Nature Medicine has retracted a randomized phase 3 study that claimed time-of-day dosing of PD-1 immunochemotherapy for non-small cell lung cancer improved outcomes, after an investigation found serious problems with result integrity. The LungTIME-C01 paper had reported a benefit for patients receiving their first four cycles before 3 p.m., but the journal said editors no longer had confidence in the data. The retraction note cited the “amount and nature of the problems identified,” following earlier concerns about trial design changes, protocol inconsistencies, and unusual efficacy and safety patterns. The study compared two PD-1 drugs—Merck’s Keytruda and Innovent’s Tyvyt—combined with chemotherapy, and originally reported large differences in progression-free survival and overall survival between early and late treatment groups. Eric Topol had amplified the study on social media shortly after publication. In the weeks that followed, the journal published an editor’s note and ultimately pulled the article after a four-month review.
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