Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Small Cell Lung Cancer Patients From Adenocarcinoma After EGFR TKI Treatment

Inclusion Criteria

• •1. Histologically confirmed SCLC and no prior systemic treatment for SCLC
• •2. Patient initially diagnosed with activating EGFR mutation (L858R, Del 19) and treated with any kind of EGFR TKI.
• •3. Confirmed SCLC transformation right after EGFR TKI treatment failure.
• •4. Age ≥19 years
• •5. ECOG performance status of 0 to 1
• •6. Had at least one measurable lesion.
• •7. Adequate organ function
• •* Absolute neutrophil count ≥ 1.5 x 109/L
• •* Platelet count ≥ 100 x 109/L
• •* Hemoglobin ≥ 9 g/dL
• •* Estimated glomerular filtration rate based on Modification of Diet in Renal Disease calculation \> 30 mL/min/1.73 m2
• •* Aspartate aminotransferase and alanine aminotransferase ≤ 3 x upper limit of normal (ULN) (or ≤ 5 x ULN for subjects with liver involvement)
• •* Total bilirubin ≤ 1.5 x ULN (or ≤ 2 x ULN for subjects with liver metastases)
• •* Prothrombin time (PT)/international normalized ratio and partial thromboplastin time or activated partial thromboplastin time ≤ 1.5 x institutional ULN Note: Subjects on stable anticoagulation therapy are allowed.
• •8. Pulmonary function: No clinically significant pleural effusion at the timepoint of screening. Pleural effusion with no significant symptom is allowed for enrollment.
• •9. Cardiac function: Cardiac ejection fraction ≥ 50%
• •10. Female subjects must either be of non-reproductive potential
• •11. Female subject with reproductive potential can be enrolled with agreement to following guidance.
• •* subject uses contraception during treatment and through 60 days after receiving last dose of tarlatamab or for 6 months after last dose of carboplatin and/or etoposide and 5 months after last dose of atezolizumab.
• •12. Subject is willing and able to comply with the protocol
• •13. Signed written informed consent