Condition: Non Small Cell Lung Cancer · Sponsor: Nuvation Bio Inc.
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.
This description comes directly from the study's public registry record.
Ying Zhao · +86 13466689296 · Ying.Zhao@nuvationbio.com
Always discuss trial participation with your own doctor first.
| The First Affiliated Hospital of Anhui Medical University | Hefei, Anhui, China | Recruiting |
| Beijing Cancer Hospital | Beijing, Beijing Municipality, China | Recruiting |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing, Beijing Municipality, China | Not Yet Recruiting |
| Chongqing University Cancer Hospital | Chongqing, Chongqing Municipality, China | Recruiting |
| The First Affiliated Hospital of Xiamen University | Xiamen, Fujian, China | Recruiting |
| The First Affiliated Hospital of Guangdong Pharmaceutical University | Guangzhou, Guangdong, China | Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou, Guangdong, China | Recruiting |
| Guangxi Medical University Cancer Hospital | Nanning, Guangxi, China | Recruiting |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang, Hebei, China | Recruiting |
| Henan Cancer Hospital | Zhengzhou, Henan, China | Not Yet Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou, Henan, China | Recruiting |
| Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan, Hubei, China | Recruiting |
+ 17 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06564324