Non-small Cell Lung CancerPhase 2NCT05758116
Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients
A Phase 2 study testing Tislelizumab in people with Non-small Cell Lung Cancer and Consolidation Immunotherapy, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The current standard of care for locally advanced non-small cell lung cancer (NSCLC) is concurrent chemoradiation and consolidation immunotherapy. In real world clinical practice, patients who cannot tolerate concurrent chemoradiation generally received radiotherapy alone or sequential chemoradiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Consolidation Immunotherapy, Radiotherapy or Sequential Chemoradiation
- What is being tested?
- Tislelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2022to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 with stage III(AJCC 8th) unresectable NSCLC, or resectable but intolerant or refusing surgery;
- Intolerable of concurrent chemoradiation;
- No progression after radiotherapy or sequential chemoradiation;
- Chemotherapy: standard dose of 2-6 cycles of paclitaxel, pemetrexed or gemcitabine in combination with platinum; Radiotherapy: starting within 3 months after chemotherapy using IMRT or VMAT technique. The target volume includes the primary tumor and regional lymph nodes, and the prescription dose 95% PTV ranges from 50Gy to 66Gy;
- ECOG PS0-2;
- PD-L1≥1%;
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- Age≥18 years, and life expectancy>3 months;
- Adequate Hematologic, biochemistry and organ function (to be confirmed by test results within 7 days prior to the first dose);
- Be able to provide written informed consent (ICF) and able to understand and agree to comply with study requirements and assessment schedule.
Who cannot join
- Patients with EGFR-sensitive mutations and ALK rearrangements;
- Any prior use of anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibodies (including Ipilimumab or any other antibody targeting the T-cell co-stimulation or checkpoint pathway);
- History of allergy to components of Tislelizumab;
- Any active malignancy within 2 years prior to enrollment, except for the specific cancers examined in this study and any locally recurrent cancers that have been eradicated (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ);
- History of interstitial lung disease or pneumonia requiring oral or intravenous steroids;
- Progression after radiotherapy or sequential chemoradiation;
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- Unresolved ≥grade2 toxicities from radiotherapy and sequential chemoradiation, (excluding those that the investigator determines do not affect study treatment, such as alopecia);
- Grade 2 or severe Pneumonia from radiotherapy or sequential chemoradiation;
- Administration of a live vaccine within 30 days prior to treatment start (seasonal influenza vaccine without live vaccine is allowed);
- Severe chronic or active infections (including tuberculosis infections, etc.) requiring systemic antibacterial, antifungal or antiviral therapy ≤ 14 days prior to treatment start;
- History of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation;
- History of active autoimmune disease requiring systemic therapy;
- Treatment with long-term systemic immunosuppressive medications (≥10 mg/d prednisone or equivalent doses of other steroids) or other immunosuppressive medications;
- History of uncontrolled cardiovascular disease; or clinically significant QT interval prolongation, or QTc interval >480 ms during screening period;
- Abnormal liver function [total bilirubin > 1.5 times of the upper limit of normal value; ALT/AST > 2.5 times of the upper limit of normal value in patients without liver metastases and ALT/AST > 5 times of the upper limit of normal value in patients with liver metastases], abnormal renal function (serum creatinine > 1.5 times of the upper limit of normal value);
- History of serious concomitant diseases (e.g., severe hypertension, diabetes, thyroid disease, active infection, etc.) ;
- History of diagnosed neurological or psychiatric disorders, including epilepsy or dementia;
- Unsuitable for participation in this study assessed by investigators;
- Patients who were already enrolled in other clinical studies;
- Mixed lung cancer with small cell components.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-label, Single-arm, Phase II Trial Investigating the Efficacy and Safety of Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients
The current standard of care for locally advanced non-small cell lung cancer (NSCLC) is concurrent chemoradiation and consolidation immunotherapy. In real world clinical practice, patients who cannot tolerate concurrent chemoradiation generally received radiotherapy alone or sequential chemoradiation. These patients are more likely to develop distant metastases and therefore may require tolerable systemic consolidation regimens. However, there is a lack of evidence from clinical studies on consolidation immunotherapy after radiotherapy alone or sequential chemoradiation. The aim of the study is to explore the efficacy and safety of Tislelizumab consolidation therapy after radiotherapy or sequential chemoradiation in locally advanced NSCLC patients who are intolerable of concurrent concurrent chemoradiation.
- Conditions
- Non-small Cell Lung Cancer, Consolidation Immunotherapy, Radiotherapy or Sequential Chemoradiation
- Being tested
- Tislelizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab: 200mg d1,q21d*17
| Study group | Role | What they receive |
|---|---|---|
| Consolidation Tislelizumab | Experimental | Patients completed radiotherapy alone or sequential chemoradiation with 42 days received consolidation Tislelizumab 200mg every 3 weeks for 12 months. Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Defined from the date of enrollment to the date of death or any recurrence.
Measured: 6 months after enrollment
Secondary outcomes (3)
Overall survival
Defined from the date of enrollment to the date of death.
Measured: From date of enrollment to maximum of 3 years or death
Objective response rate
Defined as the occurrence of a complete or partial response per RECIST 1.1 criteria.
Measured: From date of enrollment to maximum of 3 years or death
Treatment-related adverse events
Graded according to NCI-CTCAE v5.0
Measured: Duration of treatment and follow up until death or 3 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start7 Jul 2022
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Yu, MD, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758116
- Sponsor's protocol ID
- 2022YJZ46
- Status last verified
- Aug 2026
- First submitted
- 17 Feb 2023
- Last updated
- 14 Aug 2026
- Results posted
- 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 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Single-arm, Phase II Trial Investigating the Efficacy and Safety of Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients
- ClinicalTrials.gov ID
- NCT05758116
- Acronym / sponsor ID
- 2022YJZ46
- Conditions
- Non-small Cell Lung Cancer, Consolidation Immunotherapy, Radiotherapy or Sequential Chemoradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 7 Mar 2023 (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 current standard of care for locally advanced non-small cell lung cancer (NSCLC) is concurrent chemoradiation and consolidation immunotherapy. In real world clinical practice, patients who cannot tolerate concurrent chemoradiation generally received radiotherapy alone or sequential chemoradiation. These patients are more likely to develop distant metastases and therefore may require tolerable systemic consolidation regimens. However, there is a lack of evidence from clinical studies on consolidation immunotherapy after radiotherapy alone or sequential chemoradiation. The aim of the study is to explore the efficacy and safety of Tislelizumab consolidation therapy after radiotherapy or sequential chemoradiation in locally advanced NSCLC patients who are intolerable of concurrent concurrent chemoradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consolidation Tislelizumab | Experimental | Drug: TislelizumabPatients completed radiotherapy alone or sequential chemoradiation with 42 days received consolidation Tislelizumab 200mg every 3 weeks for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with stage III(AJCC 8th) unresectable NSCLC, or resectable but intolerant or refusing surgery;
- Intolerable of concurrent chemoradiation;
- No progression after radiotherapy or sequential chemoradiation;
- Chemotherapy: standard dose of 2-6 cycles of paclitaxel, pemetrexed or gemcitabine in combination with platinum; Radiotherapy: starting within 3 months after chemotherapy using IMRT or VMAT technique. The target volume includes the primary tumor and regional lymph nodes, and the prescription dose 95% PTV ranges from 50Gy to 66Gy;
- ECOG PS0-2;
Key exclusion criteria (20 listed)
- Patients with EGFR-sensitive mutations and ALK rearrangements;
- Any prior use of anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibodies (including Ipilimumab or any other antibody targeting the T-cell co-stimulation or checkpoint pathway);
- History of allergy to components of Tislelizumab;
- Any active malignancy within 2 years prior to enrollment, except for the specific cancers examined in this study and any locally recurrent cancers that have been eradicated (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ);
- History of interstitial lung disease or pneumonia requiring oral or intravenous steroids;
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 |
|---|---|---|
| TislelizumabTislelizumab: 200mg d1,q21d*17 | Drug | Consolidation Tislelizumab |
Primary outcome
Progression-free survival
Time frame: 6 months after enrollment
Defined from the date of enrollment to the date of death or any recurrence.
3 secondary outcomes
Overall survival
Time frame: From date of enrollment to maximum of 3 years or death
Objective response rate
Time frame: From date of enrollment to maximum of 3 years or death
Treatment-related adverse events
Time frame: Duration of treatment and follow up until death or 3 years after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Tislelizumab in people with Non-small Cell Lung Cancer and Consolidation Immunotherapy, run by Peking University Cancer Hospital & Institute 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 9 inclusion and 20 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: finished, as of the sponsor's last update on 14 Aug 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 6 months after enrollment). 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 14 Aug 2026.