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

Sponsor
ETOP IBCSG Partners Foundation
Study ID
NCT07203053
Phase
PHASE2
Status
Recruiting
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Conditions

  • Extensive Stage Lung Small Cell Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tarlatamab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 15, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tarlatamab

Primary Outcome Measure

Overall survival rate at 12 months (12-month OS) [ Time Frame: OS is defined as the time from the date of enrolment until death from any cause. Assessed for approximately up to 41 months. ]

Central Contacts

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