Phase 2
Completed N=161
A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment
Source: ClinicalTrials.gov NCT01610336 ↗Enrolled (actual)
161
Serious AEs
33.5%
Results posted
Apr 2021
Primary outcomePrimary: Phase Ib: Frequency of Dose Limiting Toxicities (DLTs) — 0; 0; 0; 0 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase Ib: Frequency of Dose Limiting Toxicities (DLTs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Phase II : Overall Response Rate (ORR) |
12; 17 | — |
| SECONDARY Phase Ib and II: Number of Participants With Adverse Events (AEs) |
5; 7; 6; 7; 4; 12 | — |
| SECONDARY Phase Ib and II: Number of Participants With Serious Adverse Events (SAEs) |
1; 2; 2; 3; 0; 4 | — |
| SECONDARY Phase Ib and II: Number of Patients With Dose Reductions of INC280 by Dose Level |
5; 6; 5; 6; 1; 8 | — |
| SECONDARY Phase Ib and II: Number of Patients With Dose Interruptions of Gefitinib by Dose Level |
5; 5; 6; 4; 4; 6 | — |
| SECONDARY Phase II: Overall Survival (OS) |
12.3; 15.2 | — |
| SECONDARY Phase II: Progression Free Survival (PFS) |
5.1; 5.5 | — |
| SECONDARY Phase II: Duration of Response (DoR) |
5.6; 5.6 | — |
| SECONDARY Phase I: PK Parameters AUCtau of INC280 and Gefitinib |
4510; 9140; 29200; 30300; 9660; 21400 | — |
| SECONDARY Phase I: PK Parameters Cmax of INC280 and Gefitinib |
826; 1490; 4620; 6570; 1950; 4220 | — |
| SECONDARY Phase I: PK Parameters Tmax of INC280 and Gefitinib |
1.96; 2.00; 2.00; 2.05; 1.50; 2.00 | — |
| SECONDARY Phase I: PK Parameters Apparent Systemic Plasma Clearance Rate of INC280 and Gefitinib |
26.9; 29.4; 16.3; 47.7; 27.0; 24.2 | — |
| SECONDARY Phase I: PK Parameters Half-life of INC280 and Gefitinib |
3.86; 5.10; 3.16; 3.67; 3.19; 3.01 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01610336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.