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DeLLphi-304

Tarlatamab versus standard-of-care chemotherapy in relapsed small-cell lung cancer after platinum-based chemotherapy

Phase 3N = 509NCT05740566

Population
Patients with small-cell lung cancer that progressed during or after platinum-based chemotherapy
Design
Multinational, open-label phase 3 trial of tarlatamab versus chemotherapy (topotecan, lurbinectedin or amrubicin) as second-line treatment. Primary endpoint OS; key secondary endpoints investigator-assessed PFS and patient-reported outcomes. Prespecified interim analysis, data cutoff 29 January 2025.
Primary endpoint
OS
Arms
  • Tarlatamab (experimental, n = 254): Tarlatamab
  • Chemotherapy (control, n = 255): Topotecan, lurbinectedin or amrubicin
People
Mountzios G, DeLLphi-304 Investigators
OSHR 0.60 (95% CI 0.47–0.77)Δ median OS+5.3 months
Show the numbers
Results reported for DeLLphi-304
EndpointAnalysisTarlatamabChemotherapyEffect
OSRandomised patients (509)interimMountzios 2025median 13.6 monthsmedian 8.3 months (7.0–10.2)HR 0.60 (95% CI 0.47–0.77)P<0.001The 95% CI for the tarlatamab median is 11.1 to not reached, so it is not entered as a numeric interval. Stratified hazard ratio for death. Adverse events of grade 3 or higher 54% with tarlatamab and 80% with chemotherapy; adverse events leading to discontinuation 5% and 12%. The abstract reports a significant PFS benefit but gives no PFS values.
Results reported for DeLLphi-304
EndpointAnalysisTarlatamabChemotherapyEffect
OSRandomised patients (509)interimMountzios 2025median 13.6 monthsmedian 8.3 months (7.0–10.2)HR 0.60 (95% CI 0.47–0.77)P<0.001The 95% CI for the tarlatamab median is 11.1 to not reached, so it is not entered as a numeric interval. Stratified hazard ratio for death. Adverse events of grade 3 or higher 54% with tarlatamab and 80% with chemotherapy; adverse events leading to discontinuation 5% and 12%. The abstract reports a significant PFS benefit but gives no PFS values.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.60.47–0.77
Illustrative — modelled from reported values, not trial data. OS, interim.
0%25%50%75%100%051015202530Months (modelled)
  • Tarlatamab (experimental)
  • Chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsTarlatamabChemotherapy
0100.0%100.0%
963.2%47.2%
1742.0%24.2%
2626.6%11.4%
3417.7%5.8%
Primary publication: Mountzios G, Sun L, Cho BC, Demirci U, Baka S, Gümüş M, et al. Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy. N Engl J Med. 2025;393(4):349-361. PubMedDOI

Appears in

Sources

  1. Mountzios G, Sun L, Cho BC, Demirci U, Baka S, Gümüş M, et al. Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy. N Engl J Med. 2025;393(4):349-361.

    PubMedDOI