PRiMAL (precision randomized clinical trial comparing MTB assisted care to usual care): Quality of life analysis in patients with newly diagnosed non-small cell lung cancer (NSCLC).

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1574 Background: Precision medicine—tailoring cancer treatment to a tumor’s genomic profile—is more effective and less toxic than traditional chemotherapy. However, its use in community oncology remains limited. Molecular Tumor Boards (MTBs), interdisciplinary teams that interpret genomic data and guide treatment, have improved precision medicine adoption and clinical outcomes, especially in academic centers. However, MTBs are less accessible in community practices, where most cancer care is delivered. Methods: The PRiMAL trial is a prospective, parallel-group, cluster randomized trial, comparing MTB assisted care (MTB-AC) to usual care in 10 community medical oncology practices aligned with the Markey Cancer Network. MTB-AC included nurse navigator assistance with next generation sequencing (NGS) ordering, MTB referral, and communication with treating oncologists. Usual care allowed access to the MTB at the discretion of treating oncologist. Eligible patients had untreated stage IIb-IV NSCLC. The co-primary endpoints were 1-year overall survival and health related quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy (FACT) Trial Outcome Index-Lung Cancer (FACT-L TOI), FACT-G, and FACT-L Cancer (FACT-L) administered at baseline, 8 weeks and 12 weeks after treatment initiation. A multilevel linear mixed-effects model was used to estimate the intervention effects for the QOL outcomes while controlling for demographic, clinical, and socioeconomic covariates. Results: At the data cut-off of 1/12/26, 405 pts were included for assessment of QOL at baseline (MTB, n=250; usual, n=155). Baseline demographics and disease characteristics were similar for sex, age, race, ethnicity, histology, stage and performance status. QOL assessments were completed by 292 patients at 8 weeks and 245 patients at 12 weeks; MTB-AC patients experienced numerically greater declines at 8 weeks compared to usual care (FACT-L TOI: -2.7 vs -0.5; FACT-G: -1.9 vs 0.50; FACT-L: -1.4 vs 1.1), but these differences were not significant. Between weeks 8 and 12, QOL was estimated to have declined in usual care patients while MTB-assisted care patients improved, FACT-L TOI (3.28, 95% CI: 0.10 to 6.46); FACT-G (between-group difference: 3.97, 95% CI: 0.56 to 7.38); and FACT-L (4.70, 95% CI: 0.58 to 8.81). Survival is immature. Conclusions: The preliminary analysis showed that MTB-AC demonstrated significant, and in some cases clinically meaningful, improvement in QOL between weeks 8 and 12 after treatment across all three FACT measures compared to usual care, suggesting a delayed but meaningful benefit of MTB-AC. Clinical trial information: NCT05254795 .

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