Status:
NOT_YET_RECRUITING
Sintilimab Combined With Anlotinib Therapy for Initially Unresectable Non-small Cell Lung Cancer
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Xinda Biopharmaceutical Group
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Concurrent or sequential chemoradiotherapy has been recommended as the standard treatment for locally advanced and unresectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be ...
Detailed Description
Concurrent or sequential chemoradiotherapy is the standard treatment for patients with locally advanced NSCLC, but patients receiving chemoradiotherapy have limited improvement in prognosis and are al...
Eligibility Criteria
Inclusion
- According to the 8th edition of the AJCC/UICC TNM staging system for NSCLC, patients with locally advanced (stage II-III C) NSCLC confirmed by histology who are initially unable to undergo surgery and concomitant radiochemotherapy and are confirmed to have at least one measurable lesion according to RECIST 1.1.
- Age ≥18 years and ≤75 years.
- ECOG PS score: 0 to 1.
- The main organs function is normal, that is, the following criteria met:
- Good hematopoietic function, defined as absolute neutrophil count ≥1.5×109 /L, platelet count≥100 ×109 /L, hemoglobin ≥90g/L \[no blood transfusion or no erythropoietin (EPO) dependence within 7 days before enrollment\];
- Biochemical test results should meet the following criteria: BIL \< 1.25 times the upper limit of normal value (ULN); ALT and AST \< 2.5 × ULN; in case of liver metastases, ALT and AST \< 5 × ULN; Cr ≤1.5×ULN or creatinine clearance (CCr) ≥60ml/min; Coagulation function is good, INR and PT ≤1.5 × ULN;
- The oxygen saturation of the finger tip ≥ 92% both at rest and during walking (without oxygen inhalation).
- The life expectancy ≥12 weeks.
- Signed and dated informed consent.
Exclusion
- Subjects at risk of massive hemoptysis or with blood in sputum, including but not limited to tumor lesions no more than 5 mm away from large vessels, tumors invading large vessels, and obvious lung cavity/necrotizing tumors.
- Small cell lung cancer (including mixed small cell and non-small cell lung cancer) or central squamous cell carcinoma.
- With driver mutation (EGFR/ALK/ROS1).
- With uncontrollable hypertension (systolic pressure \> 160 mmHg, diastolic pressure \> 100 mmHg) even receiving antihypertensive drug therapy.
- Has an active autoimmune disease, history of allogeneic stem cell transplantation or organ transplantation that has required systemic treatment. Replacement therapy is not considered a form of systemic treatment and is allowed.
- Has an active infection requiring systemic therapy.
- Has other malignant tumors (except radical cervical carcinoma in situ, non-melanoma skin cancer, etc.) or concomitant diseases that seriously endanger the patients or affect the patients completing the study at the same time.
- With immunodeficiency status, including but not limited to HIV infection and primary immunodeficiency diseases.
- Previously treated with ICIs.
- Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT05306847
Start Date
April 1 2022
End Date
April 1 2026
Last Update
April 1 2022
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