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Apatinib Combine With Platinum-Based Doublet Chemotherapy for First-line Treatment of Advanced NSCLC

NCT03201146 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-11-17

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and clinical activity of Apatinib in combination with AP(Pemetrexed/Carboplatin) or AC(Pemetrexed/Carboplatin) as first-line chemotherapy in subjects with advanced EGFR wild type non-squamous non-small cell lung cancer(NSCLC).

Conditions

  • Lung Cancer
  • Non Small Cell Lung Cancer
  • Combination Chemotherapy
  • Apatinib

Interventions

DRUG

Apatinib

Doses to be determined following the completion of Phase I of the study.

DRUG

AP or AC

Pemetrexed(A) 500mg/m2, IV, Day 1; Cisplatin(P) 25mg/m2,IV,Day 1-3 or Carboplatin(C) area under curve(AUC)=5, IV, Day 1; AP or AC will be administered every 21 days starting on Day 1.

DRUG

Apatinib 250mg

250mg/d,q.d.,p.o.every 21 days.

DRUG

Apatinib 500mg

500mg/d,q.d.,p.o.every 21 days.

DRUG

Apatinib 750mg

750mg/d,q.d.,p.o.every 21 days.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2020-07-01
Completion
2020-08-01

Countries

  • China

Study Locations

More Related Trials

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 NCT03201146 on ClinicalTrials.gov