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Immune Response on Neoadjuvant Therapy in Non-small-cell Lung Cancer (NSCLC)

NCT00406302 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2014-04-29

No results posted yet for this study

Summary

Primary objective is to assess the overall response rate (ORR) after induction therapy with docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and IIIa. ORR will be determined by the percentage of patients achieving objective response rates (CR + PR) according to the RECIST guidelines.

Conditions

  • Carcinoma, Non-small-cell Lung

Interventions

DRUG

Docetaxel

75mg/m², day 1,22

DRUG

oxaliplatin

40mg/m², d1,2,22,23

DRUG

cetuximab

400mg/m² (day1), 250mg/m² (day 8,15,22,29,36)

PROCEDURE

surgery

28 days after end of induction chemotherapy

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • TAKO - Tiroler Arbeitskreis Onkologie

    collaborator UNKNOWN

  • Wolfgang Hilbe

    lead OTHER

Principal Investigators

  • Wolfgang Hilbe, Prof. Dr. · University Hospital Innsbruck, Internal Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Austria

Study Locations

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Entities

Drugs
Companies

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 NCT00406302 on ClinicalTrials.gov