Non-small Cell Lung Cancer(NSCLC)
Conditions
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.
Interventions
DRUGBP102, paclitaxel, carboplatin
BP102, paclitaxel, carboplatin
DRUGAvastin®, paclitaxel, carboplatin
Avastin®, paclitaxel, carboplatin
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
BP102 in combination with paclitaxel/carboplatin compared with Avastin® in combination with paclitaxel/carboplatin
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 18 weeks | optimal ORR at 18 weeks, independent radiographic assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 41 months | Overall survival is defined as the time from day 1 (part 1) or from randomization (part 2) to date of death. |
| Disease Control Rate (DCR) | 41 months | Based on investigator reviewed radiographic tumour assessment and death. |
| Duration of Response (DoR) | 41 months | Based on investigator reviewed radiographic tumour assessment and death. |
| Progression-free survival | 41 months | 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. |
| Incidence of treatment-emergent adverse events, serious adverse events | Enrollment to 28 days after permanent treatment termination | Safety analyses will be performed using the safety population, defined as all patients receiving any study drug. |
| Positive rate of anti-bevacizumab antibody and its titer | 41 months | Immunogenicity evaluation |
| Positive rate of neutralizing antibody | 41 months | Immunogenicity evaluation |
| Quality of Life assessment using EORTC QLQ-C30 | 41 months | Evaluate subjects' quality of life |
Countries
China
Outcome results
None listed