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Table 1 Summary of Completed or Ongoing Clinical Trials of Immune Checkpoint Inhibitors in Combination with or without EGFR-TKIs in Locally Advanced or Metastatic NSCLC

From: Role of the dynamic tumor microenvironment in controversies regarding immune checkpoint inhibitors for the treatment of non-small cell lung cancer (NSCLC) with EGFR mutations

Clinical Trial Number of patients Median age (yr) Male Sex (%) Baseline Treatment ORR (%) Median OS (months) Median PFS (months) Phase Status
NCT02088112 [188] 10 NA NA TKI-naive EGFR (+) Concurrent Gefitinib+Durvalumab 77.8 NA NA 1 Active:not recruiting
10 NA NA TKI-naive EGFR (+) Priming Gefitinib monotherapy followed by concurrent Durvalumab+Gefitinib 90 NA NA 1 Active:not recruiting
NCT02040064/GEFTREM [189] 18 66 35 TKI-pretreated EGFR (+) Gefitinib+ Tremelimumab 50–80 NA NA 1 Completed
NCT02574078/CheckMate 370 [190] NA NA NA TKI-naive EGFR (+) Nivolumab + Erlotinib NA NA NA 1/2 Active:notrecruiting
13 63 54 TKI-naive EGFR (+) Nivolumab + Crizotinib NA NA NA 1/2 Active:notrecruiting
NA NA NA TKI-naive EGFR (+) Nivolumab NA NA NA 1/2 Active:notrecruiting
NCT01454102/CheckMate 012 [191] 21 NA NA TKI-naive EGFR (+) Nivolumab + Erlotinib 19 NA NAa 1 Active:not recruiting
NCT02013219 [192] 28 61 NA TKI-naive EGFR (+) and treatment-naive ALK (+) Atezolizumab+Erlotinib 75 NA 11.3 1 Active:not recruiting
NCT02039674/KEYNOTE-021 [27] 12 60 50 TKI-naive EGFR (+) Pembrolizumab+Erlotinib 41.7 2 19.5 1/2 Active:not recruiting
7 68 43 TKI-naive EGFR (+) Pembrolizumab+Gefitinib 14.3 3 1.4 1/2 Active:not recruiting
NCT02143466/TATTON [193] 10 67 30 TKI-pretreated EGFR (+) Osimertinib+Durvalumab 39–70 NA NA 1 Active:not recruiting
13 58 46 TKI-pretreated EGFR (+) 1 Active:not recruiting
11 57 55 TKI-naive EGFR (+) 1 Active:not recruiting
NCT02454933/CAUREL [27] 17 65 24 TKI-pretreated EGFR (T790 M+) Osimertinib 80 NA NA 3 Active:not recruiting
12 56 50 Osimertinib+Durvalumab 64 NA NA 3 Active:not recruiting
NCT01642004/CheckMate-017 [15] 135 62 82 Platinum-Based Chemotherapy Pretreated Nivolumab 20 9.2 3.5 3 Active:not recruiting
137 64 71 Docetaxel 9 6 2.8 3 Active:not recruiting
NCT01673867/CheckMate-057 [16] 292 61 52 Platinum-Based Chemotherapy Pretreated Nivolumab 19 12.2 2.3 3 Active:not recruiting
290 64 58 Docetaxel 12 10.4 4.2 3 Active:not recruiting
NCT01905657/Keynote-010 [17] 345 63 62 Platinum-Based Chemotherapy Pretreated Pembrolizumab 9–18 8.5–12.7 4 2/3 Active:not recruiting
346 63 62 2/3 Active:not recruiting
343 62 61 Docetaxel 18 10.4 3.9 2/3 Active:not recruiting
NCT02008227/OAK [18] 425 63 61 Platinum-Based Chemotherapy Pretreated Atezolizumab 14 13.8 2.8 3 Completed
425 64 61 Docetaxel 13 9.6 4 3 Completed
NCT01903993 /POPLAR [19] 144 62 65 Platinum-Based Chemotherapy Pretreated Atezolizumab 14 12.6 2.7 2 Completed
143 62 53 Docetaxel 13 9.7 3 2 Completed
NCT02087423/ATLANTIC [194] 111 61 NA Pretreated-EGFR (+)/ALK(+) Durvalumab NA 13.3 NA 2 Active:not recruiting
265 NA NA Pretreated-EGFR (−)/ALK(−) Durvalumab NA NA NA 2 Active:not recruiting
68 61 NA Pretreated- EGFR (−)/ALK(−)b Durvalumab NA 13.2 NA 2 Active:not recruiting
NCT01295827/Keynote-001 [180] 4 NA NA TKI-naive EGFR (+) Pembrolizumab 50 18.6 5.3 1 Completed
26 NA NA TKI-pretreated EGFR (+) Pembrolizumab 4 4 1.9 1 Completed
NCT02366143/IMpower150 [187] 45 63 38 Chemotherapy-naiveEGFR (+) Atezolizumab+Carboplatin+ Paclitaxel 36 21.4 6.9 2 Active, not recruiting
34 64 18 Atezolizumab + Carboplatin + Paclitaxel + Bevacizumab 71 NE 10.2 2
45 61 21 Carboplatin+ Paclitaxel + Bevacizumab 42 18.7 6.9 2
NCT02367781/IMpower130 [195] 32 NA NA EGFR (+)/ALK(+) Atezolizumab + Carboplatin + Paclitaxel NA 14.4 7.0 2 Active, not recruiting
12 NA NA Carboplatin + Paclitaxel NA 10.0 6.0 2
  1. EGFR Epidermal growth factor receptor, OS Overall survival, PFS Progression-free survival, ORR Objective Response Rate, ALK Anaplasticlymphoma kinase, EGFR-TKI Epidermal growth factor receptor-tyrosine kinase inhibitor, NA Not avaliable, NR Not reached, NE Not estimable, NSCLC Non-small cell lung cancer, PD-L1 Programmed death-ligand 1
  2. a24-week PFS rate was 51%
  3. breceived≥2 prior systemic treatment regimens+ ≥ 90% of TC expressing PD-L1
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Molecular Cancer

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