NSCLC
Conditions
Interventions
Case series:None
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The inclusion age is over 70 years old; 2. Patients with an ECOG score of 0-1; 3. According to the TNM staging of the International Association for the Study of Lung Cancer and the 8th Edition of the American Joint Committee on Classification of Cancer, patients with locally advanced or metastatic disease (IIIB, IIIC or IV) who are inoperable and unable to receive radical concurrent chemoradiotherapy confirmed by histology or cytology stage) NSCLC patients; 4. Tumor histology or cytology confirmed no EGFR mutation or ALK fusion positive or ROS1 fusion positive; 5. Have not received any systemic antitumor therapy for advanced/metastatic disease in the past; (for patients who have received platinum-containing adjuvant chemotherapy, neoadjuvant chemotherapy or radical chemoradiotherapy for advanced disease, if the disease progresses occurred > 6 months after the end of the last treatment to be eligible for this study); 6. Life expectancy of at least 3 months; 7. The investigator has at least one measurable lesion confirmed by the RECIST 1.1 criteria; 8. If there is brain metastasis, the lesions remain stable for at least 2 weeks after treatment; 9. The main organs function normally; 10. Women of childbearing age must have taken reliable contraceptive measures or performed a pregnancy test (serum or urine) within 7 days before enrollment, and the results are negative, and are willing to use appropriate methods during the test and 60 days after the last dose of the test drug contraception. For males, consent to use of appropriate methods of contraception or surgical sterilization during the trial and 120 days after the last dose of the trial drug; 11. Sign the written informed consent, and it is expected that the compliance with the research protocol will be good.
Exclusion criteria
Exclusion criteria: 1. Patients with active brain metastases; 2. Previous therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or against another stimulating or synergistic inhibitory T cell receptor (eg, CTLA-4, OX-40, CD137) drug; 3. Use of immunosuppressive drugs within 14 days before the first use of camrelizumab, excluding nasal and inhaled corticosteroids or systemic steroids at physiological doses (ie, no more than 10 mg/day prednisolone or other corticosteroids at equivalent pharmacological doses); 4. Received systemic systemic treatment of Chinese herbal medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, and interleukin, except for local use to control pleural effusion) within 14 days before the first administration; 5. Major surgery within 21 days before the first administration; 6. Received more than 30 Gy of pulmonary radiation therapy within 6 months before the first dose; 7. Received palliative radiation therapy within 7 days before the first dose. For patients who have received palliative radiation therapy 7 days before the first dose, all of the following conditions must be met to be enrolled: there is currently no radiation-related toxicity, no need to take glucocorticoids, and radiation pneumonitis is excluded; 8. Severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval >= 450 ms for men and >= 470 ms for women); New York Heart Association NYHA classification, see Annex 3), or echocardiography showed left ventricular ejection fraction (LVEF) 38.5°C during the screening period/before the first dose; or the first dose Major surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressive Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;1 year-Overall survival rate;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactLi Lin
Beijing Hospital
Outcome results
None listed