| CTRI Number |
CTRI/2020/01/023016 [Registered on: 28/01/2020] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50% |
|
Scientific Title of Study
|
A Randomized, Open Label, Multicenter Phase II Study Evaluating the Efficacy and Safety of Capmatinib (INC280) Plus Pembrolizumab Versus Pembrolizumab Alone as First Line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer With PD-L1≥ 50% (CINC280I12201) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2019-002660-27 |
EudraCT |
| CINC280I12201 Amended Protocol V 01(Clean) dated 05-Nov-2019 |
Protocol Number |
| NCT04139317 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Murugananthan K |
| Designation |
Country Monitoring Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G
Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai
MAHARASHTRA India
Mumbai
MAHARASHTRA
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
|
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Murugananthan K |
| Designation |
Country Monitoring Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G
Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai
MAHARASHTRA India
Mumbai
MAHARASHTRA
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
|
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Murugananthan K |
| Designation |
Country Monitoring Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G
Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai
MAHARASHTRA India
Mumbai
MAHARASHTRA
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
|
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Pharma AG, Novartis Campus 4056 – Basel, Switzerland |
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Pvt Ltd |
| Address |
6 & 7 floor, Inspire BKC, G Block, BKC Main Road, Bandra Kurla
Complex, Bandra (East), Mumbai – 400051,India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Australia
Belgium
Canada
Czech Republic
France
Germany
Greece
Hong Kong
Italy
Japan
Malaysia
Netherlands
Singapore
Spain
Taiwan
Thailand
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrNirmal Raut |
Bhaktivedanta Hospital and Research Institute |
Research Department, 5th floor,Srishti Complex, Bhaktivedanta Swami Marg,
Mira Road (East),401107,Ind
Thane
MAHARASHTRA |
912229452532
drnirmalraut@gmail.com |
| Dr Ullas Batra |
Rajiv Gandhi Cancer Institute and Research Institute |
Department of oncology, Rohini, Sector-5
New Delhi 110085
New Delhi
DELHI |
9711080001
drubresearch@gmail.com |
| Dr Bivas Biswas |
TATA Medical Centre (TMC |
Academic Block,14 Major Arterial Road (EW)
New Town, Rajarhat
Kolkata 700160
Kolkata
WEST BENGAL |
9830922005
bivas.biswas@tmckolkata.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Review Board-Dr Bivas Biswas |
Approved |
| Institutional Review Board-Dr Nirmal Raut |
Approved |
| Institutional Review Board-Dr Ullas Batra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capmatinib
|
400 mg twice a day Pembrolizumab 200mg every 3 weeks |
| Comparator Agent |
Pembrolizumab |
200mg every 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Histologically confirmed and documented locally advanced stage III (not candidates for surgical resection or definitive chemo-radiation) or stage IV (metastatic) NSCLC (per AJCC/IASLC v.8) for treatment in the first-line setting
2 Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wild type status and ALK- negative rearrangement statu
3 Have an archival tumor sample or newly obtained tumor biopsy with high PD-L1 expression (TPS ≥ 50%)
4 ECOG performance status score ≤ 1
5 Have at least 1 measurable lesion by RECIST 1.1
6 Have adequate organ function
|
|
| ExclusionCriteria |
| Details |
Prior treatment with a MET inhibitor orHGF-targeting therapy
Have untreated symptomatic centralnervous system metastases
Clinically significant, uncontrolled heart diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Progression-free survival (PFS) based on local investigator assessment as per RECIST 1.1 Progression free survival is defined as the time from randomization to the date of the first documented radiological progression using RECIST 1.1(Response evaluation criteria in solid tumor) or death due to any cause |
Time Frame: 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective response rate (ORR) based on local investigator assessment as per RECIST 1.1
Disease control rate (DCR) based on local investigator assessment as per RECIST 1.1
Time-to-response (TTR) based on local investigator assessment as per RECIST 1.1
Duration of response (DOR) based on local investigator assessment as per RECIST 1.1
AUC of Capmatinib derived from plasma capmatinib concentration |
24 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="5"
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="7" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2020 |
| Date of Study Completion (India) |
06/05/2022 |
| Date of First Enrollment (Global) |
17/12/2019 |
| Date of Study Completion (Global) |
07/02/2023 |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose is to evaluate the efficacy and safety of the combination of capmatinib with pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with locally advanced or metastatic NSCLC who have PD-L1 expression ≥ 50% and have no EGFR mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET dysregulation. The combination of capmatinib with checkpoint inhibitors has been established to be tolerable and could provide additional clinical benefit to the subjects |