A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT06498986
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BL-B01D1 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Osimertinib Mesylate Tablets — DRUG
    Oral administration, 80mg daily for a cycle of 3 weeks.

Study Details

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.

Key Dates

Start date
Jul 31, 2024
Status verified
May 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Recommended Phase II Dose (RP2D) [ Time Frame: Up to approximately 24 months ]

Central Contacts

Related Studies