207_Combined course Presentations

PROCLAIM trial: Study design

Concurrent Phase

Recovery Period

Consolidation Phase

(3–5 wks)

Pemetrexed: ‡ 500 mg/m 2 , q3w

Pemetrexed: ‡ 500 mg/m 2 Cisplatin: 75 mg/m 2 , q3w TRT: 66 Gy, 2 Gy/fx daily

4 CYCLES

Arm A

3 CYCLES

Previously untreated stage IIIA−IIIB* non-squamous NSCLC PS 0/1

PR/CR/S D per RECIST

Investigator’s choice: Etoposide-Cisplatin: (same dosing/schedule) or Vinorelbine-Cisplatin: Vin: 30 mg/m 2 iv, D1, 8, q3w Cis: 75 mg/m 2 D1, q3w or Paclitaxel-Carboplatin: Pac: 200 mg/m 2 iv, q3w Car: AUC=6 iv, q3w

R †

Etoposide: 50 mg/m 2 D1–5, q4w Cisplatin: 50 mg/m 2 D1, 8, q4w TRT: 66 Gy, 2 Gy/fx daily

Arm B

2 CYCLES

2 CYCLES

*Stratified for: ECOG PS (0 vs 1); PET scan staging (yes vs no); gender; and disease stage (IIIA vs IIIB).

† AJCC Cancer Staging Manual (ed 6), 2002. ‡ Folic acid, vitamin B 12

, and dexamethasone administered in Arm A. TRT=thoracic radiotherapy.