Non-Small Cell Lung CancerPhase 2NCT06379087
Radiation Therapy Followed by Tislelizumab and Anlotinib Aeoadjuvant/Adjuvant Therapy for Stage II-IIIA NSCLC
A Phase 2 study testing Anlotinib Hydrochloride Capsule, Tislelizumab Injection and Hypofractionated Radiotherapy in people with Non-Small Cell Lung Cancer, run by Ji Yongling at 1 site in China.
Trial summary
This study is a single-center, prospective, single-arm exploratory clinical study of hypofractionated radiotherapy followed by tislelizumab and anlotinib neoadjuvant and adjuvant therapy. It is designed for patients with stage II-IIIA non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Anlotinib Hydrochloride Capsule, Tislelizumab Injection and Hypofractionated Radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Dec 2026
- 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
- (1) Aged 18-75 years old;
- (2) Early stage II-IIIA NSCLC (AJCC 8th edition), NSCLC, confirmed in tissue (AJCC eighth edition);
- (3) All lesions are assessed to be eligible for surgical resection;
- (4) The primary tumor can be treated with hypofractionated radiotherapy after evaluation;
- (5) Epidermal growth factor receptor/anaplastic lymphoma kinase/ROS1 gene fusions mutation was negative in primary tumor or lymph node metastasis;
- (6) ECOG PS score: 0~1;
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- (7) Expected survival more than 1 year;
- (8) At least one measurable lesion (RECIST 1.1);
- (9) Females of childbearing potential should agree to use contraceptive measures (such as intrauterine device, contraceptives or condoms) during the study and within 3 months after the end of the study; have a negative serum or urine pregnancy test within 7 days before study enrollment and must be non-lactating subjects; and males should agree to use contraceptive measures during the study and within 3 months after the end of the study period;
- (10) Subjects voluntarily participate in this study, sign the informed consent form and had good compliance;
- (11) Subjects are suitable after MDT discussion.
Who cannot join
- Participants with any of the following criteria were excluded from the trial:
- (1) The location of the primary tumor was assessed by the radiologist and considered unsuitable for hypofractionated therapy;
- (2) The pathological type is small cell lung cancer, or mixed tumor with small cell components;
- (3) A history of or concurrent with other malignancies;
- (4) Received any anti-tumor treatment before this study, including chemotherapy, radiotherapy, targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors, etc.) and immunotherapy;
- (5) The Imaging (CT/MR/PET-CT) showed tumor invasion of great vessels or blurred boundary with blood vessels, or the presence of any pulmonary cavity or necrotic lesions;
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- (6) Hemoptysis, active bleeding, ulcer, intestinal perforation, intestinal obstruction within 3 months before enrollment;
- (7) Previous interstitial lung disease, drug-induced interstitial disease or any clinical evidence of active interstitial lung disease; baseline CT scan found idiopathic pulmonary fibrosis;
- (8) According to the investigator's judgment, there are serious or uncontrollable systemic diseases (such as unstable or uncompensated respiratory, cardiac, hepatic or renal diseases) or any unstable systemic diseases (including active infection, grade III hypertension, unstable angina, congestive heart failure, liver and kidney or metabolic diseases);
- (9) Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs acting on another co-inhibitory T cell receptor (e.g., CTLA-4, OX-40, CD137);
- (10) The presence of uncontrollable third space effusion, such as a large number of pleural effusion or ascites or pericardial effusion;
- (11) Urine routine showed urine protein ≥ + +, or 24h urine protein ≥ 1g or severe liver and kidney dysfunction;
- (12) Uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
- (13) Subjects requiring systemic treatment with corticosteroids (> 10 mg/day prednisone or equivalent) or other immunosuppressive agents within 14 days before the first dose;
- (14) Hyperactive/venous thrombotic events occurred within 6 months, such as cerebrovascular accident (including cerebral hemorrhage, cerebral infarction, temporary ischemic attack, etc.);
- (15) Excessive surgery or significant trauma within 28 days before enrollment;
- (16) Pregnant or lactating women;
- (17) Subjects who are considered to be unsuitable for enrollment for other reasons according to the judgment of the investigators..
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Phase II Study of Hypofractionated Radiotherapy Sequential Tislelizumab and Anlotinib in the Neoadjuvant and Adjuvant Therapy for Stage II-IIIA Non-Small Cell Lung Cancer
This study is a single-center, prospective, single-arm exploratory clinical study of hypofractionated radiotherapy followed by tislelizumab and anlotinib neoadjuvant and adjuvant therapy. It is designed for patients with stage II-IIIA non-small cell lung cancer. The efficacy and safety of hypofractionated radiotherapy sequential tislelizumab and anlotinib in the neoadjuvant and adjuvant treatment of stage II-IIIA non-small cell lung cancer are observed. Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.
Read the detailed description
This study is a single-center, prospective, single-arm, exploratory clinical study aimed at evaluating the efficacy and safety of hypofractionated radiotherapy sequential tislelizumab and anlotinib in the neoadjuvant and adjuvant treatment of stage II-IIIA non-small cell lung cancer. If the subject does not voluntarily withdraw from the trial, or the toxic and side effects caused by the drug are intolerable, or the investigator considers that the subjects are not suitable for further trials, each subject will receive the following treatments before and after surgery, and the efficacy evaluation and follow-up will be performed in each cycle.
After completing all screening activities, eligible patients will enter the study and receive the following treatment and visits: First, receive 24 Gy (8 Gy*3) of hypofractionated treatment on d1-3 after the start of the study, and then receive neoadjuvant therapy with tislelizumab combined with anlotinib within 1 week after radiotherapy. Each 3 weeks is a medication cycle, for a total of 2 cycles. Patients will undergo radical surgery after neoadjuvant treatment, and then receive tislelizumab and anlotinib adjuvant treatment after surgery. Each 3 weeks is a medication cycle, and it is maintained for 1 year. The 1-year event-free survival (EFS) rate, complete pathological response (pCR) and major pathological response (MPR) were evaluated to evaluate the safety of medical/surgical treatment for patients.
Neoadjuvant therapy regimen (2 cycles):
- Receive 3-day hypofractionated treatment on Day 1, Day 2, and Day 3, with a total dose of 24Gy (8Gy*3).
- Within 1 week after radiotherapy, receive neoadjuvant tislelizumab (200 mg, intravenous drip, d1) combined with anlotinib (10 mg, oral, D1-14) . Each 3 weeks is a medication cycle.
Surgical protocol: The surgical approach was determined by the surgeon according to the patient's condition, including but not limited to thoracoscopic/open lobectomy/sleeve lobectomy/combined lobectomy/pneumonectomy. Lymph node dissection requires at least three stations of mediastinal lymph node dissection.
Adjuvant therapy regimen: tislelizumab (200 mg, intravenous drip, d1) combined with Anlotinib (10 mg, oral, D1-14). Each 3 weeks is a medication cycle, for 1 year.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Anlotinib Hydrochloride Capsule, Tislelizumab Injection, Hypofractionated Radiotherapy
- 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.
Anlotinib Hydrochloride CapsuleDrug
Also called Anlotinib
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation by blocking VEGFR, FGFR, PDGFR, and c-Kit simultaneously.
Tislelizumab InjectionDrug
Also called Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody.
Hypofractionated RadiotherapyRadiation
Hypofractionated Radiotherapy Extent of radiotherapy: Primary lesion in the lung. Radiotherapy technique: IGRT. Radiotherapy delivery equipment: linear accelerator or TOMO accelerator or CyberKnife.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Neoadjuvant therapy regimen (2 cycles):
1. Receive 3-day hypofractionated treatment on Day 1, Day 2, and Day 3, with a total dose of 24Gy (8Gy*3).
2. Within 1 week after radiotherapy, receive neoadjuvant tislelizumab (200 mg, intravenous drip, d1) combined with anlotinib (10 mg, oral, D1-14) . Each 3 weeks is a medication cycle.
Surgical protocol: The surgical approach was determined by the surgeon according to the patient's condition, including but not limited to thoracoscopic/open lobectomy/sleeve lobectomy/combined lobectomy/pneumonectomy. Lymph node dissection requires at least three stations of mediastinal lymph node dissection.
Adjuvant therapy regimen: tislelizumab (200 mg, intravenous drip, d1) combined with Anlotinib (10 mg, oral, D1-14). Each 3 weeks is a medication cycle, for 1 year. Receives: Drug: Anlotinib Hydrochloride Capsule; Drug: Tislelizumab Injection; Radiation: Hypofractionated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR Rate
Complete pathological response (pCR), defined as the proportion of patients in the ITT analysis set and surgical population analysis set who have no residual tumor in the resected primary tumor and metastatic lymph nodes as assessed by the investigator after the completion of neoadjuvant therapy. Patients who do not meet these criteria, including those who do not undergo surgical resection, will be considered non-responders.
Measured: 12 months
Secondary outcomes (3)
1-year EFS Rate
1-year EFS rate is defined as the proportion of patients who have not experienced radiographic disease progression, local recurrence or distant metastasis, or death due to any cause assessed by the investigator according to RECIST 1.1 Version, from enrollment to 1 year in the intent-to-treat (ITT) analysis set. The 1-year EFS rate is evaluated by the Kaplan-Meier (KM) method.
Measured: Baseline up to 1 years
MPR Rate
Major pathological response (MPR) was defined as the proportion of patients in the ITT analysis set and surgical population analysis set with ≤ 10% residual viable tumor cells in the resected primary tumor and metastatic lymph nodes after the completion of neoadjuvant therapy as assessed by the investigator. Patients who do not undergo surgical resection for reasons such as disease progression will be considered non-responders.
Measured: 12 months
Adverse Events (AEs) according to CTCAE (V5.0) (Safety Evaluation)
The number of abnormal data on potential adverse reaction
Measured: Baseline 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 posted23 Apr 2024
- Study start1 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
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.
- 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
- Ji Yongling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Yongling, Zhejiang Cancer Hospital
- Investigators
- YongLing Ji, PhD, Study director, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379087
- Sponsor's protocol ID
- NEO-PIONEER
- Status last verified
- Jul 2025
- First submitted
- 11 Apr 2024
- Last updated
- 10 Jul 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 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Study of Hypofractionated Radiotherapy Sequential Tislelizumab and Anlotinib in the Neoadjuvant and Adjuvant Therapy for Stage II-IIIA Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06379087
- Acronym / sponsor ID
- NEO-PIONEER
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ji YonglingUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Apr 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 study is a single-center, prospective, single-arm exploratory clinical study of hypofractionated radiotherapy followed by tislelizumab and anlotinib neoadjuvant and adjuvant therapy. It is designed for patients with stage II-IIIA non-small cell lung cancer. The efficacy and safety of hypofractionated radiotherapy sequential tislelizumab and anlotinib in the neoadjuvant and adjuvant treatment of stage II-IIIA non-small cell lung cancer are observed. Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.
Detailed description
This study is a single-center, prospective, single-arm, exploratory clinical study aimed at evaluating the efficacy and safety of hypofractionated radiotherapy sequential tislelizumab and anlotinib in the neoadjuvant and adjuvant treatment of stage II-IIIA non-small cell lung cancer. If the subject does not voluntarily withdraw from the trial, or the toxic and side effects caused by the drug are intolerable, or the investigator considers that the subjects are not suitable for further trials, each subject will receive the following treatments before and after surgery, and the efficacy evaluation and follow-up will be performed in each cycle.
After completing all screening activities, eligible patients will enter the study and receive the following treatment and visits: First, receive 24 Gy (8 Gy*3) of hypofractionated treatment on d1-3 after the start of the study, and then receive neoadjuvant therapy with tislelizumab combined with anlotinib within 1 week after radiotherapy. Each 3 weeks is a medication cycle, for a total of 2 cycles. Patients will undergo radical surgery after neoadjuvant treatment, and then receive tislelizumab and anlotinib adjuvant treatment after surgery. Each 3 weeks is a medication cycle, and it is maintained for 1 year. The 1-year event-free survival (EFS) rate, complete pathological response (pCR) and major pathological response (MPR) were evaluated to evaluate the safety of medical/surgical treatment for patients.
Neoadjuvant therapy regimen (2 cycles):
- Receive 3-day hypofractionated treatment on Day 1, Day 2, and Day 3, with a total dose of 24Gy (8Gy*3).
- Within 1 week after radiotherapy, receive neoadjuvant tislelizumab (200 mg, intravenous drip, d1) combined with anlotinib (10 mg, oral, D1-14) . Each 3 weeks is a medication cycle.
Surgical protocol: The surgical approach was determined by the surgeon according to the patient's condition, including but not limited to thoracoscopic/open lobectomy/sleeve lobectomy/combined lobectomy/pneumonectomy. Lymph node dissection requires at least three stations of mediastinal lymph node dissection.
Adjuvant therapy regimen: tislelizumab (200 mg, intravenous drip, d1) combined with Anlotinib (10 mg, oral, D1-14). Each 3 weeks is a medication cycle, for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Anlotinib Hydrochloride Capsule, Drug: Tislelizumab Injection, Radiation: Hypofractionated RadiotherapyNeoadjuvant therapy regimen (2 cycles): 1. Receive 3-day hypofractionated treatment on Day 1, Day 2, and Day 3, with a total dose of 24Gy (8Gy*3). 2. Within 1 week after radiotherapy, receive neoadjuvant tislelizumab (200 mg, intravenous drip, d1) combined with anlotinib (10 mg, oral, D1-14) . Each 3 weeks is a medication cycle. Surgical protocol: The surgical approach was determined by the surgeon according to the patient's condition, including but not limited to thoracoscopic/open lobectomy/sleeve lobectomy/combined lobectomy/pneumonectomy. Lymph node dissection requires at least three stations of mediastinal lymph node dissection. Adjuvant therapy regimen: tislelizumab (200 mg, intravenous drip, d1) combined with Anlotinib (10 mg, oral, D1-14). Each 3 weeks is a medication cycle, for 1 year. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- (1) Aged 18-75 years old;
- (2) Early stage II-IIIA NSCLC (AJCC 8th edition), NSCLC, confirmed in tissue (AJCC eighth edition);
- (3) All lesions are assessed to be eligible for surgical resection;
- (4) The primary tumor can be treated with hypofractionated radiotherapy after evaluation;
- (5) Epidermal growth factor receptor/anaplastic lymphoma kinase/ROS1 gene fusions mutation was negative in primary tumor or lymph node metastasis;
Key exclusion criteria (18 listed)
- (1) The location of the primary tumor was assessed by the radiologist and considered unsuitable for hypofractionated therapy;
- (2) The pathological type is small cell lung cancer, or mixed tumor with small cell components;
- (3) A history of or concurrent with other malignancies;
- (4) Received any anti-tumor treatment before this study, including chemotherapy, radiotherapy, targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors, etc.) and immunotherapy;
- (5) The Imaging (CT/MR/PET-CT) showed tumor invasion of great vessels or blurred boundary with blood vessels, or the presence of any pulmonary cavity or necrotic lesions;
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 |
|---|---|---|
| Anlotinib Hydrochloride CapsuleAlso: AnlotinibAnlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation by blocking VEGFR, FGFR, PDGFR, and c-Kit simultaneously. | Drug | Single Arm |
| Tislelizumab InjectionAlso: TislelizumabTislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody. | Drug | Single Arm |
| Hypofractionated RadiotherapyHypofractionated Radiotherapy Extent of radiotherapy: Primary lesion in the lung. Radiotherapy technique: IGRT. Radiotherapy delivery equipment: linear accelerator or TOMO accelerator or CyberKnife. | Radiation | Single Arm |
Primary outcome
pCR Rate
Time frame: 12 months
Complete pathological response (pCR), defined as the proportion of patients in the ITT analysis set and surgical population analysis set who have no residual tumor in the resected primary tumor and metastatic lymph nodes as assessed by the investigator after the completion of neoadjuvant therapy. Patients who do not meet these criteria, including those who do not undergo surgical resection, will be considered non-responders.
3 secondary outcomes
1-year EFS Rate
Time frame: Baseline up to 1 years
MPR Rate
Time frame: 12 months
Adverse Events (AEs) according to CTCAE (V5.0) (Safety Evaluation)
Time frame: Baseline 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 10 Jul 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.
YongLing Ji, PhD study director
Zhejiang Cancer Hospital
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 Anlotinib Hydrochloride Capsule, Tislelizumab Injection and Hypofractionated Radiotherapy in people with Non-Small Cell Lung Cancer, run by Ji Yongling 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 11 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: looking for participants now, as of the sponsor's last update on 10 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 Min Fang, PhD (13738152645, fangmin0114@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR Rate (time frame: 12 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 10 Jul 2025.