...5.Subjects in the screening period should provide a written report of ROS1 positive, or tumor histological specimens obtained at the time of diagnosis/post before enrollment are sent to the central laboratory to confirm ROS1 positive....

The ORR of 36 efficacy evaluable patients in the phase I trial was 63.9% (95% CI 46.2%, 79.2%). In the phase II trial, 111 eligible patients in the main study cohort received unecritinib. The ORR per IRC was 80.2% (95% CI 71.5%, 87.1%) and the median progression-free survival (PFS) per IRC was 16.5 months (95% CI 10.2, 27.0)....Unecritinib is efficacious and safe for ROS1 inhibitor-naive patients with ROS1-positive advanced NSCLC, particularly patients with brain metastases at baseline, strongly supporting that unecritinib should become one of the standards of care for ROS1-positive NSCLC.

1 patient achieved complete response and 86 patients achieved partial response with ORR assessed by IRC of 78.4% (95% CI, 69.6%-85.6%) and DCR of 87.4% (95% CI, 79.7% - 92.9%). The median PFS assessed by IRC was 15.6 months (95% CI, 10.2 - 27.0) and median DoR was 20.3 (95% CI, 11.0 - 26.1)....For the first-line treatment of ROS1-positive locally advanced or meta-static NSCLC patients, TQ-B3101 showed the promising efficacy with a manageable safety profile, offering a new first-line therapeutic strategy.