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Clinical Trials/CTRI/2017/02/007805
CTRI/2017/02/007805
Not yet recruiting
Phase 3

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 Avastin® 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 sites200 target enrollmentTBD
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ConditionsHealth Condition 1: null- non-squamous Non-Small-Cell Lung Cancer (nsNSCLC)

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: null- non-squamous Non-Small-Cell Lung Cancer (nsNSCLC)
Sponsor
Cipla BioTec Pvt Ltd
Enrollment
200
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Cipla BioTec Pvt Ltd

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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