A Randomized, Double-blind, Multicentric,Parallel-group Study Comparing Efficacy, Safety andImmunogenicity of CBT124, a Candidate BiosimilarBevacizumab in Combination with Carboplatin andPaclitaxel with EU-sourced AvastinÂ® in Combinationwith Carboplatin and Paclitaxel in First-line Treatmentfor Subjects with Stage IV (Unresectable RecurrentDisease or Metastatic) Non-squamous Non-Small CellLung Cancer (NSCLC)

Cipla BioTec Pvt Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 200

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1. Adult subjects aged >= 18 to 75 years (>= 18 to 65 years for India) with histologically or
•cytologically confirmed advanced non-squamous NSCLC. Mixed tumors should be
•categorized according to the predominant histology
•2. Epidermal growth factor receptor (EGFR) negative (for example, deletion exon 19 or
•exon 21 point mutation L858R) or wild type mutations
•3. No Kirsten rat sarcoma viral oncogene homolog (KRAS) and anaplastic lymphoma
•receptor tyrosine kinase (ALK) positive subjects
•4. Stage IV (Unresectable recurrent disease or metastatic) NSCLC
•5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
•6. Evaluable disease status or measurable tumor
•7. Life expectancy > 6 months.
•8. Adequate hepatic, renal, and bone marrow function (alanine aminotransferase [ALT] and
•aspartate aminotransferase [AST] < 2.5 Ã? upper limit of normal [ULN], or ALT and AST
•< 5 Ã? ULN, if liver function abnormalities are due to underlying malignancy; total
•bilirubin <= 1.5 Ã? ULN; serum creatinine <= 1.5 Ã? ULN or calculated creatinine clearance
•>= 60 mL/min; urine dipstick < 1+ [i.e., 0 or traces]; international normalized ratio (INR)
•<= 1.5, and partial thromboplastin time <= ULN; absolute neutrophil count >= 1500/mm3;
•platelet count >= 105/mm3; hemoglobin >= 9 g/dL). Subjects with a 1+ or greater urine
•dipstick reading should undergo further assessment as per the clinical judgement of the
•Investigator, including 24 hours urine collection or a laboratory protein/creatinine index
•in urine (with quantitative protein determination in a full sized sample even if not
•necessarily a 24 hours collection), as needed. Urinary protein should be < 100 mg/24
•hours or protein/creatinine index of less than 0.2 mg/mgCreatinine or 15 mg/mmol
•Creatinine.
•9. Subjects with pre-existing hypertension must be well controlled on a stable regimen of
•antihypertensive therapy. Have systolic blood pressure <= 140 and >= 90 mmHg, diastolic
•blood pressure <= 90 and >= 50 mmHg and heart rate >= 40 and <= 90 bpm at screening and
•admission. For single measurements in the 141 to 160 mmHg range (systolic) or in the 91
•to 100 mmHg range (diastolic), a single repetition after resting for a few minutes (e.g. 5
•minutes) on a supine position on the same day is allowed and, in this case, the mean of
•both measurements will guide eligibility. The mean of both the measurements should be
•<= 140 mmHg (systolic) and <= 90 mmHg (diastolic).
•10. Ability to understand risks of participation in the study and willingness provide informed

排除标准

•1. Small cell lung cancer (SCLC) or combination of SCLC and NSCLC. Squamous-cell
•tumors and mixed adenosquamous carcinomas of predominantly squamous nature
•2. Known sensitizing EGFR mutations (for example, deletion exon 19 or exon 21
•point-mutation L858R) or EML4-ALK translocation-positive mutations. Subjects with
•KRAS mutations
•3. Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or
•VEGF receptors, including bevacizumab
•4. Prior therapy with carboplatin or paclitaxel
•5. Prior systemic therapy for metastatic disease. Prior systemic anticancer therapy or
•radiotherapy for locally-advanced NSCLC if completed < 12 months prior to screening
•6. Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation
•that in the opinion of the Investigator is likely to bleed
•7. Symptomatic brain metastasis (head computed tomography [CT]/magnetic resonance
•imaging [MRI] is required within 6 weeks of study randomization)
•8. Previous malignancy other than NSCLC in the last 5 years except for basal cell cancer of
•the skin or pre-invasive cancer of the cervix
•9. Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from
•previous anticancer therapy (including radiotherapy)
•10. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of
•bleeding. Thrombotic or hemorrhagic event <= 6 months prior to screening
•11. History of hemoptysis greater than Â½ teaspoon of bright red (fresh) blood in the past
•12. Subjects receiving long-term aspirin ( > 325 mg/day), or other non-steroidal
•anti-inflammatory agents, or other drugs known to inhibit platelet function, treatment
•with dipyridamole, ticlopidine, or clopidogrel
•13. Subjects receiving anticoagulants
•14. Subjects who plan to undergo surgery during the study period
•15. Subjects who have undergone a major surgery, or have had a significant traumatic injury
•within 4 weeks prior to randomization
•16. Subjects who have a significant non-healing wound, or bone fracture within 4 weeks
•prior to randomization
•17. Subjects with history of gastrointestinal perforation or fistula formation
•18. Subjects with known hypersensitivity to any of the ingredients of the investigational
•products, or mammalian cell-derived products
•19. Female subjects who are pregnant, breast-feeding, planning to be pregnant during the
•study, or women of child-bearing potential (any woman who is not surgically sterile i.e.,
•bilateral tubal ligation, total hysterectomy or < 2 years post menopause) not using a
•reliable method of double contraception (e.g. condom plus diaphragm, condom or
•diaphragm plus spermicidal gel/foam, tubal ligation, or stable dose of hormonal
•contraception) throughout the study period
•20. Male subject with a partner of childbearing potential (as mentioned in exclusion criteria
•19) who does not consent to the use of a reliable method of double contraception (as
•mentioned in exclusion criteria 19)
•21. Subjects with uncontrolled hypertension
•22. Subjects with active infection assessed to be clinically significant by Investigator
•23. Known history of, or positive test result for human immunodeficiency virus (HIV)

研究者

发起方

Cipla BioTec Pvt Ltd

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