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Integrative Analysis of Tumor Microenvironment and Optimization of Immunotherapy Duration in NSCL Cancer Patients | Clinical Trials | Clareo Health

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Integrative Analysis of Tumor Microenvironment and Optimization of Immunotherapy Duration in NSCL Cancer Patients

Integrative Analysis of the Tumor Microenvironment and Optimization of the Immunotherapy Duration in Non-small Cell Lung Cancer Patients (OPTIMUNE-LUNG Study)

NCT04880382•Institut Bergonié

View on ClinicalTrials.gov

Summary

Non-comparative multicentric randomized study to assess long-term benefit of PD-1 inhibition in NSCLC patients who experienced a response between 6 and 12 months after initiation of ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy)

Detailed Description

Two-arm, non-comparative, prospective, multicentric, randomized study for early discontinuation of immune checkpoint inhibitor PD1/PDL-1 blockade therapy in non-small cell lung cancer patients who achieved objective response between 6 and 12 months after treatment onset.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically or cytologically confirmed non-small cell lung carcinoma (squamous or non squamous).
•2. Locally advanced/unresectable or metastatic disease.
•3. For non-squamous histology, tumor with no oncogenic addiction: no activating EGFR mutation, no ALK or ROS1 rearrangement,
•4. Treatment with ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy):
•1. in first or second-line treatment as per market authorization. For patients in first line, ICI alone or ICI + chemotherapy,
•2. start of ICI treatment 6 to 12 months (+/- 2 weeks) before registration.
•5. 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.
•6. Patient with objective response 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
•7. At least one lesion that can be biopsied for research purpose.
•8. Age ≥ 18.
+5 more criteria

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.

Locations (5)

Centre Hospitalier de la Côte Basque

Bayonne, France

Clinique Tivoli Ducos

Bordeaux, France

Institut Bergonie

Bordeaux, France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

Clinique Marzet

Pau, France

Key Dates

Start Date

August 27, 2021

Primary Completion Date

February 23, 2026

Completion Date

February 23, 2026

Last Updated

March 4, 2026

Enrollment

ACTUAL participants

Conditions

Non Small Cell Lung Cancer

Interventions

ICI treatment discontinuation

DRUG

ICI treatment continuation

DRUG

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RECRUITING

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Integrative Analysis of Tumor Microenvironment and Optimization of Immunotherapy Duration in NSCL Cancer Patients

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)