A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment

• Status: Completed
• Trial end date: 2020-05-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Gefitinib

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