ARTEMIA - 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 (OSE2101C302).

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Seconda linea

Criteri di inclusione: 

The main inclusion criteria include but are not limited to the following:

- 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’ agreement
- Patients who progressed after ≥ 24 weeks of first-line CT-ICI, including ≥12 weeks of anti-PD(L)1 as monotherapy or in combination with another ICI prior to randomization (i.e.; ICI secondary resistance); a radiological tumor assessment by the Investigator at 24 weeks (± 2 weeks) after the start of ICI is needed to exclude PD; induction treatment with first-line CT-ICI should contain at least 2 cycles of platinum-based CT except if contraindication to platinum
- Patients who permanently stopped ICI due to radiological PD (assessed by the Investigator) occurring after ≥ 24 weeks of ICI, including at least 12-weeks of anti-PD(L)1 as monotherapy or in combination with another ICI prior to randomization
- Patients with ECOG performance status (PS) 0 or 1
- Patients with measurable or non-measurable lesions per RECIST 1.1
- Patients with adequate organ functions
- Patients without clinically significant ongoing toxicity from prior therapy (severity ≤ Grade 1; except alopecia)
- If applicable, before study treatment (OSE2101 or docetaxel) administration, a wash out of at least 28 days or 5 half-lives (whichever is shorter) since the last anticancer treatment or investigational therapy; a wash out of at least 28 days after definitive radiation or prior major surgery; wash out after palliative radiation of at least 2 weeks.

Criteri di esclusione: 

The main exclusion criteria include but are not limited to the following:

- 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 known hypersensitivity to the active substances or to any of the excipients of OSE2101 or docetaxel
- Patients with PD during induction first-line CT-ICI (to exclude hyper progression and fast progression to CT-ICI) or with PD within 24 weeks of ICI; chemotherapy, other cytotoxic agent or antiangiogenics in combination with ICI within 12 weeks prior to randomization are not authorized; patients who stopped ICI due to toxicity or other reason than PD are not eligible
- Patients with brain metastasis or previously treated brain metastasis, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
- Patients with AST and/or ALT >1.5 × ULN concomitant with ALPK > 2.5 × ULN
- Patients with active auto-immune disease and/or immune-related disease due to prior immunotherapy or other condition requiring systemic immunosuppressive treatments or chronic administration of corticosteroids > 10 mg daily prednisolone equivalent (except as replacement if adrenal insufficiency); short course of corticosteroids > 10 mg daily prednisolone equivalent is allowed if ≤ 10 days continuous duration (e.g. premedication to prevent contrast allergy, drug reaction…); topical, ocular, intra-articular, intranasal, and inhaled corticosteroids with minimal systemic absorption are allowed
- Patients with interstitial lung disease or active non-infectious pneumonitis
- Patients who have known hereditary, congenital or acquired immunodeficiencies; for human immunodeficiency virus (HIV) infection, patient may be eligible if CD4+ count ≥ 350 cells/μL, and no history of acquired immunodeficiency syndrome (AIDS) infections within 12 months prior to start of study treatment, and receiving an established antiretroviral therapy with NO known drug-drug interaction with docetaxel for at least 4 weeks prior to starting the study treatment, and have a viral load ≤ 400 copies/ μL (local laboratory)
- Patients with an active infection requiring anti-infective therapy until all signs of infection have resolved before randomization
- Patients with chronic Hepatitis B (HBV) infection who meet the criteria for antiviral therapy (according to local/international guidelines) and not treated prior to starting the study treatment; patients with an active Hepatitis C (HCV) with HCV viral load (by local laboratory) above the limit of quantification; patients who received a prior antiviral HCV treatment or no prior treatment but HCV natural resolution with HCV RNA not detectable are eligible54
- Pregnant or breastfeeding woman.

Trattamento sperimentale: 

OSE2101 (Tedopi®)

Trattamento di controllo: 

Docetaxel

Obiettivi primari dello studio: 

Sopravvivenza globale (OS)

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-509340-10-00

Data di inserimento: 29.01.2025

Promotore

OSE Immunotherapeutics

CRO

ICON Clinical Research Limited

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na