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

Trial Details

NCT ID
NCT05255302
Phase
PHASE2 / PHASE3
Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Pembrolizumab before randomization
  • Chemotherapy
  • Pemetrexed
  • Pembrolizumab after randomization
Locations (sample)
  • Aix-en-Provence, France|43.5283,5.44973
  • Amiens, France|49.9,2.3
  • Angers, France|47.47156,-0.55202
  • Avignon, France|43.94834,4.80892
  • Besançon, France|47.24878,6.01815

Key Eligibility Criteria

  • Signed Written Informed Consent:
  • Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. T…
  • Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
  • Patients with histologically confirmed metastatic NSCLC (Stage IV accordingly to 8th classification TNM, UICC 2015). A cytologically-proven NSCLC i…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Non-Small Cell (NSCLC) Lung Cancer Trials on Trialify →