NCT06564324 A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients

Trial Parameters

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Brief Summary

This is a Phase 3, randomized, open-label, comparative, multicenter, international study for NSCLC patients whose tumor tissue exhibits ROS1 fusion positivity (i.e., ROS1+) and who have not previously received an ROS1-targeted TKI (i.e., ROS1-TKI-naïve). Approximately 194 ROS-1 TKI- naïve ROS1+NSCLC patients will be randomized in a 1:1 ration to one of 2 study arms: * Arm A: Taletrectinib monotherapy at 600 mg once daily (QD); * Arm B: Crizotinib monotherapy at 250 mg twice daily (BID). Each cycle duration will be 28 days. Participants will be stratified by the presence of intracranial metastases at baseline (Yes versus No) and prior chemotherapy use for locally advanced or metastatic disease (Yes versus No). For the purposes of stratification, prior chemotherapy is defined as completion of ≥1 cycle of chemotherapy in the locally advanced or metastatic setting. Participants will be treated until they experience progressive disease (PD) assessed by the BIRC, intolerable toxicity, or another discontinuation criterion is met. Crossover from control group (crizotinib) to taletrectinib is also permitted, at the Investigator's discretion with the Sponsor's approval, for qualifying participants who have experienced objective progression confirmed by the BIRC.

Eligibility Criteria

Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of locally advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC. 2. Have documentation of ROS1 rearrangement by a positive result 3. Have at least 1 measurable (i.e., target) lesion by Investigator assessment per RECIST v1.1. 4. Prior brain metastases allowed if asymptomatic and diagnosed incidentally at study baseline. If participants have neurological symptoms or signs due to CNS metastasis, participants need to complete local therapy (surgery and/or radiation) at least 7 days before enrollment and be clinically stable without requiring for an increasing dose of corticosteroids or use of anticonvulsants to control symptoms. 5. Age ≥18 years (or ≥20 years as required by local regulations). 6. Eastern Cooperative Oncology Group (ECOG) performance status zero (0) to 1. 7. Minimum life expectancy of 3 months or more. 8. Adequate organ function meeting the follo

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