Clinical trial · Interventional
Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma
Phase II Study of Combination Rucaparib With Nivolumab in Platinum-Sensitive Small Cell Lung Carcinoma Patients as Maintenance After Induction Therapy With Platinum Doublet
NCT03958045CI-TRIAL-00081820completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rucaparib and Nivolumab | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with Stage IV SCLC
- description
- Patients with extensive stage (IV) SCLC (small cell lung cancer)
- interventionNames
- Combination Product: Rucaparib and Nivolumab
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 0-2 years
- description
- Duration (time) of progression-free survival after response to initial platinum-based therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions from starting maintenance treatment
Secondary outcomes (6)
- measure
- Disease Control Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.