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. 2021 Sep 7;11:732214. doi: 10.3389/fonc.2021.732214

Table 1.

Study characteristics of included randomized controlled trials.

Source Trial Phase Study population Line of therapy Stratification criteria Experimental arm (N) Control arm (N) Primary endpoint
Fehrenbacher, 2016 POPLAR II NSCLC ≥2L Histology, smoking status Atezolizumab (144) Docetaxel (143) OS
Jotte, 2020 IMpower131 III Stage IV squamous NSCLC 1L Age, sex, race, ECOG PS, smoking status, liver metastases, histology, number of prior systemic regimens Atezolizumab+carboplatin+nab-paclitaxel (343) Carboplatin+nab-paclitaxel (340) PFS and OS
West, 2019 IMpower130 III Stage IV non-squamous NSCLC, no EGFR/ALK mutations 1L Age, sex, ECOG PS, smoking status, liver metastases, histology, number of prior systemic regimens Atezolizumab+carboplatin+nab-paclitaxel (451) Carboplatin+nab-paclitaxel (228) PFS and OS
Reck, 2019/Socinski, 2018 IMpower150 III Stage IV or recurrent metastatic non-squamous NSCLC 1L Age, sex, EGFR, KRAS, liver metastases, histology, number of prior systemic regimens Arm A: Atezolizumab+carboplatin+paclitaxel (402);
Arm B: Atezolizumab+carboplatin+paclitaxel+bevacizumab (400)
Carboplatin+paclitaxel+bevacizumab (400) PFS and OS
Barlesi, 2018 JAVELIN Lung 200 III Stage IIIB/IV or recurrent NSCLC, PD-L1 ≥ 1%  ≥2L Age, sex, ECOG PS, histology, smoking status, region Avelumab (264) Docetaxel (265) OS
Rizvi, 2020 MYSTIC III Stage IV NSCLC without sensitizing EGFR/ALK mutations, PD-L1 ≥ 25%  1L Age, sex, histology, smoking status, race, ECOG PS Durvalumab (163) Chemotherapy (platinum-based doublet chemotherapy) (162) OS
Borghaei, 2015/Vokes, 2018 CheckMate 057 III Stage IIIB/IV or recurrent non-squamous NSCLC ≥2L Age, number of prior systemic regimens, sex, ECOG PS, smoking status, region, EGFR, KRAS, brain metastases, liver metastases, histology Nivolumab (292) Docetaxel (290) OS
Brahmer, 2015/Vokes, 2018 CheckMate 017 III Stage IIIB or IV squamous NSCLC 2L Age, sex, region, ECOG PS, smoking status, liver metastases, histology, number of prior systemic regimens Nivolumab (135) Docetaxel (137) OS
Carbone, 2017 CheckMate 026 III Stage IV or recurrent NSCLC, PD-L1 ≥ 1% 1L Age, sex, ECOG PS, histology, smoking status, number of prior systemic regimens Nivolumab (271) Chemotherapy (platinum doublet chemotherapy) (270) PFS
Wu, 2019 CheckMate 078 III Stage IIIB/IV or recurrent NSCLC, no EGFR/ALK mutations ≥2L Age, sex, ECOG PS, smoking status, brain metastases, histology, region Nivolumab (338) Docetaxel (166) OS
Mok, 2019 KEYNOTE-042 III Locally advanced or metastatic NSCLC without a sensitising EGFR/ALK mutation,PD-L1 ≥ 1% 1L Age, sex, ECOG PS, histology, smoking status, number of prior systemic regimens, region Pembrolizumab (637) Chemotherapy (platinum-based chemotherapy) (637) OS
Arrieta, 2020 PROLUNG II Advanced NSCLC ≥2L EGFR Pembrolizumab+docetaxel (40) Docetaxel (38) ORR
Hellmann, 2019 CheckMate 227 III Stage IV or recurrent NSCLC 1L Age, sex, ECOG PS, smoking status, histology, liver metastases, brain metastases, number of prior systemic regimens Nivolumab+ipilimumab (583) Chemotherapy (583) OS
Paz-Ares, 2018 KEYNOTE-407 III Metastatic, stage IV squamous NSCLC 1L Age, sex, ECOG PS, histology, number of prior systemic regimens, region Pembrolizumab+carboplatin+paclitaxel/nab-paclitaxel (278) Placebo+carboplatin+paclitaxel/nab-paclitaxel (281) PFS and OS
Gandhi, 2018/Gadgeel, 2020 KEYNOTE-189 III Metastatic non-squamous NSCLC, no EGFR/ALK mutations 1L Age, sex, ECOG PS, smoking status, brain metastases, liver metastases, histology, number of prior systemic regimens Pembrolizumab+pemetrexed+platinum (410) Placebo+pemetrexed+platinum (206) PFS and OS
Herbst, 2016/Herbst, 2020 KEYNOTE-010 II/III NSCLC with PD-L1 ≥ 1% ≥2L Age, sex, ECOG PS, histology, EGFR The pooled pembrolizumab doses (690): pembrolizumab (2 mg/kg every 3 weeks) (344)/pembrolizumab (10 mg/kg every 3 weeks) (346) Docetaxel (343) PFS and OS
Reck, 2016/Reck, 2019 KEYNOTE-024 III Stage IV NSCLC without EGFR/ALK mutations, PD-L1 ≥ 50% 1L Age, sex, ECOG PS, histology, smoking status, brain metastases, number of prior systemic regimens, region Pembrolizumab (154) Chemotherapy (platinum-based chemotherapy) (151) PFS
Fehrenbacher, 2018 OAK III NSCLC ≥2L Age, sex, histology, ECOG PS, number of prior systemic regimens, smoking status, brain metastases, EGFR, KRAS, histology, region Atezolizumab (613) Docetaxel (612) OS
Borghaei, 2018 KEYNOTE-021 II Stage IIIB/IV non-squamous NSCLC, no EGFR/ALK mutations 1L Histology, number of prior systemic regimens Pembrolizumab+chemotherapy (60) Chemotherapy (pemetrexed+carboplatin) (63) ORR

NSCLC, Non-small cell lung cancer; N, Number; 1L, First line; ≥2L, ≥ Second line; PD-L1, Programmed death-ligand 1; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, Epidermal growth factor receptor; ALK, Anaplastic lymphoma kinase; KRAS, Kirsten RAS; OS, Overall survival; PFS, Progression-free survival; ORR, Objective response rate.