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Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor

A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor

NCT06472245•OSE Immunotherapeutics

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, aged ≥ 18 years
•2. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory

Exclusion Criteria

•4. Patients with secondary resistance to ICI;

Locations (207)

Clinical Research Advisors, LLC

Beverly Hills, California, United States

Clinical Research Advisors - Encino

Encino, California, United States

Clinical Research Advisors - West Hollywood

Los Angeles, California, United States

Clinical Research Advisors - Korea Town

Los Angeles, California, United States

SCL Health - Saint Joseph Hospital Cancer Center

Littleton, Colorado, United States

Lutheran Medical Center - Cancer Centers of Colorado

Wheat Ridge, Colorado, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

Comprehensive Hematology Oncology - Bradenton Clinic

Bradenton, Florida, United States

Comprehensive Hematology Oncology - Brandon Clinic

Brandon, Florida, United States

Key Dates

Start Date

December 3, 2024

Primary Completion Date

December 15, 2027

Completion Date

December 15, 2028

Last Updated

March 6, 2026

Enrollment

363

ESTIMATED participants

Conditions

Patients With Non-Small Cell Lung Cancer

Interventions

OSE2101

DRUG

Docetaxel

DRUG

NGS HLAA2 assay

DEVICE

Contacts

Caroline Chevalier, MSc, MPH

CONTACT

+33 630 842 002 caroline.chevalier@ose-immuno.com

Bérangère Vasseur, MD

CONTACT

+33 676 448 160 berangere.vasseur@ose-immuno.com

A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer

NCT02283320

KRAS Positive Patients With Non-small Cell Lung CancerSquamous Cell Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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