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A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer


I. Determine the activity of trastuzumab (Herceptin) in patients with stage IIIB or IV
HER2-overexpressing non-small cell lung cancer.


I. Determine the duration of response in patients treated with this regimen. II. Determine
the toxicity of this treatment regimen in this patient population.

III. Assess levels of circulating HER2 and correlate with HER2 expression in this patient

V. Correlate circulating HER2 levels with non-small cell lung cancer tissue HER2 expression.


Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues
once a week in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks until disease progression or death.

PROJECTED ACCRUAL: Approximately 84 patients (42 per stratum) will be accrued for this study
within 17.5 months.

Inclusion Criteria:

- Histologically confirmed stage IIIB or IV non-small cell lung cancer

- Supraclavicular node involvement allowed

- Malignant pleural effusion allowed (cytological confirmation not required if
pleural fluid bloody or exudative)

- No stage IIIB patients eligible for CLB protocols comprising combined chemotherapy
and chest radiotherapy

- Recurrent disease allowed

- HER2 overexpression (2-3+)

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques

- At least 10 mm by spiral CT scan

- The following are not considered measurable:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Abdominal masses not confirmed and followed by imaging

- Cystic lesions

- No CNS metastases

- Performance status - ECOG 0-2

- Granulocyte count at least 1,500/mm3

- Platelet count at least 100,000/mm3

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- Creatinine no greater than 1.5 times ULN

- LVEF at least 45% (by echocardiogram or MUGA)

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV negative

- No concurrent immunologic disease (e.g., autoimmune disease)

- No history of allergy to murine products

- No prior murine antibodies

- No prior anthracyclines

- No more than 1 prior chemotherapy regimen for lung cancer

- At least 4 weeks since prior chemotherapy

- No concurrent chemotherapy

- No concurrent steroids except for adrenal failure or dexamethasone as an antiemetic

- No concurrent hormonal therapy except for nondisease-related conditions (e.g.,
insulin for diabetes)

- At least 6 months since prior radiotherapy

- No concurrent palliative radiotherapy

- At least 4 weeks since prior major surgery

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete response [CR] and partial response [PR])

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Gerald Clamon

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

February 2000

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Cancer and Leukemia Group B Chicago, Illinois  60606