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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AIO-Studien gGmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

6 Mar 2026 → ongoing

Decision date (initial)

2025-10-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AMGEN

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To prospectively evaluate the efficacy of tarlatamab treatment in patients with extensive stage small-cell lung cancer and poor performance status

Secondary objectives 3

1. Evaluate efficacy, feasibility, quality of life, and toxicity of tarlatamab in patients with extensive stage small-cell lung cancer and poor performance status.
2. Evaluate feasibility, intracranial efficacy, quality of life, and toxicity of tarlatamab in patients with brain metastases.
3. Evaluate feasibility of embedding palliative radiation with tarlatamab treatment.

Conditions and MedDRA coding

small-cell lung cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Written informed consent obtained from the subject prior to performing any protocol-related procedures.
2. Age ≥ 18 years
3. ECOG performance status 2
4. Histologically confirmed small-cell lung cancer (initial mixed histology / combined SCLC permitted if re-biopsy of current progression shows SCLC)
5. Recurrent or metastatic disease. In case of local-only recurrence, availability of local treatment options must have been excluded
6. Has received at least one prior line of treatment in the recurrent or metastatic setting
7. 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
8. Measurable disease according to RECIST v1.1

Exclusion criteria 21

1. ECOG performance status 0, 1, 3 or 4
2. Life expectancy less than one month
3. Active brain metastases with unstable symptoms (new or progressive neurological symptoms within the last 3 weeks)
4. Bone marrow insufficiency: a. neutrophil count < 1.5/nl or b. hemoglobin <8 mg/dl or c. platelets <100/nl
5. 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
6. Advanced kidney disease: CKD-EPI GFR <20 ml/min/1.73m²
7. Heart failure with reduced ejection fraction (EF < 40%)
8. Hemodynamically significant pericardial effusion
9. Clinically significant pleural effusion (Clinically significant pleural effusions must be managed by drainage. Re-check within 3 days prior to initiation of treatment)
10. 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)
11. Prior DLL3-directed treatment
12. Prior systemic therapy (chemotherapy, CPI) within 14 days prior to first dose of study treatment
13. Previous treatment in the present study (does not include screening failure)
14. History of immune-mediated encephalitis
15. Concurrent malignancy other than SCLC requiring active treatment
16. HIV infection not on stable antiviral treatment
17. Women of childbearing potential or men with partners of childbearing potential who are not adhering to contraceptive measures
18. 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
19. 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
20. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG]
21. 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]

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall survival (OS) rate at 12 months

Secondary endpoints 8

1. Overall survival (OS)
2. Progression-free survival (PFS)
3. Objective response rate (ORR) (RECIST v1.1)
4. intracranial ORR (RECIST v1.1)
5. Rate of patients tolerating tarlatamab until first disease assessment
6. Time to next-line systemic therapy
7. Safety and tolerability
8. Quality of life: o EORTC-QLQ-C30 o PRO CTCAE

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AIO-Studien gGmbH

Sponsor organisation

AIO-Studien gGmbH

Address

Kuno-Fischer-Strasse 8, Charlottenburg Charlottenburg

City

Berlin

Postcode

14057

Country

Germany

Scientific contact point

Organisation

AIO-Studien gGmbH

Contact name

Priv.-Doz. Dr. med. Marcel Wiesweg

Public contact point

Organisation

AIO-Studien gGmbH

Contact name

Katrin Krause

Locations

1 EU/EEA country · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications