Clinical trial · Interventional
A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment
A Phase IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment
NCT01610336CI-TRIAL-00051125completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study assessed the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET pathway and who had failed after benefiting on a prior treatment with either gefitinib or erlotinib.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib | Drug | Gefitinib | ALIAS |
| INC280 | Drug | Capmatinib | ALIAS |
Design
Arms and outcomes
Arms (11)
- type
- EXPERIMENTAL
- label
- INC280 100 mg Cap QD Phase Ib
- description
- cap=capsule; QD=once daily
- interventionNames
- Drug: INC280
- Drug: Gefitinib
- type
- EXPERIMENTAL
- label
- INC280 200 mg Cap QD Phase Ib
- description
- cap=capsule; QD=once daily
- interventionNames
- Drug: INC280
- Drug: Gefitinib
- type
- EXPERIMENTAL
- label
- INC280 400 mg Cap QD Phase Ib
- description
- cap=capsule; QD=once daily
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented EGFR mutation * Documented c-MET dysregulation * Prior clinical benefit on EGFR inhibitors and then subsequent progression -≥ 18 year old * Life expectancy of ≥ 3 months * ECOG performance status ≤ 2 Exclusion Criteria: * Unable to swallow tables once or twice daily * Previous treatment with c-MET inhibitor * Any unresolved toxicity from previous anticancer therapy greater than grade 1 * History of cystic fibrosis * History of acute or chronic pancreatitis * Unable to undergo MRI or CT scans * Known history of HIV * Undergone a bone marrow or solid organ transplant * Clinically significant wound or lung tumor lesions with increased likelihood of bleeding * Pregnant or nursing
References
Publications (1)
- DERIVEDWu YL, Zhang L, Kim DW, Liu X, Lee DH, Yang JC, Ahn MJ, Vansteenkiste JF, Su WC, Felip E, Chia V, Glaser S, Pultar P, Zhao S, Peng B, Akimov M, Tan DSW. Phase Ib/II Study of Capmatinib (INC280) Plus Gefitinib After Failure of Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy in Patients With EGFR-Mutated, MET Factor-Dysregulated Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Nov 1;36(31):3101-3109. doi: 10.1200/JCO.2018.77.7326. Epub 2018 Aug 29. PMID 30156984