Non-small Cell Lung Cancer
Conditions
Interventions
EGFR exon 20 insertion subgroup:Sintilimab
HER2 exon 20 insertion subgroup:Sintilimab
Sponsors
National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) aged at 18 to 75 years (including critical value), both male and female; (2) advanced or metastatic non-small cell lung cancer confirmed by histology or cytology and cannot be surgically resected; (3) exon 20 insertion mutations of EGFR gene or HER2 gene confirmed by NGS detection by tumor tissue, blood, pleural fluid or other samples. (4) progressive disease beyond previous first-line chemotherapy or first-line tyrosine kinase inhibitor treatment; (5) there was at least one radiographically measurable lesion (bone metastasis alone or central nervous system metastasis alone was not accepted as a measurable lesion) according to the RECIST v1.1(solid tumor) criteria; (6) ECOG score at 0 to 1; (7) at least 3 months of expected survival with safety and efficacy data can be followed up; (8) tumor tissue samples for biological analysis should be provided at the start of the study; (9) adequate organ and bone marrow function, and no severe hematopoietic dysfunction and nno heart, lung, liver and kidney dysfunction or immune deficiency: (10) voluntarily joined the study and signed the informed consent,also had good compliance to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: (1) patients with known primary central nervous system tumors or symptomatic brain metastases and meningeal metastases; (2) have active or primary autoimmune diseases that may recur (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.); (3) with recent history of active bleeding, or bleeding symptoms of clinical significance and clear bleeding tendency, such as hemoptysis, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood positive(1+ or above) in the baseline period; (4) underwent surgery or radical radiotherapy within 28 days prior to study initiation, received palliative radiotherapy within 14 days prior to study initiation or radiation agents (strontium, etc.) within 56 days prior to study initiation; (5) important respiratory disease such as uncontrolled hypersensitivity pneumonitis, chemical pneumonia, connective tissue disease pneumonia, pulmonary fibrosis, chronic lung disease (such as bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease (copd), emphysema, pulmonary embolism, interstitial lung disease, pulmonary tuberculosis) or uncontrolled systemic diseases, including diabetes, cardiovascular disease, urinary system diseases, etc.; (6) infection history of hepatitis b virus, hepatitis c virus, syphilis and human immunodeficiency virus (HIV); (7) received organ transplantation and needed immunosuppressive therapy; (8) with other malignant tumors in the past 5 years, with the exception of carcinoma in situ of the breast and carcinoma in situ of the cervix, had basal cell carcinoma of the skin after radical treatment; (9) patients who need to be treated with glucocorticoid (prednisone > 10mg/ day or equivalent dose of other similar drugs) or other immunosuppressive agents due to certain conditions within 14 days before drug administration; (10) received systemic anti-tumor therapy including chemotherapy, targeted therapy, immunotherapy, and biotherapy (tumor vaccine, cytokines or growth factors controlling cancer) 14 days before the study; (11) received Chinese herbal medicine or proprietary Chinese medicine treatment within 7 days before the study; (12) any active infection requiring systemic treatment by intravenous infusion occurs within 2 weeks before the first dose of the study drug; (13) patients who have received any antibody/drug (including anti-pd-1, anti-pd-L1, etc.) targeting T cell co-regulatory protein (immune checkpoint); (14) patients with severe adverse reactions or allergies to the study drugs (CTCAE grade > 3); (15) female patients during pregnancy or lactation, female patients with fertility and positive results in baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period; (16) the patient has severe concomitant diseases, or any other condition that the researcher considers the patient is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Disease Control Rate;Adverse Events;Quality of Life; | — |
Countries
China
Contacts
Public ContactWang Yan
National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing
Outcome results
None listed