Brief Summary
The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence 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.
Intervention / Treatment
- Drug: Selpercatinib
- Drug: Placebo
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 chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells 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 chemotherapychemotherapy given after primary treatment, such as surgery, to reduce the risk of your cancer coming back was administered
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer 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 dosethe amount of medication taken of study drug.