A Phase 3 interventional study of Taletrectinib and Crizotinib in Non Small Cell Lung Cancer, sponsored by Nuvation Bio Inc.. Recruiting at 29 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Nuvation Bio Inc. · Phase 3, Interventional, and Treatment
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:
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 194 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Nuvation Bio Inc. is the lead sponsor of 19 studies on the registry; 6 are open to participants now.
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Adequate organ function meeting the following criteria:
Exclusion Criteria:
97 ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer patients will be enrolled in Arm A and treated with talerectinib
Drug: Taletrectinib
97 ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer patients will be enrolled in Arm B and treated with Crizotinib
Drug: Crizotinib
Approximately 194 ROS-1TKI- 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 treated until they experience progressive disease (PD) assessed by the blinded Independent Review Committee (BIRC), intolerable toxicity, or another discontinuation criterion is met.
Approximately 194 ROS-1TKI- 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 treated until they experience progressive disease (PD) assessed by the blinded Independent Review Committee (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.
PFS (Assessed by BIRC)
Progression-Free-Survival, The time between the beginning of treatment and the occurrence of disease progression or death. Assessed by the blinded Independent Review Committee (BIRC), per RECIST v1.1
Time frame: About 49 months
PFS (Assessed by investigator)
Progression-Free-Survival is defined as the time between the beginning of treatment and the occurrence of disease progression or death. Assessed by the investigator, per RECIST v1.1 criteria.
Time frame: About 69months
ORR
Proportion of subjects with the best overall confirmed response of complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.
Time frame: About 69 months
DOR
Defined as the time from the first date of objective response (CR or PR) to the first documented date of disease progression. Response assessments are per RECIST v1.1 criteria.
Time frame: About 69 months
DCR
Defined as the proportion of subjects with a best overall response of CR, PR or stable disease per RECIST v1.1 criteria) as assessed by the investigator
Time frame: About 69 months
TTR
Defined as the overall time from the time of tumor occurrence to the patient's death. Response assessments are per RECIST v1.1 criteria.
Time frame: About 69 months
OS
Defined as the time from the first dose to death due to any cause.
Time frame: About 69 months
IC-TTP
Defined as the overall time from the time of tumor occurrence with CNS(central nervous system) metastases to the patient's death, Assessed by the BIRC, per mRECIST v1.1 criteria.
Time frame: About 69 months
IC-ORR
Proportion of CNS metastatic subjects with the best overall confirmed response of complete response (CR) or partial response (PR), Assessed by the BIRC, per mRECIST v1.1 criteria.
Time frame: About 69 months
IC-DOR
Defined as the time from the first date of objective response (CR or PR) to the first documented date of disease progression on CNS metastatic subjects. Assessed by the BIRC, per mRECIST v1.1 criteria.
Time frame: About 69 months
IC-PFS
Defined as the time between the beginning of treatment and the occurrence of disease progression or death on CNS metastatic subjects, Assessed by the BIRC, per mRECIST v1.1 criteria
Time frame: About 69 months
IC-PR at 6, 12, 18, 24, and 36 months
Partial response at 6, 12, 18, 24, and 36 months on CNS metastatic subjects, Assessed by the BIRC, per mRECIST v1.1 criteria.
Time frame: About 69 months
AE
Adverse event, including the events reported following physical examination, vital signs assessment, clinical laboratory assessment or electrocardiogram(ECG)
Time frame: About 69 months
Taletrectinib concentration in plasma
Defined as the relationship between taletrectinib concentration and time in the body
Time frame: About 12 months, at the begining of cycle 1, cycle 2, cycle 7 and cycle 12（each cycle is 28 days）
patient-reported outcomes(PRO) assessed by EORTC QLQ-C30
Patient-reported outcomes of health-related quality of life, assessed by EORTC QLQ-C30, the single-item measures range in score from 0 to 4 or 7, a high score for a symptom scale represents a high level of symptomatology / problems.
Time frame: About 69 months
PRO assessed by EORTC QLQ-L13
Patient-reported outcomes of health-related quality of life, assessed by EORTC QLQ-LC13, the single-item measures range in score from 0 to 4, a high score for a symptom scale represents a high level of symptomatology / problems.
Time frame: About 69 months
PRO assessed by EQ-5D-5L
Patient-reported outcomes of health-related quality of life, assessed by EQ-5D-5L, the scale measures range in score from 0 to 100, a high score for the health status represents a high quality of life.
Time frame: About 69 months
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