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NCT04768296 · ClinicalTrials.gov registry record · Phase 2
Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)
A Phase 2 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT04768296: Completed Phase 2 study, sponsored by EMD Serono Research & Development Institute.
NCT04768296 is a Phase 2 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04768296, a Phase 2 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main part. The safety run-in part will be conducted in Japan.
Primary Outcome
Objective response rate was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD). CR: Disappearance of all target and non-target lesions. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of their diameters, and no unequivocal progression of non-target lesions. PD: at least a 20%
Interventions
- DRUG Topotecan
- DRUG Berzosertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2021-03-29 |
| Est. Completion | 2023-07-21 |
| Phase | Phase 2 |
What the finished NCT04768296 record still lists
NCT04768296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Topotecan is the first listed.
NCT04768296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04768296 about?
NCT04768296 is a clinical study titled "Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)". The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main pa...
What is the current status of trial NCT04768296?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2021-03-29. Estimated completion is 2023-07-21.
What interventions are being tested in trial NCT04768296?
The interventions under investigation include: Topotecan (DRUG), Berzosertib (DRUG).
Who is sponsoring clinical trial NCT04768296?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04768296's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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