A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) - CA116-003
Updated: 14 March, 2023 | ClinicalTrials.gov
Print Friendly Summary
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.
We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information
Have questions? Live support is available 24/7 - Call 855-907-3286 or email firstname.lastname@example.org