Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy
This study was designed to evaluate the role of canakinumab in combination with docetaxel in subjects with advanced non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy.
Checked against the public recordLast updated Aug 21, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: Canakinumab; Drug: Docetaxel; Other: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: * Histologically confirmed advanced (stage IIIB) or metastatic NSCLC. * Subject had received one prior platinum-based chemotherapy and one prior PD-(L)1 inhibitor therapy for locally advanced or metastatic disease. * Subject with ECOG performance status (PS) of 0 or 1. * Subject with at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 in solid tumors criteria. Key Exclusion Criteria: * Subject who previously received docetaxel, canakinumab (or another IL-1β inhibitor), or any systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior PD-(L)1 inhibitor. * Subject with EGFRor ALK positive tumor. * History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or excipients of docetaxel or canakinumab.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Emory Winship Cancer InstituteAtlanta, Georgia
- Saint Luke's Hospital/Marion Bloch Neuroscience Institute Dept of RegulatoryKansas City, Missouri
- Montefiore Medical Center Albert Einstein College of MedThe Bronx, New York
- University of Cincinnati Cancer InstituteCincinnati, Ohio
- MD AndersonHouston, Texas
- Huntsman Cancer Institute Univ of Utah .Salt Lake City, Utah
- Novartis Investigative SiteBerazategui, Buenos Aires
- Novartis Investigative SiteCABA, Buenos Aires
- Novartis Investigative SiteMar del Plata, Buenos Aires
- Novartis Investigative SiteLa Rioja
- Novartis Investigative SiteSantiago del Estero
- Novartis Investigative SiteGreenslopes, Queensland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 21, 2023. Always confirm current availability with the study team.