Multicenter phase II study evaluating docetaxel, CDDP, and cetuximab as induction regimen prior to surgery in chemonaive patients with NSCLC stage IB, II, and IIIA. - INN06

• Conditions: eoadjuvant treatment of non-small lung cancer

• Registration Number: EUCTR2006-004639-31-AT
• Lead Sponsor: TAKO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-16
• Last Update Posted: 23 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Histologically confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but not small cell lung cancer
Anatomically and functionally resectable NSCLC stage IB (T2N0), stage II (T1-2 N1, T3 N0) or stage IIIA (T3 N1)
Measurable disease according to RESIST criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Evidence of brain metastases or other distand metastases equivalent to stage IV disease
History of prior malignancies, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or other curatively treated cancer with no evidence of disease for at least five years
Other serious concomitant illnesses or medical conditions
Prior chemotherapy or immunotherapy for NSCLC
Prior surgery or radiotherapy for NSCLC
Concurrent treatment with other experimental drugs, unapproved medical procedures or other anticancer therapy
Concurrent continuous treatment with systemic steroids for antiemetic use, intermittent application is allowed

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: overall response rate;Secondary Objective: pathological response<br>metabolic response<br>immunological response<br>overall survival<br>safety and tolerability;Primary end point(s): surgery