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

NCT ID: NCT05169801

Last Updated: 2021-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-25
• Study Completion Date: 2021-06-17

Brief 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.

Conditions

Non-small Cell Lung Cancer(NSCLC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group A

Group Type: EXPERIMENTAL

BP102, paclitaxel, carboplatin

Intervention Type: DRUG

BP102, paclitaxel, carboplatin

Treatment group B

Group Type: ACTIVE_COMPARATOR

Avastin®, paclitaxel, carboplatin

Intervention Type: DRUG

Avastin®, paclitaxel, carboplatin

Interventions

BP102, paclitaxel, carboplatin

BP102, paclitaxel, carboplatin

Intervention Type: DRUG

Avastin®, paclitaxel, carboplatin

Avastin®, paclitaxel, carboplatin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

HR-BP102-III-NSCLC

Identifier Type: -

Identifier Source: org_study_id