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New treatment option for Non-Small Cell Lung Cancer
Official title Radiation Therapy Followed by Tislelizumab and Anlotinib Aeoadjuvant/Adjuvant Therapy for Stage II-IIIA NSCLC
ClinicalTrials.gov ID: NCT06379087
What this study is testing
What is Anlotinib Hydrochloride Capsule?
Anlotinib Hydrochloride Capsule is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as Anlotinib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- (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;
You likely can't join if
- 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...
- (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...
See the full eligibility 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...
- (10) people voluntarily participate in this study, sign the informed consent form and had good compliance;
- (11) people are suitable after MDT discussion.
- 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...
- (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...
- (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) people 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) people who are considered to be unsuitable for enrollment for other reasons according to the judgment of the investigators..
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.