Atezolizumab in Elderly Patients With Advanced Non-Small-Cell Lung Cancer and Receiving Carboplatin Paclitaxel Chemotherapy

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT03977194
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Non Small Cell Lung Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
70 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    AUC 6 every 4 weeks
  • Paclitaxel — DRUG
    90 mg/m² D1, 8, 15, every 4 weeks
  • Atezolizumab — DRUG
    1200 mg every 3 weeks

Study Details

Non Small Cell Lung Cancer (NSCLC) remains the leading cause of death by cancer in the world. Because of the increase in lung cancer incidence with age and the increase of life expectancy, about half of the patients are patients aged 70 or older. Several clinical trials have shown the interest of adding immunotherapy to standard 1st line chemotherapy in NSCLC. Although in these studies there was not necessarily a higher age limit, in fact the proportion of included patients aged 75 or older remains low (between 7 and 10%). It is therefore necessary to conduct a trial dedicated to these patients in order to determine whether immunotherapy is as effective and tolerated as in the general population.

Key Dates

Start date
Jul 23, 2019
Status verified
Nov 2025
Primary completion
Aug 31, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
510 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A : standard treatment
    Carboplatine + paclitaxel (4 cycles of 28 days)
  • Experimental: Arm B : standard treatment + immunotherapy
    Carboplatine + paclitaxel (4 cycles of 28 days) + atezolizumab (every 21 days) until progression or toxicity

Primary Outcome Measure

Overall Survival [ Time Frame: 11 months after randomization of the last subject ]

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