NCT02815592CompletedPhase 1/2
A trial of BMS-986012 in combination with chemotherapy for small cell lung cancer
A Phase 1/2 Randomized Trial of BMS-986012 in Combination with Platinum and Etoposide as First-line Therapy in Extensive-Stage Small Cell Lung Cancer
Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 May 2024
Brief summary (registry, in English)
-Part 1 and 2: To assess the safety, tolerability, and maximum tolerated dose (MTD) or maximum administered dose (MAAD) of BMS-986012 given in combination with 4 cycles of cisplatin/etoposide (Part 1) and carboplatin/etoposide (Part 2), and then continuing as BMS-986012 monotherapy until disease progression. -Part 3: To compare the PFS of subjects randomized to receive BMS 986012 in combination with platinum and etoposide for 4 cycles and then continuing as BMS-986012 monotherapy until disease progression (Arm 3A) to that of subjects randomized to receive platinum and etoposide alone (Arm 3B) in subjects with newly diagnosed extensive-stage SCLC.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- First submitted
- 29 Apr 2024
- Start date
- 18 Oct 2016
- Lead sponsor
- Bristol Myers Squibb International Corporation
- Diseases
- Lung cancer
- NCT number
- NCT02815592
- EU CT number
- 2024-511824-15-00
- EudraCT number
- 2016-001692-67
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 1
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic therapy for lung cancer
Other illness
- 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
Other
- Symptomatic brain metastases
- Grade 2 peripheral neuropathy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.