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LIBRETTO-431NCT04194944

A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 3
Primary completion
Track this trial

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Record History

The 50 most recent of 82 versions: 38 with changes below, 12 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: details revised at 4 of 23 entries
    • Site details revised at 21 of 196 sites
  2. Study completion date: Jun 2026 to Jun 2030v81
  3. Lead sponsor: Loxo Oncology, Inc. to Eli Lilly and Company
    • Study completion date: Jun 18, 2026 to Jun 2026
    • Study sites revised (196)
    v78
  4. Results first posted: Jun 20, 2024v77
  5. Study Status, Arms and Interventions, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv76
Show 33 earlier versionsHide 33 earlier versions
  1. Study completion date: Jun 2026 to Jun 18, 2026
    • Study sites revised (196)
    • Study arms: 3 to 2
    v75
  2. Trial status: Completed to Active, Not Recruiting
    • Study completion date: May 1, 2023 to Jun 2026
    v74
  3. Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 250 to confirmed 261
    • Study completion date changed from estimate of Feb 18, 2026 to May 1, 2023
    v73
  4. Study completion date: Feb 2026 to Feb 18, 2026v72
  5. Primary completion date changed from estimate of Dec 2024 to May 1, 2023
    • Study completion date: Jul 2027 to Feb 2026
    v70
  6. Primary completion date: Jan 15, 2023 to Dec 2024
    • Study completion date: Aug 18, 2025 to Jul 2027
    v61
  7. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 199 to 196
    v59
  8. Study sites: 200 to 199v58
  9. Study sites: 202 to 200v57
  10. Study sites: 203 to 202v56
  11. Study sites: 206 to 203v55
  12. Site details revised at 24 of 206 sitesv54
  13. Study sites revised (206)v53
  14. Study sites revised (206)v52
  15. Site details revised at 15 of 206 sitesv51
  16. Study sites: 207 to 206v50
  17. Study sites revised (207)v49
  18. Study sites revised (207)v48
  19. Site details revised at 2 of 207 sitesv47
  20. Study sites revised (207)v46
  21. Study sites revised (207)v45
  22. Study sites: 208 to 207v44
  23. Study sites: 209 to 208v43
  24. Study sites revised (209)v42
  25. Study sites revised (209)v41
  26. Study sites: 210 to 209v40
  27. Study sites: 211 to 210v39
  28. Study sites revised (211)v38
  29. Study sites revised (211)v37
  30. Study sites revised (211)v36
  31. Site details revised at 1 of 211 sitesv35
  32. Study sites revised (211)v34
  33. Study sites revised (211)v33
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab)
Timeframe: Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
PFS by BICR (With or Without Pembrolizumab)
Timeframe: Baseline to Progressive Disease or Death from Any Cause Up to 31 Months

Secondary (23)

Percentage of Participant With Disease Control Rate (DCR) by BICR (With Pembrolizumab)
Percentage of Participant With DCR by BICR (With or Without Pembrolizumab)
PFS2 (With Pembrolizumab)
PFS2 (With or Without Pembrolizumab)
Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) by BICR (With Pembrolizumab)
Show 18 moreShow less
ORR: Percentage of Participants With CR or PR by BICR (With or Without Pembrolizumab)
Duration of Response (DoR) by BICR (With Pembrolizumab)
DOR by BICR (With or Without Pembrolizumab)
Overall Survival (OS) (With Pembrolizumab)
OS (With or Without Pembrolizumab)
Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 by BICR (With Pembrolizumab)
Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RECIST 1.1 by BICR (With or Without Pembrolizumab)
Median Intracranial DOR Per RECIST 1.1 by BICR (With Pembrolizumab)
Median Intracranial DOR Per RECIST 1.1 by BICR (With or Without Pembrolizumab)
Time to Deterioration of Pulmonary Symptoms (With Pembrolizumab)
Time to Deterioration of Pulmonary Symptoms (With or Without Pembrolizumab)
The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants With RET-Positive Specimens as Called by the Central Lab, Which is Also RET-Positive as Called by a Local Lab (Positive Percent Agreement)
Median Time to CNS Progression Per RECIST 1.1 by BICR (With Pembrolizumab)
Median Time to CNS Progression Per RECIST 1.1 by BICR (With or Without Pembrolizumab)
Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) by BICR (With Pembrolizumab)
Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RANO-BM by BICR (With or Without Pembrolizumab)
Intracranial DOR Per RANO-BM by BICR (With Pembrolizumab)
Intracranial DOR Per RANO-BM by BICR (With or Without Pembrolizumab)

Arms and interventions

Selpercatinib - Treatment A (TRT A)Experimental

160 milligram (mg) Selpercatinib administered orally twice daily (BID) continuously in 21-day cycles.

Pemetrexed and Platinum with or without Pembrolizumab - (TRT B)Active comparator

Pemetrexed 500 milligrams per meter squared (mg/m2) administered intravenously (IV) on Day 1, every 3 weeks (Q3W), plus investigator's choice of carboplatin area under the concentration versus time curve 5 (AUC 5 \[maximum dose of 750 mg\] IV), or cisplatin (75 mg/m2 cisplatin IV) on Day 1 Q3W for 4 cycles, plus investigator's choice with or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.

Drugs: Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab

Sites

196 sites in 26 countries

Spain 23, China 15, Taiwan 14, Italy 13, Turkey (Türkiye) 12, Brazil 11, Japan 11, Ukraine 11, Russia 10, South Korea 9, Germany 8, Australia 7, Belgium 7, Romania 7, France 6, Argentina 5, Israel 5, Greece 4, Netherlands 4, Czechia 3, Mexico 3, Canada 2, Hong Kong 2, Poland 2, Singapore 1, United Kingdom 1