Table 1

Randomised phase III trials comparing EGFR, ALK and anti-PD1 inhibitors versus chemotherapy in patients with NSCLC included in this study

TreatmentStudyPopulationArms (n)GenderHR (95% CI) for PFS
EGFR TKIWTJOGFirst line, stages IIIB–IV EGFR mutationGefitinib (n=86)Female (n=119)0.418 (0.267 to 0.654)
Male (n=53)0.67 (0.337 to 1.334)
Cisplatin-docetaxel (n=86)
OPTIMALFirst line, stages IIIB–IV EGFR mutationErlotinib (n=82)Female (n=91)0.13 (0.07 to 0.24)
Male (n=63)0.26 (0.14 to 0.50)
Carboplatin-gemcitabine (n=72)
EURTACFirst line, stages IIIA(1), IIIB, IV; EGFR mutationErlotinib (n=86)Female (n=126)0.35 (0.22 to 0.55)
Male (n=47)0.38 (0.17 to 0.84)
Standard chemotherapy (n=87)
LUX-lung 3First line, stages IIIB–IV; EGFR mutationAfatinib (n=230)Female (n=224)0.54 (0.38 to 0.76)
Male (n=121)0.61 (0.37 to 1.01)
Cisplatin-pemetrexed (n=115)
LUX-lung 6First line stages IIIB–IV EGFR mutation, AsianAfatinib (n=242)Female (n=238)0.24 (0.16 to 0.35)
Male (n=126)0.36 (0.21 to 0.62)
Cisplatin-gemcitabine (n=122)
ENSUREFirst line stages IIIB–IV EGFR mutationErlotinib (n=110)Female (n=133)0.29 (0.17 to 0.50)
Male (n=84)0.43 (0.22 to 0.83)
Cisplatin-gemcitabine (n=107)
ALK TKIPROFILE-1014ALK-rearranged recurrent, or first-line metastatic non-squamous NSCLCCrizotinib (n=172)Female (n=212)0.45 (0.32 to 0.63)
Male (n=131)0.54 (0.36 to 0.82)
Pemetrexed-carboplatin/cisplatin (n=171)
ASCEND-4ALK-rearranged recurrent, or first-line metastatic non-squamous NSCLCCeritinib (n=189)Female (n=216)0.63 (0.43 to 0.93)
Male (n=160)0.41 (0.27 to 0.63)
Pemetrexed-carboplatin/cisplatin (n=187)
ASCEND-5ALK-rearranged stage IIIB or IV NSCLC previously exposed to at least a platinum-based chemotherapy and crizotinibCeritinib (n=115)Female (n=129)0.51 (0.34 to 0.79)
versusMale (n=102)0.43 (0.26 to 0.71)
Pemetrexed or docetaxel (n=116)
NCT00932893ALK-rearranged stage locally advanced or metastatic NSCLC previously exposed to at least a platinum-based chemotherapyCrizotinib (n=173)Female (n=194)0.48 (0.34 to 0.68)
versusMale (n=153)0.52 (0.35 to 0.77)
Pemetrexed or docetaxel (n=174)
Anti-PD1KEYNOTE 010Patients with previously treated NSCLC with PD-L1 expression on at least 1%Pembrolizumab 2 mg/kg (n=344)Female (n=399)1.02 (0.78 to 1.32)
Pembrolizumab 10 mg/kg (346)Male (n=634)0.78 (0.64 to 0.94)
Docetaxel (343)
KEYNOTE 024Patients with untreated advanced NSCLC, PD-L1 ≥50% of tumour cells, EGFR and ALK negativePembrolizumab (n=154)Female (n=118)0.75 (0.46 to 1.21)
Platinum-based chemotherapy (n=151)Male (n=187)0.39 (0.26 to 0.58)
CheckMate 017Patients with stage IIIB or IV squamous cell NSCLC who had disease recurrence after one prior platinum-containing chemotherapy regimenNivolumab (n=135)Female (n=64)0.71 (0.40 to 1.26)
Docetaxel (n=137)Male (n=208)0.63 (0.46 to 0.85)
CheckMate 026Patients with untreated stage IV or recurrent NSCLC and a PD-L1 tumour expression level ≥1%Nivolumab (n=271)Female (n=332)1.36 (0.98 to 1.90)
Platinum-based chemotherapy (n=270)Male (n=209)1.05 (0.81 to 1.37)
CheckMate 057Patients with non-squamous NSCLC that had progressed during or after platinum-based doublet chemotherapyNivolumab (n=292)Female (n=263)1.04 (0.80 to 1.37)
Platinum-based chemotherapy (n=290)Male (n=319)0.81 (0.63 to 1.04)
  • NSCLC, non-small cell lung cancer; PFS, progression-free survival; TKI, tyrosine kinase inhibitor.