Chemotherapy With Pemetrexed in Combination With Platinum for Advanced Non-Small Cell Lung Cancer (NSCLC)

Lilly

Status and phase

Completed

Phase 2

Conditions

Non-Small-Cell Lung Cancer

Treatments

Drug: Cisplatin

Drug: Carboplatin

Drug: Pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT00402051

11077 (Registry Identifier)

H3E-SB-S109 (Other Identifier)

Details and patient eligibility

About

This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.

Enrollment

133 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV
No previous systemic chemotherapy for this cancer
At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 and adequate organ function
Prior radiation therapy allowed but limited to <25% of the patient's bone marrow

Exclusion criteria

Serious concomitant systemic disorder or active infection
Mild to moderate renal insufficiency, but unable to interrupt salicylates or other nonsteroidal anti-inflammatory drugs
Symptomatic central nervous system (CNS) metastases requiring concurrent corticosteroid therapy
Presence of clinically significant third-space fluid collections