Tan Tock Seng Hospital | Clinical Research and Innovation Office
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About
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.
Enrollment
Sex
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Volunteers
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:
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
Primary purpose
Allocation
Interventional model
Masking
170 participants in 2 patient groups, including a placebo group
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Central trial contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
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