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Completed

NCT Number: NCT02933346

Cohort of Patients With NSCLC Treated With Nivolumab Under the ATU Program

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Long Term Adverse Effects Long-term Adverse Effects Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nivolumab Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH du Pays d'Aix, Aix-en-Provence, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with advanced NSCLC, non-eligible for thoracic radiation therapy, having received nivolumab (at least one injection), under nominative or cohort ATU, between 23-JAN-2015 and 31-AUG-2015 (end of ATU).

Exclusion criteria

  • patients included in a biomedical research trial with nivolumab
  • patients <18 years old
  • patients included under ATU to receive nivolumab administration, but never did
  • patients with a psychiatric history that hinders the comprehension of the information leaflet
  • patients refusing their data being collected

Treatment and study plan

Primary outcomes

  1. overall survival

    Time frame: January 2015 - December 2017

    time from start of treatment to death from any cause

Secondary outcomes

  1. efficacy of nivolumab

    Time frame: January 2015 - December 2017

    progression-free survival, best overall response, exposure time

  2. 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)

  3. efficacy of the first systemic treatment post-nivolumab

    Time frame: January 2015 - December 2017

    progression-free survival, best response

Sponsors and collaborators

Lead sponsor

Intergroupe Francophone de Cancerologie Thoracique

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Acronym: CLINIVO

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Oct 14, 2016
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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