Clinical trial NCT04858204: Real Life Second-Line Nivolumab in Advanced Non-Small Cell Lung Cancer
Official title: Real Life Second-Line Nivolumab in Advanced Non-Small Cell Lung Cancer: a French Observational Multicenter Study of 259 Patients (ABCT-IMMUNOBZH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NSCLC
Keywords: Real-life
nivolumab
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced stage non-small cell lung cancer patients

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Nivolumab Objective response rate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Dinan
country: France
facility: CH DINAN
city: Lorient
country: France
facility: Centre Hospitalier de Bretagne Sud
city: Rennes
country: France
facility: CHU de Rennes
city: Saint-Malo
country: France
facility: Centre hospitalier de Saint Malo
city: St BRIEUC
country: France
facility: Centre Hospitalier Yves Le Foll
city: Vannes
country: France
facility: CH de VANNES
Study officials:
References:
citation: 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 the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy. The Oncologist. 2016 May;21(5):634-42. 3. Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E et al. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. 4. Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. 5. Herbst RS, Baas P, Kim D-W, Felip E, Pérez-Gracia JL, Han JY et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. The Lancet. 2016 Apr;387(10027):1540-50. 6. Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet Lond Engl. 2017 21;389(10066):255-65. 7. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer Oxf Engl 1990. 2009 Jan;45(2):228-47. 8. Common Terminology Criteria for Adverse Events (CTCAE) - CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf