Status:
COMPLETED
TAB008 Compared to Avastin® in Patients With EGFR Wild-type Non-squamous Non-small Cell Lung Cancer
Lead Sponsor:
BioDlink Biopharm Co., Ltd.
Conditions:
Efficacy
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
In this randomized, double-blind, multicenter, phase III similarity study, treatment naive, EGFR wild-type, locally advanced, metastatic, or recurrent non-squamous, non-small cell, lung cancer (ns-NSC...
Detailed Description
This randomized, double-blind, equivalence study was conducted in China. Treatment naïve, EGFR wild-type (by PCR or NGS) nsNSCLC patients were enrolled. Patients had to be between 18-75 years of age; ...
Eligibility Criteria
Inclusion
- Patients voluntarily participate in the study and sign the informed consent form;
- Aged 18 to 75 years (inclusive), male or female;
- Patients with histologically and/or cytologically confirmed, inoperable, locally advanced (Stage IIIb, IIIc), metastatic (Stage IV), or relapsed or progressive non-squamous cell carcinoma after local therapy (in cases of multiple tumor components, the predominant cell type is classified);
- No sensitive mutation of epidermal growth factor receptor (EGFR) gene (18, 19, 21), no other known activating mutations (such as ALK, ROS) which has treatment approved by NMPA;
- At least one measurable lesion according to RECIST 1.1 criteria; and this lesion has not received radiotherapy:
- Definition of measurable disease: Lesions that can be precisely measured in at least one dimension by any of the following: computed tomography (CT) scan or magnetic resonance imaging (MRI) scan with enhanced spiral CT or multidetector CT (MDCT) with extra-nodal lesions at least 10 mm in diameter and lymph node lesions at least 15 mm in short axis when the slice thickness is 5 mm or less；
- Patients who have never received systemic chemotherapy, anti-angiogenic drug and molecular targeted drug therapy for primary tumor or metastasis (note: subjects who received adjuvant therapy previously are allowed, but only patients who have no progression or recurrence during and within 6 months after completion of adjuvant therapy)；
- 0 ≤ ECOG PS ≤ 1;
- Expected survival time ≥ 3 months;
- The subject has recovered from the damage caused by other local treatments, including radiotherapy or surgery \> 4 weeks from the start of study treatment, and the wound has completely healed; however, patients who receive palliative radiotherapy for bone metastases 2 weeks before the start of study treatment can be allowed;
- Laboratory tests within 14 days before randomization meet the requirements.
Exclusion
- Patients with brain metastases ;
- History of bleeding diathesis, high risk of bleeding, or coagulopathy, including thrombotic disease within 6 months prior to Screening and/or hemoptysis (≥ 2.5 mL in a single cough) within 3 months prior to Screening;
- CT/MRI image shows tumor encasement or invasion into the lumen of great vessels (e.g., pulmonary artery or superior vena cava) and patients with bleeding risk judged by the investigator;
- Uncontrolled hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg after combination therapy with two or more antihypertensive agents), and patients with a previous history of hypertensive crisis or hypertensive brain;
- Significant cardiovascular or cerebrovascular disease;
- Active peptic ulcer or fracture, active infection at randomization, tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula, and intra-abdominal abscess within 6 months before screening;
- Patients who have undergone major surgical procedures (including open-heart biopsy), have major trauma, or are expected to require major surgery during the study;
- Minor surgical procedures (e.g., deep veins, ports) within 24 hours prior to receiving study drug;
- Moderate to large amount of pericardial effusion, abdominal or pleural effusion that cannot be controlled by pumping or other symptomatic treatment (symptomatic treatment is allowed, but drugs with anti-tumor indications such as chemotherapeutic drugs, anti-angiogenic drugs and molecular targeted drugs cannot be given);
- Known hypersensitivity to bevacizumab, paclitaxel and carboplatin injection and its excipients;
- Patients with other malignant tumors except lung cancer within 5 years;
- Patients who have used other clinical study treatment within 4 weeks before the start of study treatment;
- History of alcohol or drug abuse;
- Pregnant and lactating women; women of childbearing potential and male patients who require effective contraceptive methods during the study and for 6 months after administration of study drug;
- Other conditions that, in the opinion of the investigator, should not be included.
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2020
Estimated Enrollment :
549 Patients enrolled
Trial Details
Trial ID
NCT05427305
Start Date
October 20 2017
End Date
March 24 2020
Last Update
June 22 2022
Active Locations (1)
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1
TOT
Suzhou, Jiangsu, China, 215024