Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04610658 · ClinicalTrials.gov registry record · Phase 1
Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT04610658: Clinical Trial Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT04610658 is a Phase 1 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04610658, a Phase 1 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a single-arm, phase I/II trial to determine the Maximum Tolerated Dose (MTD), Recommended Phase II Dose (RP2D), and the safety and efficacy of the combination of nivolumab-ipilimumab plus lurbinectedin in patients with relapsed/recurrent small cell lung cancer after progression with first-line, platinum-based chemotherapy
Primary Outcome
Maximum tolerated Dose will be determined by testing increasing doses of Lurbinectedin along with fixed doses of Nivolumab and Ipilimumab.
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Lurbinectedin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-11-23 |
| Est. Completion | 2023-03-24 |
| Phase | Phase 1 |
Why NCT04610658 stopped before completion
NCT04610658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT04610658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04610658 about?
NCT04610658 is a clinical study titled "Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC". This is a single-arm, phase I/II trial to determine the Maximum Tolerated Dose (MTD), Recommended Phase II Dose (RP2D), and the safety and efficacy of the combination of nivolumab-ipilimumab plus lurbinectedin in patients with relapsed/recurrent small cell lung cancer after progression with first-li...
What is the current status of trial NCT04610658?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2020-11-23. Estimated completion is 2023-03-24.
What interventions are being tested in trial NCT04610658?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Lurbinectedin (DRUG).
Who is sponsoring clinical trial NCT04610658?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04610658's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI