Phase 2
Completed N=33
Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma
Source: ClinicalTrials.gov NCT03958045 ↗Enrolled (actual)
33
Serious AEs
36.4%
Results posted
Dec 2023
Primary outcomePrimary: Progression Free Survival — 11 months
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
11 | — |
| SECONDARY Disease Control Rate |
33.3 | — |
| SECONDARY Overall Survival |
93.55; 52.82 | — |
| SECONDARY Objective Response Rate |
4 | — |
| SECONDARY Quality of Life Scale Baseline |
76.1; 69.3; 78.1; 81; 72.4; 65.2 | — |
| SECONDARY Quality of Life Scale 4 Months |
70.5; 65; 75.6; 78.3; 73.3; 65.8 | — |
| SECONDARY Quality of Life Scale at Disease Progression |
66.7; 41.7; 45.8; 41.7; 50; 50 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03958045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.