RECRUITING

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

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Conditions

Patients With Non-Small Cell Lung CancerImmune Checkpoint InhibitorCancer vaccineNon-Small Cell Lung Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-12-03
Study Completion:2028-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06472245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female, aged ≥ 18 years
  2. 2. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
  3. 3. Patients with histologically or cytologically squamous or non-squamous documented NSCLC, metastatic stage at study entry, not eligible for definite surgery or radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy; other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; KRAS G12C and BRAF mutations) after Sponsor's agreement
  4. 4. Patients with secondary resistance to ICI;
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Georgetown Lombardi Comprehensive Cancer Center
Washington, District of Columbia, 20007
United States
Alliance for Multispecialty Research (AMR) - Kansas City Oncology
Merriam, Kansas, 66204
United States
NHO Revive Research Institute LLC
Lincoln, Nebraska, 68506
United States
New York Cancer & Blood Specialists - Babylon Medical Oncology
Babylon, New York, 11702
United States
Optum Medical Care - Carmel/Brewster Campus
Brewster, New York, 10509-2338
United States
New York Cancer & Blood Specialists - Eastchester Cancer Care Center
Bronx, New York, 10469
United States
Optum Medical Care - Fishkill Westage Campus
Fishkill, New York, 12524
United States
Optum Hematology Oncology - Lake Success
Lake Success, New York, 11042
United States
Optum Medical Care - Mount Kisco Campus 90
Mount Kisco, New York, 10549
United States
New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park, New York, 11042
United States
New York Cancer & Blood Specialists - Central Park Medical Oncology
New York, New York, 10028
United States
New York Cancer & Blood Specialists - Patchogue Medical Oncology
Patchogue, New York, 11772
United States
New York Cancer & Blood Specialists - Port Jefferson Station Medical Oncology
Port Jefferson Station, New York, 11776
United States
Optum Medical Care - Poughkeepsie
Poughkeepsie, New York, 12601
United States
Brooklyn Radiation Oncology
Richmond Hill, New York, 11418
United States
New York Cancer & Blood Specialists - Riverhead Medical Oncology
Riverhead, New York, 11901
United States
New York Cancer & Blood Specialists - Research Headquarters
Shirley, New York, 11967
United States
Bon Secours Hematology and Oncology
Greenville, South Carolina, 29607
United States

Collaborators and Investigators

Sponsor: OSE Immunotherapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-03
Study Completion Date2028-12-15

Study Record Updates

Study Start Date2024-12-03
Study Completion Date2028-12-15

Terms related to this study

Keywords Provided by Researchers

  • Immune Checkpoint Inhibitor
  • Cancer vaccine
  • Non-Small Cell Lung Cancer

Additional Relevant MeSH Terms

  • Patients With Non-Small Cell Lung Cancer