This is an open-label, randomised, two-arm, phase III, multi-centre clinical trial.
210 stage IB-IIIA, completely resected, non-small cell lung cancer patients will be enrolled
in this trial to evaluate the disease free survival between experimental arm (Adjuvant
Chemotherapy-Inmunotherapy + maintenance adjuvant Inmunotherapy) and control arm (Adjuvant
This is an open-label, randomised, two-arm, phase III, multicentre clinical trial.The total
sample size is 210 and 105 per arm. The population to be included are stage IB-IIIA,
completely resected, non-small cell lung cancer patients.
Patients randomised to the experimental arm will receive Nivolumab 360mg + Paclitaxel
200mg/m2 + Carboplatin AUC5 for 4 cycles every 21 days (+/- 3 days) as adjuvant treatment
followed by maintenance adjuvant treatment for 6 cycles with Nivolumab 480 mg Q4W (+/- 3
Patients randomized to the control arm will receive Paclitaxel 200mg/m2 + Carboplatin AUC5
for 4 cycles every 21 days (+/- 3 days) followed by 2 observation visits.
The primary objective is to evaluate the disease-free survival (DFS): defined as the length
of time from randomization to the earliest event defined as disease recurrence, any new lung
cancer (even in the opposite lung), or death from any cause at any known point in time.
Patient accrual is expected to be completed within 3.5 years, excluding a run-in-period of 3
months. Treatment and follow-up are expected to extend the study duration to a total of 6.5
years. Patients will be followed 2 years after adjuvant treatment or observation phase. The
study will end once survival follow-up has concluded.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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