Immunotherapy in Patient With Poor General Condition
Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
Summary
Immunotherapeutic approaches targeting immune checkpoint proteins PD-1/PD-L1 have recently
demonstrated clinical efficacy in several cancer types, and have changed the therapeutic
landscape in metastatic melanoma or non-small cell lung cancer (NSCLC).
The monoclonal anti-PD-1 antibody nivolumab has been registered by both FDA (Food and Drug
Administration) and EMA (European Medicine Agency), for metastatic NSCLC patients, after
failure of a prior platinum-based chemotherapy.
The approval was based on the results of phase III clinical trials in metastatic NSCLC. But
all the trials only enrolled patients with good general condition, PS (Performance Status) 0
or 1. However, the prevalence of poor PS patients at time of diagnosis is high in lung cancer
patients.
For patients with metastatic NSCLC and PS 3, there is no standard treatment except best
supportive care, since all trials that accrued unselected PS 3 patients fail to prove any
survival advantage, and most PS >3 patients die within 2 to 4 months from diagnosis. Indeed,
these patients are currently excluded from clinical trials. Specific dedicated clinical
trials and treatment guidelines for this patient population are urgently needed, taking into
account for the high prevalence of such patients.
Phase:
Phase 2
Details
Lead Sponsor:
Intergroupe Francophone de Cancerologie Thoracique