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Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 89 → 93 locationsv35
  2. Study sites: 88 to 89v34
  3. Study sites: 86 to 88v33
  4. Study sites: 74 to 86v32
  5. Study sites: 71 to 74v31
Show 29 earlier versionsHide 29 earlier versions
  1. Study sites: 68 to 71v30
  2. Study sites: 65 to 68v29
  3. Study sites: 63 to 65v28
  4. Study sites: 62 to 63v27
  5. Study sites: 59 to 62v26
  6. Secondary endpoints: details revised at 1 of 6 entriesv25
  7. Enrollment target: 484 to 616 Study description expanded, about 42 words · Study arms: 3 to 4 · Eligibility criteria expanded, about 3 words · 1 morev24 Show 4 more changesShow less
    • Study description expanded, about 42 words
    • Study arms: 3 to 4
    • Eligibility criteria expanded, about 3 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  8. Site contacts updated at 18 of 59 sitesv23
  9. Study sites: 58 to 59v22
  10. Study sites: 55 to 58v21
  11. Study sites revised (55)v20 See this version in full on ClinicalTrials.gov ↗
  12. Study sites: 53 to 55v19
  13. Study sites: 49 to 53v18
  14. Study sites: 46 to 49 Interventions: Carboplatin (Drug), Cisplatin (Drug), Pembrolizumab (Drug), Pemetrexed (Drug), RMC-6236 (Drug), RMC-6291 (Drug) to Carboplatin (Drug), Cisplatin (Drug), Pembrolizumab (Drug), Pemetrexed (Drug), RMC-6236 (Drug), RMC-6291 (Drug), RMC-9805 (Drug) · Eligibility criteria expanded, about 13 words · Secondary endpoints: 5 to 6 · 2 morev17 Show 5 more changesShow less
    • Interventions: Carboplatin (Drug), Cisplatin (Drug), Pembrolizumab (Drug), Pemetrexed (Drug), RMC-6236 (Drug), RMC-6291 (Drug) to Carboplatin (Drug), Cisplatin (Drug), Pembrolizumab (Drug), Pemetrexed (Drug), RMC-6236 (Drug), RMC-6291 (Drug), RMC-9805 (Drug)
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 5 to 6
    • Study description expanded, about 30 words
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 41 to 46v16
  16. Enrollment target: 352 to 484 Study sites: 35 to 41 · Secondary endpoints: details revised at 1 of 5 entries · Study description expanded, about 4 wordsv15 Show 3 more changesShow less
    • Study sites: 35 to 41
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  17. Study sites: 33 to 35v14
  18. Study sites: 30 to 33v13
  19. Study sites: 28 to 30v12
  20. Study sites: 25 to 28v11
  21. Study sites: 24 to 25v10
  22. Study sites: 20 to 24v9
  23. Study sites: 10 to 20v8
  24. Study sites: 6 to 10v7
  25. Study sites: 5 to 6v6
  26. Study sites: 3 to 5v5
  27. Study sites: 2 to 3v4
  28. Start date changed from estimate of Jan 2024 to Jan 18, 2024v3
  29. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date: Dec 2023 to Jan 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date: Dec 2023 to Jan 2024
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with each other. The first four subprotocols include the following: Subprotocol A: RMC-6291 +/- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +/- RMC-6236 + SOC Subprotocol D: RMC-9805
Trial Details
NCT Number NCT06162221
Lead Sponsor Revolution Medicines, Inc.
Conditions Non-Small Cell Lung Cancer, NSCLC, KRAS, NRAS, HRAS-mutated NSCLC, KRAS G12C-mutated Solid Tumors, Lung Cancer, Lung Cancer Stage IV, Advanced Solid Tumor, Cancer, RAS G12D-mutated NSCLC
Enrollment 616 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov