Clinical trial · Interventional
A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification
A Phase Ib/II, Open-label, Multicenter Trial With Oral cMET Inhibitor INC280 Alone and in Combination With Erlotinib Versus Platinum With Pemetrexed in Adult Patients With EGFR Mutated, cMET-amplified, Locally Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC) With Acquired Resistance to Prior EGFR Tyrosine Kinase Inhibitor (EGFR TKI)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Major challenge for enrollment of participants.
Summary
Brief summary (as posted)
The purpose of this study was to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.
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 |
|---|---|---|---|
| erlotinib | Drug | Erlotinib | ALIAS |
| INC280 single agent | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- INC280 200mg BID + ERL 150mg QD
- description
- Subjects who took INC280 200mg twice a day (BID) in combination with erlotinib (ERL) 150mg one a day (QD)
- interventionNames
- Drug: INC280 single agent
- Drug: erlotinib
- type
- EXPERIMENTAL
- label
- INC280 400mg BID + ERL 150mg QD
- description
- Subjects who took INC280 400mg twice a day (BID) in combination with erlotinib (ERL) 150mg one a day (QD)
- interventionNames
- Drug: INC280 single agent
- Drug: erlotinib
Primary outcomes (1)
- measure
- Phase Ib: Frequency and characteristics of Dose Limiting Toxicity (DLTs) to the INC280 and erlotinib combination
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced or metastatic NSCLC * EGFR mutation (L858R and /or ex19del) * cMET amplification by FISH (GCN ≥ 6), * Acquired resistance to EGFR TKI (1st or 2nd generation) * ECOG performance status (PS) ≤ 1. Exclusion Criteria: * Prior treatment with 3rd generation TKI * PhaseII : Prior treatment with any of the following agents: * Crizotinib, or any other cMET inhibitor or HGF-targeting inhibitor. * Concomitant EGFR TKI and platinum based chemotherapy as first line regimen. * Platinum-based chemotherapy as first line treatment
References
Publications (0)
Data not yet available