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.
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