A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer After Failure of Anti-PD-1/PD-L1 Monoclonal Antibodies and Platinum-based Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06382129
• Other study ID #: BL-B01D1-302
• Status: Recruiting
• Phase: Phase 3
• Start date: May 17, 2024
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: Sichuan Baili Pharmaceutical Co., Ltd.
• Contact: Sa Xiao, PHD
• Phone: +8615013238943
• Email: xiaosa[@]baili-pharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 EGFR wild-type non-small cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 558
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Voluntarily sign the informed consent and follow the requirements of the protocol;

2. Age =18 years old;

3. Expected survival time =3 months;

4. Patients with histologically or cytologically confirmed locally advanced or metastatic EGFR wild-type non-small cell lung cancer;

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

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

7. ECOG 0 or 1;

8. Toxicity of previous antineoplastic therapy has returned to = grade 1 defined by NCI-CTCAE v5.0;

9. No severe cardiac dysfunction, left ventricular ejection fraction =50%;

10. The organ function level 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;

11. Urine protein =2+ or < 1000mg/24h;

12. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, 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.

Exclusion Criteria:

1. Previous histological or cytological evidence of small cell or mixed small/non-small cell components;

2. Patients with EGFR L858R mutation, EGFR 19DEL mutation or EGFR T790M positive;

3. Chemotherapy, targeted therapy, biological therapy, etc., and palliative radiotherapy or antineoplastic therapy within 2 weeks before randomization;

4. Previous ADCs with TOPI inhibitors as toxins, antibodies/ADCs targeting EGFR and/or HER3;

5. History of severe heart disease or cerebrovascular disease;

6. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;

7. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;

8. Active malignancy diagnosed within 3 years before randomization;

9. Hypertension poorly controlled by two antihypertensive drugs;

10. Patients with poor glycemic control;

11. A history of interstitial lung disease (ILD) requiring steroid therapy, or current ILD or grade =2 radiation pneumonitis, or suspicion of such disease on imaging during screening;

12. Complicated pulmonary diseases leading to clinically severe respiratory function impairment;

13. Patients with active central nervous system metastases;

14. Severe infection within 4 weeks before randomization; evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization;

15. Patients with massive or symptomatic effusions or poorly controlled effusions;

16. Imaging examination showed that the tumor had invaded or wrapped around the large blood vessels in the abdomen, chest, neck, and pharynx;

17. Severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;

18. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;

19. Patients with inflammatory bowel disease, extensive bowel resection history, immune enteritis history, intestinal obstruction or chronic diarrhea;

20. Have a history of allergy to recombinant humanized antibodies or any of the ingredients of BL-B01D1;

21. A history of autologous or allogeneic stem cell transplantation;

22. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;

23. A history of severe neurological or psychiatric illness;

24. Received other unmarketed investigational drug or treatment within 4 weeks before randomization;

25. Subjects who were scheduled to receive live vaccine or received live vaccine within 28 days before study randomization;

26. Any other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• BL-B01D1
Administration by intravenous infusion for a cycle of 3 weeks.
• Docetaxel
Administration by intravenous infusion for a cycle of 3 weeks.

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Sichuan Baili Pharmaceutical Co., Ltd.	Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.	Up to approximately 24 months
Primary	Progression-free survival (PFS)	Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.	Up to approximately 24 months
Secondary	Objective Response Rate (ORR)	Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).	Up to approximately 24 months
Secondary	Disease Control Rate (DCR)	Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.	Up to approximately 24 months
Secondary	Duration of Response (DOR)	Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.	Up to approximately 24 months
Secondary	Treatment Emergent Adverse Event (TEAE)	TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.	Up to approximately 24 months
Secondary	Anti-drug antibody (ADA)	Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.	Up to approximately 24 months