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

Phase 1

• Conditions: stages AJCC v. 8 IIIB/IIIC (not eligible for definite chemoradiationtherapy) or stage IV (metastatic) non-small cell lung cancer (NSCLC); MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001547-32-NL
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-30
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 673

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 386
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 287

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.
5. Known active central nervous system (CNS) metastases and/or
carcinomatous meningitis.
6. Presence or history of a malignant disease, other than NSCLC, that has
been diagnosed and/or required therapy within the past 3 years prior to
randomization.
7. Active autoimmune disease that has required systemic treatment in
the past 2 years prior to randomization (i.e. with use of disease
modifying agents, corticosteroids or immunosuppressive drugs).Control
of the disorder with replacement therapy (e.g., thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency, etc) is permitted.
13. History of (non-infectious) pneumonitis that required steroids or
current pneumonitis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified