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A Study of Anti-PD-1 AK105 in Patients With Metastatic Squamous Non-small Cell Lung Cancer

NCT03866993 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2024-04-03

No results posted yet for this study

Summary

This is a phase III, randomized, double-blinded, multicenter clinical study to evaluate the efficiency and safety of AK105 (Anti-PD1 antibody) plus paclitaxel and carboplatin vs placebo plus paclitaxel and carboplatin as First-line Therapy in patients with metastatic squamous non-small cell lung cancer.

Conditions

  • Lung Cancer Non-small Cell Stage IV
  • Squamous Cell Lung Cancer

Interventions

BIOLOGICAL

AK105

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Placebo

IV infusion

Sponsors & Collaborators

  • Akeso Tiancheng, Inc

    collaborator OTHER

  • Akeso

    lead INDUSTRY

Principal Investigators

  • Shunchang Jiao, MD · Chinese PLA General Hospital

  • Baohui Han, MD · Shanghai Chest Hospital

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
2018-12-20
Primary Completion
2020-10-08
Completion
2022-01-14
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03866993 on ClinicalTrials.gov