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.
• 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.
• 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.