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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 (Jun 2026). This Phase 3 trial studies multiple treatments including OSE2101 and Docetaxel for patients with non-small cell lung cancer.

Phase 3RecruitingOSE ImmunotherapeuticsNCT06472245Data as of Jun 2026Location: International · 14 countries

Treatment: OSE2101 · Docetaxel · NGS HLAA2 assayMulticenter, 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).

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Docetaxel

Other

OSE2101NGS HLAA2 assay

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: ALK wild-type

Required: EGFR wild-type

Required: HLA-A a2 phenotype

Required: ROS1 wild-type

Allowed: BRAF mutation

Allowed: KRAS g12c

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: immune checkpoint inhibitor

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

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See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06472245 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received immune checkpoint inhibitor.

Does this trial require ALK?

Yes, ALK wild-type is a required biomarker for enrollment.

Does this trial require EGFR?

Yes, EGFR wild-type is a required biomarker for enrollment.

Does this trial require HLA-A?

Yes, HLA-A a2 phenotype is a required biomarker for enrollment.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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