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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer(NSCLC)
• Intervention / Treatment: Drug: BP102, paclitaxel, carboplatin; Drug: Avastin®, paclitaxel, carboplatin

• Study Type: Interventional
• Enrollment (Actual): 520
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Jiangsu Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A	Drug: BP102, paclitaxel, carboplatin; BP102, paclitaxel, carboplatin
Active Comparator: Treatment group B	Drug: Avastin®, paclitaxel, carboplatin; Avastin®, paclitaxel, carboplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	optimal ORR at 18 weeks, independent radiographic assessment	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Disease Control Rate (DCR)	Based on investigator reviewed radiographic tumour assessment and death.	41 months
Duration of Response (DoR)	Based on investigator reviewed radiographic tumour assessment and death.	41 months
Quality of Life assessment using EORTC QLQ-C30	Evaluate subjects' quality of life	41 months
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
Positive rate of anti-bevacizumab antibody and its titer	Immunogenicity evaluation	41 months
Positive rate of neutralizing antibody	Immunogenicity evaluation	41 months

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2018
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): June 17, 2021

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): December 27, 2021

Study Record Updates

• Last Update Posted (Actual): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Carboplatin; Paclitaxel; Bevacizumab; Albumin-Bound Paclitaxel
• Other Study ID Numbers: HR-BP102-III-NSCLC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No