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

A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients With Completely Resected Stage Ib or II Non-Small Cell Lung Cancer

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.

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