To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
NCT ID:
NCT06498986
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Osimertinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-B01D1
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
BL-B01D1+Osimertinib Mesylate Tablets
Intervention type:
Drug
Intervention name:
Osimertinib Mesylate Tablets
Description:
Oral administration, 80mg daily for a cycle of 3 weeks.
Arm group label:
BL-B01D1+Osimertinib Mesylate Tablets
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily sign the informed consent and follow the requirements of the protocol;
2. No gender limit;
3. Age ≥18 years old;
4. Expected survival time ≥3 months;
5. Patients with histologically and/or cytologically confirmed locally advanced or
metastatic non-small cell lung cancer;
6. Documentation of EGFR sensitive mutations detected from tumor tissue or blood
samples;
7. Consent to provide archived tumor tissue or fresh tissue samples from primary or
metastatic sites within 2 years for biomarker testing;
8. At least one measurable lesion meeting the RECIST v1.1 definition was required;
9. ECOG ≤1;
10. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by
NCI-CTCAE v5.0;
11. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
12. 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;
13. Blood coagulation function: international standardization ratio of 1.5 or less, and
the part activated clotting time live enzymes acuities were 1.5 x ULN;
14. Urine protein ≤2+ or ≤1000mg/24h;
15. Fertile female subjects or male subjects with fertile partners must use highly
effective contraception from 7 days before the first dose until 6 months after the
dose. Female subjects of childbearing potential had to have a negative serum
pregnancy test within 7 days before the first dose.
Exclusion Criteria:
1. Patients with prior systemic therapy;
2. Previous treatment with EGFR-TKI;
3. Participants who participated in any other clinical trial within 4 weeks before the
trial dose;
4. 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;
5. Had undergone major surgery within 4 weeks before the first dose;
6. History of severe heart disease or cerebrovascular disease;
7. Unstable thrombotic events requiring therapeutic intervention within 6 months before
screening; Infusion-related thrombosis was excluded;
8. QT prolongation, complete left bundle branch block, III degree atrioventricular
block, frequent and uncontrollable arrhythmia;
9. Previous history of interstitial lung disease requiring steroid therapy, or current
ILD or grade ≥2 radiation pneumonitis;
10. Complicated pulmonary diseases leading to clinically severe respiratory function
impairment;
11. Severe systemic infection within 4 weeks before screening;
12. Patients at risk for active autoimmune disease or with a history of autoimmune
disease;
13. Other malignant tumors within 5 years before the first dose;
14. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or
hepatitis C virus infection;
15. Hypertension poorly controlled by two antihypertensive drugs;
16. Patients with poor glycemic control;
17. Patients with massive effusions, or effusions with obvious symptoms, or poorly
controlled effusions;
18. Patients with active central nervous system metastases;
19. Imaging examination showed that the tumor had invaded or enveloped the large blood
vessels in the abdomen, chest, neck, and pharynx;
20. Severe unhealed wound, ulcer, or fracture within 4 weeks before consent signing;
21. Sign a four weeks before there were clinically significant bleeding or bleeding
tendency obviously subjects;
22. Previous history of allogeneic stem cell, bone marrow or organ transplantation;
23. Patients with a history of allergy to recombinant humanized antibodies or to any of
the excipients of BL-B01D1;
24. A history of severe neurological or psychiatric illness;
25. Pregnant or lactating women;
26. Subjects who were scheduled to receive live vaccine or received live vaccine within
28 days before study randomization;
27. Other conditions for participation in the trial were not considered appropriate by
the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Caicun Zhou
Start date:
July 31, 2024
Completion date:
August 2026
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06498986
