Efficacy Study of Nivolumab or Chemotherapy in Subjects with RelapsedSmall-cell Lung Cancer

Phase 1

• Conditions: Relapsed Small Cell Lung Cancer; MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10041070Term: Small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10041069Term: Small cell lung cancer limited stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001097-18-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

Adult men and women with histologically or cytologically confirmed SCLC that recurred or progressed after platinum-based, first-line chemotherapy or chemoradiation therapy. Subjects must have had at least 4 cycles of platinum-based, first-line chemotherapy for either limited or extensive stage disease or if less than 4 cycles, must have had a BOR of at least partial or complete response.
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 370
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 370

Exclusion Criteria

Untreated or symptomatic central nervous system (CNS) metastases, documented carcinomatous meningitis, active, known or suspected
autoimmune disease, and prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab
or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways), topotecan, or amrubicin.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the overall survival (OS) of nivolumab versus chemotherapy in subjects with relapsed SCLC after platinum-based, first-line chemotherapy;Secondary Objective: - To compare the progression free survival (PFS) of nivolumab versus chemotherapy<br>- To compare the objective response rate (ORR) of nivolumab versus chemotherapy;Primary end point(s): Overall survival (OS) in subjects with relapsed SCLC;Timepoint(s) of evaluation of this end point: Approximately 12 months. Additional survival follow-up may continue for up to 5 years from the completion of the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1-progression free survival (PFS)<br>2-objective response rate (ORR);Timepoint(s) of evaluation of this end point: Tumor response will be assessed every 6 weeks until Week 30, and every 12 weeks until disease progression or treatment discontinuation