West Cancer Center

LUNG: SCLC: RELAPSED: DS7300-188: IDEATE-LUNG02

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)

Title

Daiichi Sankyo DS7300-188 Relapsed Small Cell Lung Cancer

Study Title

Site Link

NCT06203210

Malignancy

Small cell lung cancer

Stage

Stage 4

Disease Setting

Relapsed/Refractory

Line Of Therapy

2nd line or later

Investigational Agent

Ifinatamab Deruxtecan (I-DXd)

Drug Class

B7-H3 antibody drug conjugate

Jason Porter, MD

Sponsor

Daiichi Sankyo

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC)
Has received prior therapy with only one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy and a chemotherapy free-interval of at least 30 days
Measurable disease
ECOG PS 0-1
No brain or leptomeningeal disease
No clinically significant corneal disease
Cannot have received any of the comparators in the study or any topo-1 inhibitors

Objective

Primary
- ORR
- OS
Secondary
- Investigator assessed ORR
- PFS
- DoR
- DCR
- TTR
- QOL
- Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Small cell lung cancer

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes