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CTRI Number  CTRI/2024/11/076926 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 06/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To evaluate how safe and tolerable Entrectinib is for Indian patients with advanced or metastatic solid tumors that have certain genetic changes. 
Scientific Title of Study   A phase IV, open-label, multi-cohort study to evaluate the safety and tolerability of oral Entrectinib in Indian patients with unresectable, locally advanced or metastatic solid tumors harboring specific oncogenic genomic alterations. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ML44740_V1.0_31May2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Jyotii Poddaar 
Designation  Lead -Clinical Operations  
Affiliation  Roche Products India Private Limited  
Address  Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall

Mumbai
MAHARASHTRA
400086
India 
Phone  9136064373  
Fax    
Email  jyotii.poddaar@roche.com  
 
Details of Contact Person
Public Query  
Name  Heta Khokhani 
Designation  Manager- Clinical Operations 
Affiliation  Roche Products (India) Pvt. Ltd. 
Address  146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar Mumbai,Maharashtra, 400086 India

Mumbai
MAHARASHTRA
400086
India 
Phone  9892440927  
Fax    
Email  heta.khokhani@roche.com  
 
Source of Monetary or Material Support  
Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar, Mumbai - 400 086 Maharashtra ,India 
 
Primary Sponsor  
Name  Roche Products (India) Pvt. Ltd 
Address  146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar Mumbai,Maharashtra 400086 India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Thirumalairaj Raja   Apollo Speciality Hospital  Apollo Speciality Hospital, New No. 467, Old No. 320, Padma Complex, Anna Salai, Nandanam, 600 035, Chennai, Tamil Nadu
Chennai
TAMIL NADU 		 9841070195

rajatraj@yahoo.com 
Dr Dipanjan Panda  Indraprastha Apollo Hospitals  Indraprastha Apollo Hospitals, Sarita Vihar, Mathura Road, Delhi-Mathura Road, New Delhi-110076
New Delhi
DELHI 		 919540946934

dipanjan.panda@gmail.com 
Dr Poulami Basu  Netaji Subhash Chandra Bose Cancer Hospital  Netaji Subhas Chandra Bose Cancer Hospital, 3081 Nayabad, New Garia, Kolkata 700094, West Bengal, India.
Kolkata
WEST BENGAL 		 6290073778

poulamibasu18386@gmail.com 
Dr Mansi Sharma  Rajiv Gandhi Cancer Institute & Research Centre  Rajiv Gandhi Cancer Institute and Research Centre, Rohini, Sector-5, Delhi 110085
New Delhi
DELHI 		 9873008262

mansisharma08@gmail.com 
Dr Anoop Manoharan  Regional Cancer Centre  Medical College PO, Trivandrum, Kerala,695011
Thiruvananthapuram
KERALA 		 9447134973

dranooptm@yahoo.co.in 
Dr Kumar Prabhash  Tata Memorial Hospital  OPD No. 204, 2nd floor, Homi Bhabha Block, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel East, Mumbai 400012, Maharashtra, India
Mumbai
MAHARASHTRA 		 9769328047

kprabhash1@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee N S C B C Research Institute  Approved 
Human Ethics Committee, RCC   Approved 
Institutional Ethics Committee-Clinical Studies  Approved 
Institutional Ethics Committee-I & II, Tata Memorial Hospital  Submittted/Under Review 
Institutional Review Board  Approved 
Instutional Ethics Committee-Clinical Studies  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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  Entrectinib  Unit dose strength(s) is 100 or 200 mg/capsule Adult patients will receive entrectinib at a dose of 600 mg (3x200mg capsules) orally once daily for 12 months. In pediatric patients, the recommended daily dosage is based on body surface area as below BSA (1.11 to 1.50 square metre) equal to 400 mg (2x200mg capsules) BSA (more than equal to 1.51 square metre) equal to 600 mg (3x200mg capsules) 
Comparator Agent  Not Applicable  It is an open label study and there is no comparator 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Potential patients are eligible to be included in the study only if all of the following criteria apply:
1.Age more than equal to 18 years at the time of signing Informed Consent Form
2. Ability to comply with the study protocol, in the investigator’s judgment
3. Ability to swallow entrectinib intact without chewing, crushing, or opening the capsules
4. Patient has a positive benefit/risk profile for treatment with entrectinib by the investigator.

COHORT A (ROS1-POSITIVE NSCLC) SPECIFIC INCLUSION CRITERIA:
1. Histologically- or cytologically-confirmed diagnosis of advanced or recurrent (Stage IIIB/C, not amenable for radical treatment) or metastatic (Stage IV) NSCLC that harbors a documented ROS1 gene rearrangement.
2. Documented positivity for ROS1 gene rearrangements must have been determined locally at CLIA-certified or equivalently accredited diagnostic laboratories using nucleic acid-based testing methods that rely on direct assessment of ROS1 gene rearrangements in tumor tissue. Examples of acceptable methods include NGS, Sanger sequencing, reverse transcriptase-polymerase chain reaction, NanoString and EdgeSeq. Fluorescence in situ hybridization is also an acceptable method, with ROS1 positivity, defined as the detection of at least 15 percent of neoplastic nuclei with ROS1 gene rearrangements among a minimum of 50 total neoplastic nuclei. Immunohistochemistry is not an acceptable method.

COHORT B (NTRK FUSION POSITIVE SOLID TUMOR) SPECIFIC INCLUSION CRITERIA:
1. Patients who are 12 years of age or older will be enrolled in this cohort. Patient or legal guardian must provide signed assent and informed consent to participate in the study.
2. Documented NTRK1/2/3 gene fusion positivity, as determined by a Clinical Laboratory Improvement Amendments (CLIA) or equivalently certified next-generation sequencing (NGS) assay (tissue). Gene fusion positivity is defined as a 3’ NTRK1/2/3 fusion with a protein coding 5’ gene fusion partner, which are predicted to be in-frame with an intact kinase domain. 
 
ExclusionCriteria 
Details  Potential patients are excluded from the study if any of the following criteria apply:
1. Patients unable to provide consent
2. Patient is not eligible as per local PI and investigators discretion. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
This study will evaluate the safety and tolerability of entrectinib in patients with unresectable, locally advanced, or metastatic solid tumors harboring specific oncogenic genomic alterations  Primary endpoint-
Incidence and severity of adverse events AEs with severity determined according to NCI CTCAE v5 grading scale

Secondary endpoints-
Incidence of SAEs, adverse events of special interest AESIs, greater than equal to Grade 3 AEs, AEs leading to discontinuation of treatment, AEs leading to dose reduction, AEs leading to drug interruption, AEs leading to death 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of entrectinib in patients with unresectable, locally advanced, or metastatic solid tumors harboring specific oncogenic genomic alterations.  Objective ORR, defined as the proportion of participants with a CR or PR on two consecutive occasions 4 weeks apart, as determined by the investigator according to RECIST v1.1. DOR, defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator using RECIST v1.1, or death from any cause, whichever occurs first. Duration of Treatment 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a Phase IV, open-label, multi-cohort study in patients with unresectable, locally advanced, or metastatic solid tumors harboring specific oncogenic genomic alterations. The purpose of this study is to assess the safety and tolerability of entrectinib in Indian patients with unresectable, locally advanced, or metastatic solid tumors harboring specific oncogenic genomic alterations. Entrectinib has been approved in India by the regulatory agency.  
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