Informations générales (source: ClinicalTrials.gov)
A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor
Interventional
Phase 3
OSE Immunotherapeutics (Voir sur ClinicalTrials)
décembre 2024
décembre 2028
04 octobre 2026
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Benjamin BESSE | 02/10/2026 13:15:19 | Contacter | ||
Critères
Tous
Inclusion Criteria:
1. Male or female, aged ≥ 18 years
2. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
3. 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; for patients with squamous NSCLC, the molecular tests are not mandatory if
age ≥ 50 years old and smoker ≥ 15 pack years; 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' agreement.
4. Patients with secondary resistance to ICI;
Other inclusion and exclusion criteria will apply per protocol.
1. Male or female, aged ≥ 18 years
2. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
3. 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; for patients with squamous NSCLC, the molecular tests are not mandatory if
age ≥ 50 years old and smoker ≥ 15 pack years; 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' agreement.
4. Patients with secondary resistance to ICI;
Other inclusion and exclusion criteria will apply per protocol.