Unresectable Non-small Cell Lung CancerPhase 2NCT06617936
Tislelizumab Combined With Recombinant Human Endostatin Combined With Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer.
A Phase 2 study testing neoadjuvant therapy:Tislelizumab With Recombinant human endostatin combined with Chemotherapy, surgery and Adjuvant therapy:Tislelizumab and Recombinant Human Endostatin Injection (Endostar) in people with Unresectable Non-small Cell Lung Cancer, run by Hua Zhang at 1 site in China.
Trial summary
This is a prospective, single-arm, multicenter, phase II clinical study designed to evaluate the initial efficacy and safety of patients receiving Tislelizumab in combination with recombinant human endostatin injection plus chemotherapy for stage III unresectable non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable Non-small Cell Lung Cancer
- What is being tested?
- neoadjuvant therapy:Tislelizumab With Recombinant human endostatin combined with Chemotherapy, surgery and Adjuvant therapy:Tislelizumab and Recombinant Human Endostatin Injection (Endostar)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2024to 10 Sep 2027
- 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
None listed.
Who cannot join
- Patients with known EGFR gene mutation, ALK rearrangement, ROS-1 fusion, RET fusion, HER-2 mutation, MET mutation, and non-squamous cell carcinoma with unknown driver gene status;
- Previous treatment for current lung cancer, including radiotherapy and all systemic antitumor agents, including chemotherapy, immunotherapy, targeted therapy or antiangiogenic therapy.
- Patients with large cell neuroendocrine carcinoma (LCNEC) components and non-small cell lung cancer with mixed small cell components.
- Patients received other approved systemic immunomodulators (including, but not limited to, interferon, interleukin 2, tumor necrosis factor, thymus pentapeptide, and thymofasin) within 4 weeks prior to initial administration.
- In the course of treatment, researchers determined that patients\' tumors were more likely to invade important blood vessels and cause fatal bleeding.
- Clinically significant hemoptysis (more than 50ml of hemoptysis per day), or clinically significant bleeding symptoms or significant bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occulted blood ++ or above baseline, or vasculitis) within 3 months before the study.
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- Any Chinese herbs used for cancer control were used within 14 days prior to the first administration of the study drug.
- Have received live vaccine within 30 days before the first dose. Including but not limited to the following: mumps, rubella, measles, varicella/shingles (chickenpox), yellow fever, rabies, BCG and typhoid vaccine (inactivated virus vaccine allowed); Live or attenuated vaccine is expected to be required during the study period or within 5 months after the last dose.
- For any condition requiring systemic treatment with corticosteroids (prednisone or equivalent \>10 mg/ day) or other immunosuppressive agents within 14 days prior to the first administration of the study drug, the investigator assessed the patient as having an impact on the study treatment.
- Active autoimmune diseases requiring systemic treatment in patients assessed by the investigator as having an impact on investigational treatment.
- Patients with interstitial lung disease, non-infectious pneumonia, or other diseases that are not under control, including diabetes, pulmonary fibrosis, acute lung disease, etc., that the investigators have assessed as having an impact on the study treatment.
- Patients with a history of major diseases or clinical manifestations that may affect the function of organ systems and are assessed by the investigator as having implications for the study and treatment.
- Study severe chronic or active infections (including tuberculosis) requiring systemic antimicrobial, antifungal, or antiviral treatment ≤14 days before the first administration of the drug.
- Uncontrolled active hepatitis B (defined as positive HBV surface antigen [HBsAg] test results during screening and HBV-DNA test values higher than the upper limit of normal values in the laboratory of the research center; (Participants with HBV-DNA levels \< 500 IU/mL within 28 days prior to enrollment, who have received local standard antiviral therapy for at least 14 days and who are willing to continue antiviral therapy during the study period may be enrolled); Subjects with active hepatitis C (defined as positive HCV surface antibody [HCsAb] test results during screening, positive HCV-RNA);
- Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);
- Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias;
- Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months prior to treatment;
- Concurrent participation in another therapeutic clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.
- Medical history or evidence of disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers that there are other potential risks that are not suitable for participation in the 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, 1 recruiting
- Recruiting
Shandong Public Health Clinical Center (ShandongPHCC)
Jinan, Shandong, 250000
Hua Zhang, doctor, 0531-83347512, zhanghua_science@163.com
About this study
Official title: Tislelizumab Combined With Recombinant Human Endostatin Injection Plus Chemotherapy in Unresectable Stage III NSCLC: a Prospective, Single-arm, Multicenter Phase II Clinical Study
This is a prospective, single-arm, multicenter, phase II clinical study designed to evaluate the initial efficacy and safety of patients receiving Tislelizumab in combination with recombinant human endostatin injection plus chemotherapy for stage III unresectable non-small cell lung cancer. To evaluate the surgical conversion rate of tirellizumab combined with recombinant human endostatin injection and chemotherapy induction therapy in patients with initially unresectable stage III non-small cell lung cancer.
- Conditions
- Unresectable Non-small Cell Lung Cancer
- Being tested
- neoadjuvant therapy:Tislelizumab With Recombinant human endostatin combined with Chemotherapy, surgery, Adjuvant therapy:Tislelizumab and Recombinant Human Endostatin Injection (Endostar), Standard Treatment
- Keywords
- neoadjuvant therapy, NSCLC, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant therapy:Tislelizumab With Recombinant human endostatin combined with ChemotherapyDrug
neoadjuvant therapy : Tislelizumab: 200mg, ivgtt, day 1 ; Recombinant Human Endostatin Injection (Endostar),210mg was pumped intravenously for 3 consecutive days; Pemetrexed (Non-squamous NSCLC) or Nab-paclitaxel(Squamous NSCLC):Pemetrexed: 500 mg/m^2, ivgtt, day 1. Nab-paclitaxel: 260mg/m^2, ivgtt, day 1.; Carboplatin:Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 ivgtt on day 1 ; every 21 days for 1 cycle,2-4 cycles; (If the preoperative neoadjuvant did not reach 4 cycles, the treatment with ralizumab combined with recombinant human endostatin injection and chemotherapy for 1-2 cycles can be continued after surgery, and the total cycle of chemotherapy before and after surgery is up to 4 cycles)
surgeryProcedure or surgery
Patients who are discussed by the MDT panel to evaluate surgical resection will undergo surgery.Surgery must be done within the 4th-6th week from day 1 the last cycle of neoadjuvant treatment.
Adjuvant therapy:Tislelizumab and Recombinant Human Endostatin Injection (Endostar)Drug
Adjuvant therapy Tislelizumab: 200mg, ivgtt, day 1 of each 21-day cycle, 17 cycles at most. Recombinant Human Endostatin Injection (Endostar):210mg was pumped intravenously for 3 consecutive days, every 21 days for 1 cycle,17 cycles at most.
Standard TreatmentOther
Patients assessed by the MDT panel as inoperable for surgical treatment will be selected by the investigator for a standard treatment protocol determined by the MDT discussion
| Study group | Role | What they receive |
|---|---|---|
| Participant Group/Arm A | Experimental | Participants receive 2-4 cycles of Tislelizumab With Recombinant human endostatin combined with Chemotherapy treatment during preoperative period, every 3 weeks once for 4 cycles at most.
After neoadjuvant therapy, Patients evaluated for MDT who can be surgically resected will be placed in the surgical group for surgical excision.
Surgery will be performed within 4 to 6 weeks after completion of preoperative therapy.
After surgery, participants will receive adjuvant therapy with tislelizumab combined with recombinant human endostatin injection every 3 weeks until disease progression or postoperative adjuvant therapy for 1 year. Receives: Drug: neoadjuvant therapy:Tislelizumab With Recombinant human endostatin combined with Chemotherapy; Procedure: surgery; Drug: Adjuvant therapy:Tislelizumab and Recombinant Human Endostatin Injection (Endostar) |
| Participant Group/Arm B | Experimental | Participants receive 2-4 cycles of Tislelizumab With Recombinant human endostatin combined with Chemotherapy treatment , every 3 weeks once for 4 cycles at most. After neoadjuvant therapy, Patients evaluated by MDT as unresectable will be placed in the standard treatment group, where the investigator will select the standard treatment regimen determined by the MDT discussion. Receives: Drug: neoadjuvant therapy:Tislelizumab With Recombinant human endostatin combined with Chemotherapy; Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical resection rate
Proportion of patients who underwent surgical resection after induction therapy
Measured: From enrollment to the end of surgery
Secondary outcomes (11)
Objective response rate (ORR)
ORR is defined as the percentage of participants having a complete response or a partial response, measured by RECIST 1.1.
Measured: prior to surgery
Event-Free Survival(EFS)
The time from the start of randomization (or the start of treatment in a one-arm trial) to the first occurrence of any of the following events: disease progression without surgical treatment, local or distant recurrence, death from any cause, etc.
Measured: Up to 2years
Pathological Complete Response (pCR) Rate
no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment.
Measured: 1 month after surgery
Major Pathological Response (MPR) Rate
Major Pathological Response (MPR) Rate: defined as ≤ 10% of residual tumor cells in the surgically resected tumor specimen and sampled regional lymph nodes after neoadjuvant treatment.
Measured: 1 month after surgery
Progression-Free Survival (PFS)
Progression-Free Survival (PFS): defined as the time from the first dose until the date of first documented progression or date of death from any cause, whichever came first.
Measured: Up to 12 months
Overall Survival
Time from randomization to death (from any cause)
Measured: 3 years
1 years event free survival (EFS)
1 years EFS rate is defined as the percentage of participants having no radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause within 1years after randomization.
Measured: 1 years
1 years Progression-Free Survival (PFS)
1 years Progression-Free Survival (PFS): defined as the time from the first dose until the date of first documented progression or date of death from any cause, whichever came first within 1 years after randomization.
Measured: 1 years after randomization
1 years overall survival rate (OS)
1 years OS rate is defined as the percentage of participants having no death of any cause within 1 years after operation.The Kaplan-Meier estimator will be used to estimate median OS and its 95%CI and the survival curve.
Measured: 1 years after randomization
R0 Resection Rate
R0 Resection Rate: The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope.
Measured: 1 month after surgery
Safety and Tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start27 Aug 2024
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Non-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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hua Zhang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Hua Zhang, Shandong Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617936
- Sponsor's protocol ID
- GWLCZXEC2024-55-2
- Status last verified
- Jul 2025
- First submitted
- 25 Sep 2024
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protect patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Combined With Recombinant Human Endostatin Injection Plus Chemotherapy in Unresectable Stage III NSCLC: a Prospective, Single-arm, Multicenter Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06617936
- Acronym / sponsor ID
- GWLCZXEC2024-55-2
- Conditions
- Unresectable Non-small Cell Lung Cancer
- Keywords
- neoadjuvant therapy, NSCLC, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hua ZhangOther government
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 1 Oct 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 prospective, single-arm, multicenter, phase II clinical study designed to evaluate the initial efficacy and safety of patients receiving Tislelizumab in combination with recombinant human endostatin injection plus chemotherapy for stage III unresectable non-small cell lung cancer. To evaluate the surgical conversion rate of tirellizumab combined with recombinant human endostatin injection and chemotherapy induction therapy in patients with initially unresectable stage III non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant Group/Arm A | Experimental | Drug: neoadjuvant therapy:Tislelizumab With Recombinant human endostatin combined with Chemotherapy, Procedure: surgery, Drug: Adjuvant therapy:Tislelizumab and Recombinant Human Endostatin Injection (Endostar)Participants receive 2-4 cycles of Tislelizumab With Recombinant human endostatin combined with Chemotherapy treatment during preoperative period, every 3 weeks once for 4 cycles at most. After neoadjuvant therapy, Patients evaluated for MDT who can be surgically resected will be placed in the surgical group for surgical excision. Surgery will be performed within 4 to 6 weeks after completion of preoperative therapy. After surgery, participants will receive adjuvant therapy with tislelizumab combined with recombinant human endostatin injection every 3 weeks until disease progression or postoperative adjuvant therapy for 1 year. |
| Participant Group/Arm B | Experimental | Drug: neoadjuvant therapy:Tislelizumab With Recombinant human endostatin combined with Chemotherapy, Other: Standard TreatmentParticipants receive 2-4 cycles of Tislelizumab With Recombinant human endostatin combined with Chemotherapy treatment , every 3 weeks once for 4 cycles at most. After neoadjuvant therapy, Patients evaluated by MDT as unresectable will be placed in the standard treatment group, where the investigator will select the standard treatment regimen determined by the MDT discussion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (19 listed)
- Patients with known EGFR gene mutation, ALK rearrangement, ROS-1 fusion, RET fusion, HER-2 mutation, MET mutation, and non-squamous cell carcinoma with unknown driver gene status;
- Previous treatment for current lung cancer, including radiotherapy and all systemic antitumor agents, including chemotherapy, immunotherapy, targeted therapy or antiangiogenic therapy.
- Patients with large cell neuroendocrine carcinoma (LCNEC) components and non-small cell lung cancer with mixed small cell components.
- Patients received other approved systemic immunomodulators (including, but not limited to, interferon, interleukin 2, tumor necrosis factor, thymus pentapeptide, and thymofasin) within 4 weeks prior to initial administration.
- In the course of treatment, researchers determined that patients\' tumors were more likely to invade important blood vessels and cause fatal bleeding.
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 |
|---|---|---|
| neoadjuvant therapy:Tislelizumab With Recombinant human endostatin combined with Chemotherapyneoadjuvant therapy : Tislelizumab: 200mg, ivgtt, day 1 ; Recombinant Human Endostatin Injection (Endostar),210mg was pumped intravenously for 3 consecutive days; Pemetrexed (Non-squamous NSCLC) or Nab-paclitaxel(Squamous NSCLC):Pemetrexed: 500 mg/m^2, ivgtt, day 1. Nab-paclitaxel: 260mg/m^2, ivgtt, day 1.; Carboplatin:Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 ivgtt on day 1 ; every 21 days for 1 cycle,2-4 cycles; (If the preoperative neoadjuvant did not reach 4 cycles, the treatment with ralizumab combined with recombinant human endostatin injection and chemotherapy for 1-2 cycles can be continued after surgery, and the total cycle of chemotherapy before and after surgery is up to 4 cycles) | Drug | Participant Group/Arm A, Participant Group/Arm B |
| surgeryPatients who are discussed by the MDT panel to evaluate surgical resection will undergo surgery.Surgery must be done within the 4th-6th week from day 1 the last cycle of neoadjuvant treatment. | Procedure or surgery | Participant Group/Arm A |
| Adjuvant therapy:Tislelizumab and Recombinant Human Endostatin Injection (Endostar)Adjuvant therapy Tislelizumab: 200mg, ivgtt, day 1 of each 21-day cycle, 17 cycles at most. Recombinant Human Endostatin Injection (Endostar):210mg was pumped intravenously for 3 consecutive days, every 21 days for 1 cycle,17 cycles at most. | Drug | Participant Group/Arm A |
| Standard TreatmentPatients assessed by the MDT panel as inoperable for surgical treatment will be selected by the investigator for a standard treatment protocol determined by the MDT discussion | Other | Participant Group/Arm B |
Primary outcome
Surgical resection rate
Time frame: From enrollment to the end of surgery
Proportion of patients who underwent surgical resection after induction therapy
11 secondary outcomes
Objective response rate (ORR)
Time frame: prior to surgery
Event-Free Survival(EFS)
Time frame: Up to 2years
Pathological Complete Response (pCR) Rate
Time frame: 1 month after surgery
Major Pathological Response (MPR) Rate
Time frame: 1 month after surgery
Progression-Free Survival (PFS)
Time frame: Up to 12 months
Overall Survival
Time frame: 3 years
1 years event free survival (EFS)
Time frame: 1 years
1 years Progression-Free Survival (PFS)
Time frame: 1 years after randomization
1 years overall survival rate (OS)
Time frame: 1 years after randomization
R0 Resection Rate
Time frame: 1 month after surgery
Safety and Tolerability
Time frame: Up to 3 years
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 15 Jul 2025.
- Individual participant dataSharing planned: No. Protect patient privacy
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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 neoadjuvant therapy:Tislelizumab With Recombinant human endostatin combined with Chemotherapy, surgery and Adjuvant therapy:Tislelizumab and Recombinant Human Endostatin Injection (Endostar) in people with Unresectable Non-small Cell Lung Cancer, run by Hua Zhang 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 0 inclusion and 19 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 15 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 Hua Zhang, PhD (0531-83347512, zhanghua_science@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical resection rate (time frame: From enrollment to the end of surgery). 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 15 Jul 2025.