29-25 START-lung

A multicentre phase II trial of tarlatamab in patients with pretreated extensive-stage small cell lung cancer (ES-SCLC) and ECOG PS 2

The aim of the study is to evaluate the clinical efficacy of tarlatamab in patients with extensive-stage small cell lung cancer (ES-SCLC) and ECOG PS 2, who have relapsed on or after previous standard platinum-etoposide doublet chemotherapy and immune-checkpoint inhibition therapy. The primary endpoint is the overall survival rate at 12 months.

Trial Scheme

Trial Information

Primary Endpoint:

Overall survival rate at 12 months (12-month OS)

Secondary Endpoints:

Objective response rate (ORR) according to RECIST v1.1,
Duration of response (DoR),
Disease control rate (DCR),
Progression-free survival (PFS) according to RECIST v1.1,
Incidence, nature, and severity of adverse events according to CTCAE v5, except for CRS and ICANS, that are graded according to the ASTCT criteria and TLS that are graded according to the Cairo-Bishop classification

Target Sample Size:

48 enrolled patients

Protocol Release Date:

24 September 2025

Trial Organisation

Trial Chair:

Maurice Pérol, Lyon, France

Trial Co-Chair:

Federico Cappuzzo, Rome, Italy

Sponsor:

ETOP IBCSG Partners Foundation

Coordinating Group:

ETOP IBCSG Partners Foundation

Participating Groups:

Swiss Cancer Institute (SCI) and Spanish Lung Cancer Group (SLCG)

Registrations:

EU CT number: 2025-522288-13
clinicaltrials.gov: NCT07203053

Participating Countries:

France, Greece, Italy, Spain, Switzerland

Contact

ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
start-lung@etop.ibcsg.org