Study on Selpercatinib After Surgery or Radiation for Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

• Have been diagnosed with Stage IB, II, or IIIA non-small cell lung cancer (NSCLC).
• Have a specific genetic change called RET gene fusion in the tumor, confirmed by certain lab tests.
• Have completed surgery or radiation aimed at curing the cancer.
• Have either completed available anti-cancer treatments like chemotherapy or are not suitable for them, as decided by the doctor.
• Must start the study within 10 weeks after surgery or radiation if no chemotherapy was given, or within 26 weeks if chemotherapy was given.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have good blood, liver, and kidney function.
• Agree to use effective birth control during the study and for at least two weeks after the last dose of the study drug if of reproductive potential.

Exclusion Criteria

• Have other known genetic changes driving the cancer.
• Have evidence of small cell lung cancer.
• Have signs of cancer returning or worsening after surgery or radiation.
• Have lung conditions like interstitial fibrosis or lung disease, or a history of lung inflammation requiring steroids.
• Have serious heart problems or a recent heart attack, or a specific heart rhythm issue.
• Have uncontrolled HIV infection.
• Have active hepatitis B or C.
• Have uncontrolled infections or serious ongoing illnesses like high blood pressure or diabetes.
• Have had major surgery within four weeks before starting the study drug.
• Have conditions affecting the absorption of the study drug.
• Have another active cancer, except for certain skin or cervical cancers, or cancers diagnosed over two years ago that are not active.
• Be pregnant or breastfeeding.
• Have previously been treated with a selective RET inhibitor like selpercatinib or pralsetinib.