Skip to content
Bending the Curve Trial by Trial
?

DeLLphi-301

A phase 2 study of tarlatamab in patients with previously treated small-cell lung cancer

Phase 2N = 220NCT05060016

Population
Patients with previously treated small-cell lung cancer (median of two prior lines)
Design
Phase 2 trial of tarlatamab given intravenously every 2 weeks at 10 mg or 100 mg. Primary endpoint: objective response (complete or partial) by blinded independent central review, RECIST 1.1. N=220 is the number who received tarlatamab; the registry lists 222 enrolled. The abstract does not state how patients were allocated to the two doses.
Primary endpoint
ORR
Arms
  • Tarlatamab 10 mg (experimental): Tarlatamab 10 mg intravenously every 2 weeks
  • Tarlatamab 100 mg (experimental): Tarlatamab 100 mg intravenously every 2 weeks
People
Ahn MJ, DeLLphi-301 Investigators
Show the numbers
Results reported for DeLLphi-301
EndpointAnalysisTarlatamab 10 mg / Tarlatamab 100 mgControlEffect
ORRPatients evaluated for antitumor activity and survivalBlinded independent central review, RECIST 1.1primaryAhn 202340%—Intervals are 97.5% CIs: 29 to 52 (10 mg) and 21 to 44 (100 mg). Median follow-up 10.6 months (10 mg) and 10.3 months (100 mg). Among patients with an objective response, duration of response was at least 6 months in 59% (40 of 68). Cytokine-release syndrome occurred in 51% (10 mg) and 61% (100 mg), mostly grade 1 or 2; grade 3 in 1% and 6%.
PFSPatients evaluated for antitumor activity and survivalprimaryAhn 2023median 4.9 months (2.9–6.7)—Secondary endpoint; single-arm per dose, no control group.
OSPatients evaluated for antitumor activity and survivalprimaryAhn 202368% at 9 mo—Estimated survival at 9 months; no confidence intervals in the abstract.
Results reported for DeLLphi-301
EndpointAnalysisTarlatamab 10 mg / Tarlatamab 100 mgControlEffect
ORRPatients evaluated for antitumor activity and survivalBlinded independent central review, RECIST 1.1primaryAhn 202340%—Intervals are 97.5% CIs: 29 to 52 (10 mg) and 21 to 44 (100 mg). Median follow-up 10.6 months (10 mg) and 10.3 months (100 mg). Among patients with an objective response, duration of response was at least 6 months in 59% (40 of 68). Cytokine-release syndrome occurred in 51% (10 mg) and 61% (100 mg), mostly grade 1 or 2; grade 3 in 1% and 6%.
PFSPatients evaluated for antitumor activity and survivalprimaryAhn 2023median 4.9 months (2.9–6.7)—Secondary endpoint; single-arm per dose, no control group.
OSPatients evaluated for antitumor activity and survivalprimaryAhn 202368% at 9 mo—Estimated survival at 9 months; no confidence intervals in the abstract.
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%024681012Months (modelled)
  • Tarlatamab 10 mg (experimental)
  • Tarlatamab 100 mg (experimental)

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

Data table (modelled values)
MonthsTarlatamab 10 mgTarlatamab 100 mg
0100.0%100.0%
365.4%58.7%
642.8%34.4%
928.0%20.2%
1218.3%11.9%
Primary publication: Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, et al. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. N Engl J Med. 2023;389(22):2063-2075. PubMedDOI

Appears in

Sources

  1. Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, et al. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. N Engl J Med. 2023;389(22):2063-2075.

    PubMedDOI