De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction

Immunotherapeutic approaches recently have demonstrated clinical efficacy in several cancer types, including melanoma and NSCLC. As a matter of fact, first registration trials of immune-checkpoints inhibitors (ICI) in second-line settings (pembrolizumab as well as nivolumab or atezolizumab) had stated that ICI could be continued until disease progression or not tolerable toxicity, up to 5 years. This is only for the first-line registration studies that the arbitrary maximal duration of treatment of 2 years was set up by the Companies sponsoring such trials. The aim is to study a de-escalation scheme of treatment from 2 years of immunotherapy to 6 months (27-weeks), in patients with controlled disease.

NCT Number	NCT05255302
Lead Sponsor	Intergroupe Francophone de Cancerologie Thoracique
Conditions	Metastatic NSCLC
Enrollment	1,360 participants
Start Date	2022-05-02
Primary Completion	2025-05 (estimated)
Study Completion	2029-06-01 (estimated)
Updated on ClinicalTrials.gov	2025-04-01