Previously Untreated Advanced or Metastatic Non-Squamous Non−Small Cell Lung Cancer
Conditions
Brief summary
PFS, defined as the time from randomization to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause (whichever occurs first), OS, defined as time from randomization to death from any cause
Detailed description
Confirmed objective response, defined as CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by BICR according to RECIST v1.1, Change from baseline to Cycle 5 Day 1 on the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LC13 cough item (item 31), the QLQ-C30 dyspnea item (item 8), and the QLQ-C30 Physical Functioning scale (items 1−5), DOR, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause, whichever occurs first, Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 grading scale, Change from baseline in selected vital signs and ECG parameters, Change from baseline in selected clinical laboratory test results, Presence, frequency of occurrence, severity, and/or degree of interference with daily function of selected symptomatic treatment toxicities as assessed by the NCI PRO-CTCAE, Worst post-baseline scores in the severity of selected symptomatic treatment toxicities as assessed by the NCI PRO-CTCAE, Frequency of participant’s response of the degree they are troubled with treatment symptoms, as assessed by the single-item European Organisation for Research and Treatment of Cancer (EORTC) Item List 46 (IL46), Change from baseline on the EORTC QLQ-C30 and QLQ-LC13 functional and global health status (GHS)/quality of life (QoL) scales, and symptoms to Cycle 5 Day 1 and throughout the trial
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGRO7435846
DRUGPEMETREXED
DRUGRO 743-5846/F04
DRUGRO 743-5846/F07
DRUGsolution à diluer pour perfusion
DRUGsolution pour perfusion
DRUGCISPLATIN-EBEWE
DRUG1 MG/ML
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as the time from randomization to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause (whichever occurs first), OS, defined as time from randomization to death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Confirmed objective response, defined as CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by BICR according to RECIST v1.1, Change from baseline to Cycle 5 Day 1 on the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LC13 cough item (item 31), the QLQ-C30 dyspnea item (item 8), and the QLQ-C30 Physical Functioning scale (items 1−5), DOR, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause, whichever occurs first, Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 grading scale, Change from baseline in selected vital signs and ECG parameters, Change from baseline in selected clinical laboratory test results, Presence, frequency of occurrence, severity, and/or degree of interference with daily function | — |
Countries
Belgium, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Spain
Outcome results
None listed