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SUNRAY-01NCT06119581

A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 48 versions: 46 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 418 → 415 locations
  2. Study sites: 418 to 416
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 6 of 15 entries
    • Publications: details revised at 1 of 1 entry
  3. Site details revised at 4 of 418 sitesv46
  4. Study sites: 419 to 418v45
  5. Site details revised at 1 of 419 sitesv44
Show 40 earlier versionsHide 40 earlier versions
  1. Study sites: 420 to 419v43
  2. Study sites: 422 to 420v42
  3. Study sites: 420 to 422v41
  4. Study sites: 422 to 420v40
  5. Site details revised at 2 of 422 sitesv39
  6. Study sites: 423 to 422v38
  7. Study sites: 424 to 423v37
  8. Primary completion date: Oct 2026 to Nov 2027v36 Show 5 more changesShow less
    • Enrollment target: 1016 to 1264
    • Study completion date: Oct 2029 to Jan 2031
    • Study arms: 7 to 8
    • Eligibility criteria expanded, about 3 words
    • Study description expanded, about 4 words
  9. Enrollment target: 1186 to 1016v35
  10. Enrollment target: 1016 to 1186
    • Study sites: 425 to 424
    v34
  11. Study sites: 426 to 425v33
  12. Site details revised at 4 of 426 sitesv32
  13. Study sites: 425 to 426v31
  14. Site details revised at 6 of 425 sitesv30
  15. Study sites: 427 to 425v29
  16. Study sites: 428 to 427v28
  17. Site details revised at 8 of 428 sitesv27
  18. Study sites revised (428)v26
  19. Study sites revised (428)v25
  20. Site details revised at 3 of 428 sitesv24
  21. Study sites: 427 to 428v23
  22. Study sites: 425 to 427
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: 14 to 15
    v22
  23. Study sites: 426 to 425v21
  24. Study sites: 427 to 426v20
  25. Study sites: 431 to 427v19
  26. Study sites: 428 to 431v17
  27. Study sites: 422 to 428v16
  28. Study sites: 370 to 422v15
  29. Eligibility criteria shortened, about 13 words
    • Secondary endpoints: 10 to 14
    • Collaborators shortened, about 3 words
    • Study title shortened, about 5 words
    v14
  30. Study sites: 365 to 370v13
  31. Study sites: 352 to 365v12
  32. Study sites: 373 to 352v10
  33. Study sites: 371 to 373v9
  34. Study sites revised (371)v8
  35. Study sites: 365 to 371v7
  36. Site contacts updated at 1 of 365 sitesv6
  37. Study sites: 363 to 365
    • Primary completion date: Oct 1, 2026 to Oct 2026
    • Study completion date: Oct 1, 2029 to Oct 2029
    v5
  38. Study sites: 386 to 363v4
  39. Study sites: 314 to 386v3
  40. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 218 to 314
    • Start date changed from estimate of Jan 3, 2024 to Dec 21, 2023
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE)
Timeframe: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Part A and Part B: Progression-Free Survival (PFS)
Timeframe: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)

Secondary (15)

Part A and Part B: Overall Survival (OS)
Part A and Part B: PFS
Part A and Part B: Overall Response Rate (ORR): Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
Part A and Part B: Duration of Response (DOR)
Part A and Part B: Disease Control Rate (DCR): Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD)
Show 10 moreShow less
Part A and Part B: Time to Response (TTR)
Part A and Part B: Intracranial Overall Response Rate (ORR)
Part A and Part B: Intracranial Duration of Response (DoR)
Part A and Part B: PFS2
Part A and Part B: Changes in NSCLC-related symptoms as measured by NSCLC-SAQ
Part A and Part B: Time to Worsening of NSCLC-related Symptoms as Measured by NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ)
Part A and Part B: Changes in physical function, as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning subscale and IL19
Part A and Part B: Time to Deterioration in Physical Function, as Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning Subscale and IL19
Part A and Part B: Proportion of Time with High Side-Effect Burden, as Measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT-GP5)
Part A and Part B: Change from Baseline in Overall Health-related Quality of Life, as Measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale

Arms and interventions

Dose Optimization: LY3537982 Dose Level 1 plus PembrolizumabExperimental

LY3537982 Dose level 1 administered orally in combination with pembrolizumab administered intravenously (IV) in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Dose Optimization: LY3537982 Dose Level 2 plus PembrolizumabExperimental

LY3537982 Dose level 2 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Safety Lead In: LY3537982 plus Pembrolizumab, Pemetrexed and PlatinumExperimental

LY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Part A: LY3537982 plus PembrolizumabExperimental

LY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Part A: Placebo plus PembrolizumabPlacebo comparator

Placebo administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Part B: LY3537982 plus Pembrolizumab, Pemetrexed, and PlatinumExperimental

LY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Part B: Placebo plus Pembrolizumab, Pemetrexed, and PlatinumPlacebo comparator

Placebo administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Part C: LY3537982 plus PembrolizumabExperimental

LY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Drugs: LY3537982, Pembrolizumab, Placebo, Cisplatin, Carboplatin, Pemetrexed

Sites

415 sites in 29 countries

United States 87, China 33, Japan 30, Brazil 29, Spain 20, France 18, India 18, Germany 17, Taiwan 17, Turkey (Türkiye) 17, South Korea 15, Mexico 14, Australia 11, Belgium 10, Italy 10, Greece 9, Netherlands 9, Romania 8, United Kingdom 8, Norway 7, Portugal 7, Hungary 5, Austria 3, Canada 3, Poland 3, Czechia 2, Sweden 2, Switzerland 2, Denmark 1