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A Study of Combination Therapy in NSCLC

NCT04544644 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-09-10

No results posted yet for this study

Summary

This trial is a single arm, two cohorts, phase II study. All patients are stage IIIB-IV NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene. Cohort 1 includes patients with metastatic or recurrent NSCLC after progression on treatment with platinum-based chemotherapy and PD-1/PD-L1, given concurrently or sequentially. Cohort 2 includes treatment naïve patients with advanced NSCLC. All patients will recieve AK104 15mg/kg every 3 weeks(for up to 2 years) and anlotinib(12mg/d). The primary end point are objective response rate per RECIST1.1 and safety. Secondary end points are progression-free survival and overall survival.

Conditions

Interventions

DRUG

AK104+anlotinib

AK 104 is given by intravenous infusion and anlotinib is given by oral.

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • weiwei Shi · Chinese PLA General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2022-09-30
Completion
2023-09-30

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Entities

Diseases

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 NCT04544644 on ClinicalTrials.gov