Efficacy-Safety-Immunogenicity Study of CBT124&EU-sourced Avastin® in Stage 4 NSCLC

NCT02879097 | Unknown Phase 3 DMC

• 2 other identifiers: CBT124/CT/0022016-003301-34
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether CBT124 and Avastin® are comparable in terms of efficacy, safety, immunogenicity; and whether the pharmacokinetics of CBT124 matches that of Avastin® (pharmacokinetics is nested in this study for Indian patients).

Conditions

Non-Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) criteria (version 1.1). Defined as the proportion of subjects whose best confirmed overall response over Week 1 to Week 19 is either Complete Response (CR) or Partial Response (PR). Confirmed best overall response (complete or partial response) may be claimed only if the criteria for each are met after a repeat radiologic tumor assessment (using RECIST criteria version 1.1) 6 weeks later.

  19 weeks

Secondary Outcomes (8)

• Progression-free survival (PFS) rate at 1 year

  1 year

• Overall Survival (OS) rate at 1 year

  1 year

• Pharmacokinetics: Cmax and Ctrough

  Cycle 6

• Proportion of subjects with selected adverse events (AE)

  1 year

• Proportion of subjects with other selected AEs

  1 year

Study Arms (2)

CBT124 arm

EXPERIMENTAL

CBT124 plus carboplatin and paclitaxel

Biological: CBT124; Drug: Carboplatin; Drug: Paclitaxel

EU Sourced Avastin® arm

ACTIVE COMPARATOR

EU-sourced Avastin® plus carboplatin and paclitaxel

Biological: EU-sourced Avastin®; Drug: Carboplatin; Drug: Paclitaxel

Interventions

CBT124 BIOLOGICAL

Induction Phase: CBT124 15 mg/kg IV infusion-Day 1 of each 3-week Cycle for 6 cycles; Carboplatin AUC 6 mgXmin/mL (calculation-Calvert formula recommended) on Day 1 of each 3-week Cycle for 6 cycles; Paclitaxel 200 mg/m2 on Day 1 of each 3-week Cycle for 6 cycles. Maintenance Phase: All the subjects who complete the induction phase and are alive at Week 19 without progression of the disease can be included in the maintenance phase and receive CBT124 (bevacizumab, 15 mg/kg, intravenous infusion on Day 1 of each 3-week Cycle) up to disease progression or unacceptable toxicity (that precludes further treatment with bevacizumab) or death.

CBT124 arm

EU-sourced Avastin® BIOLOGICAL

Induction Phase: EU-sourced Avastin® 15 mg/kg IV infusion-Day 1 of each 3-week Cycle for 6 cycles; Carboplatin AUC 6 mgXmin/mL (calculation-Calvert formula recommended) on Day 1 of each 3-week Cycle for 6 cycles; Paclitaxel 200 mg/m2 on Day 1 of each 3-week Cycle for 6 cycles. Maintenance Phase: All the subjects who complete the induction phase and are alive at Week 19 without progression of the disease can be included in the maintenance phase and receive CBT124 (bevacizumab, 15 mg/kg, intravenous infusion on Day 1 of each 3-week Cycle) up to disease progression or unacceptable toxicity (that precludes further treatment with bevacizumab) or death.

EU Sourced Avastin® arm

Carboplatin DRUG

Induction Phase: Carboplatin AUC 6 mgXmin/mL (calculation-Calvert formula recommended) on Day 1 of each 3-week Cycle for 6 cycles.

CBT124 arm; EU Sourced Avastin® arm

Paclitaxel DRUG

Induction Phase: Paclitaxel 200 mg/m2 on Day 1 of each 3-week Cycle for 6 cycles.

CBT124 arm; EU Sourced Avastin® arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects aged ≥ 18 to 75 years (≥ 18 to 65 years for India) with histologically or cytologically confirmed advanced non-squamous NSCLC.
• Epidermal growth factor receptor (EGFR) negative or wild type mutations
• Stage IV (Unresectable recurrent disease or metastatic) NSCLC
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Evaluable disease status or measurable tumor
• Adequate hepatic, renal, and bone marrow function
• 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.
• Ability to understand risks of participation in the study and willingness provide informed consent.

You may not qualify if:

• Small cell lung cancer (SCLC) or combination of SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature
• Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGF receptors, including bevacizumab
• Prior therapy with carboplatin or paclitaxel
• Prior systemic therapy for metastatic disease. Prior systemic anticancer therapy or radiotherapy for locally-advanced NSCLC if completed \< 12 months prior to screening
• 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
• Symptomatic brain metastasis
• 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
• Any unresolved toxicity \> Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy)
• History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. Thrombotic or hemorrhagic event ≤ 6 months prior to screening
• History of hemoptysis greater than ½ teaspoon of bright red (fresh) blood in the past 4 weeks
• 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
• Subjects receiving anticoagulants
• Subjects who plan to undergo surgery during the study period
• Subjects who have undergone a major surgery, or have had a significant traumatic injury within 4 weeks prior to randomization
• Subjects who have a significant non-healing wound, or bone fracture within 4 weeks prior to randomization

Sponsors & Collaborators

• Cipla BioTec Pvt. Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Tamal Raha, PhD

  Cipla BioTec

  STUDY DIRECTOR

Central Study Contacts

Tamal Raha, PhD

CONTACT

+91 7774097577; Tamal.Raha@Cipla.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 25, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: August 25, 2016

Record last verified: 2016-08