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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06890598




Registration number
NCT06890598
Ethics application status
Date submitted
18/03/2025
Date registered
24/03/2025

Titles & IDs
Public title
Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
Scientific title
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
Secondary ID [1] 0 0
2024-512302-25-00
Secondary ID [2] 0 0
18763
Universal Trial Number (UTN)
Trial acronym
SUNRAY-02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Olomorasib
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Durvalumab
Treatment: Drugs - Placebo

Experimental: Part A: Olomorasib + 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.

Placebo comparator: Part A: Placebo + 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.

Experimental: Part B: Olomorasib + 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.

Placebo comparator: Part B: Placebo + 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.


Treatment: Drugs: Olomorasib
Administered orally.

Treatment: Drugs: Pembrolizumab
Administered intravenously (IV).

Treatment: Drugs: Durvalumab
Administered IV.

Treatment: Drugs: Placebo
Administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Disease-Free Survival (DFS) by Investigator Assessment
Timepoint [1] 0 0
Randomization to disease recurrence or death from any cause (Estimated as approximately 48 months).
Primary outcome [2] 0 0
Part B: Progression-Free Survival (PFS)
Timepoint [2] 0 0
Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Secondary outcome [1] 0 0
Part A & B: Overall Survival (OS)
Timepoint [1] 0 0
Randomization to disease progression or death from any cause (Estimated as approximately 5 years).
Secondary outcome [2] 0 0
Part A & B: Change from baseline in health-related quality of life (HRQoL), measured by European Organization for Research & Treatment of CancerQualityofLifeQuestionnaire-Core 30 (EORTC QLQ-C30)
Timepoint [2] 0 0
Randomization through end of treatment (Estimated as approximately 3 years).
Secondary outcome [3] 0 0
Part B: Objective Response Rate (ORR) per RECIST 1.1 by BICR
Timepoint [3] 0 0
Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Secondary outcome [4] 0 0
Part B: Duration of Response (DOR) per RECIST 1.1 by BICR
Timepoint [4] 0 0
Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Secondary outcome [5] 0 0
Part B: Disease Control Rate (DCR) per RECIST 1.1 by BICR
Timepoint [5] 0 0
Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Secondary outcome [6] 0 0
Part B: Time to Response (TTR) per RECIST 1.1 by BICR
Timepoint [6] 0 0
Randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 3 years).
Secondary outcome [7] 0 0
Part B: Progression-Free Survival 2 (PFS2) by investigator assessment
Timepoint [7] 0 0
Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 3 years).]
Secondary outcome [8] 0 0
Part B: Changes in Non-Small Cell Lung Cancer (NSCLC)-related symptoms, measured by the NSCLC-Symptom Assessment Questionnaire (SAQ)
Timepoint [8] 0 0
Randomization through end of treatment (Estimated as approximately 3 years).
Secondary outcome [9] 0 0
Part B: Time to worsening of NSCLC-related symptoms, as measured by NSCLC-SAQ
Timepoint [9] 0 0
Randomization through end of treatment (Estimated as approximately 3 years).
Secondary outcome [10] 0 0
Part B: Changes in patient-reported pulmonary symptoms of cough, chest pain, and dyspnea, measured by NSCLC-SAQ
Timepoint [10] 0 0
Randomization through end of treatment (Estimated as approximately 3 years).

Eligibility
Key inclusion criteria
* Histological or cytological confirmation of NSCLC.

* Part A

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.
* Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.
* Must have disease with evidence of KRAS G12C mutation.
* Must have known programmed death-ligand 1 (PD-L1) expression
* Must have an ECOG performance status of 0 or 1.
* Able to swallow oral medication.
* Must have adequate laboratory parameters.
* Contraceptive use should be consistent with local regulations for those participating in clinical studies.
* Women of childbearing potential must

* Have a negative pregnancy test.
* Not be breastfeeding during treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have known changes in the EGFR or ALK genes.
* Have another type of cancer that is progressing or required active treatment within the past 3 years before screening.
* Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2032
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Tamworth Hospital - North Tamworth
Recruitment hospital [2] 0 0
Icon Cancer Centre Wesley - Auchenflower
Recruitment hospital [3] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 0 0
ICON Cancer Centre - Kurralta Park - Kurralta Park
Recruitment hospital [5] 0 0
Austin Health - Heidelberg
Recruitment hospital [6] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [7] 0 0
Latrobe Regional Health - Traralgon
Recruitment postcode(s) [1] 0 0
2340 - North Tamworth
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
4575 - Birtinya
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3630 - Shepparton
Recruitment postcode(s) [7] 0 0
3844 - Traralgon
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Country [187] 0 0
Turkey
State/province [187] 0 0
Adana
Country [188] 0 0
Turkey
State/province [188] 0 0
Antalya
Country [189] 0 0
Turkey
State/province [189] 0 0
Edirne
Country [190] 0 0
Turkey
State/province [190] 0 0
Gaziantep
Country [191] 0 0
Turkey
State/province [191] 0 0
Istanbul
Country [192] 0 0
Turkey
State/province [192] 0 0
Izmir
Country [193] 0 0
Turkey
State/province [193] 0 0
Samsun
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Brighton And Hove
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Devon
Country [196] 0 0
United Kingdom
State/province [196] 0 0
England
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Kensington And Chelsea
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Sutton
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Birmingham
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06890598