Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
- Conditions
- Patients With Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06472245
- Lead Sponsor
- OSE Immunotherapeutics
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 363
- Male or female, aged ≥ 18 years
- Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
- 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
- Patients with secondary resistance to ICI;
Other inclusion and exclusion criteria will apply per protocol.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: OSE2101 NGS HLAA2 assay Unit dose: 1 mL corresponding to a total of 5 mg of the combination of peptides Mode/Route: Subcutaneous injection Regimen: One injection every three weeks for six cycles, then every eight weeks for the remainder of year one and, finally every twelve weeks until the end of second year. Arm B: Docetaxel NGS HLAA2 assay Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks. GenDx CDx Tedopi NGS HLAA2 assay System of qualitative companion diagnostic devices, consisting of a polymerase chain reaction (PCR) assay Amp-HLA-A-CDx Tedopi, a DNA library preparation assay, LFK-CDx Tedopi and the software NGSengine-CDx Tedopi. Arm A: OSE2101 OSE2101 Unit dose: 1 mL corresponding to a total of 5 mg of the combination of peptides Mode/Route: Subcutaneous injection Regimen: One injection every three weeks for six cycles, then every eight weeks for the remainder of year one and, finally every twelve weeks until the end of second year. Arm B: Docetaxel Docetaxel Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks.
- Primary Outcome Measures
Name Time Method OS defined as time from randomization to death From randomization date through study completion, an average of 3 years OS defined as time from randomization to death of any cause, censored until the data analysis cut-off date
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (205)
Clinical Research Advisors, LLC
🇺🇸Beverly Hills, California, United States
Clinical Research Advisors - Encino
🇺🇸Encino, California, United States
Clinical Research Advisors - West Hollywood
🇺🇸Los Angeles, California, United States
Clinical Research Advisors - Korea Town
🇺🇸Los Angeles, California, United States
SCL Health - Saint Joseph Hospital Cancer Center
🇺🇸Littleton, Colorado, United States
Lutheran Medical Center - Cancer Centers of Colorado
🇺🇸Wheat Ridge, Colorado, United States
Eastern Connecticut Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
Georgetown Lombardi Comprehensive Cancer Center
🇺🇸Washington, District of Columbia, United States
Comprehensive Hematology Oncology - Bradenton Clinic
🇺🇸Bradenton, Florida, United States
Comprehensive Hematology Oncology - Brandon Clinic
🇺🇸Brandon, Florida, United States
Scroll for more (195 remaining)Clinical Research Advisors, LLC🇺🇸Beverly Hills, California, United States