Short-course radiation then tislelizumab plus anlotinib before and after surgery for stage II–IIIA lung cancer
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
Run by Zhejiang Cancer Hospital · NCT06379087 · Data updated 2026-11-12
This study will try short-course radiotherapy followed by the immune drug tislelizumab and the targeted drug anlotinib given before and after surgery for people with stage II–IIIA non-small cell lung cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone, tislelizumab, anlotinib |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | May 1, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | July 10, 2025 |
| Trial ID | NCT06379087 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with resectable stage II–IIIA non-small cell lung cancer, negative for EGFR/ALK/ROS1 driver mutations, ECOG 0–1, at least one measurable lesion, and eligible for hypofractionated radiotherapy are the intended participants.
✕Probably not a fit
Patients with unresectable disease, positive EGFR/ALK/ROS1 driver mutations, poor performance status, or those who cannot tolerate immunotherapy, anti-angiogenic therapy, or radiotherapy are unlikely to benefit from this regimen.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective, single-arm Phase 2 study testing hypofractionated radiotherapy (24 Gy in 3 fractions) followed within one week by two neoadjuvant 3-week cycles of tislelizumab plus anlotinib. Patients who proceed to surgery will then receive adjuvant tislelizumab and anlotinib every 3 weeks for up to one year. The trial will measure 1-year event-free survival and pathological endpoints including complete pathological response (pCR) and major pathological response (MPR), along with safety and tolerability. All participants must have resectable stage II–IIIA NSCLC without common driver mutations and meet baseline performance and organ-function requirements.
Why it matters
Potential benefit: If successful, this approach could shrink tumors before surgery and reduce recurrence after surgery, potentially increasing the chance of long-term, event-free survival.
How similar studies have gone: Neoadjuvant PD-1/PD-L1 therapies have shown promising pCR/MPR rates in other trials, but the specific sequence combining hypofractionated radiotherapy with tislelizumab plus anlotinib remains relatively novel and less well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * (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; * (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. Exclusion Criteria: 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; * (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..
Where it's running
-
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Min Fang, PhD
- Email: fangmin0114@126.com
- Phone: 13738152645
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Tislelizumab plus Anlotinib after chemoradiotherapy in limited-stage SCLC
This phase II trial tests whether adding tislelizumab and anlotinib after chemoradiotherapy helps people with limited-stage small cell lung cancer stay cancer-free.
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RC148 plus platinum chemotherapy versus tislelizumab plus platinum chemotherapy for first-line squamous non-small cell lung cancer
This study tests whether RC148 with carboplatin and paclitaxel works better than tislelizumab with the same chemotherapy for people with newly diagnosed advanced or metastatic squamous non-small cell lung cancer who have not had prior systemic treatment.
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SFRT with tislelizumab and platinum chemotherapy for initially unresectable stage III NSCLC
This trial tests whether adding spatially fractionated radiotherapy (SFRT) to tislelizumab plus platinum doublet chemotherapy can shrink tumors enough to allow surgery in adults with initially unresectable stage III non-small cell lung cancer.
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Tislelizumab with Anlotinib and Nab-Paclitaxel before surgery for resectable NSCLC
A group of adults with stage II–III non-small cell lung cancer is given tislelizumab plus anlotinib and nab-paclitaxel before surgery to see if the treatment helps shrink tumors and is safe.
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Concurrent chemoradiotherapy with surufatinib and tislelizumab for unresectable stage III non-small cell lung cancer
This tests whether adding surufatinib and tislelizumab to standard concurrent chemoradiotherapy, followed by continuing both drugs as consolidation, helps people with unresectable stage III non-small cell lung cancer.
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Neoadjuvant low-dose radiation and SBRT with tislelizumab plus platinum chemotherapy for stage IIA–IIIB NSCLC
This test tries to see if giving low-dose radiation and SBRT followed by tislelizumab combined with platinum chemotherapy helps people with stage IIA–IIIB non-small cell lung cancer achieve a complete tumor response before surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.