Study design and patients
NSCLC, tumor, bleeding, abdominal fistula, small cell carcinoma of the lung, hemorrhagic, gastroduodenal ulcer, Tumors, thrombotic, tumors
BRAIN METASTASIS, TUMOR, BLEEDING, METASTASIS, UNCONTROLLED HYPERTENSION, EVENT, RECURRENT DISEASE, GASTRODUODENAL ULCER, METASTATIC DISEASE, TUMORS, NSCLC, TUMORS
This multicenter, randomized, double‐blind, Phase III, parallel, 2‐arm study (NCT03329911) was designed to compare the efficacy and safety of BAT1706 plus paclitaxel and carboplatin (BAT1706 arm) vs EU‐bevacizumab plus paclitaxel and carboplatin (EU‐bevacizumab arm). Adult patients aged ≥18 years were eligible for inclusion if they had: histologically or cytologically confirmed Stage IV nonsquamous NSCLC or recurrent disease; tumors without EGFR mutations or ALK rearrangements; at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); received no prior systemic therapy for metastatic disease; an ECOG performance status of 0 or 1 and a life expectancy of more than 3 months; and adequate hematological, hepatic, and renal function. Key exclusion criteria included: a diagnosis of small cell carcinoma of the lung; known receptor tyrosine kinase 1 (ROS1) positive tumors; tumor cavitation, tumor invading into large blood vessels or close to large vessels with an increased risk of bleeding; having received prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGF receptor; known brain metastasis or other central nervous system (CNS) metastasis that was either symptomatic or untreated; a significant thrombotic or hemorrhagic event ≤6 months prior to screening; the need for permanent oral anticoagulation treatment (eg, warfarin, dabigatran); history of poorly controlled hypertension; and history of active gastroduodenal ulcer or abdominal fistula within 6 months prior to screening.