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NCT06449313 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement
A Phase 2 study of Non-Small Cell Lung Cancer (Stage III), sponsored by Georgetown University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 3
- Study locations
NCT06449313 is a Phase 2 study of Non-Small Cell Lung Cancer (Stage III) that is actively recruiting participants, run by Georgetown University. The registered enrollment target is 21 participants, below the 99-participant average among 6 other Non-Small Cell Lung Cancer (Stage III) trials with a reported enrollment target (79% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06449313, a Phase 2 study of Non-Small Cell Lung Cancer (Stage III), is actively recruiting participants, sponsored by Georgetown University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 3
- Study locations
Study Summary
The goal of this clinical trial is to learn about neoadjuvant cemiplimab with histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage 3 non-small cell lung cancer (NSCLC) with contralateral mediastinal or ipsilateral supraclavicular lymph node (N3) involvement.. The main question it aims to answer is whether patients with stage 3 NSCLC with involvement of lymph nodes can undergo surgery to remove the cancer after receiving treatment with chemotherapy + immunotherapy. Participants will receive FDA-approved chemotherapy called platinum-doublet chemotherapy together with an immunotherapy drug targeting the immune marker PD-1 called cemiplimab. Patients will receive a 3 drug combination for 4 total treatments given every 3 weeks before surgery. After surgery, patients will have the option to undergo radiation therapy if it is recommended by their treatment team. After this, they will receive cemiplimab every 3 weeks for one year.
Conditions Studied
Interventions
- DRUG Cemiplimab-Rwlc
Study Locations (3)
District of Columbia
- Lombardi Comprehensive Cancer Center, Georgetown University - Washington D.C.
Missouri
- Washington University School of Medicine-Sitemen Cancer Center - St Louis
Virginia
- UVA Comprehensive Cancer Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2026-04 |
| Est. Completion | 2032-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06449313
The ClinicalTrials.gov registry entry for NCT06449313 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 99-participant average among 6 other Non-Small Cell Lung Cancer (Stage III) trials with a reported enrollment target (79% lower). The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Small Cell Lung Cancer (Stage III) appearing as the primary indexed condition, and to 1 intervention - of which Cemiplimab-Rwlc is the first listed.
NCT06449313 reports 3 study locations spanning 3 distinct geographic areas - top geographies include District of Columbia, Missouri, Virginia.
Frequently Asked Questions
What is clinical trial NCT06449313 about?
NCT06449313 is a clinical study titled "Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement". The goal of this clinical trial is to learn about neoadjuvant cemiplimab with histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage 3 non-small cell lung cancer (NSCLC) with contralateral mediastinal or ipsilateral supraclavicular lymph node (N3) involvement.. The m...
What is the current status of trial NCT06449313?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2026-04. Estimated completion is 2032-09.
What conditions does trial NCT06449313 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer (Stage III).
What interventions are being tested in trial NCT06449313?
The interventions under investigation include: Cemiplimab-Rwlc (DRUG).
Who is sponsoring clinical trial NCT06449313?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06449313 being conducted?
This trial has 3 study locations across District of Columbia, Missouri, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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