Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
Sponsored by OSE Immunotherapeutics
About this study
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).
Where this study is enrolling
- I'm interested
University of Illinois Cancer Center
Chicago, Illinois
Who can participate
Inclusion 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; for patients with squamous NSCLC, the molecular tests are not mandatory if age ≥ 50 years old and smoker ≥ 15 pack years; 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' agreement.
- ✓4. Patients with secondary resistance to ICI;
- ✓Other inclusion and
Exclusion criteria
- ✕will apply per protocol.
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Trial data sourced from ClinicalTrials.gov.