A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- BL-B01D1
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Recommended Phase II Dose (RP2D)
- Status
- Recruiting
- Last Updated
- 12 months ago
Overview
Brief Summary
This phase II clinical study is a study to explore the efficacy and safety of BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with histologically and/or cytologically confirmed locally advanced or metastatic non-small cell lung cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntarily sign the informed consent and follow the requirements of the protocol;
- •No gender limit;
- •Age ≥18 years old;
- •Expected survival time ≥3 months;
- •Patients with histologically and/or cytologically confirmed locally advanced or metastatic non-small cell lung cancer;
- •Documentation of EGFR sensitive mutations detected from tumor tissue or blood samples;
- •Consent to provide archived tumor tissue or fresh tissue samples from primary or metastatic sites within 2 years for biomarker testing;
- •At least one measurable lesion meeting the RECIST v1.1 definition was required;
- •Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
- •No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
Exclusion Criteria
- •Patients with prior systemic therapy;
- •Previous treatment with EGFR-TKI;
- •Participants who participated in any other clinical trial within 4 weeks before the trial dose;
- •Traditional Chinese medicine (TCM) which had received radiotherapy within 4 weeks before the first use of the study drug and had anti-tumor indications within 2 weeks before the first use of the study drug;
- •Had undergone major surgery within 4 weeks before the first dose;
- •History of severe heart disease or cerebrovascular disease;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
- •QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •Previous history of interstitial lung disease requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;
- •Complicated pulmonary diseases leading to clinically severe respiratory function impairment;
Arms & Interventions
BL-B01D1+Osimertinib Mesylate Tablets
Participants receive BL-B01D1+Osimertinib Mesylate Tablets in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Intervention: BL-B01D1
BL-B01D1+Osimertinib Mesylate Tablets
Participants receive BL-B01D1+Osimertinib Mesylate Tablets in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Intervention: Osimertinib Mesylate Tablets
Outcomes
Primary Outcomes
Recommended Phase II Dose (RP2D)
Time Frame: Up to approximately 24 months
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.
Objective response rate (ORR)
Time Frame: Up to approximately 24 months
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Secondary Outcomes
- Progression-free survival (PFS)(Up to approximately 24 months)
- Disease control rate (DCR)(Up to approximately 24 months)
- Duration of response (DOR)(Up to approximately 24 months)
- Treatment-Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Ctrough(Up to approximately 24 months)
- Cmax(Up to approximately 24 months)
- Tmax(Up to approximately 24 months)
- ADA (anti-drug antibody)(Up to approximately 24 months)