Integrative Analysis of Tumor Microenvironment and Optimization of Immunotherapy Duration in NSCL… (NCT04880382) | Clinical Trial Compass
TerminatedPhase 2
Integrative Analysis of Tumor Microenvironment and Optimization of Immunotherapy Duration in NSCL Cancer Patients
Stopped: Enrolment was slowlier than expected.
France8 participantsStarted 2021-08-27
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
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