A Phase III, Randomized, Open-Label Study of Pralsetinib versus Standard Of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer

RET fusion−positive, metastatic Non-Small Cell Lung Cancer

1. PFS, defined as the time from randomization date to the first of documented progressive disease (PD), as assessed by investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or death due to any cause, whichever occurs first

1. Objective response rate (ORR) defined as the proportion of participants with a CR or a PR on two consecutive occasions ≥ 4 weeks apart, as assessed by investigator according to RECIST v1.1, 2. Overall survival (OS), defined as the time to randomization date to death due to any cause., 3. Incidence and severity of adverse events, with severity, as determined according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 5.0, 4. Change from baseline in ECOG performance status, 5. Change from baseline in targeted vital signs, 6. Change from baseline in targeted clinical laboratory test results, 7. Duration of response (DOR), defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as assessed by investigator according to RECIST v1.1, 8. Disease control rate (DCR), defined as the proportion of participants who experience a best response of CR, or PR, or SD, as assessed by investigator according to RECIST v1.1, 9. Clinical benefit rate (CBR), defined as the proportion of participants who experience a best response of SD with a minimum duration of 6 months, a CR, or a PR, as assessed by investigator according to RECIST v1.1

No related papers found yet.

Belgium, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain