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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02933346

Acronym

CLINIVO

Enrollment

907

Registered

2016-10-14

Start date

2016-09-30

Completion date

2020-12-15

Last updated

2023-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-term Adverse Effects, Nivolumab, Non-small Cell Lung Cancer

Keywords

Nivolumab, Real-world study, IFCT

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 description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
overall survival	January 2015 - December 2017	time from start of treatment to death from any cause

Secondary

Measure	Time frame	Description
efficacy of nivolumab	January 2015 - December 2017	progression-free survival, best overall response, exposure time
maximum toxicities of nivolumab treatment, including delayed toxicities (immune)	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	January 2015 - December 2017	progression-free survival, best response

Countries

France

Outcome results