OncoMatch/Clinical Trials/NCT06472245
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
Is NCT06472245 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including OSE2101 and Docetaxel for patients with non-small cell lung cancer.
Treatment: OSE2101 · Docetaxel · NGS HLAA2 assay — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR alterations eligible for targeted therapy
without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy
Required: ALK alterations eligible for targeted therapy
without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy
Required: ROS1 alterations eligible for targeted therapy
without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy
Allowed: KRAS G12C
other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; KRAS G12C ... after Sponsor' agreement)
Allowed: BRAF mutation
other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; ... BRAF mutations ... after Sponsor' agreement)
Disease stage
Required: Stage IV
Metastatic disease required
metastatic stage at study entry, not eligible for definite surgery or radiation
Prior therapy
Must have received: checkpoint inhibitor
secondary resistance to ICI
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Clinical Research Advisors, LLC · Beverly Hills, California
- Clinical Research Advisors - Encino · Encino, California
- Clinical Research Advisors - West Hollywood · Los Angeles, California
- Clinical Research Advisors - Korea Town · Los Angeles, California
- SCL Health - Saint Joseph Hospital Cancer Center · Littleton, Colorado
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify