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NCT04858204 Clinical Trial

Real Life Second-Line Nivolumab in Advanced Non-Small Cell Lung Cancer

NSCLC Clinical Trial

— IMMUNOBZH  

Official title:
Real Life Second-Line Nivolumab in Advanced Non-Small Cell Lung Cancer: a French Observational Multicenter Study of 259 Patients (ABCT-IMMUNOBZH)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04858204
Other study ID # IMMUNOBZH (29BRC17.0032)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 14, 2017
Est. completion date November 1, 2017

Study information
Verified date April 2017
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Data regarding nivolumab as second line treatment in advanced non-small cell lung cancer (NSCLC) are based on selected populations and might not reflect daily practice. Investigators aimed at assessing efficacy and safety of nivolumab in a real-life setting and determining a subtype of NSCLC patients that are more likely to benefit from immunotherapy.

Recruitment information / eligibility
Status Completed
Enrollment 259
Est. completion date November 1, 2017
Est. primary completion date October 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - advanced NSCLC (stage IIIB-IV) - failure of at least one line of chemotherapy. - age =18 years, - initiation of nivolumab between 01/09/2015 and 30/09/2016. Exclusion Criteria: - nivolumab initiation after October 2016 - prior involvement in an immunotherapy trial - refusal to participate.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU de Brest Brest
France CH DINAN Dinan
France Centre Hospitalier de Bretagne Sud Lorient
France CHU de Rennes Rennes
France Centre hospitalier de Saint Malo Saint-Malo
France Centre Hospitalier Yves Le Foll St BRIEUC
France CH de VANNES Vannes

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (1)

1. Malhotra J, Jabbour SK, Aisner J. Current state of immunotherapy for non-small cell lung cancer. Transl Lung Cancer Res. 2017 Apr;6(2):196-211. 2. Kazandjian D, Suzman DL, Blumenthal G, Mushti S, He K, Libeg M et al. FDA Approval Summary: Nivolumab for

Outcome
Type Measure Description Time frame Safety issue
Primary Nivolumab Objective response rate Objective response rate evaluated by RECIST 1.1 through study completion, an average of 1 year
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