Gilotrif
(Afatinib)Phase 3Small molecule
Boehringer IngelheimAfatinib 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.[1] Gilotrif is currently being investigated across 20 indications[3], with its most advanced program in Phase 3.[1]
Gilotrif is one of 437 small molecule programs targeting Neoadjuvant Treatment. It is currently in Phase 3.
20
Indications
125
Total Trials
22
Active Trials
436
Competitors
Pipeline
Status by Indication[3][1]
Indication
Showing 10 of 20 indications
Competition
Competitive Landscape
311 competitors in Advanced Solid Tumors
#DrugCompanyPhaseTrials
1Fludara
SanofiPhase 2
Avastin
RochePhase 2
Paraplatin
AAvyxa
Phase 2
Gilotrif
Boehringer IngelheimPhase 3
Beyfortus
BeiGenePhase 2
Taxotere
AAvyxa
Phase 2
Erbitux
IImclone
Phase 2
Braftovi
PfizerPhase 2
Sutent
PfizerPhase 2
Tuoyi
CCoherus Oncology, Inc.
Phase 2
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Q4 2026
Phase 2Recruiting
Advanced NSCLC
NCT06062823
Phase 1/2Recruiting
Gastric Cancer
NCT06085755
Phase 1Recruiting
Neoadjuvant Treatment
NCT06741982
Post-ApprovalActive, not recruiting
Efficacy and Safety
NCT04413201
Phase 2Active, not recruiting
Advanced Lymphoma
NCT02465060
PreclinicalActive, not recruiting
Advanced Cancer
NCT03785249
Clinical
Trials by Indication[1]
Non-Small Cell Lung Cancer12 trials
FHND9041 Versus Afatinib for Non-small Cell Lung Cancer
Enrolling by invitation·JJiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.·Phase 3·NCT06759857·350 enrolled
Show 9 more trials
Squamous Cell Carcinoma10 trials
Show 7 more trials
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
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
Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA
Completed·—·Phase 2·NCT02629523·21 enrolled
Show 5 more trials
Breast Cancer5 trials
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
Adenocarcinoma3 trials
Trial3 trials
Cambridge Brain Mets Trial 1
Terminated·—·Phase 1/2·NCT02768337·26 enrolled
Advanced Cancer3 trials
Efficacy and Safety3 trials
EGFR Mutation3 trials
Lung Adenocarcinoma2 trials
Gastric Cancer2 trials
Small Cell Lung Cancer2 trials
Esophageal Squamous Cell Carcinoma2 trials
Advanced Solid Tumours2 trials
Biomarker2 trials
Biomarker-based Study in R/M SCCHN
Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT03088059·340 enrolled
NSCLC2 trials
Chordoma2 trials
Advanced Solid Tumors2 trials
Neoadjuvant Treatment2 trials
Advanced Lymphoma2 trials
Gallbladder Carcinoma1 trial
Toripalimab1 trial
Real-world Study1 trial
Squamous Cell Cancer1 trial
Non-Small Cell Lung Carcinoma1 trial
Paclitaxel1 trial
Trial of Afatinib in Combination With Weekly Paclitaxel in the Second Line Treatment
Withdrawn·—·Phase 2·NCT02274012
Cancers1 trial
Growth1 trial
ESCC1 trial
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
Performance Status1 trial
Moderate Hepatic Impairment1 trial
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
Targeted Therapy1 trial
Chemotherapy1 trial
Gastroesophageal Junction1 trial
Neoadjuvant Therapy1 trial
Quality of Life1 trial
Genomic Alterations1 trial
Metastatic NSCLC1 trial
HNSCC1 trial
Serous Carcinoma1 trial
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Afatinib. EMBL-EBI & Wellcome Sanger Institute.
- [4]
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[2]
- Modality
- Small molecule[2]
- Highest Phase
- Phase 3[1]
- Company