Non-small Cell Lung Cancer
Conditions
Interventions
EGFR sensitive mutation/ALK fusion cohort:Chidamide combined with sintilimab
EGFR/HER2 exon 20 insertion mutation cohort:Chidamide combined with sintilimab
Driver gene wild-type cohort:Chidamide combined with sintilimab
Sponsors
National Cancer Center / National Cancer Clinical Medicine Research Center / Cancer Hospital of Peking Union Medical College, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years; 2. Patients with NSCLC confirmed by histology or cytology; 3. Patients with stage IIIB-IV; 4. Patients with at least one measurable lesion (according to RECIST v1.1 evaluation criteria); 5. Patients with ECoG score of 0-2; 6. Any of the following conditions is met: Cohort 1: EGFR classical sensitive mutation (19del / 21 L858R) or ALK was positive. There was no opportunity for follow-up targeted therapy in the treatment of previous targeted drugs (generation 1-3 EGFR / alk-tki), and there was no previous chemotherapy and no intention of chemotherapy; Cohort 2: there was EGFR 20 exon insertion mutation or her-220 exon insertion mutation (EGFR exon20ins or HER2 exon20ins mutation), and had been treated with first-line / second-line chemotherapy or first-line targeted drug therapy; Cohort 3: driving gene wild type, progression of first-line chemotherapy; 7. Patients without brain metastasis or asymptomatic brain metastasis; 8. Neutrophil absolute value >=1.5x10^9/L, platelet >=100x10^9/L, hemoglobin >=90 g/L; 9. Patients with expected survival time >=3 months; 10. Patients (paraffin embedded, 5 uM/piece, >=5 pieces) and whole blood samples were provided in screening period; 11. Patients who voluntarily participated in the clinical trial and signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients without measurable lesions, such as pleural or pericardial effusion, ascites, etc; 2. Patients who have undergone major surgery or obvious trauma within 4 weeks before enrollment, or are expected to receive major surgical treatment; 3. Patients who have previously used anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti cytotoxic T-lymphocyte associated antigen-4 (CTLA-4) antibodies (including antipyrimizumab or any other antibody or drugs specifically targeted at T-cell co stimulation or checkpoint pathway) 4. The patients who have used HDAC inhibitors (including cedabamine, romicin, vorinostat, bailestat, and barbistat) in the past; 5. Patients with meningeal metastasis or symptomatic brain metastasis; 6. Patients with a history of interstitial lung disease or pneumonia requiring oral or intravenous steroids; 7. Patients who have received or will be vaccinated with live vaccine within 30 days before the first study treatment (seasonal influenza vaccine without live vaccine is allowed); 8. Patients with active infection have active bacterial, viral, fungal, Mycobacterium, parasitic infection or other infections (excluding nail bed fungal infection) within 4 weeks before screening period, or need intravenous antibiotic treatment or targeted antiviral treatment, or any major infection event in hospital, or persistent fever within 14 days before screening; 9. Patients with a history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 10. Patients with uncontrollable important cardiovascular diseases, history of clinically significant QT interval prolongation, or QTc interval > 450 ms in screening period; 11. Abnormal liver function (total bilirubin > 1.5 times of upper limit of normal value; ALT / AST of patients without liver metastasis > 2.5 times of upper limit of normal value; ALT / AST of patients with liver metastasis > 5 times of upper limit of normal value), abnormal renal function (serum creatinine > 1.5 times of upper limit of normal value); 12. Patients of pregnant and lactating women or fertile women with positive baseline pregnancy test; or subjects of childbearing age who are not willing to take effective contraceptive measures during the study period and at least 8 weeks after the last administration; 13. According to the judgment of the researcher, there are some concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that seriously endanger the safety of patients or affect patients to complete the study; 14. Patients with a clear history of neurological or mental disorders, including epilepsy or dementia; 15. Patients who were not suitable for the study were determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Maximum Tolerated Dose;Dose Limited Toxicity;Recommended Phase II Dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Duration of Response;Overall Survival; | — |
Countries
China
Contacts
Public ContactWang Yan
National Cancer Center / National Cancer Clinical Medicine Research Center / Cancer Hospital of Peking Union Medical College, Chinese Academy of Medical Sciences
Outcome results
None listed