Overall Response Rate (ORR) Per Central Assessment (Key Secondary)
Time frame · Up to approx. 42 months
ORR is defined as the percentage of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time to Deteriration (TTD) Global Health Status, Diarrhea, Fatigue, Pain (EORTC QLQ-C30) (Key Secondary)
Time frame · Up to approx. 42 months
TTD is defined as the first deterioration of at least 10 points from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): global health status, diarrhea, fatigue, and pain.
The Quality of Life Questionnaire C30 (QLQ-C30) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess quality of life in cancer patients. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items. Raw scores are linearly transformed so each score ranged a 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Disease Control Rate (DCR) Per Central Assessment
Time frame · Up to approx. 42 months
Disease Control Rate is the percentage of participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) (centrally assessed according to RECIST 1.1). CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD).
Duration of Response (DOR) Per Central Assessment
Time frame · Up to approx. 42 months
Duration of Response defined as time from first complete or partial response to progression or death due to underlying cancer according to RECIST 1.1.
Rate of Adverse Events
Time frame · from FPFV until end of study (about 94 months)
Rate of adverse events scored according to CTCAE grade
Rate of Laboratory Toxicities
Time frame · from FPFV until end of study (about 94 months)
Rate of laboratory toxicities scored according to CTCAE grade
Overall Survival (OS)
Time frame · from FPFV until end of study (about 94 months)
OS is the time from randomization date until day of death due to any cause.