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DeLLphi-305NCT06211036

Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab

StatusActive, Not Recruiting
PhasePhase 3
SponsorAmgen
Primary completion (estimated)

At risk: Primary completion moved at least 2 years 8 months later.

See at-risk trials from Amgen

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Record History

All 46 versions: 46 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Apr 2, 2030
    • Eligibility criteria expanded, about 38 words
    • Site details revised at 2 of 219 sites
    • Publications: 1 to 2
  2. Secondary endpoints: details revised at 6 of 27 entriesv45
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 550 to confirmed 563
    • Study completion date: Oct 14, 2028 to Sep 30, 2028
    • Site details revised at 219 of 219 sites
    v44
  4. Site details revised at 2 of 219 sitesv43
  5. Study completion date: Oct 6, 2028 to Oct 14, 2028
    • Study sites revised (219)
    v42
Show 40 earlier versionsHide 40 earlier versions
  1. Site details revised at 3 of 219 sitesv41
  2. Site details revised at 4 of 219 sitesv40
  3. Site details revised at 1 of 219 sitesv39
  4. Study completion date: Jul 31, 2028 to Oct 6, 2028
    • Site details revised at 7 of 219 sites
    v38
  5. Site details revised at 2 of 219 sitesv37
  6. Site details revised at 5 of 219 sitesv36
  7. Study sites revised (219)v35
  8. Study sites revised (219)v34
  9. Study sites: 217 to 219v33
  10. Study sites: 215 to 217
    • Primary completion date: Sep 5, 2027 to Jul 5, 2027
    v32
  11. Study sites: 213 to 215v31
  12. Study sites: 211 to 213v30
  13. Study sites: 210 to 211v29
  14. Study sites: 206 to 210v28
  15. Study sites: 199 to 206v27
  16. Study sites: 196 to 199v26
  17. Study sites: 192 to 196v25
  18. Study sites: 179 to 192v24
  19. Study sites: 173 to 179
    • Study completion date: Sep 25, 2028 to Jul 31, 2028
    v23
  20. Study sites: 169 to 173v22
  21. Study sites: 165 to 169v21
  22. Study sites: 162 to 165v20
  23. Study sites: 145 to 162v19
  24. Study sites: 131 to 145v18
  25. Study sites: 105 to 131v17
  26. Study sites: 100 to 105v16
  27. Study sites: 96 to 100v15
  28. Study sites: 87 to 96v14
  29. Study sites: 81 to 87v13
  30. Eligibility criteria expanded, about 51 words
    • Study sites: 71 to 81
    v12
  31. Study sites: 67 to 71v11
  32. Study sites: 40 to 67v10
  33. Eligibility criteria shortened, about 1 word
    • Study sites: 34 to 40
    v9
  34. Study sites: 30 to 34v8
  35. Study sites: 25 to 30v7
  36. Study sites: 19 to 25v6
  37. Study sites: 13 to 19v5
  38. Study sites: 11 to 13v4
  39. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 11
    • Primary completion date: Sep 27, 2027 to Sep 5, 2027
    • Start date changed from estimate of Jun 27, 2024 to Jun 5, 2024
    v3
  40. Primary completion date: Sep 12, 2027 to Sep 27, 2027
    • Start date: Jun 12, 2024 to Jun 27, 2024
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

OS
Timeframe: Up to approximately 3 years

Secondary (27)

Progression Free Survival (PFS)
Overall Response (OR)
Disease Control (DC) Rate
Duration of Response (DoR)
PFS at 6 Months
Show 22 moreShow less
PFS at 1 Year
PFS at 2 Years
OS at 6 Months
OS at 1 Year
OS at 2 Years
OS at 3 Years
Time to Progression (TTP)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Number of Participants with TEAEs Grade 3 or Above per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Number of Participants with Serious TEAEs
Number of Participants with TEAEs Leading to Discontinuation of Treatment
Number of Participants with Fatal TEAEs
Number of Participants with Treatment-related Adverse Events (AEs)
Number of Participants with Adverse Events of Interest (EOI)
Serum Concentrations of Tarlatamab
Number of Participants with Antitarlatamab Antibody Formation
Time to First Deterioration (TTD) for Physical Function as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30)
Change in Disease Symptoms of Cough as Measured Using EORTC-QLQ LC13
Change in Disease Symptoms of Chest Pain as Measured Using EORTC-QLQ LC13
Change in Disease Symptoms of Dyspnea as Measured Using EORTC-QLQ LC13
TTD for Global Health Status as Measured by EORTC-QLQ-C30
TTD for Quality of Life as Measured by EORTC-QLQ-C30

Arms and interventions

Tarlatamab in Combination With DurvalumabExperimental

Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W).

Durvalumab AloneActive comparator

Participants will receive durvalumab Q4W alone.

Drugs: Tarlatamab, Durvalumab

Sites

219 sites in 29 countries

United States 37, China 31, Japan 19, France 12, Brazil 10, Belgium 9, Spain 9, Germany 8, Greece 7, South Korea 7, Australia 6, Hungary 6, Turkey (Türkiye) 6, Argentina 5, Czechia 5, Israel 4, Italy 4, Poland 4, Portugal 4, Switzerland 4, Taiwan 4, Austria 3, Denmark 3, Netherlands 3, Canada 2, Hong Kong 2, Mexico 2, Romania 2, Ireland 1