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

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).

Conditions

Patients With Non-Small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Patients With Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Washington

Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States, 20007

Merriam

Alliance for Multispecialty Research (AMR) - Kansas City Oncology, Merriam, Kansas, United States, 66204

Lincoln

NHO Revive Research Institute LLC, Lincoln, Nebraska, United States, 68506

Babylon

New York Cancer & Blood Specialists - Babylon Medical Oncology, Babylon, New York, United States, 11702

Brewster

Optum Medical Care - Carmel/Brewster Campus, Brewster, New York, United States, 10509-2338

Bronx

New York Cancer & Blood Specialists - Eastchester Cancer Care Center, Bronx, New York, United States, 10469

Fishkill

Optum Medical Care - Fishkill Westage Campus, Fishkill, New York, United States, 12524

Lake Success

Optum Hematology Oncology - Lake Success, Lake Success, New York, United States, 11042

Mount Kisco

Optum Medical Care - Mount Kisco Campus 90, Mount Kisco, New York, United States, 10549

New Hyde Park

New York Cancer & Blood Specialists - New Hyde Park, New Hyde Park, New York, United States, 11042

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

OSE Immunotherapeutics,

Study Record Dates

2028-12-15