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

NCT ID: NCT01610336

Last Updated: 2021-04-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-05

Study Completion Date

2020-05-27

Brief Summary

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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.

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Detailed Description

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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 MTD/RP2D of capmatinib had been determined. The Phase II dose expansion part consisted of 400 mg capmatinib twice daily (bid), as either capsules or tablets, in combination with 250 mg gefitinib.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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INC280 100 mg Cap QD Phase Ib

cap=capsule; QD=once daily

Group Type EXPERIMENTAL

INC280

Intervention Type DRUG

During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.

Gefitinib

Intervention Type DRUG

Gefitinib 250 mg taken once daily

INC280 200 mg Cap QD Phase Ib

cap=capsule; QD=once daily

Group Type EXPERIMENTAL

INC280

Intervention Type DRUG

During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.

Gefitinib

Intervention Type DRUG

Gefitinib 250 mg taken once daily

INC280 400 mg Cap QD Phase Ib

cap=capsule; QD=once daily

Group Type EXPERIMENTAL

INC280

Intervention Type DRUG

During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.

Gefitinib

Intervention Type DRUG

Gefitinib 250 mg taken once daily

INC280 800 mg Cap QD Phase Ib

cap=capsule; QD=once daily

Group Type EXPERIMENTAL

INC280

Intervention Type DRUG

During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.

Gefitinib

Intervention Type DRUG

Gefitinib 250 mg taken once daily

INC280 200 mg Cap BID Phase Ib

cap=capsule; BID=twice daily

Group Type EXPERIMENTAL

INC280

Intervention Type DRUG

During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.

Gefitinib

Intervention Type DRUG

Gefitinib 250 mg taken once daily

INC280 400 mg Cap BID Phase Ib

cap=capsule; BID=twice daily

Group Type EXPERIMENTAL

INC280

Intervention Type DRUG

During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.

Gefitinib

Intervention Type DRUG

Gefitinib 250 mg taken once daily

INC280 600 mg Cap BID Phase Ib

cap=capsule; BID=twice daily

Group Type EXPERIMENTAL

INC280

Intervention Type DRUG

During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.

Gefitinib

Intervention Type DRUG

Gefitinib 250 mg taken once daily

INC280 200 mg Tab BID Phase Ib

tab=tablet; BID=twice daily

Group Type EXPERIMENTAL

INC280

Intervention Type DRUG

During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.

Gefitinib

Intervention Type DRUG

Gefitinib 250 mg taken once daily

INC280 400 mg Tab BID Phase Ib

tab=tablet; BID=twice daily

Group Type EXPERIMENTAL

INC280

Intervention Type DRUG

During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.

Gefitinib

Intervention Type DRUG

Gefitinib 250 mg taken once daily

INC280 400 mg Cap BID Phase II

cap=capsule; BID=twice daily

Group Type EXPERIMENTAL

INC280

Intervention Type DRUG

During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.

Gefitinib

Intervention Type DRUG

Gefitinib 250 mg taken once daily

INC280 400 mg Tab BID Phase II

tab=tablet; BID=twice daily

Group Type EXPERIMENTAL

INC280

Intervention Type DRUG

During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.

Gefitinib

Intervention Type DRUG

Gefitinib 250 mg taken once daily

Interventions

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INC280

During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.

Intervention Type DRUG

Gefitinib

Gefitinib 250 mg taken once daily

Intervention Type DRUG

Other Intervention Names

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Capmatinib

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Woolloongabba, Queensland, Australia

Site Status

Novartis Investigative Site

East Bentleigh, Victoria, Australia

Site Status

Novartis Investigative Site

Auckland, , Australia

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status

Novartis Investigative Site

Shanghai, Shanghai Municipality, China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Guangzhou, , China

Site Status

Novartis Investigative Site

Strasbourg, , France

Site Status

Novartis Investigative Site

Toulouse, , France

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Freiburg im Breisgau, , Germany

Site Status

Novartis Investigative Site

Ramat Gan, , Israel

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Modena, MO, Italy

Site Status

Novartis Investigative Site

Koto Ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Maastricht, AZ, Netherlands

Site Status

Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Novartis Investigative Site

Rotterdam, , Netherlands

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Novartis Investigative Site

Gyeonggi-do, Korea, South Korea

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Seoul, Seocho Gu, South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Tainan City, , Taiwan

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Novartis Investigative Site

Bangkok, , Thailand

Site Status

Countries

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Australia Belgium China France Germany Israel Italy Japan Netherlands Singapore South Korea Spain Taiwan Thailand

References

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Wu 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.

Reference Type DERIVED
PMID: 30156984 (View on PubMed)

Other Identifiers

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2011-002569-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CINC280X2202

Identifier Type: -

Identifier Source: org_study_id

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