A Study for Non-Smoker Patients With Nonsquamous Non-Small Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-Small-Cell Lung Cancer

Treatments: Drug: erlotinib; Drug: pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00550173

H3E-MC-S103 (Other Identifier)

10725

Details and patient eligibility

About

The purpose of this study is to compare the combination of erlotinib and pemetrexed versus either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time until the objective worsening of the disease) in patients who have never smoked and have locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a first-line chemotherapy treatment.

Enrollment: 247 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
• Patients must be non-smokers
• Patients must have at least one measurable lesion
• Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale
• Patients must have failed only one prior chemotherapy regimen and must be considered eligible for further chemotherapy following progression of their disease.

Exclusion criteria

• Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
• Patients who have previously received treatment with drugs against the human epidermal growth factor receptors
• Patients who have previously received treatment with drugs which have similar targets as Pemetrexed
• Patients who have any known significant ophthalmologic abnormalities of the surface of the eye
• Patients who have a history of severe hypersensitivity reaction to erlotinib or pemetrexed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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247 participants in 3 patient groups

Pemetrexed + Erlotinib

Experimental group

Description:

Pemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.

Treatment:

Drug: erlotinib

Drug: pemetrexed

Erlotinib

Active Comparator group

Description:

Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.

Treatment:

Drug: erlotinib

Pemetrexed

Active Comparator group

Description:

Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.

Treatment:

Drug: pemetrexed