To Evaluate the Efficacy and Safety of SCT510 in the Treatment of Non-small Cell Lung Cancer

Sponsor
Sinocelltech Ltd.
Study ID
NCT03792074
Phase
PHASE3
Status
Unknown

Conditions

  • Non-squamous Cell Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • SCT510 — DRUG
    SCT510 Injection
  • Bevacizumab — DRUG
    Bevacizumab Injection
  • Paclitaxel — DRUG
    Paclitaxel Injection
  • Carboplatin — DRUG
    Carboplatin injection

Study Details

To evaluate the safety, efficacy and immunogenicity of SCT510 combined with paclitaxel and carboplatin compared with bevacizumab combined with paclitaxel and carboplatin in the first-line treatment of locally advanced metastatic or recurrent squamous cell non-small cell lung cancer.

Key Dates

First listed
Jan 3, 2019
Start date
Feb 28, 2019
Status verified
Dec 2018
Primary completion
May 31, 2021
Completion
Jan 31, 2022

Study Design

Enrollment
560 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SCT510 combined paclitaxel and carboplatin
    SCT510 15mg/kg+ paclitaxel 175mg+ carboplatin (AUC=5), intravenous infusion，on day 1，Once every 3 weeks;Four to six cycles in a row
  • Active Comparator: Bevacizumab combined paclitaxel and carboplatin
    Bevacizumab 15mg/kg+ paclitaxel 175mg+ carboplatin (AUC=5), intravenous infusion，on day 1，Once every 3 weeks;Four to six cycles in a row

Primary Outcome Measure

Objective response rate [ Time Frame: 12 weeks ]

Central Contacts