Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

Conditions

• Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sacituzumab Govitecan (SG) — DRUG
  Administered intravenously
• Topotecan — DRUG
  Administered intravenously
• Amrubicin (Japan only) — DRUG
  Administered intravenously
• Lurbinectedin (regions/countries where approved and available) — DRUG
  Administered intravenously

Study Details

The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC). The primary objectives of this study are to compare the effect of SG to SOC on overall survival (OS).

Key Dates

Start date

Apr 4, 2025

Status verified

May 2026

Primary completion

Oct 31, 2029

Completion

Oct 31, 2029

Study Design

Enrollment

695 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Group A: SG
  Participants assigned to treatment group A will receive SG 10 mg/kg intravenous (IV) infusion on Days 1 and 8 of a 21-day cycle. Participants will receive study drug until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.
• Experimental: Treatment Group B: Topotecan, or Lurbinectedin, or Amrubicin
  Participants assigned to Treatment Group B will receive one of the following investigator selected treatments within a 21 day cycle: * Topotecan 1.5 mg/m² administered daily on Days 1 through 5, or * Lurbinectedin 3.2 mg/m² administered as an intravenous infusion on Day 1 (in countries/regions where lurbinectedin is approved and available). In Japan, participants assigned to Treatment Group B may alternatively receive: • Amrubicin (available only in Japan) 40 mg/m² administered daily on Days 1 through 3 of a 21 day cycle. Study treatment will continue until disease progression, death, unacceptable toxicity, or another protocol defined criterion for treatment discontinuation is met.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to 4.5 years ]

Central Contacts

• Gilead Clinical Study Information Cente
  1-833-445-3230 (GILEAD-0)
  [email protected]

Locations (19)

Find similar trials in Hot Springs, AR

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