Non-small cell lung cancer
Conditions
Interventions
Single Arm:radiotherapy with Anlotinib/Sintilimab
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Has provided written informed consent. 2. Has unresectable or refusal to operation locally advanced (stage IIB~IIIC) non-small cell lung cancer diagnosed by pathology or cytology (according to AJCC 8th Edition Cancer Staging System), and failed after standard treatment (concurrent or sequential chemo-radiotherapy) within 6 months. 3. Not suitable for treating with EGFR/ALK/ROS1 tyrosine kinase inhibitors. 4. Age >= 18 years and = 90 g/L b. Absolute neutrophil count (ANC) >= 1.5 x 10^9/L c. Platelets (PLT) >= 100 x 10^9/L d. serum albumin (ALB) >= 30 g/L e. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 x upper limit of normal (ULN) f. Total bilirubin (TBIL) <= 1.5 x upper limit of normal (ULN) g. Serum creatinine <= 1.5 x ULN. 11. Female participants of childbearing potential must have a negative serum pregnancy test within -7 days of enrollment, except that being postmenopausal for at least 1 year or having undergone surgical sterilization or hysterectomy. 12. All participants must be willing to use efficient barrier methods of contraception during the entire treatment until 120 days after the last dose of intervention.
Exclusion criteria
Exclusion criteria: 1. Has small cell lung cancer or a mixed tumor with presence of small cell elements. 2. Has EGFR mutation or ALK/ROS1 mutation. 3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor. 4. Has received radiotherapy(RT) before first dosage and the radiation plan fits one of the following situations: (1) >=30% of the bone marrow had received RT within 14 days before treatment; (2) RT for lung lesions within 6 weeks prior to treatment (total dose > 30 Gy) and the toxicity of previous RT did not return to grade 1 or below, or patients with a history of radiation pneumonia still needed glucocorticoid treatment; (3) palliative RT finished within 7 days before the first study drug administration. 5. Patients are at high risk of bleeding due to the location of primary or metastatic tumor, or radiographic findings show significant cavity or necrosis in the lung tumor (difficult patients are evaluated by the multidisciplinary evaluation for potential inclusion). 6. Clinically uncontrollable pleural effusion/peritoneal effusion. 7. Diagnosed with any other malignant tumor except for basal cell or squamous cell carcinoma of skin or carcinoma in situ of cervix after adequate treatment. 8. Participated in any other drug clinical study within 4 weeks before the first administration. 9. Accepted Chinese drugs or immunomodulatory drugs within 2 weeks before the first administration. 10. Active autoimmune disease requiring systemic treatment (e.g., use of disease remission agents, glucocorticoids, or immunosuppressants) occurred within 2 years prior to initial administration. 11. Systemic glucocorticoid therapy within 7 days prior to initial administration, excluding nasal spray and inhaled corticosteroids or systemic steroids at physiological doses. 12. Has a clear history of biological agents of anlotinib or sintilimab. 13. Patients with history of allogeneic organ transplantation allogeneic or hematopoietic stem cell transplantation or have transplantation plan. 14. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 15. Subjects with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (QTc interval > 450 ms for males and QTc interval > 470 ms for females). Subjects with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% had myocardial infarction within 6 months before admission according to NYHA criteria. 16. The patient has severe infection within 4 weeks before first administration(such as the need for intravenous antibiotics, antifungals or antivirals) and unexplained fever within 7 days before administration, >= 38.5 degrees C. 17. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. (HBV: HBsAg positive and HBV DNA >= 500 IU/mL ; HVC: HCV RNA positive and abnormal liver function). 18. Any known mental illness or substance abuse that may have an impact on compliance with the test requirements. There are other factors lead to patients cannot participate in this clinical study by the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;DOR;OS;Safety;HRQoL; | — |
Countries
China
Contacts
Public ContactHuiming Yu
Beijing Cancer Hospital
Outcome results
None listed