A Phase 2 interventional study of ICI treatment discontinuation and ICI treatment continuation in Non Small Cell Lung Cancer, sponsored by Institut Bergonié. Terminated at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Institut Bergonié · Phase 2, Interventional, and Treatment
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)
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's enrollment of 8 is below the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Treatment with ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy):
Exclusion Criteria:
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
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
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
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
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
Time frame: 12 months
Assessment of secondary resistance in NSCLC patients who experienced a response to PD1/PDL-1 inhibition
The rate of patients who develop progression (as per RECIST v1.1) due to secondary resistance after obtaining a response to PD1/PDL-1 inhibition, independently for each therapeutic strategy
Time frame: 12 months
Duration of response independently for each therapeutic strategy
Duration of response (DoR) defined as the time interval between the first response (complete or partial response as per RECIST v1.1) to the time of the first documentation of disease progression
Time frame: Throughout the treatment period, an expected average of 12 months
1-year progression-free survival, independently for each therapeutic strategy
Progression-free survival (PFS) defined as the time interval between the date of randomization and the date of progression or death, whichever occurs first. Progression will be determined according to RECIST v1.1
Time frame: 1 year
2-year progression-free survival, independently for each therapeutic strategy
Progression-free survival (PFS) defined as the time interval between the date of randomization and the date of progression or death, whichever occurs first. Progression will be determined according to RECIST v1.1
Time frame: 2 years
1-year overall survival, independently for each therapeutic strategy
Overall Survival (OS) defined as the time interval between the date of randomization and the date of death (of any cause)
Time frame: 1 year
2-year overall survival, independently for each therapeutic strategy
Overall Survival (OS) defined as the time interval between the date of randomization and the date of death (of any cause)
Time frame: 2 years
Safety profile, independently for each therapeutic strategy: Common Terminology Criteria for Adverse Events version 5
Toxicity graded using the Common Terminology Criteria for Adverse Events version 5
Time frame: Throughout the treatment and follow-up period, an expected average of 12 months
• To describe retreatment for arm B-patients and subsequent systemic therapies for arm A-patients
Number of patients retreated by ICI will be described in Arm B. Similarly, for arm A-patients, number of patients treated by subsequent systemic therapy will be described
Time frame: Throughout the treatment and follow-up period, an expected average of 12 months
Tumor immune cells levels
Levels of immune cells in tumor will be measured by immunohistochemistry.
Time frame: At study onset (randomization) and at progression (throughout the treatment and follow-up period, an average of 12 months)
Blood cytokines levels
Levels of cytokines in blood will be measured by ELISA
Time frame: At study onset (randomization) and at progression (throughout the treatment and follow-up period, an average of 12 months)
Blood lymphocytes levels
Levels of lymphocytes in blood will be measured by flow cytometry
Time frame: At study onset (randomization) and at progression (throughout the treatment and follow-up period, an average of 12 months)
Blood kynurenine levels
Levels of kynurenine in blood will be measured by ELISA
Time frame: At study onset (randomization) and at progression (throughout the treatment and follow-up period, an average of 12 months)
Plan to share: No
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This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Institut Bergonié