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A Study of Neoadjuvant Chemotherapy Plus Anlotinib in Stage III(N2) Non-small-cell Lung Cancer

NCT04181372 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-11-29

No results posted yet for this study

Summary

Stage III non-small-cell lung cancer (NSCLC) is seen in a relatively heterogeneous group of patients with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of different treatment modalities are not clear. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant double-drug chemotherapy containing platinum plus anlotinib hydrochloride in patients with stage III(N2) non-small-cell lung cancer.

Conditions

  • Stage III Non-small-cell Lung Cancer

Interventions

DRUG

Anlotinib hydrochloride

Anlotinib hydrochloride was given 12mg once daily for two weeks, stop for one week, each 3-week cycle for 2 cycles.

DRUG

platinum-based chemotherapy medicine

(1)Carboplatin was given dosed to an AUC of 6 i.v. injection on day 1, paclitaxel was given 150 mg/m\^2 i.v. on day 1, every 21 days for 2 cycles.Or(2) Carboplatin was given dosed to an AUC 5 or Cisplatin was given 75 mg/m\^2 ,i.v. on day 1, pemetrexed was given 500 mg/m\^2 i.v. on day 1 for nonsquamous, every 21 days for 2 cycles.Or(3) Cisplatin was given 75 mg/m\^2 i.v. on day 1; docetaxel was given 75 mg/m\^2 i.v. on day 1 ,each 21-day cycle for 2 cycles.

Sponsors & Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Principal Investigators

  • Jiexia Zhang, prof. · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2021-08-01
Completion
2022-08-01

Countries

  • China

Study Locations

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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 NCT04181372 on ClinicalTrials.gov