Extrait

LUMINOSITY : Etude de phase II, en ouvert, évaluant la sécurité et l'efficacité du Telisotuzumab vedotin (ABBV-399) chez des patients présentant un cancer du poumon non à petites cellules c-Met+, préalablement traités.

Extrait Scientifique

This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2).;

Critère d'inclusion

• Histologically confirmed non-small cell lung cancer (NSCLC) with known epidermal growth factor receptor (EGFR) status (wild type or mutant; with site documented status), or histologically documented squamous cell NSCLC.
• Has locally advanced or metastatic NSCLC.
• Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory.
• If a subject meets eligibility criteria for c-Met protein expression level based on archival tissue material, subject must agree to submit fresh tumor material for assessment of c-Met protein expression level prior to first dose of telisotuzumab vedotin
• Has progressed on systemic cytotoxic therapy (or ineligible), and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible) and prior anti-cancer therapies targeting gene alterations (if applicable).
• Have received no more than 2 lines of prior systemic therapy (including no more than 1 line of prior systemic cytotoxic chemotherapy) in the metastatic setting.
• Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Critère de non inclusion

• Has received prior c-MET-targeted antibody based therapies.
• Has adenosquamous histology.
• Has received anti-cancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy as described in the protocol.
• Has known uncontrolled metastases to the central nervous system (CNS). Subjects with brain metastases are eligible if they meet requirements described in the protocol.
• Has a clinically significant condition(s) described in the protocol.
• Has unresolved clinically significant adverse events >= grade 2 from prior anticancer therapy, except for alopecia or anemia.
• Had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
• Has a history of interstitial lung disease or pneumonitis that required treatment with systemic steroids.

Liens

• e-cancer.fr
• Fiche de l'U.S. National Library of Medicine (NLM), sur ClinicalTrials.gov