Limited-stage Small Cell Lung Cancer (LS-SCLC)Phase 4NCT07485920
A Prospective, Multicenter Exploratory Clinical Study on Consolidation Therapy With Tislelizumab Combined With Nintedanib for Limited-stage Small Cell Lung Cancer
A Phase 4 study testing Tislelizumab and nintedanib in people with Limited-stage Small Cell Lung Cancer (LS-SCLC), run by The Affiliated Hospital of Qingdao University at 6 sites in China.
Trial summary
This study is a prospective, single-arm, multicenter, exploratory clinical trial. It aims to evaluate the efficacy and safety of tislelizumab combined with nintedanib as consolidation therapy for patients with limited-stage small cell lung cancer after concurrent chemoradiotherapy, and to explore the prognostic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limited-stage Small Cell Lung Cancer (LS-SCLC)
- What is being tested?
- Tislelizumab and nintedanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesChina
- Study dates
- 1 May 2026to 31 Jan 2030
- Phase
- Phase 4
- 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
- Have a thorough understanding of this study and have voluntarily signed the informed consent form;
- Age ≥ 18 years old, gender not restricted;
- ECOG score 0-1;
- Histologically or cytologically confirmed as limited-stage small cell lung cancer;
- At least one measurable lesion (according to RECISTv1.1 criteria);
- Expected survival ≥ 3 months;
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- Prophylactic cranial radiotherapy is permitted before consolidation therapy;
- Adequate organ function reserve. The subjects must meet the following laboratory indicators: Before the sample collection during the screening period, the patient has not received blood transfusion or growth factor support treatment for ≤ 14 days and: absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90 g/L，Calculated creatinine clearance rate (CrCl) (Cockcroft-Gault formula): creatinine clearance rate ≥ 60 mL/min，Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (total bilirubin of Gilbert's syndrome patients must be < 3 × ULN)，AST and ALT ≤ 2.5 × ULN，Patients not receiving anticoagulation treatment: international normalized ratio or activated partial thromboplastin time ≤ 1.5 × ULN，Albumin ≥ 25 g/L (2.5 g/dL).
- Willing and able to comply with the study plan's visits, treatment plan, laboratory tests and other research procedures;
- Pregnant women must undergo a serum pregnancy test 3 days before the first medication administration and the result must be negative. For pregnant women subjects and male subjects whose partners are pregnant women, they must agree to use effective contraceptive methods during the study and within 120 days after the last administration of the study drug.
Who cannot join
- There are patients with lung metastasis from other primary malignant tumors.
- Patients who have previously or concurrently had other systemic malignant tumors (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or in situ cancer that has undergone radical resection), excluding those with cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or in situ cancer that has undergone radical resection.
- Patients who have previously received other systemic treatments for the current lung cancer, including chemotherapy, immunotherapy, targeted therapy, or anti-angiogenic therapy, other than induction radiotherapy and chemotherapy.
- Patients who received other approved systemic immunomodulators (including but not limited to interferon, interleukin-2, tumor necrosis factor, thymus pentapeptide, and thymalfasin) within 4 weeks prior to the first administration.
- Patients whose blood pressure control is not satisfactory after drug treatment (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg).
- Patients with factors that significantly affect the absorption of oral medications, such as inability to swallow, chronic diarrhea, and intestinal obstruction, etc.
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- The investigator judges that the possibility of tumor invasion of important blood vessels and fatal bleeding caused by the tumor is relatively high during the treatment process.
- Within 3 months before the study, there was significant clinical hemoptysis (more than 50 ml of hemoptysis per day), or there were significant clinical bleeding symptoms or obvious bleeding tendencies (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above baseline, or having vasculitis, etc.)
- Within 14 days before the first administration of the study drug, any traditional Chinese medicine used for controlling cancer was used.
- Within 30 days before the first administration, the patient received live vaccines. Including but not limited to the following: mumps, rubella, measles, chickenpox/zoster (chickenpox), yellow fever, rabies, BCG (bacillus Calmette-Guérin), and typhoid vaccine (inactivated virus vaccine is allowed); or it is expected that the patient will need to receive live vaccines or attenuated live vaccines during the study period or within 5 months after the last administration
- Within 14 days before the first administration of the study drug, any situation where systemic treatment with corticosteroids (prednisone or equivalent drugs > 10 mg/day) or other immunosuppressive drugs is required, and the investigator assesses that it has an impact on the study treatment
- Patients with systemic autoimmune diseases that require systemic treatment, and the investigator assesses that it has an impact on the study treatment
- Patients with interstitial lung disease, non-infectious pneumonia, or other uncontrolled diseases, including diabetes, pulmonary fibrosis, acute lung disease, etc., and the investigator assesses that it has an impact on the study treatment
- Patients with a significant history of major diseases or clinical manifestations that may affect the function of organ systems, and the investigator assesses that it has an impact on the study treatment.
- Within 14 days before the first administration of the study drug, severe chronic or active infections (including tuberculosis infection, etc.) that require systemic antibacterial, antifungal, or antiviral treatment (including HBsAg positive in the screening period and HBV-DNA detection value higher than the upper limit of the laboratory test department of the research center; (for subjects who tested HBV-DNA content < 500 IU/mL within 28 days before enrollment and have received at least 14 days of local standard antiviral treatment and are willing to continue antiviral treatment during the study period, they can be enrolled); active hepatitis C (defined as HBsAb positive in the screening period and HCV-RNA positive) subjects.
- Uncontrolled active hepatitis B (defined as HBsAg positive in the screening period and HBV-DNA detection value higher than the upper limit of the laboratory test department of the research center; (for subjects who tested HBV-DNA content < 500 IU/mL within 28 days before enrollment and have received at least 14 days of local standard antiviral treatment and are willing to continue antiviral treatment during the study period, they can be enrolled); active hepatitis C (defined as HBsAb positive in the screening period and HCV-RNA positive) subjects
- Known human immunodeficiency virus (HIV) infection (known HIV antibody positive)
- Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and with clinically significant arrhythmias
- Any occurrence of arterial thrombosis, embolism or ischemia within 6 months prior to the inclusion in the treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, etc.
- Concurrent participation in another therapeutic clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results and prevent the subject from fully participating in the study, or other conditions that the investigator considers as other potential risks and unsuitable for inclusion in the study. The investigator considers that there are other potential risks that make participation in this study unsuitable.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Affiliated Hospital of Qingdao University
Qingdao, Shandong
jing wang, 0532-82913035, wangstella5@163.com
Qingdao Central Hospital Affiliated to Rehabilitation University
Qingdao, Shandong
zhen zhang, Zhangzhen177@126.com
Qingdao Municipal Hospital
Qingdao, Shandong
wei chen, 1378144543@qq.com
Weihai Municipal Hospital
Weihai, Shandong
fujun Yang, yangfujun228@163.com
Yantai Yuhuangding Hospital
Yantai, Shandong
aina Liu, nana4312@sina.com
Zibo Fourth People's Hospital
Zibo, Shandong
Fanghan Wang, Zllk2016@163.com
About this study
This study is a prospective, single-arm, multicenter, exploratory clinical trial. It aims to evaluate the efficacy and safety of tislelizumab combined with nintedanib as consolidation therapy for patients with limited-stage small cell lung cancer after concurrent chemoradiotherapy, and to explore the prognostic markers related to the therapeutic effect.
- Being tested
- Tislelizumab and nintedanib
- Keywords
- Limited-stage small cell lung cancer, consolidation therapy, tislelizumab, nintedanib
- 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.
Tislelizumab and nintedanibDrug
Tislelizumab (200mgQ3W, D1) combined with nintedanib (150mg bid) until disease progression, death, or the occurrence of intolerable toxic reactions
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Patients with limited-stage small cell lung cancer who did not progress after induction chemoradiotherapy were treated with tislelizumab (200mg Q3W, D1) combined with nintedanib (150mg,bid) Receives: Drug: Tislelizumab and nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival（PFS）
The time from the randomization to the first occurrence of imaging disease progression or death
Measured: Half a year after all patients were enrolled
Secondary outcomes (5)
overall survival（OS）
The time from the first administration of the drug to death due to any cause
Measured: Two years after the end of group enrollment
One-year progression-free survival rate
Measured: one year after treatment
The incidence rate of radiation pneumonitis
Measured: one year after the end of group enrollment
Disease Control Rate
The proportion of patients whose tumors achieved remission (PR + CR) and stable lesions (SD).
Measured: Half a year after the study was enrolled
Objective response rate
Measured: Half a year after the study was enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion10 Dec 2028 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited-stage Small Cell Lung Cancer (LS-SCLC)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485920
- Sponsor's protocol ID
- QYFYEC2026-04
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Exploratory Clinical Study on Consolidation Therapy With Tislelizumab Combined With Nintedanib for Limited-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07485920
- Acronym / sponsor ID
- QYFYEC2026-04
- Keywords
- Limited-stage small cell lung cancer, consolidation therapy, tislelizumab, nintedanib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 10 Dec 2028 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 20 Mar 2026 (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 study is a prospective, single-arm, multicenter, exploratory clinical trial. It aims to evaluate the efficacy and safety of tislelizumab combined with nintedanib as consolidation therapy for patients with limited-stage small cell lung cancer after concurrent chemoradiotherapy, and to explore the prognostic markers related to the therapeutic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Tislelizumab and nintedanibPatients with limited-stage small cell lung cancer who did not progress after induction chemoradiotherapy were treated with tislelizumab (200mg Q3W, D1) combined with nintedanib (150mg,bid) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have a thorough understanding of this study and have voluntarily signed the informed consent form;
- Age ≥ 18 years old, gender not restricted;
- ECOG score 0-1;
- Histologically or cytologically confirmed as limited-stage small cell lung cancer;
- At least one measurable lesion (according to RECISTv1.1 criteria);
Key exclusion criteria (21 listed)
- There are patients with lung metastasis from other primary malignant tumors.
- Patients who have previously or concurrently had other systemic malignant tumors (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or in situ cancer that has undergone radical resection), excluding those with cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or in situ cancer that has undergone radical resection.
- Patients who have previously received other systemic treatments for the current lung cancer, including chemotherapy, immunotherapy, targeted therapy, or anti-angiogenic therapy, other than induction radiotherapy and chemotherapy.
- Patients who received other approved systemic immunomodulators (including but not limited to interferon, interleukin-2, tumor necrosis factor, thymus pentapeptide, and thymalfasin) within 4 weeks prior to the first administration.
- Patients whose blood pressure control is not satisfactory after drug treatment (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg).
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 |
|---|---|---|
| Tislelizumab and nintedanibTislelizumab (200mgQ3W, D1) combined with nintedanib (150mg bid) until disease progression, death, or the occurrence of intolerable toxic reactions | Drug | treatment arm |
Primary outcome
progression-free survival（PFS）
Time frame: Half a year after all patients were enrolled
The time from the randomization to the first occurrence of imaging disease progression or death
5 secondary outcomes
overall survival（OS）
Time frame: Two years after the end of group enrollment
One-year progression-free survival rate
Time frame: one year after treatment
The incidence rate of radiation pneumonitis
Time frame: one year after the end of group enrollment
Disease Control Rate
Time frame: Half a year after the study was enrolled
Objective response rate
Time frame: Half a year after the study was enrolled
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 20 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tislelizumab and nintedanib in people with Limited-stage Small Cell Lung Cancer (LS-SCLC), run by The Affiliated Hospital of Qingdao University at 6 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 10 inclusion and 21 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 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 jing wang (0532-82913035, wangstella5@163.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: Half a year after all patients were enrolled). 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 20 Mar 2026.