| Eligibility |
Inclusion Criteria:
1. Patients aged =18 years, male and female are not limited;
2. Patients with ECOG score of 0-1;
3. Life expectancy =12 weeks;
4. Patients must have histologically or cytologicallyproved NSCLC, and present with
locally advanced, unresectable Stage III disease(according to 8th AJCC/UICC
Classification);
5. Receipt of concurrent or sequential chemoradiation therapy which must have been
completed within 42 days prior to first dose administration of the study;
Consolidation chemotherapy is not permitted.
6. No progression following definitive, platinum-based, concurrent or sequential
chemoradiation therapy;
7. Subject with prior anti-cancer treatment can only be enrolled when all toxicities of
prior anti-cancer treatment has recovered to baseline or = Grade 1, except for hearing
loss, alopecia and fatigue. (according to National Cancer Institute [NCI] Common
Terminology Criteria for Adverse Events [CTCAE] V5.0);
8. No prior exposure to any anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-VEGF
treatments, as well as therapeutic anticancer vaccines;
9. Agreement to provide tumor histological specimens required for this study;
10. Adequate organ and marrow function required;
11. Fertile female were required to have a negative serum or urine pregnancy test within
72 days before the start dose of study medication; If female of childbearing
potential, is willing to use adequate contraception for the course of the study
through 90 days after the last dose of study medication; if male with a female
partner(s) of child-bearing potential, he must agree to use adequate contraception
starting with the first dose of study medication through 90 days after the last dose
of study medication or have been surgically sterilized;
12. Provision of signed ICF.
Exclusion Criteria:
1. Mixed small cell lung cancer histology;
2. Disease progression after concurrent/sequential chemoradiotherapy;
3. Major surgical procedure (as defined by the Investigator) within 28 days prior to the
first dose of treatment;
4. Receipt of live attenuated vaccine within 28 days prior to the first dose of
treatment;
5. Previous enrolment of another study and receiving any study drug within 28 days prior
to the first dose of treatment;
6. Patients with =Grade 2 pneumonitis from the prior anti-cancerchemoradiation therapy;
7. Imaging (CT or MRI) shows the tumor invading large vessels or blurring the boundary
with vessels;
8. History of organ transplant or allogeneic hematopoietic stem cell transplantation;
9. Patients with any active autoimmune disease or history of autoimmune disease;
10. Patients with innate or acquired immune deficiency, such as human immunodeficiency
virus (HIV) infection;
11. Uuntreated active hepatitis B or, hepatitis C or active tuberculosis or currently
receiving anti-tuberculosis treatment co-infection with hepatitis B and hepatitis C;
12. Subjects receiving systemic treatment with corticosteroids (>10mg/day of prednisone or
its equivalent) or other immunosuppressants within 14 days prior to the first
administration;
13. History of another primary malignancy within 5 years prior to enrollment, except for
adequately treated basal or squamous cell carcinoma of the skin or cancer of the
cervix in situ and the disease under study;
14. Pulmonary function test: FEV1< 1.2L or DLCO < 50% of predicted value;
15. Patients with cardiac insufficiencyheart diseases including: 1) NYHA III-IV; 2)Acute
coronary syndrome; 3) Supraventricular or ventricular arrhythmias requiring clinical
intervention; 4) Pericardial and myocardial diseases; 5) Echocardiography indicates
that the left ventricular ejection fraction (LVEF) is < 50%;
16. Patients with uncontrollable hypertension (systolic blood pressure = 140 mmHg or
diastolic blood pressure = 90 mmHg, despite the best drug treatment);
17. Patients who have had arteriovenous thrombosis events within 6 months, such as
cerebrovascular accident (including cerebral embolism, deep vein thrombosis, pulmonary
embolismcerebral hemorrhage, cerebral infarction, transient ischemic attack, etc.);
18. Patients with hemoptysis, active bleeding, ulcer, intestinal perforation and
intestinal obstruction within 3 months before administration;
19. Significant hemoptysis symptoms or daily amount of hemoptysis up to 2.5mL or more
within 30 days before the first administration;
20. Known hereditary or acquired bleeding and thrombosis tendency (such as hemophilia,
coagulation dysfunction, thrombocytopenia, hypersplenism, etc.);
21. Routine urine test indicated that urine protein was = (++), or 24-hour urine protein
was = 1g, or severe liver and kidney dysfunction;
22. Patients with severe infection or fever of unknown origin > 38.5 degrees C within 24
weeks before medication;
23. Pregnant or lactating women; those with fertility who are unwilling or unable to take
effective contraceptive measures;
24. Known allergies, hypersensitivity, or intolerance to camrelizumab or its excipients,
apatinib and chemotherapy drugs;
25. Any conditions, judged by investigators, that may impair the subject or cause the
subject to be unable to meet or perform the study requirements.
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