Implementing flexible and adapted follow-up strategies in a patient-centric, phase II trial of first-line lorlatinib for advanced ALK-positive non–small cell lung cancer (CTONG2203).

Abstract

e13545 Background: We initiated the first patient-centric, multicenter, phase II trial (CTONG2203, NCT 06092086) to investigate the efficacy and safety of first-line lorlatinib and other TKIs in advanced ALK-positive non-small cell lung cancer. The follow-up schedule of treatment intervention cohorts aligns with that of the CROWN study, requiring patients to undergo frequent on-site visits over a prolonged observation period. Approximately 30% of subjects expressed a preference for reduced visit frequency, with two withdrawals due to this demanding schedule. Methods: We have made appropriate adjustments to the follow-up procedures while preserving the reliability and validity of the study results. For subjects who have received 24 months of study treatment with efficacy benefit, investigators may extend the interval of response evaluation from 8 weeks to 12 weeks. Pre-adjustment data analysis validated that the extended interval does not compromise efficacy assessment. During visit cycles in which efficacy evaluation is not required, patients may have laboratory tests performed at local hospitals (qualified through prior verification of test standardization and result consistency with study sites) and sent the results to the investigators for assessment and archiving (imaging examinations must be conducted at the study site to ensure unified evaluation standards). In a multicenter setting, the follow-up site may be relocated—upon confirming consistency across sites in medical resources, detection capacity, and follow-up procedures. as well as and documented informed consent—to accommodate changes in subjects' work or domicile. All adapted measures were approved by the medical ethics committee to ensure they adhered to the trial’s scientific objectives and did not introduce bias into the results. Results: Participants reported that these modifications significantly reduced their travel and time costs associated with follow-up visits. No more patients dropped out due to visit-related burden. About 25% of the subjects have undergone laboratory tests at local hospitals, and comparative analysis with site-based tests showed no statistically significant differences (P > 0.05), confirming that local testing did not compromise data accuracy or safety assessments. In accordance with the aforementioned adjusted protocol, one subject will relocate from the Nanchang center to the Guangzhou center due to a job change, while another will transfer from the Guangzhou center to the Fuzhou center for closer proximity to her resident. Conclusions: By incorporating patient feedback to create adaptable visit schedules, patient-centric trials can optimize long-term monitoring without compromising data integrity and accuracy, offering valuable insights for future trial design. Clinical trial information: NCT06092086 .