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A Study of AK104 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT04647344 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-04-25

No results posted yet for this study

Summary

This is a phase Ib/II , open-label, multicenter single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 combined with Carboplatin and Pemetrexed/ Paclitaxel as first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer.

Conditions

  • Lung Cancer Non-Small Cell Stage IIIB/IIIC/IV

Interventions

DRUG

AK104 plus Carboplatin and Pemetrexed

Subjects receive AK104 15mg/kg intravenously (IV) plus pemetrexed 500 mg/m\^2 IV and carboplatin area under the curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK104 15mg/kg IV plus pemetrexed 500 mg/m\^2 IV Q3W until progression.

DRUG

AK104 plus Carboplatin and paclitaxel

Subjects receive AK104 15mg/kg intravenously (IV) plus paclitaxel 175 mg/m\^2 IV and carboplatin area under the curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK104 15mg/kg IV IV Q3W until progression.

Sponsors & Collaborators

Principal Investigators

  • Li Zhang, MD · Sun Yat-sen University Cancer Center, Guangzhou, China

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-11-24
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

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 NCT04647344 on ClinicalTrials.gov