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Study of Efficacy and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C- Mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.

Study acronym: KontRASt-06
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 0 → 1 primary endpoints
See other at-risk trials from Novartis

Record History

  1. Completion moved earlier from Dec 31, 2026 to Oct 28, 2026 Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 11 of 12 entries · Study description expanded, about 5 words Show 3 more changesShow less
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 11 of 12 entries
    • Study description expanded, about 5 words
  2. Site details revised at 4 of 45 sitesv44
  3. Primary endpoint(s) modified Primary endpoint(s) modified · Site details revised at 3 of 45 sitesv43 Show 2 more changesShow less
    • Primary endpoint(s) modified
    • Site details revised at 3 of 45 sites
  4. Re-verified, no change to tracked fieldsv42
  5. Start date: Oct 31, 2022 to Dec 6, 2022 Trial sites reduced: 53 → 45 locations · Trial sites expanded: 45 → 53 locations · Completion moved earlier from Nov 30, 2027 to Dec 31, 2026 · 1 morev41 Show 4 more changesShow less
    • Trial sites reduced: 53 → 45 locations
    • Trial sites expanded: 45 → 53 locations
    • Completion moved earlier from Nov 30, 2027 to Dec 31, 2026
    • Completion pushed from Dec 31, 2026 to Nov 30, 2027
Show 39 earlier versionsHide 39 earlier versions
  1. Study sites: 45 to 53 Completion date: Dec 31, 2026 to Nov 30, 2027 · Start date: Dec 6, 2022 to Oct 31, 2022 · Study description expanded, about 2 wordsv40 Show 3 more changesShow less
    • Completion date: Dec 31, 2026 to Nov 30, 2027
    • Start date: Dec 6, 2022 to Oct 31, 2022
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Site details revised at 1 of 45 sitesv39
  3. Enrollment target: 96 to 95 Completion date: Nov 30, 2027 to Dec 31, 2026v38 Show 1 more changeShow less
    • Completion date: Nov 30, 2027 to Dec 31, 2026
  4. Study sites: 44 to 45v37
  5. Results first posted: Oct 9, 2025 Secondary endpoints revised (12) · Primary endpoint revisedv36 Show 2 more changesShow less
    • Secondary endpoints revised (12)
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  6. Start date: Oct 31, 2022 to Dec 6, 2022 Secondary endpoints: 8 to 12 · Site details revised at 5 of 44 sites · Study description shortened, about 2 wordsv35 Show 3 more changesShow less
    • Secondary endpoints: 8 to 12
    • Site details revised at 5 of 44 sites
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  7. Site details revised at 2 of 44 sitesv34
  8. 6 versions Re-verified since May 20, 2025, no change to tracked fieldsv28-v33
  9. Primary completion date: Nov 3, 2024 to Nov 4, 2024v27
  10. Primary endpoint revised Secondary endpoints: 27 to 8 · Study description expanded, about 44 words · Site details revised at 2 of 44 sites · 1 morev26 Show 4 more changesShow less
    • Secondary endpoints: 27 to 8
    • Study description expanded, about 44 words
    • Site details revised at 2 of 44 sites
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. Start date: Dec 6, 2022 to Oct 31, 2022v25
  12. Primary completion date: Nov 4, 2024 to Nov 3, 2024v24
  13. Study sites: 51 to 44v23
  14. Primary completion date changed from estimate of Nov 2, 2026 to Nov 4, 2024v22
  15. Re-verified, no change to tracked fieldsv21
  16. Study sites: 49 to 51v20
  17. Study sites: 51 to 49v19
  18. Study sites: 53 to 51v18
  19. Re-verified, no change to tracked fieldsv17
  20. Study sites: 62 to 53v16
  21. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 120 to confirmed 96 · Study sites: 79 to 62v15 Show 2 more changesShow less
    • Enrollment target: estimated 120 to confirmed 96
    • Study sites: 79 to 62
  22. Study sites: 77 to 79v14
  23. Study sites: 74 to 77v13
  24. Study sites: 73 to 74v12
  25. Study sites: 69 to 73v11
  26. Study sites: 65 to 69v10
  27. Study sites: 62 to 65 Secondary endpoints: 28 to 27 · Eligibility criteria expanded, about 1 wordv9 Show 2 more changesShow less
    • Secondary endpoints: 28 to 27
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  28. Study sites: 50 to 62v8
  29. Study sites: 40 to 50v7
  30. Study sites: 30 to 40v6
  31. Study sites: 23 to 30v5
  32. Study sites: 8 to 23v4
  33. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 8 · Start date changed from estimate of Nov 30, 2022 to Dec 6, 2022v3 Show 2 more changesShow less
    • Study sites: 0 to 8
    • Start date changed from estimate of Nov 30, 2022 to Dec 6, 2022
  34. Start date: Oct 31, 2022 to Nov 30, 2022v2
  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.
This study aims to evaluate the antitumor activity and safety of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a KRAS G12C mutation and have a PD-L1 expression \< 1% (cohort A) or a PD-L1 expression ≥ 1% and an STK11 co-mutation (cohort B).
Trial Details
NCT Number NCT05445843
Lead Sponsor Novartis Pharmaceuticals
Conditions Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation
Enrollment 95 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov