Neoadjuvant treatment of non-small lung cancer
Conditions
Interventions
Trade Name: Erbitux
Product Name: Cetuximab
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Erbitux
CAS Number: 205923564
Other descriptive name: Cetuximab
Concentration unit: mg/m2 mil
Sponsors
TAKO
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: overall response rate;Secondary Objective: pathological response metabolic response immunological response overall survival safety and tolerability;Primary end point(s): surgery | — |
Countries
Austria
Outcome results
None listed