Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation

A Phase III, Randomized, Controlled, Open-label, Multicenter, Global Study of Capmatinib Versus SoC Docetaxel Chemotherapy in Previously Treated Patients With EGFR wt, ALK Negative, Locally Advanced or Metastatic (Stage IIIB/IIIC or IV) NSCLC Harboring MET Exon 14 Skipping Mutation (METΔex14).

ClinicalTrials.gov Identifier: NCT04427072

Novartis Reference Number: CINC280A2301

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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

The purpose of the study is to learn whether the study drug (capmatinib) helps to control lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to patients suffering from a particular type of lung cancer. This type of cancer is called non-small cell lung cancer (NSCLC) with certain specific genetic alterations (called mutations) of a gene called MET, within a specific part of the gene called exon 14.

Approximately 90 people with advanced or metastatic lung cancer, with these specific mutations in the MET gene but without changes in their epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genes, will be enrolled in this study.

The study drug, capmatinib (also known as INC280), is an oral drug that is called a 'targeted' medicine, which means it targets particular processes that may not be working properly in cancer cells (called dysregulation). The dysregulation of the MET signaling in cancer cells of patients with NSCLC is believed to make the cancer worse. Capmatinib has been shown to selectively block the effects of the MET gene and therefore may help in keeping the disease under control, stopping cancer cells from growing. Docetaxel is a standard chemotherapy medicine commonly used to treat your type of lung cancer. This standard, anti-cancer medicine is a cytotoxic chemotherapy.

The reason for this study is to find out if capmatinib can control lung cancer better.

Patients will be randomly assigned to get either capmatinib or docetaxel in a 2 to 1 ratio:

Capmatinib: 2 out of 3 possibility or 66% chance of getting this treatment,
Docetaxel: 1 out of 3 possibility or 33% chance of getting this treatment.

During treatment, visits will be scheduled every 21 days.

Condition 
Carcinoma, Non-Small-Cell Lung
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
90 participants
Start date 
Sep 25, 2020
Completion date 
Feb 27, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Capmatinib
400mg of capmatinib tablets administered orally twice daily
Drug
Docetaxel
Docetaxel 75 mg/m2 by intravenous infusion every 21 days

Eligibility Criteria

Key Inclusion Criteria:

Stage IIIB/IIIC (not amenable to surgery, radiation or multi modality therapy) or IV NSCLC (according to Version 8 of the American Joint Committee on Cancer (AJCC) Staging Manual) at the time of study entry.

Histologically or cytologically confirmed diagnosis of NSCLC that is:

EGFR wt. Assessed as part of participant's standard of care by a validated test for EGFR mutations as per local guidelines. The EGFR wt status (for EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations.
AND ALK rearrangement negative. Assessed as part of participant's standard of care by a validated test.
AND has METΔex14 mutation per Novartis-designated central laboratory.
Mandatory provision of a formalin-fixed, paraffin embedded tumor tissue sample (archival tumor block or slides, or a newly obtained tumor sample)
Progressed on one or two prior lines of systemic therapy for advanced/metastatic disease (stage IIIB/IIIC [not candidates for surgery, radiation or multi modality therapy] or IV NSCLC) and must be candidates for single agent chemotherapy (docetaxel).
At least one measurable lesion as defined by RECIST 1.1
Adequate organ function
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 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.
Participants with known druggable molecular alterations (such as ROS1 translocation or BRAF mutation, etc.) which might be a candidate for alternative targeted therapies as applicable per local regulations and treatment guidelines.
Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
Substance abuse, active infection or other severe, acute, or chronic medical or psychotic conditions or laboratory abnormalities that in the opinion of the investigator may increase the risk associated with study participation

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Hungary
Novartis Investigative Site
Recruiting
Torokbalint, 2045
Pest
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1121
-
Hungary

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]