Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer

Treatments: Other: laboratory biomarker analysis; Biological: trastuzumab

Study type: Interventional

Funder types: NIH

Identifiers

NCT00004883

CLB-39810

CDR0000067555 (Registry Identifier)

U10CA031946 (U.S. NIH Grant/Contract)

NCI-2012-02318

Details and patient eligibility

About

Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer that overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells

Full description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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 population.

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

OUTLINE:

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

Treatment (trastuzumab)

Experimental group

Description:

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.

Treatment:

Biological: trastuzumab

Other: laboratory biomarker analysis