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NCT06472245 · ClinicalTrials.gov registry record · Phase 3
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
A Phase 3 study of Patients With Non-Small Cell Lung Cancer, sponsored by OSE Immunotherapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 363
- Enrollment target
- 20
- Study locations
NCT06472245: Recruiting Phase 3 study of Patients With Non-Small Cell Lung Cancer, sponsored by OSE Immunotherapeutics.
NCT06472245 is a Phase 3 study of Patients With Non-Small Cell Lung Cancer that is actively recruiting participants, run by OSE Immunotherapeutics. The registered enrollment target is 363 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06472245, a Phase 3 study of Patients With Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by OSE Immunotherapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 363 participants
- Enrollment target
- 20
- Study locations
Study Summary
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance. Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).
Primary Outcome
OS defined as time from randomization to death of any cause, censored until the data analysis cut-off date
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG OSE2101
- DEVICE NGS HLAA2 assay
Study Locations (20)
Florida
- Comprehensive Hematology Oncology - Bradenton Clinic - Bradenton
- Comprehensive Hematology Oncology - Brandon Clinic - Brandon
- Cancer Specialists of North Florida - Fleming Island - Fleming Island
- Cancer Specialists of North Florida - Riverside - Jacksonville
- Cancer Specialists of North Florida Southside - Jacksonville
- Cancer Specialists of North Florida - Northside - Jacksonville
- Cancer Specialists of North Florida - Southpoint - Jacksonville
- Cancer Specialists of North Florida - Baptist South - Jacksonville
- Cancer Specialists of North Florida - Jacksonville Beach
- Comprehensive Hematology Oncology - Largo Clinic - Largo
- Cancer Specialists of North Florida - Beaches - Neptune Beach
- Comprehensive Hematology Oncology - Palm Harbor Clinic - Palm Harbor
California
- Clinical Research Advisors, LLC - Beverly Hills
- Clinical Research Advisors - Encino - Encino
- Clinical Research Advisors - West Hollywood - Los Angeles
- Clinical Research Advisors - Korea Town - Los Angeles
Colorado
- SCL Health - Saint Joseph Hospital Cancer Center - Littleton
- Lutheran Medical Center - Cancer Centers of Colorado - Wheat Ridge
Connecticut
- Eastern Connecticut Hematology and Oncology Associates - Norwich
District of Columbia
- Georgetown Lombardi Comprehensive Cancer Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 363 participants |
| Start Date | 2024-12-03 |
| Est. Completion | 2028-12-15 |
| Phase | Phase 3 |
What NCT06472245 shows while recruiting
NCT06472245 is an interventional study that assigns participants to a tested intervention. The registered 363 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Patients With Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel is the first listed.
NCT06472245 names 20 study sites across 5 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT06472245 about?
NCT06472245 is a clinical study titled "Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor". Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance. Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docet...
What is the current status of trial NCT06472245?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 363 participants. The study started on 2024-12-03. Estimated completion is 2028-12-15.
What conditions does trial NCT06472245 study?
This clinical trial studies the following conditions: Patients With Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT06472245?
The interventions under investigation include: Docetaxel (DRUG), OSE2101 (DRUG), NGS HLAA2 assay (DEVICE).
Who is sponsoring clinical trial NCT06472245?
This trial is sponsored by OSE Immunotherapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06472245 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06472245's enrollment target sits among peer trials
363 1006th of 2000 higher than 994 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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