Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 2, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT06472245). This is a study registration, not published results. Lead sponsor: OSE Immunotherapeutics. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 363 participants (ESTIMATED). Conditions: Patients With Non-Small Cell Lung Cancer. Interventions: DRUG: OSE2101; DRUG: Docetaxel; DEVICE: NGS HLAA2 assay. Primary outcome measures: OS defined as time from randomization to death , From randomization date through study completion, an average of 3 years. Brief 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).