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

NCT04858204 | Completed

• 1 other identifier: IMMUNOBZH (29BRC17.0032)
• Study Type: observational
• Target: 259
• Locations: 1 country
• Sites: 7

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.

Conditions

NSCLC

Keywords

Real-life; nivolumab

Outcome Measures

Primary Outcomes (1)

• Nivolumab Objective response rate

  Objective response rate evaluated by RECIST 1.1

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Advanced stage non-small cell lung cancer patients

You may qualify if:

• 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.

You may not qualify if:

• nivolumab initiation after October 2016
• prior involvement in an immunotherapy trial
• refusal to participate.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (7)

CHRU de Brest

Brest, 29609, France

Location

CH DINAN

Dinan, 22101, France

Location

Centre Hospitalier de Bretagne Sud

Lorient, 56100, France

Location

CHU de Rennes

Rennes, 35000, France

Location

Centre Hospitalier Yves Le Foll

Saint-Brieuc, 22000, France

Location

Centre hospitalier de Saint Malo

St-Malo, France

Location

CH de VANNES

Vannes, 56017, France

Location

Related 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 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

  RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: April 26, 2021
• Study Start: April 14, 2017
• Primary Completion: October 31, 2017
• Study Completion: November 1, 2017
• Last Updated: April 26, 2021

Record last verified: 2017-04

Locations

FR (7)