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Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments

Study acronym: KontRASt-R
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fields
  2. Enrollment closed, study ongoing Final enrollment: 25 participants (planned 40) · Site details revised at 21 of 21 sites Show 2 more changesShow less
    • Final enrollment: 25 participants (planned 40)
    • Site details revised at 21 of 21 sites
  3. Site details revised at 1 of 21 sites
  4. Site details revised at 2 of 21 sites
  5. Site details revised at 1 of 21 sites
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 17 to 21 Eligibility criteria expanded, about 8 words · Secondary endpoints: details revised at 1 of 2 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Site details revised at 1 of 17 sitesv14
  3. Site details revised at 1 of 17 sitesv13
  4. Site details revised at 1 of 17 sitesv12
  5. Site details revised at 1 of 17 sitesv11
  6. Study sites: 16 to 17v10
  7. Study sites: 15 to 16v9
  8. Study sites: 14 to 15v8
  1. Trial sites expanded: 7 → 14 locations Primary completion date: Jun 15, 2029 to Jun 11, 2029 · Completion date: Sep 17, 2029 to Sep 11, 2029v7 Show 2 more changesShow less
    • Primary completion date: Jun 15, 2029 to Jun 11, 2029
    • Completion date: Sep 17, 2029 to Sep 11, 2029
  2. Trial sites expanded: 1 → 7 locationsv6
  3. Eligibility criteria expanded, about 115 wordsv5 See this version in full on ClinicalTrials.gov ↗
  4. Recruitment opened Start date changed from estimate of Jun 15, 2026 to Jun 8, 2026v4 Show 1 more changeShow less
    • Start date changed from estimate of Jun 15, 2026 to Jun 8, 2026
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  6. Primary completion date: Jun 25, 2029 to Jun 15, 2029 Completion date: Sep 25, 2029 to Sep 17, 2029 · Start date: Jun 24, 2026 to Jun 15, 2026v2 Show 2 more changesShow less
    • Completion date: Sep 25, 2029 to Sep 17, 2029
    • Start date: Jun 24, 2026 to Jun 15, 2026
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is to allow continued access to opnurasib (JDQ443) to participants who are benefitting from treatment with opnurasib as a single agent or in combination with other study treatments in pre-defined Novartis-sponsored opnurasib studies and to continue to assess safety in these participants.
Trial Details
NCT Number NCT07468071
Lead Sponsor Novartis Pharmaceuticals
Conditions Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer, Advanced Solid Tumors Harboring the KRAS G12C Mutation
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov