A Study of Pemetrexed Plus Carboplatin, or Pemetrexed Plus Cisplatin With Radiation Therapy Followed by Pemetrexed in Patients With Inoperable Non-Small-Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-Small-Cell Lung Cancer

Treatments: Drug: carboplatin; Drug: pemetrexed; Drug: cisplatin; Radiation: radiation therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00482014

9031

H3E-US-S047 (Other Identifier)

Details and patient eligibility

About

The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inoperable non small cell lung cancer
• No weight loss greater than 10% in 3 months prior to enrolling in trial
• Adequate kidney function
• Adequate liver function
• Adequate lung function

Exclusion criteria

• Previous surgery to remove lung tumor
• Previous chemotherapy or radiation therapy or lung cancer
• Inability to take vitamin supplementation
• Heart attack within past 6 months
• Active infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

A: Pemetrexed + Carboplatin

Experimental group

Description:

Pemetrexed + Carboplatin

Treatment:

Radiation: radiation therapy

Drug: carboplatin

Drug: pemetrexed

B: Pemetrexed + Cisplatin

Experimental group

Description:

Pemetrexed + Cisplatin

Treatment:

Radiation: radiation therapy

Drug: pemetrexed

Drug: cisplatin