Patient-Reported Outcomes Support Durvalumab Consolidation Following Chemoradiotherapy in LS-SCLC

Limited-stage small cell lung cancer (LS-SCLC) makes up around 30% of all SCLC cases and is still one of the most aggressive types of thoracic malignancies.¹ Normally, patients with LS-SCLC have a good response to initial platinum-based chemotherapy given simultaneously with thoracic radiotherapy (cCRT); however, relapse remains a common occurrence, and long-term survival rates are still low. The requirement to enhance results without negatively impacting the quality of life has led to the use of immunotherapy in this setting.²

The phase 3 ADRIATIC trial (NCT03703297) evaluated durvalumab (Imfinzi; AstraZeneca), a programmed death-ligand 1 (PD-L1) inhibitor, as a consolidation treatment following cCRT in LS-SCLC. Both survival and patient-reported outcomes (PROs) were evaluated.^1,3

ADRIATIC Trial Overview and Endpoints

ADRIATIC is a global, randomized, double-blind, placebo-controlled trial designed to recruit patients with stages 1 through 3 LS-SCLC that had not progressed after platinum-based cCRT.¹ The patients were randomly assigned at a ratio of 1:1 either to receive durvalumab alone or a placebo every 4 weeks for up to 24 months, starting the first dose within 1 to 42 days after finishing cCRT. The third arm combining durvalumab and tremelimumab (Imjudo; AstraZeneca) remains blinded for the primary analysis.¹

The primary objectives of the study were overall survival (OS) and progression-free survival (PFS), whereas secondary objectives included PRO measures such as global health status/quality of life (GHS/QoL), different functioning domains, and symptom burden assessed with validated patient questionnaires.^1,3

Survival and Efficacy Outcomes

In the first planned interim analysis, durvalumab as a consolidation therapy markedly improved both OS and PFS over placebo and set a new LS-SCLC treatment standard. Median OS in the durvalumab group was about 55.9 months compared to 33.4 months in the placebo group, which was consistent with a 27% reduction in the risk of death (HR, 0.73; p = .01). Median PFS was 16.6 months with durvalumab and only 9.2 months for placebo (HR, 0.76; p = .02), confirming that both end points were statistically significant.³ The results have been corroborated by a number of independent analyses and expert reviews, which, without raising any new or unexpected safety issues, have strengthened the clinical benefit of durvalumab consolidation in LS-SCLC.^4-6

Patient-Reported Outcomes: Quality of Life

Beyond survival, the PRO data from ADRIATIC are extremely valuable given that maintenance immunotherapy involves a long period of therapeutic exposure. The published PRO results show that the addition of durvalumab consolidation did not result in a decline in GHS/QoL, functioning, or symptom scores at any point during a follow-up of 24 months compared with placebo. Changes in means from baseline to various domains were limited and lower than the cut-offs of clinical significance in either of the treatment arms.¹

Time to deterioration analyses—which measure the duration a patient remains free from a significant worsening of symptoms or functional status—were similar for durvalumab and placebo for the majority of the outcomes; therefore, extended immunotherapy did not cause quality of life deterioration at a faster rate.¹ Notably, patients who received durvalumab showed a longer median TTD for arm/shoulder pain (25.7 vs 9.1 months; HR, 0.70) and higher rates of chest pain improvement, suggesting potential symptomatic advantages in specific areas.¹

Clinical Context and Implications

The ADRIATIC trial's results are remarkable in terms of both effectiveness and patient quality of life. Historically, the treatment of LS-SCLC had remained the same over the years, with very few therapeutic advances beyond the standard chemoradiotherapy.² The breakthrough of durvalumab consolidation indicates a move towards immunotherapy integration at the earlier stages of SCLC, similar to the changing paradigms associated with durvalumab in NSCLC and with other immunotherapy combinations in extensive-stage SCLC.^4-6

It is increasingly being acknowledged that including PROs in clinical trial end points is crucial in oncology, especially when interventions may prolong therapy duration. ADRIATIC's finding that durvalumab does not negatively affect the quality of life while also prolonging survival shows its importance from both clinical and patient-centered viewpoints.¹

Collectively, these data support the adoption of durvalumab consolidation after cCRT as a new standard of care in LS-SCLC, offering patients improved survival with preserved quality of life. As guideline recommendations evolve, PRO evidence like that from ADRIATIC will be critical in informing shared decision-making and care planning.^1,3

REFERENCES

1. Novello S, Cheng Y, Spigel D, et al. Patient-Reported Outcomes with Consolidation Durvalumab Versus Placebo Following Concurrent Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer: Results from the Phase 3 ADRIATIC Trial. J Thorac Oncol. Published online January 30, 2026. doi:10.1016/j.jtho.2026.103564

2. Li Y, Fabio. Durvalumab in Limited-Stage Small Cell Lung Cancer: Clinical Triumph and Toward Sustainable Value. JCO Global Oncology. 2025;11(11):e2500638-e2500638. doi:10.1200/go-25-00638

3. Cheng Y, Spigel DR, Cho BC, et al. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. N Engl J Med. 2024;391(14):1313-1327. doi:10.1056/NEJMoa2404873

4. Goodman A. Durvalumab Consolidation Therapy Extends Survival in Limited-Stage Small Cell Lung Cancer. The ASCO Post. Published June 25, 2024. Accessed February 10, 2026. https://ascopost.com/issues/june-25-2024/durvalumab-consolidation-therapy-extends-survival-in-limited-stage-small-cell-lung-cancer

5. Brown C. ADRIATIC Trial Shows Survival Benefit of Durvalumab in LS-SCLC. Lung Cancers Today. Published March 3, 2025. Accessed February 10, 2026. https://www.lungcancerstoday.com/post/phase-3-adriatic-trial-results-show-survival-benefit-of-durvalumab-in-ls-sclc

6. FDA approves durvalumab for limited-stage small cell lung cancer. FDA. Published December 4, 2024. Accessed February 10, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-limited-stage-small-cell-lung-cancer