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

Phase 1

• Conditions: non-small cell lung cancer; MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005562-34-FR
• Lead Sponsor: Institut Bergonié

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-10
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

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).
7. Age = 18.
8. Performance status = 2.
9. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration.
10. Patient with a social security in compliance with the French law (Loi Jardé).
11. Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
12. Voluntarily signed and dated written informed consent prior to any study specific procedure.

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 53
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

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.

Study & Design

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