A study to compare the efficacy and safety of INTP24 against Avastin® in patients with lung cancer.
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2019/08/020665
- Lead Sponsor
- Intas Pharmaceuticals Ltd Biopharma Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 32
1. Patient of either gender and aged greater than or equal to 18 years
2. Patient having histologically or cytological confirmed predominately nonsquamous, non-small cell lung cancer.
3. Patients with locally advanced, unresectable or metastatic non-small cell lung cancer or recurrent non-small cell lung cancer according to The Union for International Cancer Control (UICC) staging system.
4. At-least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 or higher criteria.
5. For patients with recurrent disease, at least 6 months must have elapsed since
completing adjuvant or neoadjuvant treatment
6. ECOG performance status less than or equal to 2.
7. Patient should be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin for the treatment of locally advanced or recurrent or metastatic non-squamous NSCLC.
8. Patient must have an adequate bone marrow, renal and hepatic function
9. Women of childbearing potential and partners of sexually active males must agree to use an accepted and effective method of contraception (oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a
secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, / and if males, absolute sexual abstinence, use of condom with spermicide by sexual partner or
temporarily sterile [at least 6 months prior to study drug administration] sexual partner) for the duration of the study and for at least 6 months after the last dose of the study treatment or permanently sterile.
Female patients who are not of childbearing potential should have undergone a documented hysterectomy and/or bilateral oophorectomy or have achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause (status may be confirmed at Investigator discretion by having a serum follicle stimulating hormone (FSH) level)
10. Patients able to understand the investigational nature of this study and give
written informed consent prior to the participation in the trial and able to comply
with study requirement in the opinion of Principal Investigator.
1. Patient who has documented evidence of sensitizing epidermal growth factor receptor (EGFR) mutations or EML4-ALK translocation positive mutations.
2. Prior systemic therapy for non-small cell lung cancer (adjuvant or neoadjuvant therapy in case of recurrent disease will be allowed).
3. Prior immunotherapy or bevacizumab therapy.
4. Concurrent treatment with other anticancer therapies (excluding that defined in the protocol). Bone directed therapies like bisphosphonates and denosumab will be allowed.
5. Pregnant and breast-feeding women. Male patients with current pregnant partners will not be eligible.
6. History of local radiation therapy for bone metastases within last 1 month prior to the day of randomization.
7. Patients with a history of gross haemoptysis (defined as bright red blood of 1/2 teaspoon (2.5 ml) or more) or haemorrhage within last 3 months
8. Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic
Anticoagulation)
9. Current or recent (within 10 days of randomization) use of aspirin (greater than 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol
10. Current use of oral or parenteral anticoagulants or thrombolytic agents for
therapeutic purposes that has not been stable for greater than 2 weeks prior to randomization
and INR/aPTT is within therapeutic limits (as per the local medical standards)
11. Therapeutic anticoagulation and/or coagulation abnormalities (e.g., INR greater than 1.5 and aPTT greater than ULN unless on prophylactic anticoagulation).
12. Patient with known brain metastases. A CT/MRI brain is required to confirm if it
was not done within 4 weeks prior to study entry.
13. Patients with non-healing wound ulcer, or bone fracture, or major surgical procedure, open biopsy, or significant traumatic injury within last 28 days or anticipation of need for major surgical procedure during the study.
14. Patients with history of gastrointestinal perforation, tracheoesophageal fistula or any grade 4 fistula
15. Patients with clinically significant cardiac diseases like New York Heart Association (NYHA) Grade II or greater, congestive heart failure (multigated acquisition [MUGA] or echocardiogram [ECHO]), unstable angina pectoris, myocardial infarction, cardiac arrhythmia, cerebral infarction, or transient ischemic attacks.
16. Uncontrolled hypertension (systolic blood pressure [BP] greater than 140 or diastolic BP
greater than 90 mmHg) (Patients with hypertension controlled by antihypertensive therapies are eligible).
17. Patients with a prior history of hypertensive crisis and hypertensive encephalopathy
18. Patient with ongoing or active infection (patient should be off anti-infective to be
eligible for participation).
19. A known case of or positive test for human immunodeficiency virus (HIV) infection or hepatitis B or hepatitis C virus (HCV).
20. History of thrombotic events like stroke, active symptomatic peripheral vascular disease within last 6 months.
21. Peripheral motor or sensory neuropathy of grade greater than 2.
22. Known hypersensitivity to any components of the study medications / chemotherapy / supportive medications or its ingredients that can impact treatment.
23. Past or current history of neoplasm other than the entry diagnosis with the except
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method