New combo therapy targets aggressive lung cancer transformation
NCT ID NCT06830694
First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This phase 2 trial tests a combination of tarlatamab (a targeted immune therapy), chemotherapy, and atezolizumab in 50 adults whose lung cancer has transformed from a common type (adenocarcinoma) to a more aggressive small cell form after initial treatment. The goal is to see if this approach can improve how long people live without their cancer growing. Participants must have a specific EGFR mutation and no prior treatment for the transformed cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tarlatamab (a drug that helps immune cells attack cancer), combined with chemotherapy (etoposide, carboplatin) and immunotherapy (atezolizumab)
- What this could lead to
- If successful, this could offer a new, more effective treatment option for people whose lung cancer has transformed into a hard-to-treat type after initial therapy.
- What could go wrong
- This is a small, early-phase trial (50 people) with no control group, so results may not apply broadly. The combination also carries risks of serious side effects from chemotherapy and immune-related reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Samsung Medical Center
RECRUITINGSeoul, Gangnam-gu, 06351, South Korea
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