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A Study Exploring Efficacy of SIBP04 in Subjects With Non-squamous Non-small Cell Lung Cancer

NCT05318443 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2023-12-27

No results posted yet for this study

Summary

This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical study. To evaluate the clinical efficacy of SIBP04 in patients with locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer.

Conditions

  • Non-squamous Non-small-cell Lung Cancer

Interventions

DRUG

SIBP04

SIBP04, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.

DRUG

Avastin

Avastin, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.

DRUG

Paclitaxel

Paclitaxel, 175mg/m2, intravenous infusion, every 3 weeks/cycle, administered on the first day of each treatment cycle.

DRUG

Carboplatin

Carboplatin, AUC=5.0, (upper limit 800mg), intravenous infusion, 3 weeks/cycle, administered on the first day of each treatment cycle.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Principal Investigators

  • Yuankai Shi, Doctor · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Aidong Qu, Master · Co., Ltd Shanghai Institute Of Biological Products

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-17
Primary Completion
2022-12-26
Completion
2023-01-12

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05318443 on ClinicalTrials.gov