Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Erlotinib With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	CALGB-30406 NCT00126581

Special Category: NCI Web site featured trial

Objectives

Primary

1. Determine the progression-free survival of patients with chemotherapy-naïve select stage IIIB or stage IV non-small cell lung cancer treated with erlotinib with or without carboplatin and paclitaxel.

Secondary

1. Determine the radiographic response rate in patients treated with these regimens.
2. Correlate the frequency of epidermal growth factor receptor (EGFR) mutations and K-ras mutations with the response rate and time to progression in patients treated with these regimens.
3. Determine the median and overall survival of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed primary non-small cell lung cancer (NSCLC)
  • Adenocarcinoma histology, including any of the following histologic variants:
    • Pure or mixed bronchoalveolar cell carcinoma
    • Adenosquamous cell carcinoma
  • No NSCLC not otherwise specified



• Pathology block or unstained slides from initial or subsequent diagnosis available
  • At least a core biopsy required
  • Fine needle aspirate alone is not sufficient



• Meets 1 of the following stage criteria:
  • Select stage IIIB disease with cytologically documented malignant pleural or pericardial effusion
  • Stage IV disease



• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • The following are considered non-measurable disease:
    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural or pericardial effusion
    • Lymphangitis cutis/pulmonis
    • Abdominal masses not confirmed and followed by imaging techniques
    • Cystic lesions



• Meets 1 of the following criteria for smoking history:
  • Non-smoker, defined as a person who smoked ≤ 100 cigarettes in their lifetime
  • Former light smoker, defined as a person who smoked ≤ 10 pack years AND quit smoking ≥ 1 year ago



• No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requires corticosteroids)

Prior/Concurrent Therapy:

Biologic therapy

• No prior trastuzumab (Herceptin®) or cetuximab

Chemotherapy

• No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy
• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics
• No concurrent hormonal therapy except for the following:
  • Hormones for non-disease-related conditions (e.g., insulin for diabetes)
  • Steroids for adrenal failure
  • Intermittent use of dexamethasone as an antiemetic or to prevent paclitaxel hypersensitivity reactions

Radiotherapy

• At least 3 weeks since prior radiotherapy, including cranial irradiation
• No concurrent radiotherapy, including palliative radiotherapy

Surgery

• At least 3 weeks since prior major surgery
• No prior significant surgical resection of the stomach or small bowel

Other

• No prior erlotinib, gefitinib, or lapatinib
• No other prior treatment targeting the HER family axis
• More than 4 weeks since prior and no other concurrent investigational agents

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL

Hepatic

• AST ≤ 2.5 times upper limit of normal (ULN)
• Total bilirubin ≤ ULN

Renal

• Creatinine ≤ 1.5 mg/dL

Gastrointestinal

• Able to swallow tablets intact or dissolved in water
• No dysphagia
• No active gastrointestinal disease or disorder that would alter gastrointestinal motility or absorption
• No lack of integrity of the gastrointestinal tract

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 180 patients (80 for arm I and 100 for arm II) will be accrued for this study within 1.5 years.

Outcomes

Progression-free survival (PFS) rate at 18 weeks

Response rate
Median and overall survival rate
Correlation of response with presence or absence of epidermal growth factor receptor (EGFR) mutations
PFS in presence or absence of EGFR mutations
Correlation of response and PFS in presence or absence of K-ras mutations
Toxicity

Outline

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

• Arm I: Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.



• Arm II: Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.

After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for up to 2 years.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Pasi Janne, MD, PhD, Protocol chair		Ph: 617-632-6076; 866-790-4500 Email: pjanne@partners.org
Vincent Miller, MD, Protocol co-chair		Ph: 212-639-7243; 800-525-2225 Email: millerv@mskcc.org

Related Information

Featured trial article

Registry Information
Official Title		A Phase II Randomized Study of OSI-774 (ERLOTINIB) (NSC #718781; IND#63, 383) With or Without Carboplatin/Paclitaxel in Patients with Previously Untreated Adenocarcinoma of the Lung who Never Smoked or were Former Light Smokers
Trial Start Date		2005-08-18
Trial Completion Date		2008-02-04 (estimated)
Registered in ClinicalTrials.gov		NCT00126581
Date Submitted to PDQ		2005-06-10
Information Last Verified		2009-08-09
NCI Grant/Contract Number		CA31946

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