ATLANTIS

ATLANTIS, trial NCT02566993 sponsored by PharmaMar and Jazz and reported in 2021, was lurbinectedin's confirmatory trial in relapsed small-cell lung cancer after one platinum line, and it missed its survival goal, though the drug stayed on the market because the combination tested was not the approved monotherapy dose. It randomised 613 patients to lurbinectedin plus doxorubicin or topotecan or CAV chemotherapy, found no difference in overall survival despite better tolerability, and the 2020 accelerated monotherapy approval, based on a basket cohort response rate, was maintained with the FDA later accepting IMforte and the LAGOON trial as confirmatory routes. OnCo links it to small-cell lung cancer, lurbinectedin and topotecan. Head-to-head second-line superiority of lurbinectedin over older chemotherapy remains unproven, which is the open question.