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

NCT07203053 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Maurice Pérol, MD · Centre Léon Bérard, Lyon, France

  • Federico Capuzzo, MD · IRCCS Regina Elena, Rome, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2029-10-31
Completion
2029-10-31

Countries

  • France
  • Greece
  • Italy
  • Spain
  • Switzerland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07203053 on ClinicalTrials.gov