A trial of BMS-986012 in combination with chemotherapy for small cell lung cancer

Phase 1

• Conditions: Extensive-Stage Small Cell Lung Cancer; MedDRA version: 19.0Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001692-67-ES
• 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: 2016-07-15
• Last Update Posted: 18 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

- Pulmonary SCLC documented by histology or cytology
- Extensive disease (Stage IV) Small Cell Lung Cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Male and Females 18 years of age or older
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 112
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

- Prior systemic therapy for lung cancer
- Symptomatic brain metastases
- Grade 2 peripheral neuropathy
- Active or chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- Other active malignancies or prior malignancy within 2 years

Study & Design

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