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A single-arm phase II-study to confirm efficacy and feasibility of tarlatamab treatment in patients with extensive stage small-cell lung cancer with poor performance status (SPACE-T)
EU CTIS ID: 2025-522437-65-00
What this study is testing
To prospectively evaluate the efficacy of tarlatamab treatment in patients with extensive stage small-cell lung cancer and poor performance status
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent obtained from the subject prior to performing any protocol-related procedures.
- Age ≥ 18 years
- ECOG performance status 2
- Histologically confirmed small-cell lung cancer (initial mixed histology / combined SCLC permitted if re-biopsy of current progression shows SCLC)
- Recurrent or metastatic disease. In case of local-only recurrence, availability of local treatment options must have been excluded
- Has received at least one prior line of treatment in the recurrent or metastatic setting
You likely can't join if
- ECOG performance status 0, 1, 3 or 4
- Respiratory compromise leading to an unjustifiable risk in case of higher-grade CRS, in the judgment of the investigator (possible criteria leading to such judgment: oxygen support at rest >2l/min, active pneumonia or pneumonitis)
- Prior DLL3-directed treatment
- Prior systemic therapy (chemotherapy, CPI) within 14 days prior to first dose of study treatment
- Previous treatment in the present study (does not include screening failure)
- History of immune-mediated encephalitis
See the full eligibility criteria
Who can join
- Written informed consent obtained from the subject prior to performing any protocol-related procedures.
- Age ≥ 18 years
- ECOG performance status 2
- Histologically confirmed small-cell lung cancer (initial mixed histology / combined SCLC permitted if re-biopsy of current progression shows SCLC)
- Recurrent or metastatic disease. In case of local-only recurrence, availability of local treatment options must have been excluded
- Has received at least one prior line of treatment in the recurrent or metastatic setting
- Has received a prior treatment line with platinum, etoposide, and a PD-L1 antibody. Treatment with chemotherapy only is acceptable if the patient had a contraindication for CPI treatment
- Measurable disease according to RECIST v1.1
What rules you out
- ECOG performance status 0, 1, 3 or 4
- Respiratory compromise leading to an unjustifiable risk in case of higher-grade CRS, in the judgment of the investigator (possible criteria leading to such judgment: oxygen support at rest >2l/min, active pneumonia or pneumonitis)
- Prior DLL3-directed treatment
- Prior systemic therapy (chemotherapy, CPI) within 14 days prior to first dose of study treatment
- Previous treatment in the present study (does not include screening failure)
- History of immune-mediated encephalitis
- Concurrent malignancy other than SCLC requiring active treatment
- HIV infection not on stable antiviral treatment
- Women of childbearing potential or men with partners of childbearing potential who are not adhering to contraceptive measures
- Female subjects of childbearing potential a. unwilling to use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 60 days after the last dose of tarlatamab b. who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab c. planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab d. with a positive pregnancy test at screening
- Male subjects a. with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of tarlatamab b. with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab c. unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab
- Life expectancy less than one month
- Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG]
- Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG]
- Active brain metastases with unstable symptoms (new or progressive neurological symptoms within the last 3 weeks)
- Bone marrow insufficiency: a. neutrophil count < 1.5/nl or b. hemoglobin <8 mg/dl or c. platelets <100/nl
- Advanced liver disease: a. Subjects with pre-existing chronic liver disease: i. Total bilirubin > 1.5xULN or ii. ALT or AST > 3xULN b. Subjects with no relevant prior chronic liver disease and elevated liver parameters due to liver metastases: i. Total bilirubin > 3xULN or ii. ALT or AST > 10xULN c. International normalized ratio (INR) > 2.0 and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≥ 1.5 x ULN, except for subjects undergoing new class anticoagulant therapy (eg, Apixaban, Rivaroxaban, Edoxaban) with stable dose for 2 weeks prior to enrollment
- Advanced kidney disease: CKD-EPI GFR <20 ml/min/1.73m²
- Heart failure with reduced ejection fraction (EF < 40%)
- Hemodynamically significant pericardial effusion
- Clinically significant pleural effusion (Clinically significant pleural effusions must be managed by drainage. Re-check within 3 days prior to initiation of treatment)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.