Clinico-genomic characteristics of clinical trial participation and its impact on clinical outcome in metastatic NSCLC: A nationwide database analysis in Japan.

• DOI: 10.1200/jco.2025.43.16_suppl.8626
• Publication Date: 2025-05-28T21:06:45Z
• Authors: Kentaro Gosho; Yuji Uehara; Takafumi Koyama; Rui Kitadai; Yusuke Okuma; Mao Okada; Jun Sato; Yuki Katsuya; Takashi Kohno; Yasushi Goto; Noboru Yamamoto

8626 Background: The clinico-genomic factors influencing clinical trial participation and their impact on outcomes remain unclear. We investigated which characteristics predict in patients with metastatic NSCLC whether improves compared to nonparticipation, using a nationwide database. Methods: retrospectively analyzed 2,966 who underwent comprehensive genomic profiling (CGP) testing from March 2019 December 2023 the Center for Cancer Genomics Advanced Therapeutics, Multivariable logistic regression identified associated participation. Cox model OS between participants non-trial participants, adjusting age, sex, smoking status, performance liver/brain metastases, FDA-approved/potentially druggable genes, PD-L1 tumor proportion score (TPS). Overall response rate (ORR) by line of therapy was evaluated. Results: Of patients, 167 (6%) participated trials. In multivariable analysis, EGFR mutation (mut), non-squamous (sq) histology, male sex were higher likelihood participation, whereas STK11 mut lower After stepwise selection, biomarker ( mut, KRAS G12C RET fusion, MET exon 14 skipping TPS ≥ 50%) explained 72% increased odds, while (age < 65, non-sq histology) accounted 28%. Among lung adenocarcinoma (LUAD), predicted participation; among those sq cell carcinoma (LUSC), Participation did not confer an benefit overall cohort (HR, 0.94; 95% CI, 0.74–1.19), LUAD 1.03; 0.78–1.37), or -mut 0.99; 0.52–1.88), but significantly improved LUSC 0.29; 0.10–0.78). ORR different 1L (49% vs. 57%, P=0.25), 2L (30% 34%, P=0.75), 4L (25% 19%, P=0.56) lines, 3L (46% 23%, P=0.002) ≥5L (48% 18%, P=0.0001). Conclusions: Biomarker contributed NSCLC, underscoring importance CGP. Clinical exhibited survival comparable nonparticipants. Their later lines suggests that may be potent therapeutic option, particularly after standard treatment.