TG4010 is an attenuated vaccine. In a previous study, TG4010 combined with chemotherapy showed activity in non-small-cell lung cancer and the baseline value of CD16, CD56, CD69 triple-positive activated lymphocytes (TrPAL) was shown to be potentially predictive of TG4010 efficacy. Patients in this RCT were stratified according to baseline value of TrPAL (≤ or > the upper limit of normal [ULN]). In patients with TrPAL values of less than or equal to the ULN, the HR for progression-free survival was 0.75 (0.54–1.03); the posterior probability of the HR being less than 1 was 98.4%, and thus the primary endpoint was met. In patients with TrPAL values of greater than the ULN, the HR for progression-free survival was 0.77 (0.42–1.40); the posterior probability of the HR being greater than 1 was 31.3%, and the primary endpoint was not met. As the primary endpoint for TrPAL values of less than or equal to the ULN was met the trial will continue into the phase 3 part