Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy

A Phase III Randomized, Controlled, Open-label, Multicenter, Global Study of Capmatinib in Combination With Osimertinib Versus Platinum - Pemetrexed Based Doublet Chemotherapy in Patients With Locally Advanced or Metastatic NSCLC Harboring EGFR Activating Mutations Who Have Progressed on Prior Generation EGFR-TKI Therapy and Whose Tumors Are T790M Mutation Negative and Harbor MET Amplification (GE

ClinicalTrials.gov Identifier: NCT04816214

Novartis Reference Number: CINC280L12301

Last Update: May 10, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This phase III study is designed to evaluate the anticancer activity of capmatinib in combination with osimertinib compared to platinum-pemetrexed based doublet chemotherapy as second line treatment in patients with advanced or metastatic non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation, T790M negative, mesenchymal-to-epithelial transition factor (MET) amplified who progressed following EGFR tyrosine kinase inhibitors (TKIs). The randomized part will be preceded by a safety run-in part in which the recommended dose of the combination of capmatinib and osimertinib will be confirmed.

Condition 
Carcinoma, Non-Small-Cell Lung
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Sep 22, 2021
Completion date 
Apr 15, 2027
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
capmatinib
film-coated tablet for oral use
Drug
pemetrexed
concentrate for solution for intravenous use
Drug
cisplatin
concentrate for solution for intravenous use
Drug
carboplatin
concentrate for solution for intravenous use
Drug
osimertinib
tablet for oral use

Eligibility Criteria

Key Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of NSCLC with EGFR mutations known to be associated with EGFR TKI sensitivity, EGFR T790M negative and MET gene amplification
Stage IIIB/IIIC or IV NSCLC
Patients must have progressed on one prior line of therapy (1st/2nd generation EGFR TKIs, osimertinib or other third generation EGFR TKIs) for advanced/metastatic disease (stage IIIB/IIIC and must be candidates for platinum (cisplatin or carboplatin) - pemetrexed doublet based chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Participants must have recovered from all toxicities related to prior systemic therapy to grade ≤ 1 Common Terminology Criteria Adverse Event 5.0 (CTCAE v 5.0)
At least one measurable lesion as defined by RECIST 1.1

Key Exclusion Criteria:

Prior treatment with any MET inhibitor or HGF-targeting therapy
Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
Carcinomatous meningitis
Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years
Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome
Clinically significant, uncontrolled heart diseases
known druggable molecular alterations that may render participants eligible for alternative targeted therapies

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

United States
UCLA Santa Monica Hematology / Oncology
Recruiting
Santa Monica, 90404 - California
Contact: Joanna Gutierrez (310-453-2213) - [email protected] - Edward B Garon
United States
University of California at Los Angeles
Recruiting
Torrance, 90502 - California
Contact: Andy Amaya (310-222-2345) - [email protected] - Mykola Onyshchenko
United States
Rocky Mountain Cancer Centers RMCC - Longmont
Recruiting
Denver, 80501 - Colorado
Contact: (303-385-2000) Hossein Maymani
United States
Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology
Recruiting
Dallas, 75246 - Texas
Contact: Sarah Shipley (214-370-1279) - [email protected] - Kartik Konduri
United States
Tacoma General Hospital
Recruiting
Tacoma, 98405 - Washington
Contact: Nehal Masood
United States
France
Novartis Investigative Site
Recruiting
Villejuif Cedex, 94800
-
France
Israel
Novartis Investigative Site
Recruiting
Haifa, 3109601
-
Israel
Novartis Investigative Site
Recruiting
Kfar Saba, 4428164
-
Israel
Novartis Investigative Site
Recruiting
Petach Tikva, 4941492
-
Israel
Japan
Novartis Investigative Site
Recruiting
Kashiwa, 277 8577
Chiba
Japan
Novartis Investigative Site
Recruiting
Sunto Gun, 411 8777
Shizuoka
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 05505
-
Korea, Republic of
Poland
Novartis Investigative Site
Recruiting
Warszawa, 02 781
-
Poland
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169610
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Santander, 39008
Cantabria
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]