NCT07203053

A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2

A Multicentre Phase II Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

START-lung is an international, multicentre, single-arm phase II trial. Protocol treatment consists of tarlatamab administered as an intravenous infusion until disease progression according to RECIST v1.1 criteria, unacceptable toxicity, or patient decision, whichever comes first. The primary objective of the trial is to assess the clinical efficacy of tarlatamab, in terms of 12-month OS rate, in patients with ES-SCLC and ECOG PS 2 who have previously received only one line of platinum-etoposide doublet chemotherapy with immune-checkpoint inhibition and whose disease has progressed.

Conditions

• Extensive Stage Lung Small Cell Cancer

Interventions

Type	Name	Description
DRUG	Tarlatamab	Protocol treatment consists of tarlatamab, administered as an intravenous (i.v.) infusion: * 1 mg on day 1 (C1D1), * 10 mg on day 8 (C1D8) and * 10 mg on day 15 (C1D15), * then 10 mg every two weeks (Q2W) until disease progression according to RECIST v1.1 criteria, unacceptable toxicity, or patient decision, whichever comes first.

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2025-10-02
• Last updated: 2026-03-25

Locations

19 sites across 5 countries: France, Greece, Italy, Spain, Switzerland