A study to evaluate the safety of Nivolumab in patients with advanced or metastatic non-small cell lung cancer

Phase 1

• Conditions: Advanced or metastatic non-small cell lung cancer; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2016-003731-37-RO
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-26
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1) Subjects with Advanced or Metastatic Non small cell lung cancer (Squamous or non-squamous)
2) One prior anti-cancer therapy that did not work
3) ECOG Performance Scale 0-1
4) Naive to immuno-oncology therapy
5) with at least 1 measurable disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1) Subjects haivng Cancer that has spread to the brain or leptomeninges unless there is no evidence of progression by MRI for 8 weeks after treatment is complete and within 28 days before first dose of study drug
2) Corticosteroids within 2 weeks of study drug administration

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the safety of nivolumab 480 mg, IV over 30 minutes every 4 weeks;Secondary Objective: To estimate the efficacy of nivolumab 480 mg, IV over 30 minutes every 4 weeks;Primary end point(s): Safety of Nivolumab assessed by incidence of treatment-related select Adverse Events;Timepoint(s) of evaluation of this end point: Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Progression-free Survival (PFS)<br>2) Objective Response Rate (ORR)<br>3) Overall Survival (OS)<br>4) Duration of Response (DOR);Timepoint(s) of evaluation of this end point: Up to 2 years <br>