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

NCT05169801•Jiangsu HengRui Medicine Co., Ltd.

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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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
+2 more criteria

Locations (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Key Dates

Start Date

January 25, 2018

Primary Completion Date

October 21, 2019

Completion Date

June 17, 2021

Last Updated

December 27, 2021

Enrollment

520

ACTUAL participants

Conditions

Non-small Cell Lung Cancer(NSCLC)

Interventions

BP102, paclitaxel, carboplatin

DRUG

Avastin®, paclitaxel, carboplatin

DRUG

A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib

NCT01712217

Non-small Cell Lung Cancer(NSCLC)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 27, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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