Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma
Completed · Phase 2
Conditions studied: Small Cell Lung Cancer
In brief
The purpose of this study is to evaluate survival and response rate of the combination rucaparib and nivolumab as maintenance therapy in platinum-sensitive small cell lung carcinoma.
Key facts
- Study ID
- NCT03958045
- Run by
- Zhonglin Hao
- People needed
- 33
- Starts
- 2019-09-04
- Expected to finish
- 2022-11-15
- Last updated by the study team
- 2024-10-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with histologically or cytologically confirmed stage IV, extensive stage, small cell lung cancer who achieved either partial or complete remission per RECIST 1.1 post frontline chemotherapy with platinum doublet (Cisplatin or Carboplatin/etoposide).
- Enrollment is within 6 weeks of last (4th cycle) of chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate Bone Marrow Function
- Adequate Hepatic Function
You may not qualify if…
- Prior therapy with any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints)
- Major surgery within 4 weeks of initiation of study medication.
- Current use of (some) immunosuppressants
- Active infection requiring systemic therapy
- HIV/AIDS
- Hepatitis B virus or hepatitis C virus infection at screening
- Autoimmune disease
- Persisting toxicity related to prior therapy
- Pregnancy
- Vaccination (except inactive) within 4 weeks of the first dose of nivolumab
- Hypersensitivity to the study drugs
- Cardiovascular disease
- Untreated central nervous system (CNS) metastases or leptomeningeal carcinomatosis
- (Some) active secondary malignancy
- Active pneumonitis or interstitial lung disease
Where it is running
- Markey Cancer Center, University of Kentucky — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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