Table 1

Study visit schedule

AssessmentBaselinePeriod 1Washout/
second visit
Period 2Final visit
D0D1D14 (±1)D26D28D29–31
(±3)
D32 (±3)D46 (±1)D58D60D61 (±3)
Blood collection (biomarker analysis, safety blood tests)XFirst dose of study drug/placebo for period 1XFinal dose of study drug/placebo for period 1XFirst dose of study drug/placebo for period 2XFinal dose of study drug/placebo for period 2X
DXAXXX
WeightXXX
ECGXXX
QoL: FACT-L and ACSXXX
AccelerometerX*X*X*
24 hours dietary recallXXX
Assessment of toxicityXXXXX
  • *Wear accelerometer.

  • ACS, Anorexia Cachexia Scale; DXA, dual X-ray absorptiometry; FACT-L, Functional Assessment of Cancer Therapy—Lung; QoL, quality of life.