Endpoints and assessments
death, Tumor, Cancer
DISEASE PROGRESSION, ADVERSE EVENT, TUMOR, SECONDARY, CANCER
The primary endpoint of the TAGS study was OS (defined as the time from randomization to death). Key secondary endpoints were investigator-assessed PFS (defined as the time from randomization to radiological disease progression, per RECIST v1.1, or death), time to ECOG ≥ 2, and safety and tolerability.Tumor assessments of the chest, abdomen, and pelvis (as clinically indicated) were performed within 28 days prior to treatment initiation and every 8 weeks thereafter until radiological disease progression, death, or the initiation of subsequent antineoplastic therapy. Safety and tolerability were assessed based the incidence of AEs (graded per National Cancer Institute Common Terminology Criteria for Adverse Events v4.03) that occurred between the provision of informed consent and 30 days after the final dose of study treatment.