Small-cell Lung CancerNCT06514118
Chemoimmunotherapy Plus Residual Lesion Irradiation for the Treatment of Extensive Stage Small-cell Lung Cancer
An observational study of Small-cell Lung Cancer and Residual Tumor, run by Qingdao Central Hospital at 3 sites in China.
Trial summary
This is a phase II trial studies the effect of chemoimmunotherapy sequential residual tumor irradiation in treating patients with extensive stage small cell lung cancer. Even though small cell lung cancer is initially highly responsive to first-line chemotherapy plus PD-L1 inhibitors, treatment resistance inevitably… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Small-cell Lung Cancer, Residual Tumor, Radiation
- What is being tested?
- residual tumor irradiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 70 participants
- Where
- 3 sitesChina
- Study dates
- 17 Apr 2024to 16 Mar 2027
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with extensive disease of small-cell lung cancer are enrolled and treated with chemotherapy plus PD-L1 immunotherapy for 4 cycles. Patients with esponse or stable disease are selected to receive residual lesions irratiation for 50GY/25f.
Who may be able to join
- >= 18 years of age Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 at the time of study treatment initiation Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC) Patient should have extensive stage disease, defined as, malignant pleural effusion, pulmonary metastases in the contralateral lung, and/or the presence of extra-thoracic metastatic disease Must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 prior to starting platinum-based systemic chemotherapy Absolute neutrophil count (ANC) >= 1.5 x 10^9/L Platelets >= 100 x 10^9/L Hemoglobin >= 9 g/dL Serum creatinine =< 1.5 x institution upper limit of normal (ULN) and calculated creatinine clearance of at least 15 ml/min.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN) (ALT and AST =< 5 x ULN is acceptable if liver metastases are present) Total serum bilirubin =< 1.5 x ULN. For patients with well documented Gilbert's syndrome, total bilirubin =< 3 x ULN with direct bilirubin within normal range.
- Participant must understand the investigational nature of this study and sign an approved written informed consent form prior to receiving any study related procedure.
Who cannot join
- ad major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery Positive for immunosuppressive disease, acquired immunodeficiency syndrome (AIDS) or other immune depressing diseases. For human immunodeficiency virus (HIV), HVC and HBC-mandatory testing is required prior to enrollment Patient has known hypersensitivity to the components of the study drugs or any analogs History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, including, but not limited to: Myocardial infarction or arterial or venous thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease. History of documented congestive heart failure (New York Heart Association functional classification III or IV) within 6 months prior to baseline. Poorly controlled arrhythmias
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Qingdao Central Hospital
Qingdao, Shandong, 266042
KEKE NIE, MD, 68665078, NIEKEKEQD@163.COM
- Recruiting
Qingdao Central Hospital
Qingdao, Shandong, 266042
Yunhong You, MD, 18561857907, kevinji78@yahoo.com
- Recruiting
Qingdao Central Hospital
Qingdao, Shandong, 266042
youxin ji, md, 86-532-68665078
youxin ji, md
About this study
Official title: Chemoimmunotherapy Plus Ratiotherapy for Extensive Stage Small-cell Lung Cancer
This is a phase II trial studies the effect of chemoimmunotherapy sequential residual tumor irradiation in treating patients with extensive stage small cell lung cancer. Even though small cell lung cancer is initially highly responsive to first-line chemotherapy plus PD-L1 inhibitors, treatment resistance inevitably happens. Residual tumor irradiation my prolong drug resistance, and may help prevent the growth and spread of the tumor cells to other parts of the body.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the progression-free survival (PFS) and overall survival of chemoimmunotherapy sequential residual tumor irradiation in patients with extensive stage small cell lung cancer (SCLC).
SECONDARY OBJECTIVES:
II. To assess the overall response rate (ORR) and toxicity in extensive stage SCLC patients treated with chemoimmunotherapy squential residual tumor irradiation
- Conditions
- Small-cell Lung Cancer, Residual Tumor, Radiation
- Being tested
- residual tumor irradiation
- Medical subject headings
- Small Cell Lung Carcinoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
residual tumor irradiationRadiation
lung residual tumor will be given external beam irradiation for 50GY in 25 fractions in total
| Study group | Role | What they receive |
|---|---|---|
| Combined chemotherapy and immunotherapy plus residual lesion irradiation | Patients receive carboplatin 5/AUC intravenously (IV) on day 1, adebrelimab 1200mg IV on day 1, and etoposide100mg/m2 IV on days 1-3. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity; redsidual tumor irradiation for 50GY in 25 fraction. Receives: Radiation: residual tumor irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
PFS: time to disease progression or patient death
Measured: 24 months
Secondary outcomes (1)
Overall survival (OS)
OS: time to patient death
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start17 Apr 2024
- Primary completion16 Mar 2026 (estimated)
- Study completion16 Mar 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 Lung CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youxin Ji, Qingdao Central Hospital
- Investigators
- chunling zhang, md, Study chair, Qingdao Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514118
- Sponsor's protocol ID
- KY202400902
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoimmunotherapy Plus Ratiotherapy for Extensive Stage Small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06514118
- Acronym / sponsor ID
- KY202400902
- Conditions
- Small-cell Lung Cancer, Residual Tumor, Radiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Qingdao Central HospitalUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 16 Mar 2026 (estimated)
- Study completion
- 16 Mar 2027 (estimated)
- First posted
- 23 Jul 2024 (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.
This is a phase II trial studies the effect of chemoimmunotherapy sequential residual tumor irradiation in treating patients with extensive stage small cell lung cancer. Even though small cell lung cancer is initially highly responsive to first-line chemotherapy plus PD-L1 inhibitors, treatment resistance inevitably happens. Residual tumor irradiation my prolong drug resistance, and may help prevent the growth and spread of the tumor cells to other parts of the body.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the progression-free survival (PFS) and overall survival of chemoimmunotherapy sequential residual tumor irradiation in patients with extensive stage small cell lung cancer (SCLC).
SECONDARY OBJECTIVES:
II. To assess the overall response rate (ORR) and toxicity in extensive stage SCLC patients treated with chemoimmunotherapy squential residual tumor irradiation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined chemotherapy and immunotherapy plus residual lesion irradiation | – | Radiation: residual tumor irradiationPatients receive carboplatin 5/AUC intravenously (IV) on day 1, adebrelimab 1200mg IV on day 1, and etoposide100mg/m2 IV on days 1-3. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity; redsidual tumor irradiation for 50GY in 25 fraction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with extensive disease of small-cell lung cancer are enrolled and treated with chemotherapy plus PD-L1 immunotherapy for 4 cycles. Patients with esponse or stable disease are selected to receive residual lesions irratiation for 50GY/25f.
Key inclusion criteria (3 listed)
- >= 18 years of age Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 at the time of study treatment initiation Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC) Patient should have extensive stage disease, defined as, malignant pleural effusion, pulmonary metastases in the contralateral lung, and/or the presence of extra-thoracic metastatic disease Must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 prior to starting platinum-based systemic chemotherapy Absolute neutrophil count (ANC) >= 1.5 x 10^9/L Platelets >= 100 x 10^9/L Hemoglobin >= 9 g/dL Serum creatinine =< 1.5 x institution upper limit of normal (ULN) and calculated creatinine clearance of at least 15 ml/min.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN) (ALT and AST =< 5 x ULN is acceptable if liver metastases are present) Total serum bilirubin =< 1.5 x ULN. For patients with well documented Gilbert's syndrome, total bilirubin =< 3 x ULN with direct bilirubin within normal range.
- Participant must understand the investigational nature of this study and sign an approved written informed consent form prior to receiving any study related procedure.
Key exclusion criteria (1 listed)
- ad major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery Positive for immunosuppressive disease, acquired immunodeficiency syndrome (AIDS) or other immune depressing diseases. For human immunodeficiency virus (HIV), HVC and HBC-mandatory testing is required prior to enrollment Patient has known hypersensitivity to the components of the study drugs or any analogs History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, including, but not limited to: Myocardial infarction or arterial or venous thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease. History of documented congestive heart failure (New York Heart Association functional classification III or IV) within 6 months prior to baseline. Poorly controlled arrhythmias
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 |
|---|---|---|
| residual tumor irradiationlung residual tumor will be given external beam irradiation for 50GY in 25 fractions in total | Radiation | Combined chemotherapy and immunotherapy plus residual lesion irradiation |
Primary outcome
progression-free survival (PFS)
Time frame: 24 months
PFS: time to disease progression or patient death
1 secondary outcome
Overall survival (OS)
Time frame: 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 23 Jul 2024.
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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.
chunling zhang, md study chair
Qingdao Central Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small-cell Lung Cancer and Residual Tumor, run by Qingdao Central Hospital at 3 sites in China.
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 3 inclusion and 1 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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.
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 chunling zhang, md (1718865657, kevinji78@yahoo.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: 24 months). 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 23 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.