Full Title
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 (WIRB)Purpose
In this study, researchers are comparing with effectiveness of the drug selpercatinib with a placebo (inactive drug) in people with stage I-III non-small cell lung cancer (NSCLC) who have had lung cancer surgery or radiation therapy. Moreover, the patients in this study have NSCLC that contains a genetic change called a RET gene fusion.
Participants will be randomly assigned to receive either selpercatinib or a placebo. Patients in the placebo group will have an option to cross over to the selpercatinib group. Both drugs are taken orally (by mouth).
Selpercatinib is already FDA-approved for the treatment of metastatic (stage IV) NSCLC with a RET fusion; its use in this study is considered investigational. It works by targeting the RET mutations that can fuel lung cancer growth.
Who Can Join
To be eligible for this study, patients must meet several requirements, including:
- Participants must have stage IB, II, or IIIA NSCLC containing a RET mutation.
- At least 4 weeks must pass after lung cancer surgery or 6 weeks since finishing radiation therapy and receipt of the study treatment.
- Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
- This study is for people age 18 and older.
For more information about this study and to ask about eligibility, please contact the office of Dr. Alexander Drilon at 646-608-3758.