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CTRI Number  CTRI/2025/07/091106 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study on Olomorasib in Lung Cancer Patients 
Scientific Title of Study   A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination with Standard of Care Immunotherapy in Participants with Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
J3M-MC-JZQH version no. Initial protocol dated 13-NOV-2024  Protocol Number 
NCT06890598  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manish Mistry  
Designation  Medical Director  
Affiliation  Eli Lilly and Company (India) Pvt. Ltd  
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon Haryana-122001 India

Gurgaon
HARYANA
122001
India 
Phone  9820234897  
Fax    
Email  manish_mistry@lilly.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Manish Mistry  
Designation  Medical Director  
Affiliation  Eli Lilly and Company (India) Pvt. Ltd  
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon Haryana-122001 India

Gurgaon
HARYANA
122001
India 
Phone  9820234897  
Fax    
Email  manish_mistry@lilly.com   
 
Details of Contact Person
Public Query  
Name  Dr Rajeev Sharan Shrivastava  
Designation  Associate Director  
Affiliation  Eli Lilly and Company (India) Pvt. Ltd  
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon Haryana-122001 India

Gurgaon
HARYANA
122011
India 
Phone  9810308697  
Fax    
Email  shrivastava_rajeev_sharan@lilly.com   
 
Source of Monetary or Material Support  
Eli Lilly and Company (India) PVT LTD, Plot 92, Sector-32, Gurgaon, Haryana-122001 
 
Primary Sponsor  
Name  Eli Lilly and Company (India) Pvt Ltd 
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon Haryana-122001 India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Australia
Austria
Belgium
Brazil
Chile
China
Czech Republic
France
Germany
Greece
Hungary
India
Israel
Italy
Japan
Netherlands
Norway
Poland
Portugal
Republic of Korea
Romania
Slovakia
Spain
Sweden
Switzerland
Taiwan
Turkey
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chetan Dilip Deshmukh  Deenanath Mangeshkar Hospital and Research Centre  Gulawani Maharaj Road, Erandwane, Pune, Maharashtra, India, 411004
Pune
MAHARASHTRA 		 919850811449

drchetandeshmukh@gmail.com 
Dr Ketan Shirsath  Galaxy Superspeciality Hospital  Agnihotra Chowk, opp to Punjabi National Bank, Ulkanagari, Aurangabad Maharashtra- 431001 India
Aurangabad
MAHARASHTRA 		 9970694242

drketan.galaxy@gmail.com 
Dr Chirag Jyotiker Desai  Hemato Oncology Clinic Ahmedabad Pvt. Ltd  Nirmaya Complex, Ground Floor to Third Floor, Beside Pandit Dindayal Upadhyay Auditorium, Rajpath Club Road, Off S.G. Highway, Ahmedabad- 380054 Gujarat, India
Ahmadabad
GUJARAT 		 919824047561

chiragdesai.oncology@gmail.com 
Dr Bipinesh Sansar  Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) and Homi Bhabha Cancer Hospital (HBCH)  OPD No. 28, Department of Medical Oncology, Sundar Bagiya, Near Nariya Gate, Banaras Hindu University Campus, Varanasi – 221005, Uttar Pradesh, India
Varanasi
UTTAR PRADESH 		 918002583913

bipinesh04@yahoo.co.in 
Dr Nandhini Devi R  Malabar Cancer Centre  Department of Clinical Hematology and Clinical Oncology, Malabar Cancer Centre, Post Graduate Institute of Oncology Science & Research, Moozhikkara PO, Kodiyerum Thalassery, Kannur, Kerala India - 670103
Kannur
KERALA 		 9496369909

drnandiniamutha@gmail.com 
Dr Rahul Suhas Kulkarni  Medipoint Hospitals Pvt. Ltd.  241/1 New D. P. Road, Aundh, Pune- 411007, Maharashtra, India
Pune
MAHARASHTRA 		 919726317512

drrahulkulkarni.medipoint@gmail.com 
Dr Manoj Umeshchandra Mahajan  Pacific Medical College & Hospital  Bhillo Ka Bedla Girwa Pratapura Udaipur, Rajasthan-313001, India
Udaipur
RAJASTHAN 		 91 9818051316

drmanojm.clinicaltrials@gmail.com 
Dr Kannan Jayaraman  Rajiv Gandhi Government General Hospital Madras Medical College  GH Post Office, Ponamalle High Road, 3 Grans Southern Trunk Road, Park Town, Nera Chennai Central, Chennai, Tamil Nadu- 600004
Chennai
TAMIL NADU 		 9444143950

drkannan.rgghcr@gmail.com 
Dr Anoop T M  Regional Cancer Centre College Campus  Trivandrum, Kerala- 695011
Thiruvananthapuram
KERALA 		 4712522653

dranooptm@yahoo.co.in 
Dr Avinash Pandey  Savera Cancer & Multispeciality Hospital  Lohiya Nagar, Near Rajendra Nagar Overbridge, Dr. R.N. Singh Road, Kankarbagh, Patna- 800020
Patna
BIHAR 		 91 9967673497

dr.avinashp9@gmail.com 
Dr Sewanti Atul Limaye  Sir H.N. Reliance Foundation Hospital and Research Centre  Prarthana Samaj, Raja Rammohan Roy Road, Girgaum Mumbai, Maharashtra 400004.
Mumbai
MAHARASHTRA 		 919619607339

sewanti.limaye@rfhospital.org 
Dr Bhavesh Poladia  Thangam Cancer Center and Research Institute  54 Dr. Sankaran Road, Namakkal, Tamil Nadu, India, 637001
Namakkal
TAMIL NADU 		 73732 33333

bhaveshpoladia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Ethics Committee of Ishwar Institute of Healthcare  Approved 
Human Ethics Commiteee, (Regional Cancer Centre - Thiruvananthapuram  Submittted/Under Review 
IEC of Sir H.N. Reliance Foundation Hospital and Research Centre  Approved 
Institutional Ethics Committee - Malabar Cancer Centre  Submittted/Under Review 
Institutional Ethics Committee Deenanath Mangeshkar Hospital & Research Centre  Submittted/Under Review 
Institutional Ethics Committee, MPMMCC and HBCH (Unit of Tata Memorial Centre, Mumbai)  Submittted/Under Review 
Institutional Human Ethics Committee of PMCH  Approved 
Madras Medical College  Submittted/Under Review 
Penta-Med Ethics Committee Medipoint Hospitals Pvt. Ltd  Approved 
Savera Cancer & Multispecialty Hospital- Institutional Ethics Committee  Approved 
Swarnim Ethics Committee Netralaya Super Speciality Eye Hospital  Submittted/Under Review 
Thangam Hospital-Institutional Ethics Committee  Approved 
 
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  Part A: Olomorasib plus Pembrolizumab  Participants will receive olomorasib administered orally in combination with pembrolizumab intravenously (IV) for up to 1 year followed by olomorasib alone for up to 3 years of total treatment. 
Comparator Agent  Part A: Placebo plus Pembrolizumab  Participants will receive placebo administered orally in combination with pembrolizumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment. 
Intervention  Part B: Olomorasib plus Durvalumab  Participants will receive olomorasib administered orally in combination with durvalumab administered IV for up to 1 year followed by olomorasib alone for up to 3 years of total treatment. 
Comparator Agent  Part B: Placebo plus Durvalumab  Participants will receive placebo administered orally in combination with durvalumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Histological or cytological confirmation of NSCLC.
1.1 Part A
1.1.1 Clinical Stage II-IIIB (N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.

2. Pathologic Stage II-IIIB (N2) NSCLC treated with initial upfront resection.
2.1 Part B
2.1.1 Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.

3. Must have disease with evidence of KRAS G12C mutationn
4. Must have known programmed death-ligand 1 (PD-L1) expression
5. Must have an ECOG performance status of 0 or 1.
6. Able to swallow oral medication.
7. Must have adequate laboratory parameters.
8. Contraceptive use should be consistent with local regulations for those participating in clinical studies.
9. Women of childbearing potential must have a negative pregnancy test and not be breastfeeding during treatment 
 
ExclusionCriteria 
Details  1. Have known changes in the EGFR or ALK genes.
2. Have another type of cancer that is progressing or required active treatment within the past 3 years before screening.
3. Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
4. Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Part A: Disease-Free Survival (DFS) by Investigator Assessment

Part B: Progression-Free Survival (PFS)  		 Part A: Randomization to disease recurrence or death from any cause (Estimated as approximately 48 months).

Part B: Randomization to disease progression or death from any cause (Estimated as approximately 3 years). 
 
Secondary Outcome  
Outcome  TimePoints 
Part A & B: Overall Survival (OS)  Randomization to disease progression or death from any cause (Estimated as approximately 5 years) 
Part A & B: Change from baseline in health-related quality of life (HRQoL), measured by European Organization for Research & Treatment of CancerQualityofLifeQuestionnaire-Core 30  Randomization through end of treatment (Estimated as approximately 3 years) 
Part B: Objective Response Rate (ORR)  Randomization to disease progression or death from any cause (Estimated as approximately 3 years) 
Part B: Duration of Response (DOR)  Randomization to disease progression or death from any cause (Estimated as approximately 3 years) 
Part B: Time to Response (TTR)  Randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 3 years) 
Part B: Progression-Free Survival 2 (PFS2)  Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 3 years) 
Part B: Changes in Non-Small Cell Lung Cancer (NSCLC)-related symptoms, measured by the NSCLC-Symptom Assessment Questionnaire (SAQ)  Randomization through end of treatment (Estimated as approximately 3 years) 
Part B: Time to worsening of NSCLC-related symptoms, as measured by NSCLC-SAQ  Randomization through end of treatment (Estimated as approximately 3 years) 
Part B: Changes in patient-reported pulmonary symptoms of cough, chest pain, and dyspnea, measured by NSCLC-SAQ   Randomization through end of treatment (Estimated as approximately 3 years) 
Part B: Disease Control Rate (DCR)  Randomization to disease progression or death from any cause (Estimated as approximately 3 years). 
 
Target Sample Size   Total Sample Size="700"
Sample Size from India="50" 
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)   03/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/03/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="6"
Months="6"
Days="10" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  www.vivli.org

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 31-01-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant. 
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