Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Centus Biotherapeutics Limited
Study ID
NCT02810457
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer

Key Dates

First listed
Jun 23, 2016
Start date
Sep 7, 2016
Status verified
Feb 2022
Primary completion
Jan 24, 2019
Completion
Jan 26, 2022

Study Design

Enrollment
731 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FKB238 / paclitaxel / carboplatin
    Drug: FKB238: 15 mg/kg IV infusion on Day 1 of each 21-day cycle. Drug: Paclitaxel: 200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles. Drug: Carboplatin: Area Under Curve (AUC) = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
  • Active Comparator: Avastin / paclitaxel / carboplatin
    Drug: Avastin: 15 mg/kg IV infusion on Day 1 of each 21-day cycle. Drug: Paclitaxel: 200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles. Drug: Carboplatin: AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.

Primary Outcome Measure

Overall Response Rate (ORR) Assessed as the Proportion of Patients With a Best Overall Response (BOR) of Either Complete Response (CR) or Partial Response (PR) [ Time Frame: Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months. ]

Locations (11)

FacilityCityStateZIPSite coordinators
Research Site 7814 - Compassionate Care Research GroupFountain ValleyCalifornia92708-
Research Site 7811 - Innovative Clinical Research InstituteWhittierCalifornia90603-
Research Site 7803 - 21st Century OncologyJacksonvilleFlorida32204-
Research Site 7812 - Joliet Oncology-Hematology Associates, Ltd.JolietIllinois60435-
Research Site 7810 - Edward H. Kaplan, MD and AssociatesSkokieIllinois60076-
Research Site 7813 - Trinity Cancer Care CenterMinotNorth Dakota58701-
Research Site 7801 - Gabrail Cancer CenterCantonOhio44718-
Research Site 7805 - Hematology & Oncology Associates, Inc.CantonOhio44708-
Research Site 7804 - Tri-County Hematology & Oncology Associates, Inc.MassillonOhio44646-
Research Site 7809 - Millennium OncologyHoustonTexas77090-
Research Site 7806 - Vista Oncology Inc. PSOlympiaWashington98502-

Find similar trials in Fountain Valley, CA

By research site
Research Site 7814 - Compassionate Care Research Group· Fountain Valley, CAResearch Site 7811 - Innovative Clinical Research Institute· Whittier, CAResearch Site 7803 - 21st Century Oncology· Jacksonville, FLResearch Site 7812 - Joliet Oncology-Hematology Associates, Ltd.· Joliet, ILResearch Site 7810 - Edward H. Kaplan, MD and Associates· Skokie, ILResearch Site 7813 - Trinity Cancer Care Center· Minot, ND

Related Studies