Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 3

Conditions: Small Cell Lung Cancer

Treatments: Drug: etoposide; Drug: carboplatin; Drug: pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00363415

9691

H3E-MC-JMHO

Details and patient eligibility

About

This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.

Enrollment: 908 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of extensive stage small cell lung cancer (SCLC)
• Capable of self-care but may be unable to carry out any work activities.
• No prior anticancer therapy for SCLC

Exclusion criteria

• have previously participated in a study involving pemetrexed
• have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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908 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: pemetrexed

Drug: carboplatin

B

Active Comparator group

Treatment:

Drug: etoposide

Drug: carboplatin