CTRI/2025/10/096678 [Registered on: 30/10/2025] Trial Registered Prospectively
Last Modified On:
30/10/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Two clinical trials for people with advanced lung cancer that has a KRAS G12C mutation: one is a Phase 2 study testing adagrasib alone and with pembrolizumab, and the other is a Phase 3 study comparing the combination of adagrasib and pembrolizumab to pembrolizumab alone.
Scientific Title of Study
A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab in Patients with Advanced Non Small Cell Lung Cancer with KRAS G12C Mutation
Trial Acronym
Krystal 7
Secondary IDs if Any
Secondary ID
Identifier
849-007 version 9.0 dated 24 Sep 2024
Protocol Number
NCT04613596
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Suhail Ahmad
Designation
Regulatory Affairs Manager
Affiliation
Pharmaceutical Research Associates India Private Limited
Address
Level 3 & 4, Prestige Blue Chip Software Park, Municipal No. 9, Hosur Road, Adugodi, Madiwala Range, Ward No. 63, Bangalore, Tavarekere, Bangalore South
Bangalore KARNATAKA 560029 India
Phone
9990852838
Fax
Email
suhail.ahmad@iconplc.com
Details of Contact Person Public Query
Name
Suhail Ahmad
Designation
Regulatory Affairs Manager
Affiliation
Pharmaceutical Research Associates India Private Limited
Address
Level 3 & 4, Prestige Blue Chip Software Park, Municipal No. 9, Hosur Road, Adugodi, Madiwala Range, Ward No. 63, Bangalore, Tavarekere, Bangalore South
Bangalore KARNATAKA 560029 India
Phone
9990852838
Fax
Email
suhail.ahmad@iconplc.com
Source of Monetary or Material Support
Mirati Therapeutics, Inc. a Bristol Myers Squibb Company, Route 206 and Province Line Road Princeton, NJ 08543, USA.
Primary Sponsor
Name
Mirati Therapeutics, Inc. a Bristol Myers Squibb Company
Address
Route 206 and Province Line Road Princeton, NJ 08543, USA.
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Pharmaceutical Research Associates India Private Limited
Level 3 & 4, Prestige Blue Chip Software Park, Municipal No. 9, Hosur Road, Adugodi, Madiwala Range, Ward No. 63, Bangalore, Tavarekere, Bangalore South, Bangalore-560029,
Karnataka, India.
Countries of Recruitment
Argentina Australia Austria Belgium Brazil Bulgaria Chile China Colombia Croatia Czech Republic Denmark Finland France Georgia Germany Greece Hong Kong Hungary India Ireland Israel Italy Japan Malaysia Mexico Netherlands New Zealand Norway Poland Portugal Republic of Korea Romania Serbia Singapore South Africa Spain Taiwan Thailand Turkey United Kingdom United States of America
Sites of Study
No of Sites = 16
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr K Pavithran
Amrita Institute of Medial Sciences
Medical Oncology, A Block, Tower 3, Ground Floor, Room- 02, AIMS Ponekkara P.O.
Kochi–682041, Kerala, India
Ernakulam KERALA
9895367090
pavithrank@aims.amrita.edu
Dr Senthil J Rajappa
Basavatarakam Indo American Cancer Hospital & Research Institute (BIACH&RI)
Dept of Clinical Trials, Block 3, 1st floor,
Room 367, Road No 10, Banjara hills, Hyderabad-500034,Telangana, India
Hyderabad TELANGANA
9849213102
senthiljrajappa@gmail.com
Dr Chirag Jyotiker Desai
Hemato Oncology Clinic Ahmedabad Pvt. Ltd
Research Department, 3rd Floor, Room no: 310, Nirmaya Complex, Ground Floor to Third Floor, Beside Pandit
Dindayal Upadhyay Auditorium, Rajpath Club Road, Off SG Highway, Ahmedabad-380054, Gujarat, India
Ahmadabad GUJARAT
9824047561
chiragdesai.oncology@gmail.com
Dr Pratap Kishore Das
Indraprastha Apollo Hospitals
Medical Oncology, Ground Floor, Room no: 1115, Sarita Vihar, Mathura Road, New Delhi, India–110076 South DELHI
9810444600
drpratapdas@gmail.com
Dr Rohan Bhise
KLES Dr Prabhakar Kore Hospital & Medical Research Centre
Department of Medical oncology, Ground Floor, Room C4,Nehrunagar, Belagavi-590010, Karnataka, India Belgaum KARNATAKA
9448866712
Rohanbhise30@gmail.com
Dr Anuj Gupta
Mahamana Pandit Madan Mohan Malaviya Cancer Centre
Medical Oncology Department, Ground Floor, D & T Block, Room No.: 33, Sundar Bagiya, Near Nariya Gate, Banaras Hindu University Campus, Varanasi, Uttar Pradesh-221005, India Varanasi UTTAR PRADESH
9588229594
dr.anuj.gupta24@gmail.com
Dr Mule Tushar Rajendra
Marathwada Cancer Hospital and Research Institute
Department of Oncology, 4th Floor, 404
Plot No. 2, Dnyaneshwar Nagar, In front of Stadium, Garkheda, Aurangabad, Maharashtra–431002, India Aurangabad MAHARASHTRA
9820493558
drtusharmule22985@gmail.com
Dr Bhavesh B Parekh
Marengo CIMS Hospital Pvt. Ltd.
Oncology Department, Basement 1, room no: 10, Plot 67/1, Nr. Shukan Mall, opp. Panchamrut Bunglows, off. science city road, Sola, Ahmedabad-380060, Gujarat, India Ahmadabad GUJARAT
9825034353
Bhavesh.parekh@marengoasia.com
Dr Saju Sekharan Vilasini
Meenakshi Mission Hospital & Research Centre
Department of Oncology, Oncology Building, 1st Floor, Lake Area, Melur Road. Madurai-625107, Tamil Nadu, India Madurai TAMIL NADU
7904423513
drsajusv@gmail.com
Dr Vikas L
Mysore Medical College and Research Institute
Department Of Radiation Oncology, Ground floor, Room no 22, Mysore Medical College and Research Institute, K.R. Hospital, Irwin Road, Mysore-570001, Karnataka, India Mysore KARNATAKA
9663099774
vikilaxman@gmail.com
Dr Chandrakanth MV
Narayana Superspeciality Hospital
Department: Medical Oncology, Ground floor, Room no-18, 120/1, Andul Road, Howrah-711103, West Bengal, India Haora WEST BENGAL
7003206633
drmvch@gmail.com
Dr Rajiv Lochan Jena
Netaji Subhas Chandra Bose Cancer Hospital & Research Institute
Department of Medical Oncology, Ground Floor, Room no: 05, 3081 Nayabad, New Garia, Kolkata, West Bengal, India-700094. Kolkata WEST BENGAL
8617775659
rajivjena1986@gmail.com
Dr Anshul Rajendraprasad Agarwal
Nirmal Hospital Pvt. Ltd.
Clinical Research Department, Ring Road, Surat-395002, Gujarat, India Surat GUJARAT
9969465723
dranshulragarwal@gmail.com
Dr Sandeep Kumar Jasuja
R.K. Birla Cancer Center, S.M.S Medical College & Attached Hospital
JLN Marg, Jaipur, 302004, Rajasthan India. Jaipur RAJASTHAN
9660121475
sandeepjasuja@gmail.com
Dr Alok Ranjan
State Cancer Institute Indira Gandhi Institute of Medical Sciences
Department of Medical Oncology, State Cancer Institute, IGIMS, 1st floor, SCI OPD, Room no: 114, Sheikhpura, Patna-800014, Bihar, India Patna BIHAR
9572240838
dralokranjansciigims@gmail.com
Dr Kumar Prabhash
Tata Memorial Centre
Medical oncology, 2nd floor, Room- 204, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai-400012, Maharashtra, India Mumbai MAHARASHTRA
9167760576
kprabhash1@gmail.com
Details of Ethics Committee
No of Ethics Committees= 16
Name of Committee
Approval Status
Ethics Committee N.S.C.B.C Research Institute, Netaji Subhas Chandra Bose Cancer Hospital
Approved
Ethics Committee of Marengo Asia Healthcare Pvt. Ltd.
Approved
Ethics Committee SMS Medical College & Attached Hospitals
Submittted/Under Review
IEC, KLE Academy of Higher Education & Research
Submittted/Under Review
IEC- MMC and RI and Associated Hospital
Approved
Institutional Ethics Committee Amrita Institute of Medical Sciences
Submittted/Under Review
Institutional Ethics Committee Basavatarakam Indo American Cancer Hospital & RI
Approved
Institutional Ethics Committee Meenakshi Mission Hospital and Research Centre
Approved
Institutional Ethics committee Tata Memorial Hospital
Approved
Institutional Ethics Committee – Clinical Studies, Indraprastha Apollo Hospitals
Approved
Institutional Ethics Committee, IGIMS
Approved
Institutional Ethics Committee, MPMMCC & HBCH, Mahamana Pandit Madan Mohan Malaviya Cancer Centre
Submittted/Under Review
MGM Ethics Committee for Research on Human Subjects
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Adagrasib + pembrolizumab
Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W
Comparator Agent
Pembrolizumab
Pembrolizumab 200 mg IV Q3W
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
• Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS more than equal to 50 percentage.
• Phase 3: Presence of evaluable or measurable disease per RECIST
• Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:
1. No evidence of brain metastases
2. Untreated brain metastases not needing immediate local therapy
3. Previously treated brain metastases not needing immediate local therapy
ExclusionCriteria
Details
• Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).
• Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:
1. Any untreated brain lesions more than 1.0 cm in size
2. Any brainstem lesions
3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of more than 10 mg of prednisone (or equivalent) prior to randomization.
4. Have poorly controlled (more than 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy
• Phase 3: Radiation to the lung more than 30 Gy within 6 months prior to the first dose of study treatment
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab: Progression Free Survival per RECIST 1.1 by Blinded Independent Central Review (BICR) and Overall Survival
36 months
Secondary Outcome
Outcome
TimePoints
To evaluate the safety and tolerability in the study population: Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities.
36 months
To evaluate the PK of adagrasib administered in the study population: Pharmacokinetics (PK) Blood plasma Adagrasib and potential metabolite concentrations
36 months
To evaluate health-related quality of life (HRQOL) and lung cancer specific symptoms in the study population: Patient Reported Outcomes to measure quality of life
36 months
Progression Free Survival per RECIST 1.1 by Investigator: Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
36 months
Duration of Response (DOR) per RECIST 1.1 by Investigator and BICR:Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
36 months
Objective Response Rate (ORR) per RECIST 1.1 by Investigator and BICR: Defined as the percent of patients documented to have a confirmed CR or PR.
36 months
Target Sample Size
Total Sample Size="550" Sample Size from India="51" 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 3
Date of First Enrollment (India)
12/11/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
18/03/2024
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Not Yet Recruiting
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
The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.