Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)

Required: ALK wild-type

Required: EGFR wild-type

Required: ROS1 rearrangement

Must have received: definitive locoregional curative surgery — adjuvant

Received definitive locoregional curative surgery for stage IB, II, or IIIA NSCLC. All surgical margins of resection must be negative for tumor.

Cannot have received: postoperative or planned radiation therapy

Exception: neoadjuvant radiotherapy allowed if completed ≥4 weeks prior to Randomization

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.

Cannot have received: adjuvant anticancer therapy other than standard postoperative platinum-based doublet chemotherapy

Exception: adjuvant immune checkpoint inhibitor (ICI) allowed if ≤4 cycles and ≥12 weeks washout; neoadjuvant chemotherapy with or without ICIs allowed if ≥12 weeks since last ICI

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. Adjuvant immune checkpoint inhibitor (ICI) treatment is allowed, but participants should have received no more than 4 cycles of the ICI, and at the time of Randomization, have at least 12 weeks of washout from the last dose of the ICI. Any prior immune-related toxicity, such as immune-related hepatitis, colitis, or pneumonitis, must be completely resolved prior to Randomization. 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.

Cannot have received: major surgery (including surgical resection of the primary tumor but excluding placement of vascular access port)

Major surgery (including surgical resection of the primary tumor but excluding placement of vascular access port) within 4 weeks of Randomization.

Cannot have received: segmentectomy or wedge resection (except for stage IB T2aN0M0, tumor size >3 to ≤4 cm, and without visceral pleura or central invasion)

Exception: Allowed for patients with stage IB disease with T2aN0M0, tumor size >3 to ≤4 cm, and without visceral pleura or central invasion

Segmentectomies or wedge resections, instead of complete resections, of the primary tumor. Note: These limited resections are allowed for patients with stage IB disease with T2aN0M0, with tumor size >3 to ≤4 cm, and without visceral pleura or central invasion.

Cannot have received: investigational therapy for any condition other than NSCLC within 6 months

Any investigational therapy for any condition other than NSCLC within 6 months of Randomization.