Integrative analysis of the tumor microenvironment and optimization of the immunotherapy duration in non-small cell lung cancer patients. OPTIMUNE-LUNG study - OPTIMUNE-LUNG

Institut Bergonié0 sites80 target enrollmentFebruary 10, 2021

DrugsKEYTRUDA ALIMTA CISPLATINE CARBOPLATINE PACLITAXEL TECENTRIQ OPDIVO

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Institut Bergonié
Enrollment: 80
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 10, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Institut Bergonié

Eligibility Criteria

Inclusion Criteria

•1\. Histologically or cytologically confirmed non\-small cell lung carcinoma (squamous or non squamous).
•2\. Locally advanced/unresectable or metastatic disease.
•3\. Treatment with ICI (immune checkpoint inhibitor PD1/PDL\-1 blockade therapy):
•a. in first or second\-line treatment as per market authorization. For patients in first line, ICI alone or ICI \+ chemotherapy,
•b. start of ICI treatment 6 to 12 months (\+/\- 2 weeks) before registration.
•4\. At least one measurable lesion according to the RECIST v1\.1 criteria before ICI treatment onset and confirmed by centralized review (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST v1\.1\). At least one site of disease must be uni\-dimensionally \= 10 mm.
•5\. Patient with objective response (CR, PR) according to RECIST v1\.1 criteria at 6 months or more and less than 12 months after ICI treatment onset. Response must be confirmed by centralized review on the basis of all CT scan carried out since the initiation of ICI treatment up to registration. PET\-CT are also acceptable (several PET\-CTs or CT scans compared with PET\-CTs), under the following conditions:
•a. Target lesions must be evaluable on PET\-CT according to RECIST v1\.1\. This will be determined by the centralized radiologist at the time of the review. If target lesions are not evaluable according to RECIST v1\.1, patient will not be eligible.
•b. PET\-CT is acceptable only for the centralized review. If not available, an additional CT scan must be performed within four weeks prior to registration (\+1 week tolerance) to be used as baseline tumor assessment. Patient must be then followed using the same technique throughout the duration of the protocol.
•6\. At least one lesion that can be biopsied for research purpose. Note that in case of complete response or too small size lesion, the investigator must ensure the availability of suitable paraffin embedded (FFPE) archived tumor material (primary or metastatic site).

Exclusion Criteria

•1\. Female who is pregnant or breast\-feeding.
•2\. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
•3\. Hypersensitivity to one of the active substances or to one of the excipients
•4\. Any contraindication to pursue ICI treatment as per investigator judgement.
•5\. Previous enrolment in the present study.
•6\. Individual deprived of liberty or placed under legal guardianship.