Tarlatamab with carboplatin/etoposide and atezolizumab for EGFR‑mutant lung adenocarcinoma that changed into small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, single‑center, interventional trial combining tarlatamab (a DLL3‑directed bispecific T‑cell engager) with carboplatin and etoposide plus the PD‑L1 inhibitor atezolizumab in patients whose EGFR‑mutant lung adenocarcinoma has histologically transformed into small cell lung cancer after EGFR TKI failure. Eligible patients are adults with ECOG 0–1, no prior systemic therapy for the transformed SCLC, at least one measurable lesion, and adequate organ function. The regimen is given systemically with safety and clinical activity monitored by imaging and labs according to protocol schedules. The primary goals are to characterize safety and clinical benefit of the combination in this specific, post‑EGFR‑TKI transformed population.

Why it matters

Who can join: the full rules

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

Exclusion Criteria:

1. Treated with additional chemotherapy after confirmed with transformed SCLC.
2. Previously exposed to the immune checkpoint inhibitor treatment.
3. Untreated symptomatic brain metastases or leptomeningeal disease.

   * Asymptomatic brain metastases can be enrolled per investigator decision
4. Uncontrolled systemic illness including uncontrolled hypertension, active bleeding, or active infection.
5. Past medical history of interstitial lung disease, drug induced interstitial lung disease, radiation pneumonitis which required steroid treatment, active non- infectious pneumonitis
6. Active or prior documented autoimmune or inflammatory disorders
7. Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months prior to first dose of study treatment
8. History of solid organ transplant.
9. Major surgical procedures within 28 days prior to first dose of study treatment.
10. History of allergic reactions or acute hypersensitivity reactions to antibody therapies, platinum chemotherapy, or etoposide.
11. Disagree to the guidance of contraception during the study.

Where it's running

• Samsung Medical Center
  Seoul, Gangnam-gu, South Korea Recruiting

Study contacts

• Study coordinator: Sehhoon Park, M.D.
• Email: sehhoon.park@samsung.com
• Phone: 82-2-3410-3746

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.