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NCT03840915 · ClinicalTrials.gov registry record · Phase 1
M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT03840915: Completed Phase 1 study, sponsored by EMD Serono Research & Development Institute.
NCT03840915 is a Phase 1 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03840915, a Phase 1 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
The main purpose of the study was to evaluate the safety and tolerability of M7824 in combination with chemotherapy.
Primary Outcome
DLT was defined as Adverse Events(AEs) with any of following toxicities: Grade 4 nonhematologic toxicity or hematologic toxicity lasting more than equal to(\>=) 7 days despite medical intervention; Grade 3 nausea, vomiting, and diarrhea lasting \>= 3 days despite supportive care; Any Grade 3 or Grade 4 nonhematologic lab value leading to hospitalization or persisting for \>= 7 days; Grade 3 or Grade 4: grade 3 is defined as absolute neutrophil count (ANC) less than (\<) 1,000/Cubic Millimeter(mm
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-04-02 |
| Est. Completion | 2022-07-29 |
| Phase | Phase 1 |
What the finished NCT03840915 record still lists
NCT03840915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT03840915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03840915 about?
NCT03840915 is a clinical study titled "M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)". The main purpose of the study was to evaluate the safety and tolerability of M7824 in combination with chemotherapy.
What is the current status of trial NCT03840915?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2019-04-02. Estimated completion is 2022-07-29.
What interventions are being tested in trial NCT03840915?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Gemcitabine (DRUG), Nab-paclitaxel (DRUG).
Who is sponsoring clinical trial NCT03840915?
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 NCT03840915's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 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
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