PROCLAIM: A Phase III Study of Pemetrexed, Cisplatin, and Radiation Therapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiation Therapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Locally Advanced Stage III Non–Small-Cell Lung Cancer of Other than Predominantly Squamous Cell Histology


Everett E. Vokes; Suresh Senan; Joseph A. Treat; Neill A. Iscoe


Clin Lung Cancer. 2009;10(3):193-198. 

In This Article

Special Considerations

There are obvious asymmetries in the chemotherapy delivery of this study that could not be overcome because of the varying cycle lengths of the chemotherapy regimens in the concurrent phase. The 3 cycles of pemetrexed and cisplatin during the concurrent phase of therapy more closely approximates the overall platinum dose administration of the control arm than a 2-cycle program (225 mg/m2 vs. 200 mg/m2). The length of consolidation therapy also differs in that the experimental arm uses a 12-week program compared with a 6-or 8-week program on the control arm. However, the programs also differ in that the control arm uses a platinum doublet versus single agent pemetrexed in the experimental arm. The selection of 4 cycles of single-agent pemetrexed as consolidation was based on the ongoing CALGB trial[25] demonstrating 4 cycles of pemetrexed can be given safely following concurrent chemotherapy and radiation and also from the recently reported maintenance trial that this approach can have a significant effect on overall time to disease progression in metastatic NSCLC with minimal additional toxicity.[27]

Finally, the trial will undertake close monitoring and review of the radiation treatment delivered to ensure any observed differences in either efficacy or safety are not a consequence of greater or lesser adherence to the radiation prescription defined in the protocol.


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