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Extensive Stage Lung Small Cell CancerPhase 2START-lungNCT07203053

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

A Phase 2 study testing Tarlatamab in people with Extensive Stage Lung Small Cell Cancer, run by ETOP IBCSG Partners Foundation at 19 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Extensive Stage Lung Small Cell Cancer
What is being tested?
Tarlatamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
19 sitesin 5 countries
Study dates
15 Apr 2026to Oct 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed ES-SCLC.
  • Previous treatment with only one line of platinum-etoposide doublet chemotherapy with immune-checkpoint inhibition for SCLC.
  • Patients treated with a platinum-etoposide doublet chemotherapy for prior limited stage (LS)-SCLC may be eligible for the study if the disease has progressed on treatment or within 6 months from chemotherapy completion (i.e. during durvalumab consolidation): the platinum-etoposide line of therapy will count as one prior line of therapy.
  • Progressive disease on or after the first-line treatment for SCLC.
  • ECOG Performance Status 2.
  • Age ≥18 years.
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  • Adequate haematological, renal and liver function.
  • Coagulation function: Prothrombin time (PT)/international normalised ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5x ULN, except for patients receiving anticoagulation, who must be on a stable dose of anticoagulation therapy for 6 weeks prior to enrolment.
  • Pulmonary function:
  • No clinically significant pleural effusion. Pleural effusion managed with indwelling pleural catheter (e.g., PleurX) are allowed.
  • Baseline oxygen saturation >90% on room air.
  • Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan (preferred), and no clinically significant electrocardiogram (ECG) findings.
  • Women of childbearing potential, must have a negative urinary or serum pregnancy test within 5 weeks before enrolment. Pregnancy test must be repeated within 3 days before the first dose of tarlatamab treatment.
  • Written Informed Consent must be signed and dated by the patient and the investigator prior to any trial-related intervention.

Who cannot join

  • Symptomatic CNS metastases Patients with untreated asymptomatic brain metastases and patients with treated and stable brain metastases are eligible.
  • Diagnosis or evidence of leptomeningeal disease or spinal cord compression
  • Prior history of immune-checkpoint inhibitor treatment resulting in:
  • any severe or life-threatening immune-mediated adverse event,
  • history of immune-mediated encephalitis or another immune-mediated CNS event (any grade),
  • grade ≥2 immune-mediated recurrent pneumonitis,
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  • infusion-related reactions leading to permanent discontinuation of the immunotherapy agent.
  • Exception: patients with a history of immune-checkpoint inhibitor-induced endocrinopathy which is clinically stable on replacement therapy.
  • Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.
  • History of solid organ transplantation.
  • Treatment with live virus, including live-attenuated vaccination within 14 days prior to enrolment and inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines (e.g., Jynneos for Monkeypox infection) within 3 days prior to enrolment.
  • History of other malignancy within the past 2 years, with the following exceptions:
  • Low-risk malignancy treated with curative intent and with no known active disease present for ≥1 year before enrolment and believed to be at low risk for recurrence per investigator discretion.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated cervical carcinoma in situ without evidence of disease.
  • Adequately treated breast ductal carcinoma in situ without evidence of disease.
  • Prostatic intraepithelial neoplasia without evidence of prostate cancer.
  • Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ.
  • Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association >class II) within 12 months prior to enrolment.
  • History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 12 months prior to enrolment.
  • Presence/history of an uncontrolled viral infection:
  • Known uncontrolled human immunodeficiency virus (HIV) infection.
  • Active hepatitis C infection (patients with detectable hepatitis C antibody [HCV Ab] and HCV RNA viral load above the limit of quantification).
  • Patients with presence of HCV Antibodies and HCV RNA viral load below the limit of quantification (HCV RNA negative) with or without prior treatment are allowed.
  • Active hepatitis B infection (presence of hepatitis B surface antigen [HBsAg] and hepatitis B virus [HBV] DNA viral load above the limit of quantification [HBV DNA positive]).
  • Patients with resolved HBV infection defined as absence of HBsAg and presence of HBV core antibody (anti-HBc) followed by an HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.
  • Patients with chronic HBV infection inactive carrier state defined as presence of HBsAg and HBV DNA viral load below the limit of quantification [HBV DNA negative] are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.
  • Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.
  • Prophylactic dexamethasone for the management of tarlatamab-related adverse events and any anti-emetic therapies are allowed.
  • Low-dose corticosteroids (prednisone ≤10 mg per day or equivalent) is permitted during the trial.
  • Patients with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.
  • Patient has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the patient may be considered eligible for the study from an infection standpoint.
  • Note: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Subjects requiring oral antibiotics who have been afebrile for >24 hours, have no leucocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required unless otherwise noted as exclusion criteria.
  • Evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Major surgical procedures within 5 weeks prior to enrolment.
  • Any concurrent medical condition which, in the opinion of the investigator, would compromise patient safety or interfere with the evaluations for tarlatamab.
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
  • Women who are pregnant or in the period of lactation.
  • Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the trial until at least 60 days after the last dose of tarlatamab treatment.

Trial locations and contacts

19 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Heidi Roschitzki, PhD contact

+41 31 511 94 00

heidi.roschitzki@etop.ibcsg.org

Susanne Roux contact

+41 31 511 94 00

START-lung@etop.ibcsg.org

19 sites in 5 countries

Italy5 sites, 5 recruiting

  • Irccs Irst

    Meldola

    Angelo Delmonte

    Not yet recruiting

  • Instituto Europeo di Oncologia (IEO)

    Milan

    Filippo de Marinis

    Not yet recruiting

  • Santa Maria della Misericordia Hospital

    Perugia

    Giulio Metro

    Not yet recruiting

  • AO San Giovanni Addolorata

    Roma

    Antonio Lugini

    Not yet recruiting

  • Istituto Nazionale Tumori "Regina Elena"

    Roma

    Federico Capuzzo

    Recruiting

Other trials in Italy

Spain5 sites, 5 recruiting

  • Hospital General Universitario Alicante

    Alicante

    Juan Luis Martí

    Recruiting

  • Hospital de la Santa Creu I Sant Pau

    Barcelona

    Andrés Barba Joaquin

    Recruiting

  • Hospital Universitatrio Vall d'Hebron

    Barcelona

    Pedro Rocha

    Recruiting

  • ICO Hospitalet H. Duran I Reynals / H. Bellvitge

    Barcelona

    Miguel Ángel Mosteiro Lamas

    Not yet recruiting

  • Hospital Universitatrio Puerta del Hierro

    Madrid

    Mariano Provencio

    Not yet recruiting

Other trials in Spain

France4 sites, 4 recruiting

  • CHU Angers

    Angers

    Youssef Oulkhouir

    Recruiting

  • Institut Bergonie

    Bordeaux

    Sophie Cousin

    Not yet recruiting

  • Lyon - Centre Léon Bérard

    Lyon

    Maurice Perol

    Recruiting

  • Hôpital Nord de Marseille

    Marseille

    Laurent Greillier

    Not yet recruiting

Other trials in France

Switzerland4 sites, 4 recruiting

  • Kantonsspital Baden

    Baden

    Sacha Rothschild

    Recruiting

  • HFR - Hôpital cantonal

    Fribourg

    Adrienne Bettini

    Recruiting

  • Geneva University Hospitals

    Geneva

    Alfredo Addeo

    Recruiting

  • Kantonsspital St.Gallen

    Sankt Gallen

    Kira-Lee Koster

    Recruiting

Other trials in Switzerland

Greece1 site, 1 recruiting

  • Henry Dunant Hospital Center

    Athens

    Giannis Mountzios

    Recruiting

Other trials in Greece

About this study

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

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.

Being tested
Tarlatamab
Keywords
ES-SCLC, Tarlatamab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TarlatamabDrug

    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 groups in NCT07203053
Study groupRoleWhat they receive
TarlatamabExperimentalNot described
Receives: Drug: Tarlatamab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The OS rate at 12 months is the primary endpoint of the trial. It is defined as the proportion of patients who are alive at 12 months from enrolment. The rate will be calculated as the number of patients alive at 12 months divided by the number of patients on follow-up at 12 months or with an earlier observed death event.

    Measured: OS is defined as the time from the date of enrolment until death from any cause. Assessed for approximately up to 41 months.

Secondary outcomes (5)

  1. Objective response rate (ORR)

    Objective response rate (ORR) is defined as the rate of patients, among all those enrolled, who achieve a best overall response [complete response (CR) or partial response (PR)] according to the RECIST v1.1 across all post-enrolment time-points until the end of follow up for disease progression.

    Measured: Assessed for approximately up to 41 months.

  2. Duration of response (DoR)

    Duration of response (DoR) is defined as the time from the date of first documentation of objective response (CR or PR according to RECIST v1.1) to the date of first documented progression or death. Censoring will occur at the last tumour assessment with response other than progression. Patients without tumour assessment after documented objective response will be censored at the date of documented objective response (plus 1 day).

    Measured: Assessed for approximately up to 41 months.

  3. Disease control rate (DCR)

    Disease control rate (DCR) is defined as the rate of patients, among all those enrolled, who achieve CR or PR according to RECIST v1.1 or stabilisation of disease (SD), lasting for at least 12 weeks.

    Measured: Assessed for approximately up to 41 months.

  4. Progression-free survival (PFS)

    Progression-free survival (PFS) is defined as the time from the date of enrolment until documented progression (according to RECIST v1.1) or death if progression is not documented. Censoring (for patients without documented progression or death) will occur at the date of last tumour assessment. Patients without a post-baseline tumour assessment will be censored at the date of enrolment (plus 1 day).

    Measured: Assessed for approximately up to 41 months.

  5. Incidence, nature, and severity of adverse events

    Incidence, nature, and severity of adverse events according to CTCAE v5, except for CRS and ICANS, that are graded according to the ASTCT criteria21 and TLS that are graded according to the Cairo-Bishop classification

    All safety parameters will be summarised in tables to evaluate the toxicity/safety profile of the protocol treatment based on:

    • Adverse events (AEs) according to CTCAE v5.0 (any-cause as well as treatment-related) including AEs leading to dose delays and/or interruptions, withdrawal of protocol treatment, and death.
    • Occurrence of CRS and ICANS, defined according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria published by Lee et al. (2019).
    • Occurrence of TLS, defined according to the Cairo-Bishop classification.22
    • Severe and serious AEs.
    • Laboratory parameters and abnormalities, and vital signs.

    Measured: Assessed for approximately up to 41 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2025
  2. Study start15 Apr 2026
  3. Primary completionOct 2029 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07203053
Sponsor's protocol ID
ETOP 29-25
Acronym
START-lung
Status last verified
Sep 2026
First submitted
24 Sep 2025
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tarlatamab in people with Extensive Stage Lung Small Cell Cancer, run by ETOP IBCSG Partners Foundation at 19 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Italy, Spain, France, Switzerland, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heidi Roschitzki, PhD (+41 31 511 94 00, heidi.roschitzki@etop.ibcsg.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07203053.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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