West Cancer Center

LUNG: SMALL CELL: EXTENSIVE STAGE: 2nd Line: EVOKE-SCLC-04

A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Title

Gilead GS-US-600-6165 ES-SCLC 2nd line

Study Title

Site Link

NCT06801834

Malignancy

Lung cancer, small cell lung cancer, SCLC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd line

Investigational Agent

sacituzumab govitecan

Drug Class

TROP-2 ADC

Ramakrishna Battini, MD

Sponsor

Gilead Sciences

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically confirmed diagnosis of small cell lung cancer that is extensive stage
ECOG PS 0-1
Measureable disease
Disease progression after 1 prior line of platinum containing therapy with or without PD-1/L1 therapy
- If treated with platinum agent for limited stage SCLC it is counted as a line of therapy if disease progressed within 180 days from last platinum treatment
- Patients may participate following tarlatamab treatment
No prior therapy with irinotecan, topotecan, SG, SN-38, exatecan derivatives or anything targeting topo-1.
Did not receive lurbinectedin after progression on platinum based chemo
No active brain mets

Objective

Primary
- OS
Secondary
- PFS
- ORR
- DOR
- Functional deterioration
- Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Small cell lung cancer

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes