Small Cell Lung Cancer Extensive StagePhase 2TERENCT06851819
Tislelizumab in Combination with Chemotherapy ± Radiotherapy for Extensive-Stage Oligometastatic Small Cell Lung Cancer.
A Phase 2 study testing radiotherapy and immunechemotherapy in people with Small Cell Lung Cancer Extensive Stage, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn the efficacy and safety of tislelizumab in combination with chemotherapy(etoposide/cisplatin ) ± concurrent radiotherapy for extensive-stage oligometastatic small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer Extensive Stage
- What is being tested?
- radiotherapy and immunechemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 30 Jun 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥ 18 years old;
- Signed written informed consent;
- Histologically or cytologically confirmed oligometastatic extensive-stage small cell lung cancer (oligometastasis is defined as the number of distant metastatic organs≤ 3, and the number of metastases ≤ 5; The ninth edition of the AJCC/UICC/IASLC TNM Staging Criteria for Lung Cancer (Annex 1), extensive-stage SCLC for any T stage, any N stage, M1a/b/c or T3-4 cannot be included in a tolerable radiotherapy program due to multiple nodules in the lungs or excessive tumor size);
- chemotherapy must include a combination of cisplatin and etoposide;
- Expected survival≥ 12 weeks;
- ECOG score of 0 or 1 (Annex 2);
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- Weight> 40 kg;
- At least 1 lesion (no prior radiotherapy) according to RECIST 1.1 guidelines, with a maximum diameter of ≥10 mm as accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline (except for lymph nodes, which must be ≥15 mm in their short axis); And the lesion is suitable for repeated and accurate measurement.
- Have not received anti-tumor therapy in the past;
- Have adequate organ and bone marrow function,
- Echocardiography: Left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%)
- Evidence of postmenopausal status in female patients, or negative urine or serum pregnancy test results in premenopausal female patients. A woman is considered menopausal when she stops menstruation for 12 months without an other medical cause.
- Within 2 weeks (±1 week) prior to enrollment, the following examinations required for staging must be completed: 1) MRI of the head, CT scan of the chest and upper abdomen, ultrasound of superficial lymph nodes and whole-body ECT; Whole-body PET/CT scan is done if necessary.
- Patients with asymptomatic or stable brain metastases after treatment are allowed to enroll, and patients are required to do not need glucocorticoid therapy or discontinue glucocorticoids within 3 days before the first study dose.
Who cannot join
- Personnel involved in the design and/or conduct of this study.
- Previous receipt of investigational drug in this study.
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
- There are medical contraindications to etoposide-platinum-based chemotherapy.
- History of thoracic radiotherapy prior to systemic therapy.
- Concomitant administration of any chemotherapy, biologics, or hormonal therapy for cancer treatment. Hormone therapy for noncancer-related conditions, such as hormone replacement therapy, is acceptable.
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- Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose.
- History of allogeneic organ transplantation.
- Patients who have been cured of aplastic anemia or other blood diseases and patients who have undergone stem cell transplantation.
- Have an autoimmune paraneoplastic syndrome (PNS) that requires systemic therapy (systemic steroids or immunosuppressants) or have clinical symptoms suggestive of an exacerbation of PNS.
- Active or previously documented autoimmune or inflammatory disease (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [except diverticular disease], systemic lupus erythematosus, Sarcoidosis syndrome, nephrotic syndrome or nephritis, Wegener syndrome [granulomatous vasculitis, Graves' disease, rheumatoid arthritis, hypophysitis and uveitis, etc.]). The following exceptions are made to this criterion: patients with vitiligo or alopecia; Patients with hypothyroidism (e.g., after Hashimoto syndrome) who are stable after receiving hormone replacement therapy; Any chronic skin condition that does not require systemic therapy; Patients with no active disease in the past 3 years may be included in the study after discussion with the study physician; Patients with celiac disease who can be controlled by diet alone.
- Uncontrolled intercurrent illness including, but not limited to: persistent or active infection, interstitial lung disease, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, cardiac arrhythmia, severe chronic gastrointestinal disease with diarrhea, or psychiatric/social problems that may limit compliance with study requirements, recent (within 3 months) new cerebral infarction/intracerebral hemorrhage, psychiatric/social problem conditions that result in a significantly increased risk of AEs, or affect the subject's ability to provide written informed consent.
- History of another primary malignancy, with the following exceptions: malignancy treated with curative intent, no known active disease for 5 years ≥ prior to the first dose and a low risk of potential recurrence; adequately treated non-melanoma skin cancer or lentigo maligna nevus with no evidence of disease; Carcinoma in situ that has been adequately treated and has no evidence of disease.
- History of leptomeningeal carcinoma.
- History of active primary immunodeficiency.
- Active infection, including tuberculosis (clinical evaluation, including clinical history, physical examination, imaging findings, and TB examination consistent with local clinical practice), hepatitis B (known to be HBV surface antigen [HbsAg] positive), hepatitis C, or human immunodeficiency virus (HIV1/2 antibody positive). Patients with prior HBV infection or who have been cured (defined as the presence of hepatitis B core IgG antibodies and the absence of HBsAg) are eligible. Patients who are positive for hepatitis C virus (HCV) antibodies are eligible only if they are negative for HCV RNA polymerase chain reaction.
- Female patients who are pregnant or lactating.
- Those who are considered inappropriate by the investigator to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050000
Xuehan Guo, 8613833156327, 448707059@qq.com
About this study
Official title: The Efficacy and Safety of Tislelizumab in Combination with Chemotherapy(etoposide/cisplatin )± Radiotherapy for Extensive-Stage Oligometastatic Small Cell Lung Cancer, a Randomized，Controlled , Phase II Clinical Trial.
The goal of this clinical trial is to learn the efficacy and safety of tislelizumab in combination with chemotherapy(etoposide/cisplatin ) ± concurrent radiotherapy for extensive-stage oligometastatic small cell lung cancer. 64 Patients with Extensive-Stage Oligometastatic Small Cell Lung Cancer will be randomly divided into the experimental group (tislelizumab combined with chemotherapy and radiotherapy) and the control group (tislelizumab combined with chemotherapy).Researchers will compare treatment efficacy and safety between the two groups.
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Being tested
- radiotherapy, immunechemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
Palliative radiotherapy for oligometastases can be combined with chemoradiotherapy and immunomaintenance therapy period. The investigator determines the number, timing and regimen of oligometastases according to the location, size, symptoms and patient tolerance of oligometastases
immunechemotherapyDrug
Tislelizumab in Combination With Chemotherapy(etoposide/cisplatin )
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Chemotherapy and tislelizumab with Concurrent Chest Radiotherapy or Radiotherapy for oligometastases Receives: Radiation: radiotherapy; Drug: immunechemotherapy |
| placebo group | Placebo comparator | Chemotherapy and tislelizumab with no radiotherapy Receives: Drug: immunechemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression free survival
Measured: 2years
Secondary outcomes (1)
Overall survival
Overall survival
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2029 (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 Cancer Extensive StageStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbin SHEN, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851819
- Sponsor's protocol ID
- 2024245
- Acronym
- TERE
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Tislelizumab in Combination with Chemotherapy(etoposide/cisplatin )± Radiotherapy for Extensive-Stage Oligometastatic Small Cell Lung Cancer, a Randomized，Controlled , Phase II Clinical Trial.
- ClinicalTrials.gov ID
- NCT06851819
- Acronym / sponsor ID
- TERE / 2024245
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 28 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 goal of this clinical trial is to learn the efficacy and safety of tislelizumab in combination with chemotherapy(etoposide/cisplatin ) ± concurrent radiotherapy for extensive-stage oligometastatic small cell lung cancer. 64 Patients with Extensive-Stage Oligometastatic Small Cell Lung Cancer will be randomly divided into the experimental group (tislelizumab combined with chemotherapy and radiotherapy) and the control group (tislelizumab combined with chemotherapy).Researchers will compare treatment efficacy and safety between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Radiation: radiotherapy, Drug: immunechemotherapyChemotherapy and tislelizumab with Concurrent Chest Radiotherapy or Radiotherapy for oligometastases |
| placebo group | Placebo comparator | Drug: immunechemotherapyChemotherapy and tislelizumab with no radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must be ≥ 18 years old;
- Signed written informed consent;
- Histologically or cytologically confirmed oligometastatic extensive-stage small cell lung cancer (oligometastasis is defined as the number of distant metastatic organs≤ 3, and the number of metastases ≤ 5; The ninth edition of the AJCC/UICC/IASLC TNM Staging Criteria for Lung Cancer (Annex 1), extensive-stage SCLC for any T stage, any N stage, M1a/b/c or T3-4 cannot be included in a tolerable radiotherapy program due to multiple nodules in the lungs or excessive tumor size);
- chemotherapy must include a combination of cisplatin and etoposide;
- Expected survival≥ 12 weeks;
Key exclusion criteria (18 listed)
- Personnel involved in the design and/or conduct of this study.
- Previous receipt of investigational drug in this study.
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
- There are medical contraindications to etoposide-platinum-based chemotherapy.
- History of thoracic radiotherapy prior to systemic therapy.
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 |
|---|---|---|
| radiotherapyPalliative radiotherapy for oligometastases can be combined with chemoradiotherapy and immunomaintenance therapy period. The investigator determines the number, timing and regimen of oligometastases according to the location, size, symptoms and patient tolerance of oligometastases | Radiation | experimental group |
| immunechemotherapyTislelizumab in Combination With Chemotherapy(etoposide/cisplatin ) | Drug | experimental group, placebo group |
Primary outcome
Progression free survival
Time frame: 2years
Progression free survival
1 secondary outcome
Overall survival
Time frame: 2years
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 28 Feb 2025.
- Individual participant dataSharing planned: No
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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 radiotherapy and immunechemotherapy in people with Small Cell Lung Cancer Extensive Stage, run by Hebei Medical University Fourth Hospital at 1 site 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 14 inclusion and 18 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: opening soon, as of the sponsor's last update on 28 Feb 2025. 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 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. Some participants in this study may receive a placebo. 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 Wenbin Shen (8615831183879, wbshen2024@hebmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 2years). 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 28 Feb 2025.