Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Pemetrexed; Drug: Cisplatin; Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00409006

10918

H3E-AA-S110 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
• Have not received any prior chemotherapy, molecular therapy, immunotherapy, biological therapy, or radiotherapy. Exception: palliative radiotherapy that is completed at least 4 weeks prior to study enrolment.
• Have 'never smoked' (defined as having smoked <100 cigarettes during his/her lifetime)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion criteria

• Concurrent administration of any other tumor therapy
• Other co-existing malignancies
• Pregnancy or breast feeding
• Serious concomitant disorders
• Inability or unwillingness to take folic acid or vitamin B12 supplementation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Pemetrexed/Cisplatin/Gefitinib

Experimental group

Description:

Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.

Treatment:

Drug: Gefitinib

Drug: Pemetrexed

Drug: Cisplatin

Pemetrexed/Cisplatin

Experimental group

Description:

Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.

Treatment:

Drug: Pemetrexed

Drug: Cisplatin