6/29/23, 1:34 AM PARAMOUNT Pathway Feedback Search Clinical Topics Home Studies PARAMOUNT PARAMOUNT Disease Non-small cell lung cancer Trial question What is the role of pemetrexed continuation maintenance therapy in patients with advanced nonsquamous non-small cell lung cancer? Study design Multi-center Double blinded RCT Population Characteristics of study participants 42.1% female N = 939 57.9% male 939 patients (226 female, 313 male) Inclusion criteria: patients with advanced nonsquamous non-small cell lung cancer who received four cycles of pemetrexed-cisplatin induction therapy Key exclusion criteria: concurrent administration of other antitumour therapy and tumour histology that was predominantly squamous cell, mixed small cell, or a combination of both histologies Interventions N=359 pemetrexed (continuation pemetrexed 500 mg/m IV plus best supportive care, on day 1 of 21-day cycles) N=180 placebo (0.9% sodium chloride IV plus best supportive care, on day 1 of 21-day cycles) https://web.pathway.md/studies/recjo23JKqsHIwxKp 1/2 6/29/23, 1:34 AM PARAMOUNT Pathway Primary outcome Overall survival 13.9 months 13.9 11 10.4 months 7.0 months 3.5 months Significant increase 0.0 months Pemetrexed Placebo Significant increase in overall survival (13.9 months vs. 11 months; HR 1.28, 95% CI 1.04 to 1.56) Secondary outcomes No significant difference in survival for complete/partial responders induction response (15.5 vs. 11.2; HR 1.23, 95% CI 0.9 to 1.69) No significant difference in survival for patients with stable disease (13.7 vs. 11.1; HR 1.32, 95% CI 0.99 to 1.75) Safety outcomes Significant differences in durg-related grade 3-4 anemia (6.4% vs. 0.6%), neutropenia (5.8% vs. 0%), and fatigue (4.7% vs. 1.1%). Conclusion In patients with advanced nonsquamous non-small cell lung cancer who received four cycles of pemetrexed-cisplatin induction therapy, pemetrexed was superior to placebo with respect to overall survival. Reference Paz-Ares LG, de Marinis F, Dediu M et al. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Aug 10;31(23):2895-902. Open reference URL https://web.pathway.md/studies/recjo23JKqsHIwxKp 2/2