Visit | Baseline | On treatment: BEP chemotherapy Cycles 1 to 4 | End of BEP chemotherapy safety assessment (Initial response assessment) | Final response assessment | Follow-up until progression | Follow-up after progression | |
---|---|---|---|---|---|---|---|
Within 21 days prior to randomisation | Day 1 of Cycle (or within 3 days) | Day 8 and 15 of Cycle (or within 3 days) | 30–42 days after the last dose of study treatment | 6 months from randomisation, or after completion of all post-chemo surgery and other interventions (± 1 month) | 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months from randomisation, then annually (± 1 month) | Every 6 months (± 1 month) | |
Clinical assessment | X | X | X | X | X (until 60 months) | ||
Respiratory symptoms/signs | X | X | X | X | |||
Adverse Event | X | X | |||||
Blood tests including tumour markers | X | X | X | X | X | X (until 60 months) | |
CT imaging | X | X | X | X (12, 24, 36, 60 months) | |||
Chest X-Ray | X | X | X | ||||
Patient-Rated Measures | X | X | X | X (9, 12, 18 months) | |||
Translational blood and tissue | Optional | ||||||
Patient Status | X | X | X | X | X |