Clinical trial NCT05169801: To Compare the Efficacy and Safety of BP102 vs. Avastin® in Combination With Paclitaxel/Carboplatin in First-line Treatment of Advanced or Relapsed NSCLC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer(NSCLC)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-27
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: BP102 in combination with paclitaxel/carboplatin compared with Avastin® in combination with paclitaxel/carboplatin
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective response rate
timeFrame: 18 weeks
Secondary outcomes:
measure: Progression-free survival
timeFrame: 41 months
measure: Overall survival (OS)
timeFrame: 41 months
measure: Disease Control Rate (DCR)
timeFrame: 41 months
measure: Duration of Response (DoR)
timeFrame: 41 months
measure: Quality of Life assessment using EORTC QLQ-C30
timeFrame: 41 months
measure: Incidence of treatment-emergent adverse events, serious adverse events
timeFrame: Enrollment to 28 days after permanent treatment termination
measure: Positive rate of anti-bevacizumab antibody and its titer
timeFrame: 41 months
measure: Positive rate of neutralizing antibody
timeFrame: 41 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
Study officials:
References: