Small Cell Carcinoma of LungPhase 2NCT06830694
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
A Phase 2 study testing Atezolizumab, Etoposide, Carboplatin, Tarlatamab in people with Small Cell Carcinoma of Lung, run by Sehhoon Park at 1 site in South Korea.
Trial summary
The primary treatment option for non-small cell lung cancer (NSCLC) adenocarcinoma (ADC) with activating epidermal growth factor receptor (EGFR) mutation is EGFR tyrosine kinase inhibitor (TKI). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Small Cell Carcinoma of Lung
- What is being tested?
- Atezolizumab, Etoposide, Carboplatin, Tarlatamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 May 2025to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed SCLC and no prior systemic treatment for SCLC
- Patient initially diagnosed with activating EGFR mutation (L858R, Del 19) and treated with any kind of EGFR TKI.
- Confirmed SCLC transformation right after EGFR TKI treatment failure.
- Age ≥19 years
- ECOG performance status of 0 to 1
- Had at least one measurable lesion.
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- 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.
- Pulmonary function: No clinically significant pleural effusion at the timepoint of screening. Pleural effusion with no significant symptom is allowed for enrollment.
- Cardiac function: Cardiac ejection fraction ≥ 50%
- Female subjects must either be of non-reproductive potential
- 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.
- Subject is willing and able to comply with the protocol
- Signed written informed consent
Who cannot join
- Treated with additional chemotherapy after confirmed with transformed SCLC.
- Previously exposed to the immune checkpoint inhibitor treatment.
- Untreated symptomatic brain metastases or leptomeningeal disease.
- Asymptomatic brain metastases can be enrolled per investigator decision
- Uncontrolled systemic illness including uncontrolled hypertension, active bleeding, or active infection.
- Past medical history of interstitial lung disease, drug induced interstitial lung disease, radiation pneumonitis which required steroid treatment, active non- infectious pneumonitis
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- Active or prior documented autoimmune or inflammatory disorders
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment
- History of solid organ transplant.
- Major surgical procedures within 28 days prior to first dose of study treatment.
- History of allergic reactions or acute hypersensitivity reactions to antibody therapies, platinum chemotherapy, or etoposide.
- Disagree to the guidance of contraception during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam-gu, 06351
Sehhoon Park, M.D., 82-2-3410-3746, sehhoon.park@samsung.com
About this study
Official title: 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: Phase II Multicenter Clinical Trial
The primary treatment option for non-small cell lung cancer (NSCLC) adenocarcinoma (ADC) with activating epidermal growth factor receptor (EGFR) mutation is EGFR tyrosine kinase inhibitor (TKI). After a certain period of treatment with EGFR TKI, acquired resistance emerges most frequently with a secondary mutation, p.T790M (36-50%), followed by MET amplification (10-19%). Interestingly, up to 3-5% of patients experience histological transformation into small cell lung cancer (SCLC).
As an underlying mechanism, ADC with a predisposed clonally inactivated Rb and p53 mutation and APOBEC mutation signature is known to be associated with SCLC transformation. The transformed SCLC harbors similar morphological and immunohistochemical (IHC) characteristics as those observed in de novo SCLC, including high expression of chromogranin and synaptophysin. However, little is known about the clinical outcomes of transformed SCLC, with limited studies arguing that their outcomes are similar to those of de novo SCLC, where the median overall survival is approximately 9 to 10 months after the transformation.
Read more
As the first line treatment of SCLC, atezolizumab or durvalumab with four cycles of conventional chemotherapy followed by maintenance therapy demonstrated prolonged overall survival (OS) and placed as the standard treatment option. However, median progression-free survival (PFS) of both study was only 5.2 months and 5.1 months, despite the objective response rate showing 60.2% and 79%. This finding suggest further development of maintenance treatment strategy to prolonged longer duration of response to the treatment.
In addition to the conventional treatment, Tarlatamab (AMG757), bispecific t-cell engager (BiTE), designed to engage DLL3 on SCLC and CD3 on T-cell has been tested in SCLC. DLL3 is expressed in more than 80% of patients with SCLC, regardless of disease stage and researched for the potential target protein for the antibody based treatment in SCLC. By targeting DLL3 using Tarlatamab, engagement of tumor antigen and CD3 lead to cytotoxic synapse formation, triggering the release of proinflammatory cytokines, perforin, and granzymes from activated T-cells, potentially resulting apoptosis. The first clinical outcome of Tarlatamab was reported from the DeLLphi-300 study, phase 1 dose exploration study, showing confirmed partial response in 23% of the heavily treated SCLC and 37% of the patients showed decrease in tumor burden. Median duration of response was 13.0 months (95% confidential interval CI: 6.2 - 14.9 months), median PFS of 3.7 months and median OS was 13.2 months. In the treatment naïve SCLC, DeLLphi-303 study, phase 1b study combining tarlatamab + PD-L1 inhibitor + carboplatin and etoposide, is ongoing to evaluate the clinical efficacy in the front line setting which include only histologically confirmed extensive disease SCLC population (NCT05361395).
Based on previous clinical and pre-clinical outcomes, showing similar disease characteristics between transformed SCLC from the adenocarcinoma who treated with EGFR TKI with de novo SCLC, this study is designed to evaluate the clinical efficacy of tarlatamab with currently standard treatment in transformed SCLC.
- Conditions
- Small Cell Carcinoma of Lung
- Being tested
- Atezolizumab, Etoposide, Carboplatin, Tarlatamab
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atezolizumab, Etoposide, Carboplatin, TarlatamabDrug
Cycle 1~4 : Atezolizumab 1200 mg IV, carboplatin AUC 5.0 IV, Etoposide 100 mg/m2 IV Cycle 5~ : Atezolizumab 1200 mg IV, Tarlatamab 1 or 10mg IV
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | * Concomitant Chemotherapy Phase: for 4 cycles Q3W Cycle 1 (21-day cycle): Atezolizumab 1200 mg IV followed by carboplatin to match AUC 5.0 IV on day 1 and then etoposide 100 mg/m2 IV on day 1- day 3.
* Maintenance Tarlatamab Q2W plus Atezolizumab Q4W Cycle 5 (28-day cycle): Atezolizumab 1200 mg IV Q4W on day 1 followed by tarlatamab 1mg IV on day 1 and 10mg IV on day 8 and Day 15 in the maintaining setting. From C6 Atezolizumab 1200 mg IV Q4W on day 1 followed by tarlatamab 10mg IV on day 1 and day 15 will be applied. Receives: Drug: Atezolizumab, Etoposide, Carboplatin, Tarlatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
Measured: Up to 6months
Secondary outcomes (3)
Objective response rate(ORR)
Measured: About 36 months
Duration of response(DOR)
Measured: About 36 months
Overall survival(OS)
Measured: About 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start13 May 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Carcinoma of LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sehhoon Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sehhoon Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830694
- Sponsor's protocol ID
- 2025-01-014
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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: Phase II Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT06830694
- Acronym / sponsor ID
- 2025-01-014
- Conditions
- Small Cell Carcinoma of Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sehhoon ParkUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary treatment option for non-small cell lung cancer (NSCLC) adenocarcinoma (ADC) with activating epidermal growth factor receptor (EGFR) mutation is EGFR tyrosine kinase inhibitor (TKI). After a certain period of treatment with EGFR TKI, acquired resistance emerges most frequently with a secondary mutation, p.T790M (36-50%), followed by MET amplification (10-19%). Interestingly, up to 3-5% of patients experience histological transformation into small cell lung cancer (SCLC).
As an underlying mechanism, ADC with a predisposed clonally inactivated Rb and p53 mutation and APOBEC mutation signature is known to be associated with SCLC transformation. The transformed SCLC harbors similar morphological and immunohistochemical (IHC) characteristics as those observed in de novo SCLC, including high expression of chromogranin and synaptophysin. However, little is known about the clinical outcomes of transformed SCLC, with limited studies arguing that their outcomes are similar to those of de novo SCLC, where the median overall survival is approximately 9 to 10 months after the transformation.
As the first line treatment of SCLC, atezolizumab or durvalumab with four cycles of conventional chemotherapy followed by maintenance therapy demonstrated prolonged overall survival (OS) and placed as the standard treatment option. However, median progression-free survival (PFS) of both study was only 5.2 months and 5.1 months, despite the objective response rate showing 60.2% and 79%. This finding suggest further development of maintenance treatment strategy to prolonged longer duration of response to the treatment.
In addition to the conventional treatment, Tarlatamab (AMG757), bispecific t-cell engager (BiTE), designed to engage DLL3 on SCLC and CD3 on T-cell has been tested in SCLC. DLL3 is expressed in more than 80% of patients with SCLC, regardless of disease stage and researched for the potential target protein for the antibody based treatment in SCLC. By targeting DLL3 using Tarlatamab, engagement of tumor antigen and CD3 lead to cytotoxic synapse formation, triggering the release of proinflammatory cytokines, perforin, and granzymes from activated T-cells, potentially resulting apoptosis. The first clinical outcome of Tarlatamab was reported from the DeLLphi-300 study, phase 1 dose exploration study, showing confirmed partial response in 23% of the heavily treated SCLC and 37% of the patients showed decrease in tumor burden. Median duration of response was 13.0 months (95% confidential interval CI: 6.2 - 14.9 months), median PFS of 3.7 months and median OS was 13.2 months. In the treatment naïve SCLC, DeLLphi-303 study, phase 1b study combining tarlatamab + PD-L1 inhibitor + carboplatin and etoposide, is ongoing to evaluate the clinical efficacy in the front line setting which include only histologically confirmed extensive disease SCLC population (NCT05361395).
Based on previous clinical and pre-clinical outcomes, showing similar disease characteristics between transformed SCLC from the adenocarcinoma who treated with EGFR TKI with de novo SCLC, this study is designed to evaluate the clinical efficacy of tarlatamab with currently standard treatment in transformed SCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: Atezolizumab, Etoposide, Carboplatin, Tarlatamab* Concomitant Chemotherapy Phase: for 4 cycles Q3W Cycle 1 (21-day cycle): Atezolizumab 1200 mg IV followed by carboplatin to match AUC 5.0 IV on day 1 and then etoposide 100 mg/m2 IV on day 1- day 3. * Maintenance Tarlatamab Q2W plus Atezolizumab Q4W Cycle 5 (28-day cycle): Atezolizumab 1200 mg IV Q4W on day 1 followed by tarlatamab 1mg IV on day 1 and 10mg IV on day 8 and Day 15 in the maintaining setting. From C6 Atezolizumab 1200 mg IV Q4W on day 1 followed by tarlatamab 10mg IV on day 1 and day 15 will be applied. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically confirmed SCLC and no prior systemic treatment for SCLC
- Patient initially diagnosed with activating EGFR mutation (L858R, Del 19) and treated with any kind of EGFR TKI.
- Confirmed SCLC transformation right after EGFR TKI treatment failure.
- Age ≥19 years
- ECOG performance status of 0 to 1
Key exclusion criteria (12 listed)
- Treated with additional chemotherapy after confirmed with transformed SCLC.
- Previously exposed to the immune checkpoint inhibitor treatment.
- Untreated symptomatic brain metastases or leptomeningeal disease.
- Uncontrolled systemic illness including uncontrolled hypertension, active bleeding, or active infection.
- Past medical history of interstitial lung disease, drug induced interstitial lung disease, radiation pneumonitis which required steroid treatment, active non- infectious pneumonitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atezolizumab, Etoposide, Carboplatin, TarlatamabCycle 1~4 : Atezolizumab 1200 mg IV, carboplatin AUC 5.0 IV, Etoposide 100 mg/m2 IV Cycle 5~ : Atezolizumab 1200 mg IV, Tarlatamab 1 or 10mg IV | Drug | Single arm |
Primary outcome
Progression-free survival(PFS)
Time frame: Up to 6months
3 secondary outcomes
Objective response rate(ORR)
Time frame: About 36 months
Duration of response(DOR)
Time frame: About 36 months
Overall survival(OS)
Time frame: About 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab, Etoposide, Carboplatin, Tarlatamab in people with Small Cell Carcinoma of Lung, run by Sehhoon Park at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sehhoon Park, M.D. (82-2-3410-3746, sehhoon.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: Up to 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.