NCT04181372

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

A Phase II Study of Neoadjuvant Double-drug Chemotherapy With Platinum Plus Anlotinib Hydrochloride in Stage III(N2) Non-small-cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, open-label, multi-institutional, positive medicine control of equal rank comparative study of neoadjuvant double-drug chemotherapy with platinum plus anlotinib hydrochloride in stage III(N2) non-small-cell lung cancer.The main purpose of this study was to compare the difference in N2 downgrade rate of lymph node and resectability rate between the experimental and control groups, to evaluate the efficacy of anlotinib hydrochloride, and to observe and evaluate its objective response rate(ORR)，Disease-free Survival (DFS)and overall survival(OS).

Conditions

• Stage III Non-small-cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-08-01
• Completion: 2022-08-01
• First posted: 2019-11-29
• Last updated: 2019-11-29

Locations

1 site across 1 country: China