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

NCT03866980 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

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 compare efficacy and safety of AK105 (Anti-PD1 antibody) combined with Carboplatin and Pemetrexed vs Placebo combined with Carboplatin and Pemetrexed as first-line therapy in patients with EGFR and ALK wild type metastatic nonsquamous non-small cell lung cancer.

Conditions

  • Lung Cancer Non-small Cell Stage IV

Interventions

BIOLOGICAL

AK105

IV infusion

DRUG

carboplatin

IV infusion

DRUG

pemetrexed

IV infusion

DRUG

placebo

IV infusion

DRUG

Anlotinib

PO

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
2018-11-27
Primary Completion
2023-06-30
Completion
2023-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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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 NCT03866980 on ClinicalTrials.gov