Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Non-Small Cell Lung Cancer (Stage III), sponsored by Georgetown University.
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 86-participant average among 8 other Non-Small Cell Lung Cancer (Stage III) trials with a reported enrollment target (76% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pathologic complete response (pCR): 0% viable tumor in primary tumor and resected lymph nodes.
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 |
What NCT06449313 shows while recruiting
NCT06449313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 86-participant average among 8 other Non-Small Cell Lung Cancer (Stage III) trials with a reported enrollment target (76% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer (Stage III)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06449313's enrollment target sits among peer trials
21 8th of 8 higher than 1 of 8 other Non-Small Cell Lung Cancer (Stage III) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer (Stage III) 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
-
HEARTS Trial for Thoracic Cancers
RECRUITING · Phase 2
-
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
RECRUITING · Phase 2
-
Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
RECRUITING · Phase 2
-
Pulmonary Rehabilitation in Advanced Lung Cancer Survivors
RECRUITING · Phase 2
-
Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance
RECRUITING · Phase 2
-
Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02447874 · 21 participants · Phase 1
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
- NCT03826992 · 21 participants · Phase 1
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
- NCT04107077 · 21 participants · Phase 2
Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer
- NCT04158635 · 21 participants · Phase 1
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia