Study of efficacy and safety of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 627

Inclusion Criteria

1. Histologically confirmed locally advanced or metastatic NSCLC
2. Measurable disease by RECIST 1.1
3. Known PD-L1 status
4. ECOG performance status (PS) = 1.
5. Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 314
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 313

Exclusion Criteria

1. Previous immunotherapy or treatment with IL-1ß inhibitor.
2. Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations and/or ALK rearrangement
3. History of severe hypersensitivity reaction to monoclonal antibodies, platinum containing drugs, nab-paclitaxel, paclitaxel, pemetrexed or any known excipients of these drugs
4. Other protocol-defined exclusion criteria may apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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