Spots Global Cancer Trial Database for A Study of BL-B01D1 Combined With Osimertinib Mesylate Tablets in Patients With Non-small Cell Lung Cancer

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Trial Identification

Brief Title: A Study of BL-B01D1 Combined With Osimertinib Mesylate Tablets in Patients With Non-small Cell Lung Cancer

Official Title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With EGFR-sensitive Mutations

Study ID: NCT05880706

Conditions

Non-small Cell Lung Cancer

Interventions

BL-B01D1

Osimertinib Mesylate Tablets

Study Description

Brief Summary: A Phase II clinical study to evaluate the efficacy and safety of BL-B01D1 for injection in combination with Osimertinib Mesylate Tablets in patients with locally advanced or metastatic non-small cell lung cancer with EGFR-sensitive mutations

Detailed Description: Objective: To evaluate the safety, tolerability, and efficacy of BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-sensitive mutations, and to further explore the optimal dose and mode of combination. Secondary objective: To evaluate the PK, immunogenicity, and drug-drug interaction (DDI) of the investigational drug BL-B01D1. Exploratory objective: To explore potential predictive, prognostic biomarkers in relation to study drug therapy responses, including levels of biomarkers, including but not limited to EGFR, HER3, etc., in archived and/or fresh tumor tissue and blood samples obtained before and/or after study therapy completion, and/or at the time of disease progression.