OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoi… (NCT02654587) | Clinical Trial Compass
TerminatedPhase 3
OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure
Stopped: due to COVID-19
United States219 participantsStarted 2016-02-12
Plain-language summary
The aim of this clinical trial was to determine if the therapeutic cancer vaccine OSE2101 (TEDOPI) was more effective than standard chemotherapy (docetaxel or pemetrexed) in treating HLA-A2 positive patients with metastatic NSCLC who progressed after sequential or concurrent chemotherapy and immune checkpoint inhibitor given in first or second-line treatment.
The main questions were to compare the survival, the tolerance to treatment and the quality of life of patients between the two arms of treatment (OSE2101 versus standard chemotherapy)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed and dated informed consent
✓. Willingness and ability to comply with the clinical study procedures.
✓. Female or male, 18 years of age or older
✓. Histologically or cytologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced (stage III) unsuitable for radiotherapy or metastatic (stage IV) according to the 8th edition of tumor, node, metastasis (TNM) in Lung Cancer
✓. Subjects with disease recurrence or progression after immune checkpoint inhibitor and platinum-based chemotherapy:
✓. Subjects with measurable or non-measurable lesions according to RECIST 1.1
✓. Subjects must express HLA-A2 phenotype (central test in blood)
✓. Subjects must be considered suitable for chemotherapy with single-agent pemetrexed or single-agent docetaxel
Exclusion criteria
✕. Small-cell lung cancer/mixed NSCLC with small cell component or other neuroendocrine lung cancers (typical and atypical carcinoids, large-cell neuroendocrine carcinomas)
✕. Patients with squamous cell carcinoma histology, and who had docetaxel as part of his prior chemotherapy
✕. Current or previous treatment with investigational therapy in another therapeutic clinical trial (interrupted less than 4 weeks before study treatment initiation)
✕. Patients whose tumor harbors EGFR gene mutation that sensitizes tumors to Tyrosine-Kinase Inhibitor (TKI) (EGFR exon 18-21) or Anaplastic Lymphoma Kinase (ALK) rearrangement
✕. Ongoing immunotherapy (checkpoint inhibition, antigen immunotherapy that would be scheduled to continue concomitantly to the study)
✕. Spinal cord compression (unless treated with the patient attaining good pain control and stable or recovered neurologic function), carcinomatous meningitis, or leptomeningeal disease
✕. Patients with squamous cell histology or non-squamous cell histology previously treated by pemetrexed with a contraindication for docetaxel with grade ≥ 2 neuropathy or hypersensitivity reaction to medications formulated with polysorbate 80 (Tween 80)
✕. Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications