Phase 3 Non-squamous non-small cell - Lung cancer
Conditions
Interventions
During this study, the patient will be randomly assigned (by chance) to one of
the two treatment possibilities (called *treatment arms*). The patient will
have a 1 in 2 (50%) chance of being assigne
Sponsors
Hoffmann-La Roche
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male or female, 18 years of age or older - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Histologically or cytologically confirmed, Stage IV non-squamous NSCLC - No prior treatment for Stage IV non-squamous NSCLC - Patients who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for nonmetastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last dose of chemotherapy and/or radiotherapy -Measurable disease, as defined by RECIST v1.1 - Adequate hematologic and end organ function - For patients enrolled in the extended China enrollment phase: current residence of mainland China, Hong Kong, or Taiwan and of Chinese ancestry. - For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of
Exclusion criteria
Exclusion criteria: Cancer-Specific Exclusions - Patients with a sensitizing mutation in the EGFR gene or an ALK fusiononcogene - Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments - Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 2 weeks prior to randomization - Leptomeningeal disease - Uncontrolled tumor-related pain - Uncontrolled or symptomatic hypercalcemia (> 1.5 millimole/Liter ionized calcium or calcium > 12 milligram/deciliter or corrected serum calcium > upper limit of normal) - Malignancies other than NSCLC within 5 years prior to randomization - Known tumor PD-L1 expression status from other clinical studies , General Medical Exclusions: - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - History of certain autoimmune disease - History of idiopathic pulmonary fibrosis, organizing pneumonia, druginduced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis - Severe infections within 4 weeks prior to randomization - Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina , Exclusion Criteria Related to Medications and Chemotherapy: - Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti*PD-1, and anti*PD-L1 therapeutic antibodies - Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug prior to randomization - Treatment with systemic immunosuppressive medications , Exclusion Criteria Related to Chemotherapy: - History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds - Patients with hearing impairment (cisplatin) - Grade >= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 criteria (cisplatin) - Creatinine clearance (CRCL) =
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The co-primary efficacy outcome measures for this study are: * PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment. Patients with no post-baseline tumor assessment will be censored at the randomization date plus 1 day. * OS, defined as the time from randomization to death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy outcome measures for this study are: * Objective response, defined as PR or CR as determined by the investigator according to RECIST v1.1 * DOR, defined as the time interval from first occurrence of a documented objective response to the time of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever comes first * OS at 1 and 2 year landmark timepoints * TTD in patient reported lung cancer symptoms, defined as time from randomization to deterioration (10 point change) on each of the EORTC QLQ-C30 and EORTC QLQ-LC13 symptom subscales * Change from baseline in patient reported lung cancer symptoms (cough, dyspnea, or chest pain) with use of the SILC scale symptom score | — |
Countries
Netherlands
Outcome results
None listed