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

NCT06472245

RecruitingPhase 3

Sponsor: OSE Immunotherapeutics

Conditions: Patients With Non-Small Cell Lung Cancer

Interventions: OSE2101, Docetaxel, NGS HLAA2 assay

Countries: United States, Belgium, Canada, France, Germany, Greece, Hungary, Italy

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (207)
  • Beverly Hills, California, United States
  • Encino, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Littleton, Colorado, United States
  • Wheat Ridge, Colorado, United States
  • Norwich, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Bradenton, Florida, United States
  • Brandon, Florida, United States
  • Fleming Island, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville Beach, Florida, United States
  • Largo, Florida, United States
  • Neptune Beach, Florida, United States
  • Palm Harbor, Florida, United States
  • Saint Augustine, Florida, United States
  • St. Petersburg, Florida, United States
  • St. Petersburg, Florida, United States
  • Trinity, Florida, United States
  • Chicago, Illinois, United States
  • Merriam, Kansas, United States
  • Baton Rouge, Louisiana, United States
  • Covington, Louisiana, United States
  • Hammond, Louisiana, United States
  • Baltimore, Maryland, United States
  • + 177 more on CT.gov