CAPTRA-Lung study is a prospective observational study that captured real-world data on patients with advanced or metastatic non–small cell lung cancer (NSCLC) across China. This study aims to complement the results from current therapeutic regimens to improve the standard of diagnosis and treatments, evaluate the effectiveness and safety of systemic therapy, and determine the factors influencing the outcomes and responses to treatment.
From January 2018 to December 2023, eligible patients with advanced or metastatic NSCLC who are newly diagnosed, receiving treatment and being follow-up at 16 institutions in China are enrolled in this study. The demographic, clinical, laboratory, and treatment characteristics as well as responses to treatment of each case are recorded in a paper case report form (CRF) and transcribed into an electronic data capture (EDC) system. The data integrity and consistency are supervised by a built-in EDC module or manually by the Clinical Research associate, data manager or study medical team. Based on the disease characteristics and treatment strategies, four sub-cohorts are established, including the sub-cohort of patients with driver mutations, patients receiving immunotherapy, wild-type patients and those with unknown driver mutations, and wild-type non-squamous NSCLC patients receiving first-line anti-VEGF therapy. Overall survival (OS), progress free survival (PFS), overall response rate (ORR) and incidence of adverse events (AE) will be calculated as time from initial enrolment until progression evaluated by physicians, last contact, date of death or date of the cutoff for analysis, respectively. The difference between groups will be determined by Chi-square/Fisher exact test or T-test/F-test. The linear/logistics regression will be used to investigate the relationship between variables. Survival analysis will be applied to obtain survival curve and hazard ratio (HR). Unless specified, all statistical analysis is two-tailed and at the 5% significance level. The main advantages of this observational study are its high external validity by enrolling a wide range of patients across different treatment settings, providing evidence of effectiveness to support treatment strategies, and ensuring the drug safety in a broad population of patients. Limitations of this study may include the effects of potential confounding by diagnosis bias cross different institutions; the nature of lacking blinding in the real-world study and the intervention from potential external clinical trials participants. Moreover, the attrition could be another important source of bias affecting the strength of the conclusions.
Clinical trial identification
NCT03334864 (Last Release Date: 11/02/2017).
Legal entity responsible for the study
Peking Union Medical College Hospital.
Beijing Cancer Prevention and Treatment Research Association.
All authors have declared no conflicts of interest.