Immunotherapy in Patient With Poor General Condition

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT04108026
Phase
PHASE2
Status
Completed

Conditions

  • Non-small Cell Lung Cancer Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 14, 2020
Status verified
Sep 2025
Primary completion
Nov 30, 2023
Completion
Sep 26, 2025

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Immunotherapy
    Durvalumab 1500 mg every 4 weeks until the progression of disease, discontinuation due to toxicity or withdrawal of consent, for a maximum duration of 2 years.

Primary Outcome Measure

Proportion of patients experiencing Grade 3-5 Treatment Related Adverse Event at 8 weeks of durvalumab [ Time Frame: 8 weeks ]

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