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KontRASt-02NCT05132075

Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer

StatusTerminated
PhasePhase 3
Primary completion
Track this trial

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Record History

The 50 most recent of 56 versions: 37 with changes below, 13 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial terminated Sponsor's reason: Business reasons and not based on any safety concerns. Show 4 more changesShow less
    • Study completion date changed from estimate of Oct 3, 2026 to Oct 5, 2026
    • Secondary endpoints: 14 to 1
    • Study description shortened, about 30 words
    • Site details revised at 7 of 51 sites
  2. Primary completion date changed from estimate of Aug 25, 2026 to Sep 3, 2026 Show 5 more changesShow less
    • Study completion date: Sep 23, 2026 to Oct 3, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 8 of 14 entries
    • Site details revised at 3 of 51 sites
    • Study description expanded, about 2 words
  3. Site details revised at 1 of 51 sitesv51
  4. Study sites: 52 to 51v49
  5. Study sites: 53 to 52v48
Show 32 earlier versionsHide 32 earlier versions
  1. Primary completion date: Feb 28, 2026 to Aug 25, 2026
    • Study completion date: Mar 30, 2026 to Sep 23, 2026
    • Site details revised at 13 of 53 sites
    v46
  2. Site details revised at 17 of 53 sitesv45
  3. Study sites: 52 to 53v44
  4. Site details revised at 3 of 52 sitesv42
  5. Study sites: 53 to 52v38
  6. Enrollment target: 96 to 95v36
  7. Primary completion date: Oct 1, 2025 to Feb 28, 2026
    • Study completion date: Oct 31, 2025 to Mar 30, 2026
    • Start date: Jun 23, 2022 to Jun 15, 2022
    • Site details revised at 2 of 53 sites
    v35
  8. Site details revised at 1 of 53 sitesv32
  9. Primary completion date: May 24, 2025 to Oct 1, 2025
    • Study completion date: May 24, 2025 to Oct 31, 2025
    v31
  10. Start date: Jun 15, 2022 to Jun 23, 2022v29
  11. Enrollment target: 95 to 96
    • Study sites: 69 to 53
    • Primary and study completion dates: Apr 24, 2025 to May 24, 2025
    v28
  12. Study sites: 65 to 69
    • Primary and study completion dates: May 24, 2025 to Apr 24, 2025
    v27
  13. Primary completion date: Sep 9, 2024 to May 24, 2025
    • Study sites: 55 to 65
    v26
  14. Study sites: 68 to 55v25
  15. Study sites: 89 to 68v24
  16. Study sites: 97 to 89v23
  17. Study sites: 115 to 97
    • Primary completion date: Apr 21, 2025 to Sep 9, 2024
    • Study completion date: Dec 31, 2025 to May 24, 2025
    v22
  18. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 360 to confirmed 95
    • Study sites: 156 to 115
    v21
  19. Study sites: 149 to 156v20
  20. Study sites: 141 to 149v19
  21. Study sites: 128 to 141v18
  22. Study sites: 121 to 128v17
  23. Study sites: 114 to 121v16
  24. Study sites: 89 to 114v15
  25. Eligibility criteria revised
    • Study description expanded, about 4 words
    v14
  26. Study sites: 80 to 89
    • Eligibility criteria expanded, about 7 words
    • Study description expanded, about 6 words
    v13
  27. Study sites: 72 to 80
    • Study completion date: May 29, 2025 to Dec 31, 2025
    v12
  28. Study sites: 68 to 72v11
  29. Study sites: 43 to 68
    • Primary completion date: Jan 20, 2025 to Apr 21, 2025
    • Study completion date: Jan 20, 2025 to May 29, 2025
    v10
  30. Study sites: 35 to 43
    • Primary completion date: Aug 9, 2024 to Jan 20, 2025
    • Study completion date: May 29, 2025 to Jan 20, 2025
    • Study description expanded, about 23 words
    v9
  31. Study sites: 27 to 35v8
  32. Study sites: 18 to 27
    • Secondary endpoints revised (14)
    v7
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Progression free survival (PFS)
Timeframe: Approximately up to 24 months

Secondary (1)

Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Arms and interventions

JDQ443Experimental

Participants treated with JDQ443

DocetaxelActive comparator

Participant treated with docetaxel following local guidelines as per standard of care and product labels

Drugs: JDQ443, docetaxel

Sites

51 sites in 25 countries

China 8, Turkey (Türkiye) 6, Spain 4, Greece 3, Italy 3, Argentina 2, Australia 2, Canada 2, Hong Kong 2, India 2, Malaysia 2, Portugal 2, Finland 1, Hungary 1, Iceland 1, Jordan 1, Lebanon 1, Mexico 1, Romania 1, Slovenia 1, South Korea 1, Taiwan 1, Thailand 1, United States 1, Vietnam 1