The purpose of this phase 3 multicenter double-blind randomized study is to assess the use of taletrectinib in the early-stage non-small cell lung cancer (NSCLC). The study compares taletrectinib (study drug) versus placebo (sugar pill) in patients with ROS1-fusion positive stage IB, II, IIIA NSCLC. The study will evaluate if taletrectinib is better than placebo at preventing the participant's disease from coming back after the participant's lung tumor was removed.
Histologically confirmed stage IB, II, or IIIA NSCLC (AJCC 9th edition) based on pathological staging.
Documented ROS1 rearrangement in primary tumor by a validated local assay performed in CLIA-certified or locally equivalent diagnostic laboratories.
Adequate tissue is available for prospective central laboratory confirmatory testing. Confirmation of central test positivity is required prior to Randomization.
Age ≥18 years (or ≥20 years as required by local regulations).
Postoperative or planned radiation therapy for the current lung cancer. Note: radiotherapy in the neoadjuvant setting is allowed and must be completed at least 4 weeks prior to Randomization.
Any adjuvant anticancer therapy (including investigational therapy) for treatment of NSCLC other than standard postoperative platinum-based doublet chemotherapy. Participants should have received no more than 4 cycles of the platinum doublet regimen.
Neoadjuvant chemotherapy with or without ICIs is allowed. Those treated with prior ICIs are eligible if ≥12 weeks have elapsed after completion of the ICI at the time of Randomization. Any prior immune-related toxicity (if an ICI was given), such as immune-related hepatitis, colitis, or pneumonitis, must be completely resolved prior to Randomization.
Major surgery (including surgical resection of the primary tumor but excluding placement of vascular access port) within 4 weeks of Randomization.