Clinical Trial: Cohort of Patients With NSCLC Treated With Nivolumab Under the ATU Program

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Assessment and Follow-up of Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Nivolumab Under the French Temporary Authorization for Use (ATU) Program

Brief Summary: Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated under the Temporary Authorization for Use (ATU, compassionate use) setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. The profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.

Detailed Summary:

Although the oncogene addiction concept has led to effective targeted treatments for certain histological non-small cell lung cancer (NSCLC) types, most patients with advanced tumors are still treated with first-line chemotherapy. In 2015, several studiess demonstrated the efficacy of nivolumab, an immunotherapy targeting immune checkpoints. In France, besides the clinical trials, this molecule has been made available in January 2015 under a Temporary Authorization for Use (ATU, compassionate use).

Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated under the ATU setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. The profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.


Sponsor: Intergroupe Francophone de Cancerologie Thoracique

Current Primary Outcome: overall survival [ Time Frame: January 2015 - December 2017 ]

time from start of treatment to death from any cause


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • efficacy of nivolumab [ Time Frame: January 2015 - December 2017 ]
    progression-free survival, best overall response, exposure time
  • maximum toxicities of nivolumab treatment, including delayed toxicities (immune) [ Time Frame: January 2015 - December 2017 ]
    Maximum toxicity according to the investigator (Adverse events with NCI-CTC 4.0 Grade ≥2, categorized as: hepatic, pulmonary, endocrine, cutaneous, gastrointestinal, renal, hematologic, other immune toxicities)
  • efficacy of the first systemic treatment post-nivolumab [ Time Frame: January 2015 - December 2017 ]
    progression-free survival, best response


Original Secondary Outcome: Same as current

Information By: Intergroupe Francophone de Cancerologie Thoracique

Dates:
Date Received: October 12, 2016
Date Started: September 2016
Date Completion: December 2017
Last Updated: February 16, 2017
Last Verified: February 2017