Combining SI-B001 with Docetaxel for Lung Cancer Treatment

Phase III Clinical Study of SI-B001 Combined With Docetaxel Second-line Therapy in Patients With Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma Without Actionable Genomic Alterations Who Failed Only First-line Treatment With PD-1/PD-L1 Monoclonal Antibody Plus Platinum-Based Chemotherapy

This study is testing if adding a new drug called SI-B001 to the standard lung cancer treatment Docetaxel can help people with certain types of lung cancer live longer and feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 584 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT05943795 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness of SI-B001 in combination with Docetaxel for patients with non-small cell lung adenocarcinoma and lung squamous cell carcinoma. The primary focus is on assessing overall survival and progression-free survival compared to Docetaxel alone. Secondary objectives include measuring response rates, disease control, and the safety profile of the combination treatment. Participants will undergo ctDNA testing and must have measurable lesions as defined by RECIST criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with confirmed locally advanced or metastatic non-small cell lung cancer.

Not a fit: Patients with severe cardiac dysfunction or those who have had recent blood transfusions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced lung cancer.

How similar studies have performed: Other studies have shown promise in combining targeted therapies with traditional chemotherapy, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Sign the informed consent form voluntarily and follow the protocol requirements;
2. Gender is not limited;
3. Age ≥18 years old and ≤80 years old;
4. Expected survival time ≥3 months;
5. Patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer;
6. Subjects had to consent to complete ctDNA testing during the screening period;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. ECOG 0 or 1;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. No blood transfusion is allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements on the premise that albumin and colony-stimulating factor are not allowed;
12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
13. Proteinuria ≤2+ or \< 1000mg/24h;
14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be 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. Patients with previous docetaxel use;
2. Patients with non-small cell lung cancer (NSCLC) confirmed by histology or cytology except lung squamous cell carcinoma and lung adenocarcinoma;
3. The patients had received chemotherapy or biological therapy within 4 weeks or 5 half-lives before the first dose, and had received palliative radiotherapy or modern traditional Chinese medicine approved by NMPA for anti-tumor treatment within 2 weeks;
4. The history of severe cardiovascular and cerebrovascular diseases within six months before screening;
5. Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
6. Complicated with pulmonary diseases leading to severe impairment of lung function;
7. Active autoimmune and inflammatory diseases;
8. Other malignancies diagnosed within 5 years before the first dose;
9. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \&gt; 150 mmHg or diastolic blood pressure \&gt; 100 mmHg);
10. Patients with previous or current clinical manifestations or high risk factors such as ILD, drug-associated pneumonia, and radiation pneumonitis;
11. With untreated central nervous system metastases and/or carcinomatous meningitis/or spinal cord compression;
12. Patients with a history of allergy to the recombinant humanized or human-mouse chimeric antibody or to SI-B001 or any of the excipients of the chemotherapy drugs used in this trial;
13. Had a history of autologous or allogeneic stem cell transplantation or organ transplantation;
14. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
15. Serious infection within 4 weeks before the first dose of study drug;
16. Pleural, pericardial, or abdominal effusion requiring drainage and/or associated with symptoms within 4 weeks before the first dose of study drug;
17. Received other investigational drugs or treatments within 4 weeks before the first dose;
18. A history of severe neurological or psychiatric illness;
19. Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels or pericardium or heart;
20. Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informed consent;
21. Patients had hemoptysis or hemoptysis within 4 weeks before signing the informed consent, but those with blood in sputum were not excluded;
22. Had severe infusion reactions (CTCAE grade ≥3) to antibody therapy;
23. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
24. History of intestinal obstruction, inflammatory bowel disease, extensive bowel resection or chronic diarrhea;
25. Who are scheduled to receive the live vaccine or who receive it within 30 days before the first dose;
26. The investigator did not consider it appropriate to apply other criteria for participation in the trial.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Sa Xiao, PHD

Conditions Non-small Cell Lung Adenocarcinoma; Squamous Cell Carcinoma of Lung