Study of efficacy and safety of canakinumab in combination with docetaxel in subjects with non-small cell lung cancers as a second or third line therapy.

Phase 1

• Conditions: on-small cell lung cancer; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 20.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2018-002480-26-ES
• Lead Sponsor: ovartis Farmacéutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-25
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

The main inclusion criteria are listed below. Other inclusion criteria, defined in the protocol, may apply.
• Histologically confirmed locally advanced (stage IIIB) or metastatic NSCLC.
• Subject has 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.
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 122
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 122

Exclusion Criteria

The main exclusion criteria are listed below. Other exclusion criteria, defined in the protocol, may apply.
• Subject who previously received docetaxel, canakinumab (or another IL-1ß 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.

Study & Design

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