To Compare the Efficacy and Safety of BP102 vs. Avastin® in Combination With Paclitaxel/Carboplatin in First-line Treatment of Advanced or Relapsed NSCLC

Non-small Cell Lung Cancer(NSCLC) Clinical Trial

Official title:

To Compare the Efficacy and Safety of BP102 in Combination With Paclitaxel/Carboplatin and Avastin® in Combination With Paclitaxel/Carboplatin in First-line Treatment of Advanced or Relapsed NSCLC - a Randomized, Double-blind, Positive Parallel Control, Multicentre Phase III Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05169801
• Other study ID #: HR-BP102-III-NSCLC
• Status: Completed
• Phase: Phase 3
• Start date: January 25, 2018
• Est. completion date: June 17, 2021

Study information

• Verified date: December 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, positive parallel control, multicentre Phase III clinical trial, a clinical trial of biosimilar drugs, so the type of comparison is equivalence test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: June 17, 2021
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Aged from 18 to 75 (including 18 and 75), male or female;

2. Patients with locally advanced and unresectable NSCLC that has been histologically or cytologically proven, metastatic, or recurrent NSCLC.

3. No previous systematic antitumor therapy for current stage diseases. If previous adjuvant therapy has been received, it is necessary to ensure that the interval between the end of adjuvant therapy and the first administration of this study is more than 6 months, and that all adjuvant treating-related toxic reactions have recovered.

4. Patients must be able to document the EGFR mutation and ALK fusion gene status, and ALK must be negative. Patients who have not previously been tested for EGFR and ALK genes should be tested during screening;

5. There must be at least one measurable lesion as a target (according to RECIST V1.1);

6. ECOG: 0~1;

7. Life expectancy =24 weeks;

8. Major organs' function well.

Exclusion Criteria:

1. Patients with non-small cell lung cancer of other pathological tissue types;

2. Tumor histology or cytology confirmed positive ALK fusion gene;

3. Patients with imaging evidence of tumor invasion of large blood vessels;

4. Patients with uncontrolled pleural effusion and pericardial effusion that require repeated drainage;

5. Patients with abdominal effusion;

6. During the screening period, chest CT showed tumor cavity formation, or CT scan was highly suspected of idiopathic pulmonary fibrosis, mechanized pneumonia, drug-associated pneumonia, idiopathic pneumonia or active pneumonia;

7. Patients with hypertension whose blood pressure has not been satisfactorily controlled by antihypertensive drugs, and patients with previous hypertensive crisis or hypertensive encephalopathy;

8. Have heart disease or clinical symptoms that are not well controlled;

9. Patients with unhealed wounds, active gastric ulcers or fractures;

10. Patients diagnosed with esophagotracheal fistula;

11. People with known hereditary bleeding tendency or coagulation disorder;

12. Patients with known central nervous system metastases.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer(NSCLC)

Intervention

Drug:
• BP102, paclitaxel, carboplatin
BP102, paclitaxel, carboplatin
• Avastin®, paclitaxel, carboplatin
Avastin®, paclitaxel, carboplatin

Locations

Country	Name	City	State
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	optimal ORR at 18 weeks, independent radiographic assessment	18 weeks
Secondary	Progression-free survival	Progression-free survival is the time from randomization to the first documented objective disease progression (PD) using RECIST v1.1 or death due to any cause, whichever occurs first.	41 months
Secondary	Overall survival (OS)	Overall survival is defined as the time from day 1 (part 1) or from randomization (part 2) to date of death.	41 months
Secondary	Disease Control Rate (DCR)	Based on investigator reviewed radiographic tumour assessment and death.	41 months
Secondary	Duration of Response (DoR)	Based on investigator reviewed radiographic tumour assessment and death.	41 months
Secondary	Quality of Life assessment using EORTC QLQ-C30	Evaluate subjects' quality of life	41 months
Secondary	Incidence of treatment-emergent adverse events, serious adverse events	Safety analyses will be performed using the safety population, defined as all patients receiving any study drug.	Enrollment to 28 days after permanent treatment termination
Secondary	Positive rate of anti-bevacizumab antibody and its titer	Immunogenicity evaluation	41 months
Secondary	Positive rate of neutralizing antibody	Immunogenicity evaluation	41 months