Lung cancer immunotherapy duration study halted early
NCT ID NCT04880382
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how long to continue immunotherapy in people with advanced non-small cell lung cancer who had already responded well to treatment for 6 to 12 months. The goal was to see if stopping or continuing treatment made a difference in keeping the cancer from growing. Only 8 people took part before the study was stopped early, so the results are very limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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8 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 9. Performance status \< 2. 10. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration. 11. Patient with a social security in compliance with the French law (Loi Jardé). 12. Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 13. Voluntarily signed and dated written informed consent prior to any study specific procedure. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Hospitalier de la Côte Basque
Bayonne, 64109, France
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Clinique Marzet
Pau, France
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Clinique Tivoli Ducos
Bordeaux, 33000, France
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Institut Bergonie
Bordeaux, 33076, France
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Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33077, France
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