What is tarlatamab studying for extensive-stage small cell lung cancer?

Tarlatamab is being studied to evaluate its effect on patients with extensive-stage small cell lung cancer who have previously received specific chemotherapy and immune therapy. Researchers want to see how well it works in improving survival and controlling the disease. The trial is sponsored by ETOP IBCSG Partners Foundation.

Is there any cost to participate in this extensive-stage small cell lung cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07203053

Phase II Study of Intravenous Tarlatamab for Adults with Extensive-stage Small Cell Lung Cancer ES-SCLC Who Have Had One Prior Platinum-Etoposide Chemotherapy Line and ECOG Performance Status 2

Q: Who may be eligible for this extensive-stage small cell lung cancer clinical trial?

Adults aged 18 years or older with confirmed extensive-stage small cell lung cancer who have received only one prior line of platinum-etoposide chemotherapy combined with immune-checkpoint inhibition may be eligible. Participants must have an ECOG Performance Status of 2 and adequate organ function. Please review eligibility criteria for more details.

Led by ETOP IBCSG Partners Foundation · Updated on 2026-07-16

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating tarlatamab in patients with extensive-stage small cell lung cancer ES-SCLC who have already received one line of platinum-etoposide chemotherapy combined with immune-checkpoint inhibition and have an ECOG Performance Status of 2. This phase II international trial aims to assess the clinical effectiveness of tarlatamab by measuring the overall survival rate at 12 months in this population whose disease has progressed. Participants receive tarlatamab through an intravenous infusion starting with 1 mg on day 1, followed by 10 mg on days 8 and 15, and then 10 mg every two weeks thereafter. This treatment continues until disease progression, unacceptable side effects, or the participant decides to stop. The study includes only one treatment arm with tarlatamab. During the trial, participants are monitored for overall survival up to about 41 months, along with other outcomes such as response to treatment, disease control, progression-free survival, and adverse events. The study involves regular assessments to track these outcomes while ensuring patient safety. The total study duration extends until October 2029.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologically or cytologically confirmed extensive-stage small cell lung cancer.
Previous treatment with only one line of platinum-etoposide chemotherapy combined with immune-checkpoint inhibition.
Progressive disease after first-line treatment for small cell lung cancer.
ECOG Performance Status of 2.
Age 18 years or older.
Adequate blood, kidney, and liver function.
Prothrombin time/INR and PTT/aPTT less than or equal to 1.5 times the upper limit of normal, or stable anticoagulation therapy for at least 6 weeks prior.
No significant pleural effusion; pleural effusion managed with indwelling catheter is allowed.
Baseline oxygen saturation above 90% on room air.
Left ventricular ejection fraction of 50% or higher and no significant pericardial effusion or ECG abnormalities.
Negative pregnancy test for women of childbearing potential within 5 weeks before enrollment and again within 3 days before first treatment dose.
Signed informed consent before any study procedure.

You will not qualify if you...

Symptomatic brain metastases; untreated symptomatic brain metastases excluded.
Diagnosis or evidence of leptomeningeal disease or spinal cord compression.
Prior immune-checkpoint inhibitor treatment causing severe or life-threatening immune-related adverse events, including encephalitis or recurrent pneumonitis.
Active autoimmune disease requiring recent systemic treatment or immunosuppressive therapy.
History of solid organ transplantation.
Recent live virus vaccination within 14 days or other vaccinations within 3 days before enrollment.
Other malignancies within the 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 such as HIV, active hepatitis B or C with certain viral load criteria.
Systemic corticosteroid or immunosuppressive therapy within 7 days prior to first dose, except low-dose corticosteroids or prophylactic dexamethasone.
Active uncontrolled infection requiring parenteral antibiotics.
Evidence of interstitial lung disease or active pneumonitis.
Major surgery within 5 weeks prior to enrollment.
Any medical condition compromising safety or study evaluations.
Inability or unwillingness to comply with study procedures.
Pregnant or breastfeeding women.
Sexually active individuals of childbearing potential not willing to use effective contraception during and for 60 days after treatment.

Research Team

Heidi Roschitzki, PhD

Susanne Roux

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Phase II Study of Intravenous Tarlatamab for Adults with Extensive-stage Small Cell Lung Cancer ES-SCLC Who Have Had One Prior Platinum-Etoposide Chemotherapy Line and ECOG Performance Status 2

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria