A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
Summary
The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.
Timeline
- Start
- 2021-12-20
- Primary completion
- 2026-01-12
- Completion
- 2028-05
Outcome
Met primary endpoint
paper hazard ratio for disease recurrence, progression, or death, 0.17; 95% confidence interval [CI], 0.06 to 0.51; P<0.001. PMID 42223087 ↗
release “Phase 3 LIBRETTO-432 clinical trial of Retevmo (selpercatinib) as adjuvant therapy versus placebo. The study met its primary endpoint” lilly.com ↗
Publications
- Wu YL, Hochmair M, Yang Y, Yang XN, Tsuboi M, Paz-Ares L, Yang JC, Wu L, Kim HR, Rieke DT, Johnson M, Besse B, Sharma N, Maeda P, Peterson P, Lin BK, Frimodt-Moller B, Goldman J, Drilon A; LIBRETTO-432 Trial Investigators. Selpercatinib in Early-Stage RET Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2026 May 31. doi: 10.1056/NEJMoa2602628. Online ahead of print.
- Tsuboi M, Goldman JW, Wu YL, Johnson ML, Paz-Ares L, Yang JC, Besse B, Su W, Chao BH, Drilon A. LIBRETTO-432, a phase III study of adjuvant selpercatinib or placebo in stage IB-IIIA RET fusion-positive non-small-cell lung cancer. Future Oncol. 2022 Sep;18(28):3133-3141. doi: 10.2217/fon-2022-0656. Epub 2022 Aug 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Selpercatinib | Small molecule | — | Oral |