Real-World Evidence of First- or Second-Line Immune Checkpoint Inhibitors Versus Chemotherapy in Advanced NSCLC: A Prospective Pragmatic Multicenter Korean Study
In brief
First-line immunotherapy was linked to 20-month median survival versus 9 with chemotherapy
In this Korean real-world study, patients receiving first-line immune checkpoint inhibitor-based treatment had median overall survival of 20.1 months, compared with 9.0 months for chemotherapy; tumor response was also more common. The chemotherapy group was a retrospective historical control, so differences between groups could influence the comparison, and second-line results were less clear.
- Journal
- JTO clinical and research reports (Q1)
- Published
- 21 August 2026
- Study design
- Prospective / inception cohort
- Evidence level
- Level 2, Moderate (CEBM 2b)
- Authors
- Jinyong Kim, Sehhoon Park, Gyeong-Won Lee, Il-Hwan Kim, Dong-Wan Kim, Yun-Gyoo Lee, et al.
- PMID
- 42960209
- DOI
- 10.1016/j.jtocrr.2026.101064
Why clinicians should know about it
- Picked for Oncology and Radiation Oncology (paper of the day, 2 November 2026): ICI ± C improves survival vs chemotherapy in NSCLC
Abstract
INTRODUCTION: Immune checkpoint inhibitors (ICIs) have become the standard first-line treatment for advanced NSCLC. However, prospective real-world evidence comparing ICI-based therapy with chemotherapy remains limited. We evaluated the effectiveness and safety of ICI-based regimens versus chemotherapy in patients with advanced NSCLC. METHODS: In this nationwide prospective pragmatic study, patients with advanced or metastatic NSCLC who received first- or second-line ICIs with or without chemotherapy (ICI ± C) or chemotherapy alone were included. The ICI ± C cohort was prospectively enrolled, whereas the chemotherapy cohort was retrospectively assembled as a historical control. The co-primary endpoints were progression-free survival (PFS) and overall survival (OS). Secondary endpoints included the objective response rate, safety, and subgroup analyses. RESULTS: Among 1520 patients, 1234 received first-line therapy (ICI ± C, N = 525; chemotherapy, n = 709) and 286 received second-line therapy (ICI, n = 262; chemotherapy, n = 24). In the first-line setting, ICI ± C significantly improved survival compared with chemotherapy, with a median PFS of 8.1 versus 5.1 months (hazard ratio [HR] = 0.59, 95% CI: 0.52-0.67) and a median OS of 20.1 versus 9.0 months (HR = 0.47, 95% CI: 0.40-0.54). The objective response rate was 41.0% with ICI ± C and 11.4% with chemotherapy. In the second-line setting, PFS was similar (2.1 versus 3.6 mo; HR = 1.05), whereas OS was longer with ICIs (10.9 versus 6.0 mo; HR = 0.60). Multivariable Cox analyses confirmed that ICI ± C remained independently associated with improved survival (adjusted HR = 0.44 for OS and 0.58 for PFS). Treatment-related adverse events were more frequent with ICI ± C but were generally manageable. CONCLUSION: In this large prospective real-world cohort, ICI-based therapy significantly improved survival outcomes compared with chemotherapy in advanced NSCLC, particularly in the first-line setting, supporting the effectiveness of immunotherapy-based strategies in routine clinical practice.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.