Ing and progressing on all SOC argeted therapies for an oncogenic driver alteration, no measurable illness identified ahead of registration, baseline blood pressure outdoors of protocol-specified range, getting more than a single line of anti D-1/PD-L1 therapy, and baseline scans for measurable disease not of diagnostic high-quality (1 patient each and every). On the 82 patients randomly assigned to the investigational arm, 13 individuals have been not eligible due to the following reasons: not receiving or progressing from anti D-1/PD-L1 therapy per protocol-specified timeframe (4), getting extra than a single line of anti D-1/PD-L1 therapy (two), not progressing from platinum-based chemotherapy (two), no measurable illness identified before registration, receiving systemic therapy inside 21 days prior to random assignment, not receiving platinum-based chemotherapy, receiving radiation therapy within 14 days before random assignmentand inadequate renal function, and getting corticosteroids for brain metastasis within 7 days ahead of random assignment (a single patient each). bOf the 55 around the RP arm with reported progression, 41 (75 ) went off-RP at the time of progression (PD), four (7 ) discontinued therapy prior to PD, and 10 received therapy following PD. With the 10, durations have been 4 for , 1 month, two for 1-3 months, one for 3-6 months, and two 6-18 months, and 1 remains on therapy as of final follow-up at 2.1 months soon after PD. AE, adverse occasion; PD, progression of disease; PD-1, programmed death 1; PD-L1, programmed death ligand 1; RP, ramucirumab plus pembrolizumab; SOC, standard of care.cycles of ramucirumab, five (1-28) cycles of docetaxel (with or without the need of ramucirumab), or five.five (1-19) cycles of gemcitabine. The one particular patient on pemetrexed received six cycles. Ten (14 ) individuals on the RP arm received study therapy beyond progression, with six for , three months and two for . 6 months.2298 2022 by American Society of Clinical OncologyPrior Therapy In the 136 eligible sufferers, 74 (54 ) previously received immunotherapy combined with platinum-based chemotherapy, 59 (43 ) received platinum-based chemotherapy, followed by immunotherapy, and 3 (two ) receivedVolume 40, IssueRamucirumab and Pembrolizumab in NSCLC After Prior ImmunotherapyTABLE 1. Baseline Demographics and CharacteristicsCharacteristic Age, years, median (range) Sex Male Female Race White Black Asian Native American Multiracial Unknown Hispanic Smoking status Existing smoker Previous smoker By no means smoked PS 0 1 Tumor histology Adenocarcinoma Squamous cell Mixed , 50 squamous cell Mixed 50 squamous cell Other non mall-cell, NOS Prior lines of remedy for stage IV disease 0 1 2 3 PD-L1 statusa , 1 1 1 -49 50 Unknown Tumor mutational burden by F1CDXa Median (range, IQR variety) 10 7.MIP-2/CXCL2 Protein Source six (0-25.TNF alpha, Human (His) 2, 3.PMID:26895888 8-12.six) ten.1 (0-40.four, five.0-15.1) 25 (40) 33 (51) 26 (41) 38 (59) 22 (34) 16 (25) 3 (4) 29 (47) 33 (53) 21 (34) 12 (19) 7 (ten) 4 (six) 33 (49) 17 (25) 13 (19) four (six) 35 (51) 19 (28) 11 (16) 39 (58) 27 (40) 1 (1) 1 (1) 4 (six) 36 (52) 28 (41) 9 (13) 58 (87) 23 (33) 46 (67) 18 (27) 43 (64) six (9) 19 (28) 44 (64) 6 (9) 1 (1) two (three) two (3) 58 (87) 6 (9) two (three) 60 (87) five (7) 1 (1) 1 (1) 42 (63) 25 (37) 41 (59) 28 (41) SOC (n five 67) 65.eight (45.6-84.3) RP (n 5 69) 66.four (37.6-85.3)immunotherapy, followed by platinum-based chemotherapy (Table two). Twenty-three sufferers received extra chemotherapy just after their platinum-based chemotherapy and immunotherapy regimens; 50 sufferers received chemotherapy just before mixture immu.
