NSCLCPhase 2NCT07085182
Tislelizumab Combined With sCRT in Stage IIIB/C-IV Non-Squamous Non-Small Cell Lung Cancer：A Prospective, Single-Arm, Phase II Study
A Phase 2 study testing SBRT combined with Tislelizumab followed by Tislelizumab in people with NSCLC and Tislelizumab, run by Zibo Municipal Hospital at 1 site in China.
Trial summary
In clinical practice, some patients cannot tolerate concurrent chemoradiotherapy. The purpose of this study is to observe the efficacy and safety of Tislelizumab combined with platinum-based doublet chemotherapy followed by hypofractionated radiotherapy and Tislelizumab in patients with stage IIIB/C-IV non-squamous… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC, Tislelizumab, Chemotherapy
- What is being tested?
- SBRT combined with Tislelizumab followed by Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2024to 10 Dec 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old, gender is not limited;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Patients with stage IIIB/C-IV non-squamous non-small cell lung cancer confirmed by cytology or histology;
- Patients who have not received prior systemic therapy;
Who cannot join
- Patients with uncontrolled autoimmune diseases;
- Patients who have had autoimmune reactions in the past 6 months and have not improved or are unstable despite appropriate treatment, such as untreated or unstable pneumonia, thyroiditis, myocarditis, etc.;
- Patients known to carry driver gene mutations such as EGFR mutation, ALK translocation, BRAF, ROS1, RET, MET, etc.;
- Patients who have received prior systemic therapy, or those who have received adjuvant or neoadjuvant therapy with a recurrence time of less than 3 months from the last treatment;
- Patients with known allergies or contraindications to the study drug or its excipients;
- Pregnant or lactating female patients, or female patients of childbearing potential with a positive baseline pregnancy test;
- Female patients of childbearing potential or male patients with reproductive plans who are unwilling to use effective contraception during the entire trial period and for 6 months after the end of the trial;
- Patients whose comorbidities or other conditions may affect compliance with the protocol or are deemed unsuitable for participation in this study by the investigator.
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, 1 recruiting
- Recruiting
Zibo Municipal Hospital
Zibo, Shandong, 250000
Qiang Wang, 18953316759, 18953316759@163.com
About this study
Official title: Tislelizumab Combined With sCRT in Stage IIIB/C-IV Non-Squamous Non-Small Cell Lung Cancer
In clinical practice, some patients cannot tolerate concurrent chemoradiotherapy. The purpose of this study is to observe the efficacy and safety of Tislelizumab combined with platinum-based doublet chemotherapy followed by hypofractionated radiotherapy and Tislelizumab in patients with stage IIIB/C-IV non-squamous non-small cell lung cancer. This study aims to provide more treatment options for patients with locally advanced non-small cell lung cancer.
- Conditions
- NSCLC, Tislelizumab, Chemotherapy, Hypofractionated Radiotherapy
- Being tested
- SBRT combined with Tislelizumab followed by Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT combined with Tislelizumab followed by TislelizumabDrug
SBRT:3-10Gy/F, once daily, 5 times a week; Tislelizumab(200mg,iv,q3w):Tislelizumab was added after five sessions of SBRT radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | For patients with driver gene-negative stage IIIB/C-IV non-squamous non-small cell lung cancer, after 4 cycles of Tislelizumab combined with platinum-based doublet chemotherapy, if the tumor efficacy evaluation reaches SD, PR, or CR, radiotherapy will be administered to the tumor lesions combined withTislelizumab. After that, Tislelizumab maintenance therapy will be continued. Receives: Drug: SBRT combined with Tislelizumab followed by Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose until the first documentation of progression or death from any cause, whichever occurs first, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Up to approximately 30 months
Secondary outcomes (4)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR), as assessed by the investigator using RECIST v1.1.
Measured: Up to approximately 30 months
Overall Survival (OS)
OS is defined as the time from first dose until the date of death due to any cause
Measured: Up to ~60 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD), as assessed by the investigator using RECIST v1.1.
Measured: Up to ~24 months
Adverse events
The incidence and severity of AEs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0).
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start13 Jan 2024
- Primary completion10 Dec 2027 (estimated)
- Study completion10 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zibo Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085182
- Sponsor's protocol ID
- 2024-Ethical Review -01
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Combined With sCRT in Stage IIIB/C-IV Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07085182
- Acronym / sponsor ID
- 2024-Ethical Review -01
- Conditions
- NSCLC, Tislelizumab, Chemotherapy, Hypofractionated Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zibo Municipal HospitalUniversity, hospital or other
- Study start
- 13 Jan 2024 (actual)
- Primary completion
- 10 Dec 2027 (estimated)
- Study completion
- 10 Dec 2028 (estimated)
- First posted
- 25 Jul 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.
In clinical practice, some patients cannot tolerate concurrent chemoradiotherapy. The purpose of this study is to observe the efficacy and safety of Tislelizumab combined with platinum-based doublet chemotherapy followed by hypofractionated radiotherapy and Tislelizumab in patients with stage IIIB/C-IV non-squamous non-small cell lung cancer. This study aims to provide more treatment options for patients with locally advanced non-small cell lung cancer.
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: SBRT combined with Tislelizumab followed by TislelizumabFor patients with driver gene-negative stage IIIB/C-IV non-squamous non-small cell lung cancer, after 4 cycles of Tislelizumab combined with platinum-based doublet chemotherapy, if the tumor efficacy evaluation reaches SD, PR, or CR, radiotherapy will be administered to the tumor lesions combined withTislelizumab. After that, Tislelizumab maintenance therapy will be continued. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years old, gender is not limited;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Patients with stage IIIB/C-IV non-squamous non-small cell lung cancer confirmed by cytology or histology;
- Patients who have not received prior systemic therapy;
Key exclusion criteria (8 listed)
- Patients with uncontrolled autoimmune diseases;
- Patients who have had autoimmune reactions in the past 6 months and have not improved or are unstable despite appropriate treatment, such as untreated or unstable pneumonia, thyroiditis, myocarditis, etc.;
- Patients known to carry driver gene mutations such as EGFR mutation, ALK translocation, BRAF, ROS1, RET, MET, etc.;
- Patients who have received prior systemic therapy, or those who have received adjuvant or neoadjuvant therapy with a recurrence time of less than 3 months from the last treatment;
- Patients with known allergies or contraindications to the study drug or its excipients;
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 |
|---|---|---|
| SBRT combined with Tislelizumab followed by TislelizumabSBRT:3-10Gy/F, once daily, 5 times a week; Tislelizumab(200mg,iv,q3w):Tislelizumab was added after five sessions of SBRT radiotherapy. | Drug | treatment arm |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to approximately 30 months
PFS is defined as the time from the first dose until the first documentation of progression or death from any cause, whichever occurs first, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 30 months
Overall Survival (OS)
Time frame: Up to ~60 months
Disease Control Rate (DCR)
Time frame: Up to ~24 months
Adverse events
Time frame: Through study completion, an average of 2 year
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 25 Jul 2025.
- 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.
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 SBRT combined with Tislelizumab followed by Tislelizumab in people with NSCLC and Tislelizumab, run by Zibo Municipal 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 4 inclusion and 8 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 25 Jul 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. 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 Qiang Wang (+8618953316759, 18953316759@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: Up to approximately 30 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 25 Jul 2025.