Skip to main content
/ Amsterdam UMC / SCLC / BMS-CA001-050

BMS-CA001-050

A Randomized, Open-label Phase 2 Clinical Trial of BMS-986012 in Combination with Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive stage Small Cell Lung Cancer

Contact opnemen

Enrollment

Recruiting

No. of patients

Main study : 0/120

Sub study   : 0/15

Population

Participants eligible for participation in CA001050 at qualified sites who do not meet any imaging exclusion criteria will be eligible to participate in this PET imaging study.\

Design

A Phase II, randomized,open label study

Key Outcome parameters

Assess the safety and tolerability and PFS

Intervention

Main study: Study treatment can consist of the following:

  • BMS-986012 Concentrate for Solution for Infusion
  • Nivolumab (BMS-936558) Solution for Injection
  • Carboplatin
  • Etoposide

PET study:

  • BMS-986279 IV Injection followed by 4 PET scans

Key inclusion criteria

  • Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC) and extensive-stage disease
  • Participants taking part in the separate PET tracer sub-study must provide a fresh tumor biopsy from any disease site (primary or metastatic)
  • Archived tumor specimens, in the form of blocks or sectioned slides, are mandatory for all participants except those participating in the separate PET tracer sub-study for whom the archived tumor specimen is optional
  • Performance status (ECOG PS) 0 or 1
  • At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI)
  • Adequate hematologic and end organ function
  • Must agree to follow specific methods of contraception, if applicable

Key exclusion criteria

  • Women who are pregnant or breastfeeding. Japan only: participation in the study is not allowed even if breastfeeding is suspended
  • Prior chemotherapy, radiation therapy, or biologic therapy for SCLC. Previously treated limited stage SCLC (LS-SCLC) participants are also excluded
  • Symptomatic brain or other central nervous system (CNS) metastases
  • Paraneoplastic autoimmune syndrome requiring systemic treatment
  • History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan
  • Grade ≥ 2 peripheral sensory neuropathy at study entry
  • Significant uncontrolled cardiovascular disease
  • Active, known or suspected autoimmune disease or inflammatory disorder

Contact opnemen over een studie

Neem contact op voor meer informatie over de studies van de afdeling thoracale oncologie van Amsterdam UMC.

Naar contactpersonen