IFCT-1805 ELDERLY Phase III randomized trial of atezolizumab in elderly patients with advanced Non-Small-Cell Lung Cancer and receiving monthly carboplatin with weekly paclitaxel chemotherapy

Intergroupe Francophone De Cancerologie Thoracique68 sites in 1 country510 target enrollmentJuly 23, 2019

DrugsRO5541267 Tecentriq 1 200 mg concentrate for solution for infusion CARBOPLATIN PACLITAXEL

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Intergroupe Francophone De Cancerologie Thoracique
Enrollment: 510
Locations: 68
Primary Endpoint: Overall survival
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To determine the activity of anti-PDL1 antibody ATEZOLIZUMAB in elderly patient in first line treatment by measuring overall survival probability in patients treated in the standard arm versus overall survival probability in the experimental arm (atezolizumab + carboplatin and paclitaxel)

Registry

euclinicaltrials.eu

Start Date

July 23, 2019

End Date

December 1, 2026

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Investigators

Sponsor

Intergroupe Francophone De Cancerologie Thoracique

Responsible Party

Principal Investigator

Contact

Scientific

Intergroupe Francophone De Cancerologie Thoracique

Eligibility Criteria

Inclusion Criteria

•Signed Written Informed Consent: - Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care. - Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing
•Life expectancy of at least 12 weeks
•For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate [ 1% per year] when used consistently and correctly, and to continue its use for 6 months after the last dose of treatment. Male patients should not donate sperm during this study and for at least 6 months after the last dose of treatment. Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the treatment. Male patients must always use a condom.
•Patient covered by a national health insurance
•Protected adults can participate if they are able to make decision about their medical treatment according to guardianship judgment.
•Histologically confirmed NSCLC. A cytologically-proven NSCLC is allowed if a cytoblock has been prepared.
•Age: 70 to 89 years
•Performance status ≤
•Stage IIIB or IIIC non irradiable or IV (8th classification TNM, UICC 2015)
•Measurable disease as defined by RECIST 1.

Exclusion Criteria

•Small cell lung cancer or tumors with mixt histology including a SCLC component
•Symptomatic brain metastases requiring corticosteroids.
•Spinal cord compression not definitely treated by surgery and/or radiation therapy or with neurological sequelae.
•Leptomeningeal disease
•Uncontrolled tumor-related pain.
•Uncontrolled or symptomatic or requiring Denosumab hypercalcemia.
•Corticosteroids > 10mg oral prednisone/day or equivalent.
•Immunosuppressive medications within 2 weeks before randomization
•History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
•HIV positive serology (test at screening)