RET Inhibitor
Selpercatinib
Phase
3
Enrolling
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*
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Key Inclusion Criteria
- Stage IB, II, or IIIA non-small cell lung cancer (NSCLC)
- Activating RET gene fusion in tumor based on polymerase chain reaction (PCR) or next-generation sequencing (NGS)
- Prior definitive locoregional therapy with curative intent (surgery or radiotherapy) for stage IB, II, or IIIA NSCLC
- Participants must have undergone the available anticancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator’s discretion
- Complete recovery from definitive therapy (surgery or radiotherapy) as well as adjuvant therapy at the time of randomization
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic, hepatic, and renal function
- Patients with reproductive potential must use conventional and highly effective birth control for the duration of the treatment
Key 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 6 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 ms
- Uncontrolled HIV infection or 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 ≥2 years previously and not currently active
- Pregnancy or lactation
- Prior treatment with a selective RET inhibitor (eg, selpercatinib or pralsetinib)
*
This clinical trial is being conducted globally.
†
Selpercatinib or placebo equivalent is administered PO.
