Actively Recruiting
A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2
Led by ETOP IBCSG Partners Foundation · Updated on 2026-04-21
48
Participants Needed
19
Research Sites
180 weeks
Total Duration
On this page
Sponsors
E
ETOP IBCSG Partners Foundation
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)
- Only one prior line of platinum-etoposide chemotherapy with immune checkpoint inhibition for SCLC
- Progressive disease after first-line treatment for SCLC
- ECOG Performance Status of 2
- Age 18 years or older
- Adequate blood, kidney, and liver function
- Coagulation tests within acceptable limits or stable anticoagulation therapy for at least 6 weeks
- No clinically significant pleural effusion; pleural effusion managed with catheter allowed
- Baseline oxygen saturation above 90% on room air
- Cardiac function with left ventricular ejection fraction 50% or higher and no significant pericardial effusion or ECG abnormalities
- Negative pregnancy test for women of childbearing potential before enrollment and before first dose
- Signed informed consent form before any trial procedures
You will not qualify if you...
- Symptomatic central nervous system (CNS) metastases
- Diagnosis or evidence of leptomeningeal disease or spinal cord compression
- Prior severe or life-threatening immune-related adverse events from immune checkpoint inhibitors
- History of immune-mediated encephalitis or other CNS immune events
- Grade 2 or higher recurrent immune-mediated pneumonitis
- Infusion reactions causing permanent discontinuation of immunotherapy
- Active autoimmune disease requiring systemic treatment within past 2 years or immunosuppressive therapy during study
- History of solid organ transplant
- Live virus vaccination within 14 days prior to enrollment or certain inactive/viral vaccines within 3 days prior
- Other malignancies within past 2 years except certain low-risk or treated cancers without active disease
- Recent myocardial infarction or symptomatic congestive heart failure within 12 months
- History of arterial thrombosis within 12 months
- Uncontrolled viral infections including HIV, active hepatitis B or C infections
- Systemic corticosteroid or immunosuppressive therapy within 7 days prior to first study dose (except specified low-dose or prophylactic treatments)
- Acute or uncontrolled infections requiring parenteral antibiotics within 7 days prior to first dose
- Evidence of interstitial lung disease or active non-infectious pneumonitis
- Major surgery within 5 weeks prior to enrollment
- Any medical condition that may compromise safety or study evaluations
- Inability or unwillingness to comply with study procedures
- Pregnant or breastfeeding women
- Men and women of childbearing potential not willing to use effective contraception during and 60 days after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
CHU Angers
Angers, France
Not Yet Recruiting
2
Institut Bergonie
Bordeaux, France
Not Yet Recruiting
3
Lyon - Centre Léon Bérard
Lyon, France
Not Yet Recruiting
4
Hôpital Nord de Marseille
Marseille, France
Not Yet Recruiting
5
Henry Dunant Hospital Center
Athens, Greece
Not Yet Recruiting
6
Irccs Irst
Meldola, Italy
Not Yet Recruiting
7
Instituto Europeo di Oncologia (IEO)
Milan, Italy
Not Yet Recruiting
8
Santa Maria della Misericordia Hospital
Perugia, Italy
Not Yet Recruiting
9
AO San Giovanni Addolorata
Roma, Italy
Not Yet Recruiting
10
Istituto Nazionale Tumori "Regina Elena"
Roma, Italy
Not Yet Recruiting
11
Hospital General Universitario Alicante
Alicante, Spain
Not Yet Recruiting
12
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
Not Yet Recruiting
13
Hospital Universitatrio Vall d'Hebron
Barcelona, Spain
Not Yet Recruiting
14
ICO Hospitalet H. Duran I Reynals / H. Bellvitge
Barcelona, Spain
Not Yet Recruiting
15
Hospital Universitatrio Puerta del Hierro
Madrid, Spain
Not Yet Recruiting
16
Kantonsspital Baden
Baden, Switzerland
Actively Recruiting
17
HFR - Hôpital cantonal
Fribourg, Switzerland
Not Yet Recruiting
18
Geneva University Hospitals
Geneva, Switzerland
Actively Recruiting
19
Kantonsspital St.Gallen
Sankt Gallen, Switzerland
Not Yet Recruiting
Research Team
H
Heidi Roschitzki, PhD
CONTACT
S
Susanne Roux
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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