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

  • STATUS
    Recruiting
  • End date
    Mar 7, 2024
  • participants needed
    90
  • sponsor
    Novartis Pharmaceuticals
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Updated on 3 March 2021
See if I qualify
systemic therapy
measurable disease
growth factor
epidermal growth factor receptor
EGFR
docetaxel
cancer chemotherapy
epidermal growth factor
lung carcinoma

Summary

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.

Description

Participants eligible for the study will be randomized in a 2:1 ratio to one of the two treatment arms: capmatinib (investigational therapy) or docetaxel. The randomization will be stratified by prior lines of systemic therapy received for advanced/metastatic disease (one line vs. two lines).

For all participants, the respective treatment (either with capmatinib or docetaxel) may be continued beyond initial disease progression as per RECIST 1.1 (as assessed by the investigator and confirmed by BIRC) if, in the judgment of the investigator, there is evidence of clinical benefit, and the participant wishes to continue on the study treatment. After treatment discontinuation, all participants will be followed for safety evaluations during the safety follow-up period, and the participant's status will be collected every 12 weeks as part of the survival follow-up.

Participants randomized to docetaxel treatment will be eligible to crossover to receive capmatinib treatment after BIRC-confirmed, RECIST 1.1-defined progressive disease and after meeting the eligibility criteria prior to crossover.

The primary objective of this study is to compare the efficacy of capmatinib versus docetaxel by comparing progression-free survival (PFS) by blinded independent review committee (BIRC) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 between treatment arms.

Details
Condition Non-Small Cell Lung Cancer
Treatment docetaxel, capmatinib
Clinical Study IdentifierNCT04427072
SponsorNovartis Pharmaceuticals
Last Modified on3 March 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Non-Small Cell Lung Cancer?
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
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 METex14 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

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
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