Table 1

Investigated prognostic variables

Baseline characteristic Randomisation stratification factor Prespecified in both protocols
Tumour histology (LUME-Lung 1: squamous vs non-squamous; LUME-Lung 2: adenocarcinoma vs non-adenocarcinoma)
Baseline ECOG performance status (0 vs 1)
Prior bevacizumab therapy (yes vs no)
Brain metastases at baseline (yes vs no)
Liver metastases (yes vs no)
Sex (men vs women)
Age (<65 vs ≥65 years)
Best response to first-line chemotherapy (CR/PR/SD vs PD/unknown/NA/missing)
Concomitant bisphosphonates at baseline (yes vs no)
Disease stage at diagnosis (<IIB/IV vs IIIB vs IV)
Region (LUME-Lung 1: Asia vs rest of world; LUME-Lung 2: Asia vs non-Asia)
Time between start of first-line therapy and randomisation into the trial (‘TSFLT’) (months)
Adrenal metastases (yes vs no)*
Number of metastatic organs at baseline*
Lactate dehydrogenase level at baseline* (>1 x ULN vs≤1 x ULN)
  • *Additionally identified from the literature.

  • †Lactate dehydrogenase (LDH) levels at baseline were transformed into a binary variable (>1 ×  ULN vs ≤1 ×  ULN) because the range of LDH values was very limited (5th percentile, 0.5; 95th percentile, 2.0). This categorisation of LDH levels has been used previously.47,48

  • ✓=yes; ⨯=no; CR, complete response; ECOG, Eastern Cooperative Oncology Group; NA, not available; PD, progressive disease; PR, partial response; SD, stable disease; TSFLT, time since start of first-line therapy; ULN, upper limit of normal.