OncoMatch/Clinical Trials/NCT07423585
Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer
Is NCT07423585 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tarlatamab for extensive stage lung small cell carcinoma.
Treatment: Tarlatamab — This phase II trial tests the effect of tarlatamab in treating patients with small cell lung cancer (SCLC) that has spread from where it first started to other parts of the body (extensive-stage). SCLC is an aggressive cancer which has a low 5-year survival rate. Tarlatamab is a bispecific antibody that can bind to two different antigens at the same time. Tarlatamab binds to DLL3 which is a protein found on the surface of some types of tumor cells, including small-cell lung cancer, and to CD3 which is present on immune system T-cells (a type of white blood cell) and may interfere with the ability of tumor cells to grow and spread. This may increase the length of time to progression (growing, spreading, or getting worse) and help patients with extensive-stage SCLC live longer.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage IV
Metastatic disease required
extensive-stage (i.e., metastatic and/or recurrent) SCLC
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: any prior treatment for SCLC
Exception: Subjects with limited-stage SCLC (LS-SCLC) who progressed after 6 months from completing chemotherapy and radiation may be considered after discussion with the sponsor; palliative radiotherapy to non-target lesions allowed if completed ≥ 7 days prior to first dose
Prior treatment for SCLC. Subjects with limited-stage SCLC (LS-SCLC) who progressed after 6 months from completing chemotherapy and radiation may be considered for inclusion after discussion with the sponsor. Palliative radiotherapy is allowed to non-target lesions, and must have been completed at least 7 days prior to the first dose of tarlatamab
Cannot have received: investigational agent
Patients currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1500 cells/uL; Platelets ≥ 100,000/uL; Hemoglobin ≥ 9.0 g/dL; Lymphocyte count ≥ 500/uL
Kidney function
Estimated glomerular filtration rate (eGFR) based on MDRD calculation ≥ 30 mL/min/1.73 m^2
Liver function
Total bilirubin < 1.5 x ULN (or < 2 x ULN for subjects with liver metastases, or < 3 x ULN for subjects with known Gilbert disease); AST < 3 x ULN (or < 5 x ULN for subjects with liver involvement); ALT < 3 x ULN (or < 5 x ULN for subjects with liver involvement); ALP < 3 x ULN (or < 5 x ULN for subjects with liver involvement); Albumin ≥ 2.5 g/dL
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no clinically significant electrocardiogram (ECG) findings
ANC ≥ 1500 cells/uL; Platelets ≥ 100,000/uL; Hemoglobin ≥ 9.0 g/dL; Lymphocyte count ≥ 500/uL; eGFR ≥ 30 mL/min/1.73 m^2; Total bilirubin < 1.5 x ULN (or < 2 x ULN for subjects with liver metastases, or < 3 x ULN for subjects with known Gilbert disease); AST < 3 x ULN (or < 5 x ULN for subjects with liver involvement); ALT < 3 x ULN (or < 5 x ULN for subjects with liver involvement); ALP < 3 x ULN (or < 5 x ULN for subjects with liver involvement); Albumin ≥ 2.5 g/dL; LVEF ≥ 50%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no clinically significant ECG findings
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
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