Recruiting
A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) - CA116-003
Atualizado:
17 julho, 2023
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ClinicalTrials.gov
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Recruiting
Inclusion Criteria: - Histologically or cytologically documented metastatic NSCLC AC (as defined by the 8th International Association for the Study of Lung Cancer Classification). - Participants without genetic alterations or unknown genetic alterations in the metastatic setting after receiving: i) 1 prior line of therapy if platinum-doublet chemotherapy and anti-PD-1/PD-L1 were given concurrently or ii) 2 prior lines of therapy if platinum-doublet chemotherapy and anti-PD-1/PD-L1 were given sequentially. - Participants with known targetable genetic alterations in the metastatic setting after receiving: i) At least 1 approved targeted therapy and ii) No more than 3 prior lines of systemic therapy (including no more than 1 line of chemotherapy). - Either FFPE tissue block (preferred), newly cut unstained slides or newly obtained biopsies must be available for assessment by IHC at a central laboratory prior to randomization. Exclusion Criteria: - NSCLC histologies other than AC (ie, squamous cell carcinoma, large cell carcinoma). - Pulmonary function test (PFT) abnormalities: Forced expiratory volume during first second of forced breath (FEV1) < 70%, or forced vital capacity (FVC) < 60%, and diffusing capacity of the lung for carbon monoxide (DLCO) < 80%. - Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage. - Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed > 12 months before treatment. - Recent chest radiotherapy. Participants with chest or chest wall radiation may be permitted if chest radiation is documented > 6 months before starting study treatment. Other protocol-defined inclusion/exclusion criteria apply.
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