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A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS

Study acronym: TRITON
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion moved earlier from Dec 8, 2026 to Oct 23, 2026 Completion pushed from Dec 23, 2027 to Feb 28, 2028 · Enrollment target: 100 to 103v25 Show 2 more changesShow less
    • Completion pushed from Dec 23, 2027 to Feb 28, 2028
    • Enrollment target: 100 to 103
  2. Phase: Phase 3 to Phase 2 Primary endpoints: 2 to 3 · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 280 to confirmed 100 · 5 morev24 Show 8 more changesShow less
    • Primary endpoints: 2 to 3
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 280 to confirmed 100
    • Study sites: 105 to 47
    • Primary completion date: Aug 17, 2027 to Dec 8, 2026
    • Completion date: Mar 20, 2031 to Dec 23, 2027
    • Secondary endpoints: 12 to 9
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv23
  4. Site details revised at 26 of 105 sitesv22
  5. Site details revised at 1 of 105 sitesv21
Show 19 earlier versionsHide 19 earlier versions
  1. Study sites: 102 to 105 Start date: Apr 5, 2024 to Apr 4, 2024v20 Show 1 more changeShow less
    • Start date: Apr 5, 2024 to Apr 4, 2024
  2. Study sites: 101 to 102 Secondary endpoints: details revised at 4 of 12 entriesv19 Show 1 more changeShow less
    • Secondary endpoints: details revised at 4 of 12 entries
  3. Study sites: 100 to 101 Start date: Apr 4, 2024 to Apr 5, 2024 · Interventions: Carboplatin (Drug), Cisplatin (Drug), Durvalumab (Drug), Pembrolizumab (Drug), Pemetrexed (Drug), Pemetrexed (Drug), Tremelimumab (Drug) to Carboplatin (Drug), Cisplatin (Drug), Durvalumab (Drug), Pembrolizumab (Drug), Pemetrexed (Drug), Tremelimumab (Drug) · Secondary endpoints revised (12) · 3 morev18 Show 6 more changesShow less
    • Start date: Apr 4, 2024 to Apr 5, 2024
    • Interventions: Carboplatin (Drug), Cisplatin (Drug), Durvalumab (Drug), Pembrolizumab (Drug), Pemetrexed (Drug), Pemetrexed (Drug), Tremelimumab (Drug) to Carboplatin (Drug), Cisplatin (Drug), Durvalumab (Drug), Pembrolizumab (Drug), Pemetrexed (Drug), Tremelimumab (Drug)
    • Secondary endpoints revised (12)
    • Study description shortened, about 6 words
    • Study title expanded, about 9 words
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 98 to 100v17
  5. Site details revised at 2 of 98 sitesv16
  6. Study sites: 95 to 98v15
  7. Study sites: 91 to 95v14
  8. Study sites: 89 to 91 Completion date: Oct 14, 2032 to Mar 20, 2031v13 Show 1 more changeShow less
    • Completion date: Oct 14, 2032 to Mar 20, 2031
  9. Study sites: 86 to 89 Completion date: Aug 26, 2033 to Oct 14, 2032v12 Show 1 more changeShow less
    • Completion date: Aug 26, 2033 to Oct 14, 2032
  10. Study sites: 81 to 86 Completion date: Mar 20, 2031 to Aug 26, 2033v11 Show 1 more changeShow less
    • Completion date: Mar 20, 2031 to Aug 26, 2033
  11. Study sites: 75 to 81v10
  12. Study sites: 70 to 75 Completion date: Mar 12, 2031 to Mar 20, 2031v9 Show 1 more changeShow less
    • Completion date: Mar 12, 2031 to Mar 20, 2031
  13. Study sites: 64 to 70 Completion date: Mar 5, 2031 to Mar 12, 2031v8 Show 1 more changeShow less
    • Completion date: Mar 5, 2031 to Mar 12, 2031
  14. Study sites: 57 to 64 Start date changed from estimate of Mar 29, 2024 to Apr 4, 2024v7 Show 1 more changeShow less
    • Start date changed from estimate of Mar 29, 2024 to Apr 4, 2024
  15. Start date: Feb 28, 2024 to Mar 29, 2024 Study sites: 51 to 57v6 Show 1 more changeShow less
    • Study sites: 51 to 57
  16. Study sites: 44 to 51 Start date: Jan 31, 2024 to Feb 28, 2024v5 Show 1 more changeShow less
    • Start date: Jan 31, 2024 to Feb 28, 2024
  17. Trial status: Not Yet Recruiting to Recruiting Start date: Dec 29, 2023 to Jan 31, 2024 · Study sites: 40 to 44v4 Show 2 more changesShow less
    • Start date: Dec 29, 2023 to Jan 31, 2024
    • Study sites: 40 to 44
  18. Primary completion date: Mar 5, 2031 to Aug 17, 2027 Start date: Nov 29, 2023 to Dec 29, 2023 · Study sites: 22 to 40v3 Show 2 more changesShow less
    • Start date: Nov 29, 2023 to Dec 29, 2023
    • Study sites: 22 to 40
  19. Primary completion date: Nov 30, 2026 to Mar 5, 2031 Start date: Oct 16, 2023 to Nov 29, 2023 · Study sites: 0 to 22 · Completion date: Oct 22, 2031 to Mar 5, 2031v2 Show 3 more changesShow less
    • Start date: Oct 16, 2023 to Nov 29, 2023
    • Study sites: 0 to 22
    • Completion date: Oct 22, 2031 to Mar 5, 2031
  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 the study is to assess the efficacy of durvalumab plus tremelimumab in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy in metastatic NSCLC patients with non-squamous histology who have mutations and/or co-mutations in STK11, KEAP1, or KRAS.
Trial Details
NCT Number NCT06008093
Lead Sponsor AstraZeneca
Conditions Carcinoma, Non-Small-Cell Lung
Enrollment 103 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov