DeLLphi-305: Tarlatamab plus Durvalumab Maintenance in Extensive-Stage Small-Cell Lung Cancer
For healthcare professionals. Educational summary of published literature; not patient-specific medical advice. Always consult the original publication. This entry was written from the published abstract only — full text was not accessed.
- Study / trial name
- DeLLphi-305; NCT06211036. Phase 3, international, open-label, randomized. Presented at ESMO Congress 2026 (Presidential Symposium I, LBA3) with simultaneous publication in N Engl J Med.
- Population
- Patients with extensive-stage small-cell lung cancer without disease progression after initial (first-line) chemoimmunotherapy
- Intervention vs. control
- Maintenance tarlatamab (a bispecific T-cell engager targeting DLL3 and CD3) plus durvalumab (n=282) vs. durvalumab alone (n=281); n=563 randomized
- Primary endpoint & results
- Overall survival, measured from randomization at the start of maintenance. At the prespecified interim analysis (data cutoff July 7, 2026; median follow-up 15.9 and 16.1 months), median OS was 21.1 months (95% CI 20.8–not estimable) vs. 12.7 months (95% CI 11.2–14.8) — HR 0.42 (95% CI 0.32–0.54), P<0.001.
- Key secondary endpoints
- Progression-free survival (key secondary): median 7.4 months (95% CI 5.6–9.1) vs. 1.9 months (95% CI 1.9–2.0) — HR 0.34 (95% CI 0.28–0.42), P<0.001.
- Toxicity
- Grade ≥3 adverse events in 46.8% with tarlatamab-durvalumab vs. 40.6% with durvalumab alone. Cytokine release syndrome, mainly grade 1–2, occurred in nearly half of patients receiving tarlatamab.
- Practice impact
- A large overall-survival benefit for adding tarlatamab to first-line maintenance durvalumab — an approximately 8-month gain in median OS in a disease where median survival has been about 12–13 months. Likely to be practice-changing once regulators and guidelines review it. Limitations: open-label interim analysis with modest follow-up; applies only to patients without progression after induction; cytokine release syndrome requires monitoring arrangements. No regulatory approval for this indication has been reviewed for this entry.
Sources
Primary publication: Pérol M, et al. "Tarlatamab-Durvalumab Maintenance for Extensive-Stage Small-Cell Lung Cancer." N Engl J Med. Published online 2026 Oct 24. DOI: 10.1056/NEJMoa2609482 · PubMed 42929702 (abstract only).
Conference presentation: ESMO Congress 2026, Madrid, October 23–27, 2026 — Presidential Symposium I, LBA3 (Targeted Oncology recap). Trial registry: ClinicalTrials.gov NCT06211036 (Phase 3).
Last reviewed: November 1, 2026
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Summary written by Dr. Zubair Ali. Independent summary; not affiliated with or endorsed by the trial investigators, NEJM, or FDA.