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

NCT04880382 | Terminated Phase 2 DMC

• 2 other identifiers: IB 2019-072020-005562-34
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 5

Brief 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)

Conditions

Non Small Cell Lung Cancer

Keywords

Immune checkpoint inhibition; non-small cell lung cancer; treatment duration; long-term benefit

Outcome Measures

Primary Outcomes (1)

• Assessment of the long-term benefit of PD-1 inhibition in NSCLC patients who experienced a response between 6 and 12 months after initiation of ICI

  Long-term benefit will be assessed in terms of progression-free rate (PFR) at 12 months after randomization, for each therapeutic strategy

  12 months

Secondary Outcomes (12)

• Assessment of secondary resistance in NSCLC patients who experienced a response to PD1/PDL-1 inhibition

  12 months

• Duration of response independently for each therapeutic strategy

  Throughout the treatment period, an expected average of 12 months

• 1-year progression-free survival, independently for each therapeutic strategy

  1 year

• 2-year progression-free survival, independently for each therapeutic strategy

  2 years

• 1-year overall survival, independently for each therapeutic strategy

  1 year

Study Arms (2)

Standard Arm A: treatment by ICI will be continued

OTHER

After achieving objective response between 6 and 12 months after treatment onset, for these patients ICI treament will continue as per market authorization

Drug: ICI treatment continuation

Experimental Arm B: treatment by ICI will be discontinued

EXPERIMENTAL

After achieving objective response between 6 and 12 months after treatment onset, for these patients first-line or second line regimen should be discontinued. Patients will be followed as per standard management.

Drug: ICI treatment discontinuation

Interventions

ICI treatment discontinuation DRUG

After achieving objective response between 6 and 12 months after treatment onset, for these patients, first or second line treatment by immune checkpoint inhibitor will be discontinued. Patients will be followed as per standard mangement thereafter

Experimental Arm B: treatment by ICI will be discontinued

ICI treatment continuation DRUG

After achieving objective response between 6 and 12 months after treatment onset, for these patients, first or second line treatment by immune checkpoint inhibitor will be continued until disease progreession or unacceptable toxicity

Standard Arm A: treatment by ICI will be continued

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed non-small cell lung carcinoma (squamous or non squamous).
• Locally advanced/unresectable or metastatic disease.
• For non-squamous histology, tumor with no oncogenic addiction: no activating EGFR mutation, no ALK or ROS1 rearrangement,
• Treatment with ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy):
• in first or second-line treatment as per market authorization. For patients in first line, ICI alone or ICI + chemotherapy,
• start of ICI treatment 6 to 12 months (+/- 2 weeks) before registration.
• 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
• At least one lesion that can be biopsied for research purpose.
• Age ≥ 18.
• Performance status \< 2.
• Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration.
• Patient with a social security in compliance with the French law (Loi Jardé).
• Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
• Voluntarily signed and dated written informed consent prior to any study specific procedure.

You may not qualify if:

• Female who is pregnant or breast-feeding.
• 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.
• Hypersensitivity to one of the active substances or to one of the excipients
• Any contraindication to pursue ICI treatment as per investigator judgement.
• Previous enrolment in the present study.
• Individual deprived of liberty or placed under legal guardianship.

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (5)

Centre Hospitalier de la Côte Basque

Bayonne, 64109, France

Location

Clinique Tivoli Ducos

Bordeaux, 33000, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33077, France

Location

Clinique Marzet

Pau, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized phase II study in which eligible patients will be randomized (1:1) according to two therapeutic strategies

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 10, 2021
• Study Start: August 27, 2021
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)