung Cancer

Enrolling by invitation·JJiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.·Phase 3·NCT06759857·350 enrolled

The Study Observes Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT04206787·72 enrolled

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)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01853826·481 enrolled

Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01953913·542 enrolled

Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer

Terminated·VVanderbilt-Ingram Cancer Center·Phase 1·NCT03054038·22 enrolled

Xentuzumab (BI 836845) Plus Afatinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02191891·32 enrolled

Squamous Cell Carcinoma10 trials

To Evaluate the Efficacy of Afatinib in Advanced Lung Squamous Cell Carcinoma With EGFR Sensitive Mutation

Unknown status·SShanghai Chest Hospital·Phase 4·NCT04132102·20 enrolled

A Biomarker-implemented Clinical Study Evaluating Mutations in MET and TP53 in a Population of Treatment-refractory Squamous Cell Carcinoma

Unknown status·NNational University Hospital, Singapore·Phase 2·NCT04533321·20 enrolled

Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the U.S.

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT04750824·110 enrolled

Show 7 more trials

Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck

Completed·CCentre Leon Berard·Phase 3·NCT01427478·134 enrolled

Neoadjuvant Afatinib Window Study in Squamous Cell Carcinoma of the Head and Neck

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT01538381·30 enrolled

Afatinib and Nivolumab as Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Withdrawn·VVanderbilt-Ingram Cancer Center·Phase 1·NCT03652233

Testing Afatinib in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT03157089·24 enrolled

Afatinib Plus Chemotherapy Against Esophageal or Lung Squamous Cell Carcinoma

Unknown status·FFujian Cancer Hospital·Phase 2·NCT03486509·2 enrolled

Afatinib After Chemoradiation and Surgery in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck at High-Risk of Recurrence

Terminated·EECOG-ACRIN Cancer Research Group·Phase 2·NCT01824823·3 enrolled

Phase 2 Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT05070403·35 enrolled

Lung Cancer8 trials

Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer

Completed·IIntergroupe Francophone de Cancerologie Thoracique·Phase 2·NCT02716311·118 enrolled

LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01523587·795 enrolled

Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA

Completed·—·Phase 2·NCT02629523·21 enrolled

Show 5 more trials

Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation

Withdrawn·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT01836341

Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer

Completed·TThe Netherlands Cancer Institute·Phase 2·NCT03727724·37 enrolled

Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02208843·60 enrolled

Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients

Completed·UUniversity College, London·Phase 2·NCT01415011·39 enrolled

Maintaining ERBB Blockade in EGFR-mutated Lung Cancer

Terminated·AAIO-Studien-gGmbH·Phase 2·NCT02488694·4 enrolled

Breast Cancer5 trials

Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT01441596·121 enrolled

Clinical Study for the Treatment of Breast Cancer: the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone

Terminated·TTranslational Research in Oncology·Phase 2·NCT02115048·44 enrolled

Dual Blockage With Afatinib and Trastuzumab as Neoadjuvant Treatment for Patients With Locally Advanced or Operable Breast Cancer Receiving Taxane-anthracycline Containing Chemotherapy

Completed·GGBG Forschungs GmbH·Phase 2·NCT01594177·65 enrolled

Show 2 more trials

A Study of HER2+ Breast Cancer Patients With Active Brain Metastases Treated With Afatinib & T-DM1 vs. T-DM1 Alone

Unknown status·Xxuexin he·Phase 2·NCT04158947·130 enrolled

Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT01325428·26 enrolled

Head and Neck Squamous Cell Cancer4 trials

LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01345682·483 enrolled

LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01345669·617 enrolled

LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01856478·340 enrolled

Show 1 more trial

LUX-Head & Neck 4: Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02131155·36 enrolled

62 more indications

Head and Neck Squamous Cell Carcinoma4 trials

Afatinib in Patients with Fanconi Anemia (FA) and Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Recruiting·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 1/2·NCT06648096·25 enrolled

Afatinib and Pembrolizumab for Head and Neck Squamous Cell Carcinoma (ALPHA Study)

Completed·NNational Taiwan University Hospital·Phase 2·NCT03695510·29 enrolled

Neoadjuvant Tislelizumab With Afatinib for Resectable Head and Neck Squamous Cell Carcinoma

Completed·WWest China Hospital·Phase 2·NCT05517330·23 enrolled

Show 1 more trial

A Prospective Randomized Controlled Trial Comparing Low-Dose Radiotherapy Combined With Targeted Therapy and Immunotherapy Versus Targeted Therapy and Immunotherapy Alone as Neoadjuvant Therapy in Patients With Operable Head and Neck Squamous Cell Carcinoma.

Completed·WWest China Hospital·Phase 2·NCT07040956·98 enrolled

Trial3 trials

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

Cambridge Brain Mets Trial 1

Terminated·—·Phase 1/2·NCT02768337·26 enrolled

Advanced Cancer3 trials

A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene

Completed·UUniversity Health Network, Toronto·Phase 2·NCT02506517·12 enrolled

An Explorative Study of Afatinib in the Treatment of Advanced Cancer Carrying an EGFR, a HER2 or a HER3 Mutation

Unknown status·UUniversitair Ziekenhuis Brussel·Phase 2·NCT03810872·87 enrolled

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1

Active, not recruiting·MMirati Therapeutics Inc.·Preclinical·NCT03785249·731 enrolled

Adenocarcinoma3 trials

Phase II Study of Afatinib as Third- or Further-line Treatment for Patients With Stage IV Bronchial Adenocarcinoma, Harboring Wild-type EGFR, Expressing the Neurotensin - Neurotensin Receptor Complex

Withdrawn·FFondation Hôpital Saint-Joseph·Phase 2·NCT02876081

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

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT01466660·319 enrolled

A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT01003899·43 enrolled

Efficacy and Safety3 trials

To Evaluate the Efficacy and Safety of Afatinib for Advanced ALTRK-negative ESCC

Unknown status·PPeking University·Phase 2·NCT05818982·72 enrolled

Efficacy and Safety of Precision Therapy in Refractory Tumor

Unknown status·BBaodong Qin·Phase 2·NCT03239015·300 enrolled

AFAMOSI: Efficacy and Safety of Afatinib Followed by Osimertinib Compared to Osimertinib in Patients with EGFRmutated/T790M Mutation Negative Nonsquamous NSCLC

Active, not recruiting·MMichael Hopp·Phase 4·NCT04413201·34 enrolled

EGFR Mutation3 trials

Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation

Unknown status·MMassachusetts General Hospital·Phase 2·NCT01746251·92 enrolled

Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02514174·25 enrolled

Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC

Terminated·NNational Cancer Centre, Singapore·Phase 1·NCT03711422·2 enrolled

Chordoma2 trials

Afatinib in Locally Advanced and Metastatic Chordoma

Completed·LLeiden University Medical Center·Phase 2·NCT03083678·43 enrolled

Study to Evaluate the Efficacy of Afatinib in Skull Base Chordoma

Unknown status·HHuashan Hospital·Phase 2·NCT05519917·20 enrolled

Small Cell Lung Cancer2 trials

Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.

Suspended·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT02470065·38 enrolled

Afatinib in Patients With Non Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02044380·14 enrolled

Lung Adenocarcinoma2 trials

Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT04795245·805 enrolled

Neoadjuvant Afatinib Therapy for Potentially Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma

Completed·SShanghai Pulmonary Hospital, Shanghai, China·Phase 2·NCT04201756·47 enrolled

Biomarker2 trials

Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE)

Terminated·UUniversität Duisburg-Essen·Phase 2·NCT02595840·4 enrolled

Biomarker-based Study in R/M SCCHN

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT03088059·340 enrolled

Gastric Cancer2 trials

Afatinib, Paclitaxel, 2nd Line, Advanced Gastric Cancer

Completed·YYonsei University·Phase 2·NCT02501603·72 enrolled

Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer

Recruiting·JJeeyun Lee·Phase 1/2·NCT06085755·61 enrolled

Advanced Solid Tumors2 trials

Afatinib (GILOTRIF®) in Patients Suffering From Tumors Harboring Neuregulin 1 (NRG1) Gene Alterations (Specifically NRG1 Gene Fusion-positive Advanced Solid Tumors)

No longer available· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT05107193

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Active, not recruiting· Amgen logo

Amgen·Phase 1·NCT04185883·610 enrolled

Advanced Solid Tumours2 trials

Trial of Afatinib (BIBW 2992) + Cetuximab in Advanced Solid Tumours

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02020577·58 enrolled

BIBW 2992 (Afatinib) and Vinorelbine in Japanese Patients With Advanced Solid Tumours

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01214616·17 enrolled

Esophageal Squamous Cell Carcinoma2 trials

JMT101 Combined With Afatinib in Patients With Advanced Esophageal Squamous Cell Carcinoma After Standard Therapy

Unknown status·PPeking University·Phase 1·NCT05164848·50 enrolled

A Trial of the Combination of Afatinib and Palbociclib in Previously Treated Advanced Esophageal Squamous Cell Carcinoma

Recruiting·WWest China Hospital·Phase 1/2·NCT06753747·45 enrolled

NSCLC2 trials

Afatinib With CT and RT for EGFR-Mutant NSCLC

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT01553942·19 enrolled

Afatinib in Pretreated Patients With Advanced NSCLC Harbouring HER2 Exon 20 Mutations

Completed·EETOP IBCSG Partners Foundation·Phase 2·NCT02369484·13 enrolled

Advanced Lymphoma2 trials

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

MATCH Treatment Subprotocol A: Phase II Trial of Afatinib in Patients With Solid Tumors (Other Than Small Cell and Non-Small Cell Lung Cancer) or Lymphomas, That Have Activating Mutations of EGFR and Have Progressed After Standard Treatment

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06385483·19 enrolled

HNSCC2 trials

A Prospective, Single-arm Clinical Study of Immune-targeted Therapy Combined With Lysogenic HSV Virus for the Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma

Withdrawn·WWest China Hospital·Phase 1·NCT06741982

A Prospective, Single-arm Clinical Study of Immune-targeted Therapy Combined With Lysogenic HSV Virus for the Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma

Active, not recruiting·WWest China Hospital·Preclinical·NCT07010120·29 enrolled

HER2 Mutation1 trial

Afatinib in NSCLC With HER2 Mutation

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT02597946·18 enrolled

Phase II1 trial

Phase II Umbrella Study Directed by Next Generation Sequencing

Unknown status·GGuangdong Association of Clinical Trials·Phase 2·NCT03574402·400 enrolled

ESCC1 trial

Afatinib in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification (ESCC-A01)

Unknown status·PPeking University·Phase 2·NCT03940976·40 enrolled

Head and Neck Cancer1 trial

Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer

Completed·—·Phase 1·NCT01783587·29 enrolled

Function1 trial

Afatinib in Subjects With Kidney Dysfunction

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02096718·30 enrolled

Diarrhea1 trial

ADAM-Afatinib Diarrhea Assessment and Management

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01814553·40 enrolled

Observational Study1 trial

Observational Study of Afatinib 30 mg Daily

Recruiting·NNational University Hospital, Singapore··NCT04909073·69 enrolled

Gallbladder Carcinoma1 trial

Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA

Recruiting·SShanghai Jiao Tong University School of Medicine·Phase 2·NCT04183712·102 enrolled

Toripalimab1 trial

Afatinib Plus Toripalimab in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification

Unknown status·PPeking University·Phase 2·NCT04880811·43 enrolled

Real-world Study1 trial

Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study

Unknown status·GGuangdong Association of Clinical Trials··NCT04575415·272 enrolled

Neoadjuvant Chemotherapy1 trial

Neoadjuvant Chemotherapy, Tislelizumab With Afatinib for HNSCC

Completed·WWest China Hospital·Phase 2·NCT05516589·40 enrolled

Squamous Cell Cancer1 trial

Dual Inhibition of EGFR With Afatinib and Cetuximab in the Treatment of Advanced Squamous Cell Cancers of the Head and Neck

Completed·YYale University·Phase 2·NCT02979977·50 enrolled

Interaction1 trial

Drug Interaction Study With Rifampicin and Afatinib

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01396265·22 enrolled

Gemcitabine1 trial

A Phase I Dose Escalation Trial of Afatinib Plus Gemcitabine or Plus Docetaxel

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT01251653·94 enrolled

Osimertinib1 trial

Afatinib Osimertinib Sequencing NIS

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT03370770·204 enrolled

Non-Small Cell Lung Carcinoma1 trial

Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma

Unknown status·CCenter Trials & Treatment Europe·Phase 1·NCT03827070·12 enrolled

Cancer1 trial

Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer.

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01649271·13 enrolled

Performance Status1 trial

Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02695290·1 enrolled

Moderate Hepatic Impairment1 trial

Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01298063·35 enrolled

Induction Chemotherapy1 trial

A Phase I/II Study Afatinib/Carboplatin/Paclitaxel Induction Chemotherapy In HPV-Negative HNSCC.

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1/2·NCT01732640·9 enrolled

Non-metastatic1 trial

Research of Biomarkers of Activity and Efficacy of BIBW2992 in Untreated Non-metastatic HNSCC Patients

Completed·UUNICANCER·Phase 2·NCT01415674·61 enrolled

Gastroesophageal Junction1 trial

Palbociclib Combined With Afatinib for Advanced Squamous Carcinoma of Esophagus or Gastroesophageal Junction

Recruiting·AAiping Zhou·Phase 2·NCT05865132·30 enrolled

Neoadjuvant Therapy1 trial

Trial of Afatinib With Paclitaxel for Neoadjuvant Therapy of TNBC and Research of Biomarkers of Afatinib

Unknown status·NNational Taiwan University Hospital·Phase 2·NCT02511847·40 enrolled

Quality of Life1 trial

Evaluate the Impact of Afatinib on Quality of Life and Symptom Burden of Greek Subjects With Advanced NSCLC in Routine Patient Care Settings

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT02440854·80 enrolled

Resistance1 trial

Deciphering Afatinib Response and Resistance With INtratumour Heterogeneity

Completed·UUniversity College, London·Phase 2·NCT02183883·12 enrolled

Genomic Alterations1 trial

Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT02795156·100 enrolled

First Line Therapy1 trial

GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT02047903·161 enrolled

Pediatric1 trial

Trial of Afatinib in Pediatric Tumours

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1/2·NCT02372006·56 enrolled

Paclitaxel1 trial

Trial of Afatinib in Combination With Weekly Paclitaxel in the Second Line Treatment

Withdrawn·—·Phase 2·NCT02274012

Cancers1 trial

Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers

Terminated·MMerus B.V.·Phase 2·NCT05588609·13 enrolled

Malignancies1 trial

Afatinib in Advanced NRG1-Rearranged Malignancies

Completed·GGerman Cancer Research Center·Phase 2·NCT04410653·3 enrolled

Growth1 trial

LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT01271725·74 enrolled

Advanced NSCLC1 trial

Study of EGFR TKI in Patients With Advanced NSCLC Harbouring EGFR Mutations

Recruiting·NNational University Hospital, Singapore·Phase 2·NCT06062823·35 enrolled

Brain Cancer1 trial

Safety Study of Afatinib for Brain Cancer

Completed·SSantosh Kesari·Phase 1·NCT02423525·24 enrolled

Targeted Therapy1 trial

Neoadjuvant Radiotherapy Plus Targeted Therapy and Immunotherapy vs. Targeted Therapy Plus Immunotherapy in Resectable HNSCC

Withdrawn·WWest China Hospital·Phase 2·NCT06804850

Chemotherapy1 trial

Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT02780687·42 enrolled

Pancreatic1 trial

Afatinib as Cancer Therapy for Exocrine Pancreatic Tumours

Unknown status·PPD Dr. med. Volker Heinemann·Phase 2·NCT01728818·119 enrolled

Metastatic NSCLC1 trial

Afatinib vs Erlotinib as 2nd TKI After Failure to 1st TKI and Chemotherapy for Metastatic NSCLC

Completed·TThe University of Hong Kong·Phase 2·NCT02625168·25 enrolled

Neoadjuvant Treatment1 trial

Low-dose Radiotherapy Plus Tislelizumab in Combination With Afatinib for Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma

Completed·WWest China Hospital·Phase 1·NCT06494189·9 enrolled

ESS1 trial

Afatinib Expanded Access Program

Approved for marketing· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT01649284

Glioblastoma1 trial

Biomarker and Tumor Cell Culture-Driven Pilot Trial for Treatment of Recurrent Glioblastoma

Enrolling by invitation·AAHS Cancer Control Alberta·Phase 1·NCT05432518·10 enrolled

Solid Tumor1 trial

A Phase Ia/Ib Study of the Combination of the FGFR Inhibitor Pemigatinib and the EGFR Inhibitor Afatinib in Advanced Refractory Solid Tumors

Recruiting·MMassachusetts General Hospital·Phase 1·NCT06302621·32 enrolled

NSCLC Stage IV1 trial

A Phase II Study of Primary Tumor Resection for Stage IV Non-small-cell Lung Cancer Without Progression After First-line Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor

Recruiting·NNational Taiwan University Hospital·Phase 2·NCT05215548·100 enrolled

Serous Carcinoma1 trial

A Phase II Evaluation of Afatanib, an Irreversible Human Epidermal Growth Factor Receptor 2 (Her2/Neu) Tyrosine Kinase Inhibitor, in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma

Recruiting·YYale University·Phase 2·NCT02491099·50 enrolled

Unspecified1 trial

Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01426958·24 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 12, 2013

GILOTRIF

NDA NDA201292

Nov 21, 2013

GILOTRIF

NDA NDA201292

Jul 31, 2014

GILOTRIF

NDA NDA201292

Nov 9, 2015

GILOTRIF

NDA NDA201292

Dec 28, 2015

GILOTRIF

NDA NDA201292

Apr 15, 2016

GILOTRIF

NDA NDA201292

Apr 20, 2016

GILOTRIF

NDA NDA201292

Oct 4, 2016

GILOTRIF

NDA NDA201292

Nov 6, 2017

GILOTRIF

NDA NDA201292

Jan 12, 2018

GILOTRIF

NDA NDA201292

Oct 11, 2019

GILOTRIF

NDA NDA201292

Apr 7, 2022

GILOTRIF

NDA NDA201292

Sources

References

[1]
ClinicalTrials.gov — 125 trial records for Afatinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Gilotrif drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Afatinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Afatinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA201292). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Boehringer Ingelheim company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Receptor Protein-Tyrosine Kinase Erbb-4 Inhibitor; Epidermal Growth Factor Receptor Erbb1 Inhibitor; Receptor Protein-Tyrosine Kinase Erbb-2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Boehringer Ingelheim

Gilotrif

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer12 trials

Squamous Cell Carcinoma10 trials

Lung Cancer8 trials

Breast Cancer5 trials

Head and Neck Squamous Cell Cancer4 trials

Head and Neck Squamous Cell Carcinoma4 trials

Trial3 trials

Advanced Cancer3 trials

Adenocarcinoma3 trials

Efficacy and Safety3 trials

EGFR Mutation3 trials

Chordoma2 trials

Small Cell Lung Cancer2 trials

Lung Adenocarcinoma2 trials

Biomarker2 trials

Gastric Cancer2 trials

Advanced Solid Tumors2 trials

Advanced Solid Tumours2 trials

Esophageal Squamous Cell Carcinoma2 trials

NSCLC2 trials

Advanced Lymphoma2 trials

HNSCC2 trials

HER2 Mutation1 trial

Phase II1 trial

ESCC1 trial

Head and Neck Cancer1 trial

Function1 trial

Diarrhea1 trial

Observational Study1 trial

Gallbladder Carcinoma1 trial

Toripalimab1 trial

Real-world Study1 trial

Neoadjuvant Chemotherapy1 trial

Squamous Cell Cancer1 trial

Interaction1 trial

Gemcitabine1 trial

Osimertinib1 trial

Non-Small Cell Lung Carcinoma1 trial

Cancer1 trial

Performance Status1 trial

Moderate Hepatic Impairment1 trial

Induction Chemotherapy1 trial

Non-metastatic1 trial

Gastroesophageal Junction1 trial

Neoadjuvant Therapy1 trial

Quality of Life1 trial

Resistance1 trial

Genomic Alterations1 trial

First Line Therapy1 trial

Pediatric1 trial

Paclitaxel1 trial

Cancers1 trial

Malignancies1 trial

Growth1 trial

Advanced NSCLC1 trial

Brain Cancer1 trial

Targeted Therapy1 trial

Chemotherapy1 trial

Pancreatic1 trial

Metastatic NSCLC1 trial

Neoadjuvant Treatment1 trial

ESS1 trial

Glioblastoma1 trial

Solid Tumor1 trial

NSCLC Stage IV1 trial

Serous Carcinoma1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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