Clinical trial · Interventional
Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer
Phase I Feasibility and Safety Study of Nivolumab in Combination With Irinotecan in Relapsed or Refractory Small Cell Lung Cancer (SCLC) Followed by Maintenance Nivolumab
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed by the IRB 5/26/22 due to non-compliance
Summary
Brief summary (as posted)
This study will determine the frequency of adverse events (side effects) in patients with relapsed or refractory small cell lung cancer (SCLC) when given nivolumab and irinotecan together followed by nivolumab maintenance. This study will test the safety of the study treatments when given together and see what effect (good or bad) it has on participants and their cancer.
Conditions
Conditions (2)
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 |
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan Injection [Camptosar] | Drug | Irinotecan | ALIAS |
| Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nivolumab and Irinotecan
- description
- Drug: Nivolumab 360mg IV Day 1 of each 21 day cycle until disease progression or unacceptable toxicity + Drug: Irinotecan 500mg IV Day of each 21 day cycle for 2 cycles Followed by maintenance nivolumab (without irinotecan)
- interventionNames
- Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
- Drug: Irinotecan Injection [Camptosar]
Primary outcomes (1)
- measure
- Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance.
- timeFrame
- through study completion, an average of 1 year
- description
- CTCAE v.4.0. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed SCLC with known UGT1A genotype. * Patients who have received at least 1 prior platinum-based chemotherapy. * Life expectancy of 3 months or more. * Measurable disease. Exclusion Criteria: * Patients with UGT1A polymorphism. * Currently receiving chemotherapy. * Pregnant and nursing women.
References
Publications (0)
Data not yet available