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Erlotinib Versus Vinorelbine/Cisplatin as Adjuvant Treatment in Stage IIIA NSCLC Patients With EGFR Mutations

NCT01410214 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-12-23

No results posted yet for this study

Summary

The purpose of this study is to assess the effect and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in patients with stage IIIA NSCLC after complete resection with EGFR activating mutations and to explore a new treatment strategy for this subset.

Conditions

  • Non-small Cell Lung Cancer Stage IIIA

Interventions

DRUG

Erlotinib

In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.

DRUG

vinorelbine/cisplatin

In the adjuvant treatment phase, patient will receive vinorelbine 25mg/m2 IV on day 1 and day 8, and cisplatin 25mg/m2 on day 1 and day 2 and day 3, of a 3-week schedule for 4 cycles or till disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • Chinese PLA General Hospital

    collaborator OTHER

  • Qingdao University

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    collaborator OTHER

  • The Second Affiliated Hospital of Harbin Medical University

    collaborator OTHER

  • Hebei Medical University Fourth Hospital

    collaborator OTHER

  • The Second People's Hospital of Sichuan

    collaborator OTHER

  • Chinese Lung Cancer Surgical Group

    lead OTHER

Principal Investigators

  • Changli Wang · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-07-31
Completion
2017-07-31

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 NCT01410214 on ClinicalTrials.gov