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NCT03574818 · ClinicalTrials.gov registry record · Phase 2
Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001
A Phase 2 study, sponsored by Montefiore Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT03574818 is a Phase 2 study that was terminated before completion, run by Montefiore Medical Center. The registered enrollment target is 1 participants.
The verdict
NCT03574818, a Phase 2 study, was terminated before completion, sponsored by Montefiore Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
This will be a single-arm study to primarily evaluate the feasibility of administering necitumumab added to gemcitabine and cisplatin as neoadjuvant treatment in treatment-naïve patients with stage IB (tumor size \>4cm), II or IIIA squamous NSCLC. Feasibility will be assessed by the proportion of patients able to proceed to surgery after administering necitumumab in the neoadjuvant setting. These patients would otherwise be offered standard adjuvant chemotherapy (without necitumumab) for squamous cell lung cancer. Determination of surgical resectability will be reviewed at a multidisciplinary thoracic tumor board, attended by surgical oncology, medical oncology, radiation oncology, radiology, and pathology.
Interventions
- DRUG Necitumumab-Gemcitabine-Cisplatin
- DIAGNOSTIC_TEST Evaluation to determine if patient is a candidate to proceeed with surgical resection or not
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-05-29 |
| Est. Completion | 2019-09-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03574818
The ClinicalTrials.gov registry entry for NCT03574818 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Necitumumab-Gemcitabine-Cisplatin is the first listed.
NCT03574818 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03574818 about?
NCT03574818 is a clinical study titled "Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001". This will be a single-arm study to primarily evaluate the feasibility of administering necitumumab added to gemcitabine and cisplatin as neoadjuvant treatment in treatment-naïve patients with stage IB (tumor size \>4cm), II or IIIA squamous NSCLC. Feasibility will be assessed by the proportion of pa...
What is the current status of trial NCT03574818?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2018-05-29. Estimated completion is 2019-09-26.
What interventions are being tested in trial NCT03574818?
The interventions under investigation include: Necitumumab-Gemcitabine-Cisplatin (DRUG), Evaluation to determine if patient is a candidate to proceeed with surgical resection or not (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03574818?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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