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

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: Non-small Cell Lung Cancer(NSCLC)

Treatments: Drug: Avastin®, paclitaxel, carboplatin; Drug: BP102, paclitaxel, carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05169801

HR-BP102-III-NSCLC

Details and patient eligibility

About

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.

Enrollment: 520 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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;
11. People with known hereditary bleeding tendency or coagulation disorder;
12. Patients with known central nervous system metastases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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520 participants in 2 patient groups

Treatment group A

Experimental group

Treatment:

Drug: BP102, paclitaxel, carboplatin

Treatment group B

Active Comparator group

Treatment:

Drug: Avastin®, paclitaxel, carboplatin