A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment
Launched by NOVARTIS PHARMACEUTICALS · Jun 1, 2012
Trial Information
Current as of June 20, 2025
Completed
Keywords
ClinConnect Summary
The Phase Ib dose escalation part was aimed at the determination of the MTD/RP2D of capmatinib in combination with 250 mg gefitinib in patients with NSCLC patients with epidermal growth factor receptor (EGFR) mutation and cMET dysregulation and showing disease progression following EGFR tyrosine-kinase inhibitor (EGFR TKI) therapy. Dose escalation started with a dose of 100 mg/day to a maximum of 1200 mg/day, as capsule or tablet formulation. Successive cohorts of patients were to receive increasing doses of capmatinib in combination with a 250 mg once daily (qd) dose of gefitinib until the...
Gender
ALL
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
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Amsterdam, , Netherlands
Leuven, , Belgium
Woolloongabba, Queensland, Australia
Milano, Mi, Italy
East Bentleigh, Victoria, Australia
Auckland, , Australia
Guangzhou, , China
Freiburg, , Germany
Seoul, Korea, Korea, Republic Of
Frankfurt, , Germany
Ramat Gan, , Israel
Singapore, , Singapore
Bangkok, , Thailand
Toulouse Cedex 9, , France
Rotterdam, , Netherlands
Barcelona, Catalunya, Spain
Taipei, , Taiwan
Frankfurt, , Germany
Seoul, Korea, Korea, Republic Of
Shanghai, Shanghai, China
Beijing, , China
Modena, Mo, Italy
Madrid, , Spain
Strasbourg Cedex, , France
Tainan, , Taiwan
Gyeonggi Do, Korea, Korea, Republic Of
Maastricht, Az, Netherlands
Rotterdam, , Netherlands
Koto Ku, Tokyo, Japan
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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