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

• Registration Number: EUCTR2018-002480-26-HU
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• 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/metastatic (stage IIIBIV)
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.
• Serum lipase = 1.5 x ULN.
• Creatinine clearance = 60 mL/ min by calculation using Cockcroft-
Gault formula.
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.
• Subjects with pure squamous cell histology that are known to have
EGFR/ ALK sensitizing mutations are excluded.
• Subjects with known BRAF V600 mutation or ROS1 rearrangement will
be excluded if required by local guidelines.
• History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or excipients of docetaxel or canakinumab.
6.Subject with suspected or proven immunocompromised state or infections, including evidence of active or latent tuberculosis (TB) as determined by locally approved screening methods. If the results of the screening per local treatment guidelines or clinical practice require treatment, then the patient is not eligible.
12.Subject with history of interstitial lung disease or pneumonitis grade = 2.
18.Participation in a prior investigational study within 30 days prior to enrollment or within 5-half lives of the investigational product (other
than chemotherapy or checkpoint inhibitors), whichever is longer or those who are expected to receive any other investigational drug or device the conduct of the study.

Study & Design

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