A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Platinum Based Chemotherapy (First-line of Systemic Treatment) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After EGFR-TKI Failure

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR-sensitive mutations after EGFR-TKI failure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Voluntarily sign the informed consent and follow the requirements of the protocol;

• Age ≥18 years old;

• Expected survival time ≥3 months;

• Histologically or cytologically confirmed locally advanced or metastatic non-squamous non-small cell lung cancer;

• Documented classical EGFR mutations detected from tumor tissue or blood samples;

• Had not received any systemic therapy other than EGFR-TKIs;

• Radiographic disease progression documented during or after third-generation EGFR-TKI therapy for metastatic or locally advanced disease;

• Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;

• Must have at least one measurable lesion according to RECIST v1.1 definition;

⁃ ECOG score 0 or 1;

⁃ 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%;

⁃ The level of organ function must meet the requirements on the premise that blood transfusion is not allowed within 14 days before the screening period and no cell growth factor drugs are allowed;

⁃ Coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN;

⁃ Urine protein ≤2+ or \< 1000mg/24h;

⁃ For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
+8615013238943
Time Frame
Start Date: 2024-05-22
Estimated Completion Date: 2026-05
Participants
Target number of participants: 428
Treatments
Experimental: BL-B01D1
Participants receive BL-B01D1 as intravenous infusion for 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.
Experimental: Pemetrexed+Cisplatin or Carboplatin
Participants receive Pemetrexed +Cisplatin or Carboplatin 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.
Sponsors
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Leads: Sichuan Baili Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov