Carboplatin, Pemetrexed, Pembrolizumab in advanced or metastatic non-small cell lung cancer

Regimen in use at

FDA-recommended dose

Study	Evidence	Comparator	Efficacy
Langer et al. 2016 (KEYNOTE-021)	Randomized Phase II (E)	See link	See link
Gandhi et al. 2018 (KEYNOTE-189)	Phase III (E)	See link	See link

Note: selection of platinum agent in KEYNOTE-189 was per investigator choice.

Carboplatin (Paraplatin) AUC 5 IV over 15 to 60 minutes once on day 1, given third
Pemetrexed (Alimta) 500 mg/m² IV over 10 minutes once on day 1, given second
Pembrolizumab (Keytruda) 200 mg IV over 30 minutes once on day 1, given first, at least 30 minutes prior to chemotherapy

"Premedication with folic acid, vitamin B12, and corticosteroids was administered according to local guidelines."

21-day cycle for 4 cycles

KEYNOTE-021: Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508. Epub 2016 Oct 10. link to original article contains verified protocol supplementary appendix PubMed
KEYNOTE-189: Gandhi L, Rodríguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. Epub 2018 Apr 16. link to original article link to protocol contains verified protocol PubMed