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

Last Update: May 19, 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

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.

Condition 
Carcinoma, Non-Small-Cell Lung
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Sep 25, 2020
Completion date 
Apr 22, 2025
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 as determined by Novartis-designated central laboratory or by locally performed, tissue-based test, validated according to local regulation, from a Clinical Laboratory Improvement Amendments (CLIA)-certified US laboratory or an accredited local laboratory outside of the US. The positive METΔex14 mutation result as determined per local test must be documented in the participant's source documents and in the CRF prior to entering main screening.

Mandatory provision of a formalin-fixed, paraffin embedded tumor tissue sample (archival tumor block or slides, or a newly obtained tumor sample) with quality and quantity sufficient to allow assessment of METΔex14 mutation status (as defined in the study [laboratory manual]). This pertains to all participants, including those who have a METΔex14 mutation result from a local test. Tumor samples must contain at least 10% tumor content.

6. Participants must have progressed on one or two prior lines of

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 docetaxel naïve and candidates for single agent chemotherapy (docetaxel). Treatment failure is defined as documented disease progression or intolerance to treatment., however participants must have progressed on or after the last therapy before study entry.
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.
Participants must have a life expectancy of at least 3 months.

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 ROS1and RET rearrangement, BRAF mutation, KRAS mutation, NTRK fusion, etc.) which might be a candidate for alternative targeted therapies.
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
Novartis Investigative Site
Recruiting
Roeselare, 8800
-
Belgium
Brazil
Novartis Investigative Site
Recruiting
Barretos, 14784 400
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 01246 000
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 04014-002
SP
Brazil
Bulgaria
Novartis Investigative Site
Recruiting
Pleven, 5800
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1303
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1407
-
Bulgaria
France
Novartis Investigative Site
Recruiting
Le Mans, 72037
Cedex 09
France
Novartis Investigative Site
Recruiting
Angers Cedex 9, 49933
-
France
Novartis Investigative Site
Recruiting
Bordeaux, 33076
-
France
Novartis Investigative Site
Recruiting
Caen Cedex, 14021
-
France
Novartis Investigative Site
Recruiting
Clermont-Ferrand, 63011
-
France
Novartis Investigative Site
Recruiting
Paris, 75231
-
France
Novartis Investigative Site
Recruiting
Paris, 75877
-
France
Novartis Investigative Site
Recruiting
Pierre Benite Cedex, 69495
-
France
Novartis Investigative Site
Recruiting
Rennes, 35043
-
France
Germany
Novartis Investigative Site
Recruiting
Regensburg, 93053
Bavaria
Germany
Novartis Investigative Site
Recruiting
Gauting, 82131
Bayern
Germany
Novartis Investigative Site
Recruiting
Berlin, 13125
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 14165
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60488
-
Germany
Novartis Investigative Site
Recruiting
Gottingen, 37075
-
Germany
Novartis Investigative Site
Recruiting
Grosshansdorf, 22947
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50937
-
Germany
Novartis Investigative Site
Recruiting
Oldenburg, 26121
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89081
-
Germany
Hungary
Novartis Investigative Site
Recruiting
Torokbalint, 2045
Pest
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1121
-
Hungary
India
Novartis Investigative Site
Recruiting
New Delhi, 110076
Delhi
India
Novartis Investigative Site
Recruiting
Pune, 411013
Maharashtra
India
Novartis Investigative Site
Recruiting
Vellore, 632 004
Tamil Nadu
India
Italy
Novartis Investigative Site
Recruiting
Bologna, 40138
BO
Italy
Novartis Investigative Site
Recruiting
Meldola, 47014
FC
Italy
Novartis Investigative Site
Recruiting
Genova, 16132
GE
Italy
Novartis Investigative Site
Recruiting
Milano, 20141
MI
Italy
Novartis Investigative Site
Recruiting
Milano, 20162
MI
Italy
Novartis Investigative Site
Recruiting
Padova, 35100
PD
Italy
Novartis Investigative Site
Recruiting
Aviano, 33081
PN
Italy
Novartis Investigative Site
Recruiting
Parma, 43100
PR
Italy
Novartis Investigative Site
Recruiting
Reggio Emilia, 42123
RE
Italy
Novartis Investigative Site
Recruiting
Roma, 00128
RM
Italy
Korea, Republic of
Novartis Investigative Site
Recruiting
Gyeonggi do, 10408
Korea
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 05505
-
Korea, Republic of
Lithuania
Novartis Investigative Site
Recruiting
Vilnius, LT-08660
-
Lithuania
Malaysia
Novartis Investigative Site
Recruiting
Kuantan, 25100
Pahang
Malaysia
Novartis Investigative Site
Recruiting
Kuala Lumpur, 50586
Wilayah Persekutuan
Malaysia
Novartis Investigative Site
Recruiting
Pulau Pinang, 10990
-
Malaysia
Netherlands
Novartis Investigative Site
Recruiting
Nijmegen, 6500 HB
-
Netherlands
Portugal
Novartis Investigative Site
Recruiting
Lisboa, 1769-001
-
Portugal
Novartis Investigative Site
Recruiting
Matosinhos, 4454 513
-
Portugal
Novartis Investigative Site
Recruiting
Porto, 4200-072
-
Portugal
Russian Federation
Novartis Investigative Site
Recruiting
Arkhangelsk, 163045
-
Russian Federation
Novartis Investigative Site
Recruiting
Chelyabinsk, 454048
-
Russian Federation
South Africa
Novartis Investigative Site
Recruiting
Port Elizabeth, 6045
Western Cape
South Africa
Novartis Investigative Site
Recruiting
Cape Town, 7500
-
South Africa
Spain
Novartis Investigative Site
Recruiting
Malaga, 29010
Andalucia
Spain
Novartis Investigative Site
Recruiting
Oviedo, 33011
Asturias
Spain
Novartis Investigative Site
Recruiting
Hospitalet de LLobregat, 08907
Catalunya
Spain
Novartis Investigative Site
Recruiting
Valencia, 46026
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
La Coruna, 15006
Galicia
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28041
-
Spain
Thailand
Novartis Investigative Site
Recruiting
Songkhla, 90110
Hat Yai
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10700
-
Thailand
Vietnam
Novartis Investigative Site
Recruiting
Hanoi, 100000
-
Vietnam

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

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