Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Related Information
Registry Information

Alternate Title

Erlotinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Closed	18 and over	NCI	ECOG-E3503 E3503, NCT00085280

Special Category: NCI Web site featured trial

Objectives

Primary

1. Determine downstream markers of epidermal growth factor receptor-linked signaling pathways that are predictive of response to erlotinib in patients with stage IIIB or IV or recurrent non-small cell lung cancer.

Secondary

1. Determine antitumor objective response rate in patients treated with this drug.
2. Determine disease control rate (complete response, partial response, or stable disease) in patients treated with this drug.
3. Determine time to progression and overall survival of patients treated with this drug.
4. Determine whether a grade 2 rash is a predictor of response to this drug and of survival of these patients.
5. Determine the safety profile of this drug in these patients.
6. Correlate smoking status, as measured by the Smoking Status Survey, with disease outcome and overall survival in patients treated with this drug.

Entry Criteria

Disease Characteristics:

• Histologically confirmed non-small cell lung cancer (NSCLC)*
  • Stage IIIB with malignant pleural effusion or IV or recurrent disease

   [Note: *Must have diagnostic specimen available on paraffin-embedded block]




• Measurable disease
  • Previously irradiated areas are considered measurable if there is documented disease progression



• Stable, treated brain metastases allowed provided patients are asymptomatic and not taking corticosteroids

Prior/Concurrent Therapy:

Biologic therapy

• More than 2 weeks since prior immunotherapy and recovered
• No concurrent routine myeloid growth factors

Chemotherapy

• No prior chemotherapy for metastatic disease
  • Prior adjuvant chemotherapy for stage IB-IIIA disease OR chemoradiotherapy for stage IIIA or IIIB disease allowed provided both of the following criteria are met:
    • Prior treatment completed ≥ 6 months ago
    • Patient now presents with advanced disease

Endocrine therapy

• See Disease Characteristics
• More than 2 weeks since prior hormonal therapy and recovered

Radiotherapy

• See Disease Characteristics
• See Chemotherapy
• More than 2 weeks since prior radiotherapy and recovered

Surgery

• More than 21 days since prior major surgical procedure
• No prior surgical procedure affecting absorption

Other

• No prior epidermal growth factor receptor inhibitors
• No prior targeted therapy for metastatic disease
• At least 1 week since prior CYP3A4 inducers or inhibitors
• Concurrent warfarin allowed
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent grapefruit juice
• No concurrent enrollment in any other clinical trial

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,500/mm³
• Platelet count > 100,000/mm³

Hepatic

• AST and ALT < 2 times upper limit of normal
• Bilirubin < 1.5 mg/dL

Renal

• Creatinine < 1.5 mg/dL

  OR

• Creatinine clearance > 50 mL/min

Cardiovascular

• No unstable angina pectoris
• No symptomatic congestive heart failure
• No symptomatic cardiac arrhythmia

Gastrointestinal

• No requirement for IV alimentation
• No active peptic ulcer disease
• No gastrointestinal tract disease resulting in an inability to take oral medication

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No bone fracture
• No serious non-healing wound
• No active or ongoing infection
• No psychiatric illness that would preclude study compliance
• No comorbidity that would preclude study participation

Expected Enrollment

A total of 129 patients will be accrued for this study within 6 months.

Outline

This is a pilot, multicenter study.

Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients complete the Smoking Status Survey, a questionnaire regarding smoking habits, at baseline, and then every 3 months during study treatment.

After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3 years.

Kolesar J, Brahmer J, Lee J, et al.: Final results of ECOG 3503: a pilot study to determine if downstream markers of EGFR linked signaling pathways predict response to erlotinib (OSI-774) in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 25 (Suppl 18): A-7588, 406s, 2007.

Solomon BJ, Roder H, Robert R, et al.: Validation of proteomic classifier for clinical benefit from erlotinib as first line treatment for advanced non-small cell lung cancer (ECOG 3503). [Abstract] J Clin Oncol 25 (Suppl 18): A-7508, 387s, 2007.

Kolesar J, Brahmer J, Li S, et al.: ECOG 3503: a pilot study to determine if downstream markers of EGFR linked signaling pathways predict response to erlotinib (OSI-774) in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 24 (Suppl 18): A-7162, 404s, 2006.

Taguchi F, Solomon B, Gregorc V, et al.: Mass spectrometry to classify non-small-cell lung cancer patients for clinical outcome after treatment with epidermal growth factor receptor tyrosine kinase inhibitors: a multicohort cross-institutional study. J Natl Cancer Inst 99 (11): 838-46, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Julie Brahmer, MD, Protocol chair		Ph: 410-502-7159
Anne Traynor, MD, Protocol co-chair		Ph: 608-262-5092; 800-622-8922

Related Information

Featured trial article

Registry Information
Official Title		A Pilot Study To Determine If Downstream Markers of EGFR linked Signalling Pathways Predict Response To OSI-774 (Erlotinib) In First-Line Treatment Of Patients With Advanced Non-Small Cell Lung Cancer
Trial Start Date		2004-09-29
Trial Completion Date		2005-01-31 (estimated)
Registered in ClinicalTrials.gov		NCT00085280
Date Submitted to PDQ		2004-04-27
Information Last Verified		2007-06-30
NCI Grant/Contract Number		CA21115

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