Clinical trial · Interventional
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Selpercatinib | Drug | Selpercatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Selpercatinib
- description
- Selpercatinib administered orally.
- interventionNames
- Drug: Selpercatinib
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo administered orally.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Event-Free Survival (EFS)
- timeFrame
- Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have histologically confirmed Stage IB, II, or IIIA NSCLC. * Must have an activating RET gene fusion in tumor based on polymerase chain reaction (PCR), next generation sequencing (NGS), or another molecular test per sponsor's approval. * Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC. \-- Must have undergone the available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator's discretion. * Maximum time allowed between definitive therapy completion and randomization must be: * 10 weeks if no chemotherapy was administered * 26 weeks if adjuvant chemotherapy was administered * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Adequate hematologic, hepatic, and renal function. * Willingness of men and women of reproductive potential to observe conventional and highly effective birth control for the duration of the study and for at least 2 weeks after last dose of study drug. Exclusion Criteria: * Additional oncogenic drivers in NSCLC, if known. * Evidence of small cell lung cancer. * Clinical or radiologic evidence of disease recurrence or progression following definitive therapy. * Known or suspected interstitial fibrosis or interstitial lung disease or history of (noninfectious) pneumonitis that required steroids. * Clinically significant active cardiovascular disease or history of myocardial infarction within six months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) greater than 470 milliseconds. * Have known uncontrolled human immunodeficiency virus (HIV)-1/2 infection. * Have known active hepatitis B or C. * Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. * Major surgery within 4 weeks prior to planned start of selpercatinib. * Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug. * Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed greater than or equal to two years previously and not currently active. * Pregnancy or lactation. * Prior treatment with a selective RET inhibitor (e.g. selpercatinib or pralsetinib).
References
Publications (2)
- DERIVEDWu 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. PMID 42223087
- DERIVEDTsuboi 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. PMID 35950566