Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: pemetrexed; Drug: carboplatin; Drug: cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00269152

10105 (Registry Identifier)

H3E-SB-S089 (Other Identifier)

Details and patient eligibility

About

This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC).

A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven non-small cell lung cancer stage Ib, IIa or IIb
• Must have complete tumor resection by pneumonectomy or lobectomy
• Must have been surgically proven to be N2 negative

Exclusion criteria

• Serious concomitant systemic disorder
• Post-operative complications or other surgery related conditions
• A prior malignancy other than NSCLC unless that malignancy was diagnosed and treated at least 5 years ago

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

A: Pemetrexed + Cisplatin

Experimental group

Treatment:

Drug: cisplatin

Drug: pemetrexed

B: Pemetrexed + Carboplatin

Experimental group

Treatment:

Drug: carboplatin

Drug: pemetrexed