Table 1

General characteristics of the included trials

First author (trial)Rittmeyer et al
(OAK)9
Herbst et al
(KEYNOTE-010)8
Borghaei et al (CheckMate 057)11Brahmer et al
(CheckMate 017)10
ImmunotherapyAtezolizumabPembrolizumabNivolumabNivolumab
Patient’s characteristics and definition of treatment
Median age (years) (range)64.0 (30–85)62.66 (56-69)62 (21–85)63 (39–85)
Disease stage (n (%))IIIB and IV (non-specified)Advanced (non-specified)IIIB: 44 (8)
IV: 538 (92)
IIIB: 53 (19)
IV: 217 (80)
Not reported: 2 (1)
Performance status (n (%))ECOG 0: 315 (37)
ECOG 1: 535 (63)
ECOG 0: 49 (32)
ECOG 1: 102 (67)
ECOG 2: 1 (1)
ECOG 0: 179 (31)
ECOG 1: 402 (69)
Unknown: 1 (<1)
ECOG 0: 64 (24)
ECOG 1: 206 (76)
Unknown: 1 (<1)
Histology (n (%))Non-squamous: 628 (74)
Squamous: 222 (26)
Non-squamous: 724 (70.1)
Squamous: 222 (21.5)
Other: 25 (2.4)
Unknown: 62 (6.0)
Non-squamous: 582 (100)Squamous: 272 (100)
EGFR mutation negative (n (%))628 (74)875 (84.70)500 (86)Not reported
EGFR mutant (n (%))85 (10)
Unknown: 137 (16)
86 (8.32)
Unknown: 72 (6.96)
82 (14)Not reported
Positive ALK translocation (n (%))2 (<1)8 (<1)21 (4)Not reported
Positive KRAS mutation (n (%))59 (7)Not reported62 (11)Not reported
Previous treatmentChemotherapy: 1011 (97.9)
Immunotherapy: 4 (<1)
EGFR tyrosine kinase inhibitor: 143 (13.8)
ALK inhibitor: 10 (<1)
Chemotherapy: 1011 (86.5)
Immunotherapy: 4 (<1)
EGFR tyrosine kinase inhibitor: 143 (12.24)
ALK inhibitor: 10 (<1)
Platinum-based therapy: 582 (100)
EGFR tyrosine kinase inhibitor: 53 (9)
ALK inhibitor: 3 (1)
Platinum duplet chemotherapy:
(Paclitaxel 34%, gemcitabine 44%, etoposide 13%)
EGFR tyrosine kinase inhibitor: 3 (1)
Inclusion criteriaOlder than 18 years. Measurable disease per RECIST 1.1.
One or more previous cytotoxic chemotherapy, including platinum-based chemotherapy or previous use of tyrosine kinase inhibitors
Older than 18 years.
Progression after two or more cycles of platinum-doublet chemotherapy or tyrosine kinase inhibitor.
Measurable disease per RECIST 1.1.
PD-L1 expression on at least 1% of tumour cells
Older than 18 years.
Documented IIIB or IV disease or recurrent non-squamous NSCLC after radiation therapy or surgical resection.
Disease recurrence or progression during or after one prior platinum-based doublet chemotherapy regimen. EGFR mutation or ALK translocation allowed to have received or be receiving an additional line of tyrosine kinase inhibitor therapy and a continuation of or switch to maintenance therapy with pemetrexed, bevacizumab or erlotinib
Older than 18 years.
Disease recurrence after one prior platinum-containing regimen in squamous NSCLC.
Prior maintenance therapy including an EGFR tyrosine kinase inhibitor was allowed.
Exclusion criteriaAutoimmune diseases. Previous treatment with docetaxel or therapies targeting the PD-L1 and PD-1 pathway.Autoimmune disease requiring systemic steroids.
Previous treatment with
PD-1 checkpoint inhibitors or docetaxel.
Known active brain metastases or carcinomatous meningitis.
Active interstitial lung disease or history of pneumonitis requiring systemic steroids.
Autoimmune disease
Symptomatic interstitial lung disease
Systemic immunosuppression.
Prior therapy with T cell costimulation or checkpoint targeted agents or prior docetaxel therapy.
Autoimmune disease
Symptomatic interstitial lung disease
Systemic immunosuppression.
Prior therapy with T cell costimulation or checkpoint targeted agents or prior docetaxel therapy.
Immunotherapy dose1200 mg intravenous every 3 weeks2 mg/kg intravenous every 3 weeks.
10 mg/kg intravenous every 3 weeks
3 mg/kg every 2 weeks3 mg/kg every 2 weeks
Docetaxel dose75 mg/m2 intravenous every 3 weeks75 mg/m2 intravenous every 3 weeks75 mg/m2 intravenous every 3 weeks75 mg/m2 intravenous every 3 weeks
PD-L1 staining subgroups/antibody clone and method (n (%))1% or less: 379 (45)
>1%: 463 (54)
>5%: 265 (31)
>50%: 137 (16)
SP-142 (Ventana Medical Systems, Oro Valley, Arizona, USA)
1%–49%: 591 (57.2)
≥50%: 442 (42.8)
22C3 (Dako, Carpinteria California, USA)
<1%: 209 (36.0)
>1%: 246 (42.3)
Not quantifiable: 127 (21.7)
28–8 (Dako)
<1%: 106 (39.0)
>1%: 119 (43.7)
Not quantifiable: 47 (17.3)
28–8 Dako
Number of previous lines for advanced disease (n (%))1: 640 (75)
2: 201 (25)
1: 713 (69.02)
2: 210 (20.32)
≥3: 90 (8.71)
Unknown: 2 (<1)
1: 515 (88)
2: 66 (11)
3: 1 (<1)
1: 271 (99)
2: 1 (1)
Enrolment time and sample sizeFrom March 2011 to November 2014.
n=850
From August 2013 to February 2015.
n=1033.
From November 2012 to December 2013. n=582From October 2012 to December 2013.
n=272
Primary end pointOverall survivalOverall survival and progression-free survivalOverall survivalOverall survival
Secondary end pointsProgression-free survival.
Proportion of patients who had an objective response.
Duration of response
Safety
Response rate
Duration of response
Safety
Objective response rate
Progression-free survival
Patient-reported outcomes
Objective response rate
Progression-free survival
Patient-reported outcomes
  • ALK, anaplastic lymphoma kinase gene; ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; KRAS, K-ras gene; NSCLC, non-small cell lung cancer; PD-1, programmed cell death receptor 1; PD-L1, programmed cell death ligand 1.