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Phase II Selection Design Trial Of Concurrent Chemotherapy + Cetuximab Vs. Chemotherapy Followed By Cetuximab In Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase II Selection Design Trial Of Concurrent Chemotherapy + Cetuximab Vs. Chemotherapy Followed By Cetuximab In Advanced Non-Small Cell Lung Cancer (NSCLC)



- Compare overall survival of patients with selected stage IIIB or stage IV non-small
cell lung cancer treated with concurrent vs sequential paclitaxel, carboplatin, and


- Compare response rates (confirmed and unconfirmed, complete and partial) in patients
treated with these regimens.

- Compare the toxic effects of these regimens in these patients.

- Correlate epidermal growth factor receptor polymorphisms and downstream biomarkers with
response to cetuximab in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I (concurrent cetuximab): Patients receive cetuximab IV over 1 hour (over 2 hours
on day 1 of course 1 only) on days 1, 8, and 15 and paclitaxel IV over 3 hours and
carboplatin IV over 30 minutes on day 8. Treatment repeats every 21 days for a total of
4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity.
Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour once
weekly in the absence of disease progression or unacceptable toxicity.

- Arm II (sequential cetuximab): Patients receive paclitaxel IV over 3 hours and
carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a total of
4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity.
Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour (over 2
hours on week 13 only) once weekly in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this
study within 9 months.

Inclusion Criteria


- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of one
of the following stages:

- Newly diagnosed selected stage IIIB disease (T4 lesion due to malignant pleural
effusion, any N, M0)

- Newly diagnosed stage IV disease (any T, any N, M1)

- Recurrent stage IV disease after prior surgery or radiotherapy

- The following subtypes are eligible:

- Adenocarcinoma

- Squamous cell carcinoma

- Large cell carcinoma

- Unspecified

- Measurable disease by CT scan, MRI, x-ray, or physical exam

- Pleural effusions, ascites, or laboratory parameters are not acceptable as the
only evidence of disease

- Not within prior radiotherapy field unless a new lesion is present

- Not within area of prior surgical resection

- No known brain metastases by CT scan or MRI



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 mg/dL


- Bilirubin ≤ 2 times upper limit of normal (ULN)

- SGOT or SGPT ≤ 2 times ULN

- Alkaline phosphatase ≤ 2 times ULN

- No known acute hepatitis


- Creatinine ≤ ULN

- Creatinine clearance ≥ 50 mL/min


- No significant cardiac disease

- No uncontrolled hypertension

- No unstable angina

- No congestive heart failure


- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission

- No active or uncontrolled infection

- No sensory neuropathy ≥ grade 2

- No known human anti-mouse antibodies

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy

- No prior biologic therapy for NSCLC

- No prior chimeric or murine monoclonal antibody therapy

- No prior cetuximab


- No prior systemic chemotherapy for NSCLC

Endocrine therapy

- Not specified


- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered


- See Disease Characteristics

- At least 2 weeks since prior thoracic or major surgery and recovered


- No prior gefitinib or other investigational agents that target the epidermal growth
factor receptor pathway

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Select a regimen based on overall survival

Outcome Description:

To select a regimen based on overall survival via a Phase II selection design of chemotherapy in conjunction with cetuximab (concurrent vs. sequential) for Phase III testing against chemotherapy alone in Stage IIIB and Stage IV non-small cell lung cancer.

Outcome Time Frame:

From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years

Safety Issue:


Principal Investigator

Roy S. Herbst, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 2004

Completion Date:

July 2011

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • squamous cell lung cancer
  • large cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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