| Eligibility |
Inclusion Criteria:
1. Histological or cytological diagnosis of non-squamous non-small cell lung
cancer(NSCLC)
2. Patients with asymptomatic BM or intracranial hypertension symptoms can be controlled
after dehydration therapy, who can continue medication to maintain stable symptoms at
enrollment or during the study;
3. Patients with MRI confirmed parenchymal brain metastases with = 3 brain lesions; or
patients with 1-2 brain lesions who are not suitable for or refuse local therapy. At
least one measurable lesion must be = 5 mm in diameter in brain lesions; patients with
local meningeal metastases are allowed to be included, but those with extensive
meningeal metastases are not included;
4. No prior systemic therapy for metastatic NSCLC; chemotherapy and/or radiotherapy as
part of neoadjuvant/adjuvant therapy are allowed, but the time interval from the end
of surgery to diagnosis of advanced or metastatic disease should be no less than 6
months;
5. Study sites must be able to provide relevant documentation of EGFR mutation and ALK
fusion status of subjects which must be negative. If tumor tissue samples at or after
the diagnosis of advanced tumors are available, archived within 1 year prior to the
first dose or freshly obtained, testing for PD-L1 levels can be performed prior to
enrollment or during the study;
6. Age = 18 years;
7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
8. Life expectancy of more than 3 months;
9. Adequate hematopoietic function, defined as absolute neutrophil count = 1.5 × 109/L,
platelet count = 100 × 109 /L, hemoglobin = 90 g/L [no blood transfusion within 7 days
or no erythropoietin (EPO) dependence];
10. Adequate liver function, defined as total bilirubin level = 1.5 times the upper limit
of normal (ULN); for patients without liver metastases, aspartate aminotransferase
(AST) and alanine aminotransferase (ALT) levels = 2.5 times ULN; for patients with
documented liver metastases, AST and ALT levels = 5 times ULN;
11. Adequate renal function, defined as serum creatinine = 1.5 times ULN or calculated
creatinine clearance = 60 ml/min (Cockcroft-Gault formula); urine protein in urine
routines less than 2+, if the patient has a urine protein = 2+ at baseline, 24-hour
urine should be collected and tested to ensure 24-hour urine protein quantification =
1 g;
12. Adequate coagulation, defined as international normalized ratio (INR) or prothrombin
time (PT) = 1.5 times ULN; anticoagulant therapy is allowed, as long as the PT is
within the intended range of the anticoagulant drugs;
13. Female subjects of childbearing potential should have a negative urine or serum
pregnancy test within 7 days prior to receiving the first dose of the study drug
(Cycle 1, Day 1). If a urine pregnancy test cannot be confirmed as negative, a blood
pregnancy test is required; women and men of childbearing potential must agree to use
appropriate methods of contraception or have been surgically sterilized during the
study and within 90 days after the last dose of the study drugs;
14. Able to comply with the study and follow-up procedures;
15. Sign the written informed consent prior to the implementation of any study-related
procedures.
Exclusion Criteria Subjects who meet any of the following criteria are not eligible for
inclusion in this study:
1. Mixed non-small cell and small cell carcinoma, or adenosquamous cell lung cancer with
an adenocarcinoma component < 50% (if the adenocarcinoma component is = 50%, the
inclusion criteria are met);
2. Currently participating in an interventional clinical trial, or receiving other study
drugs or treatment with study devices within 4 weeks prior to the first dose;
3. Patients who have received prior systemic anti-tumor therapy;
4. Patients who have received solid organ or blood system transplantation;
5. Active autoimmune disease requiring systemic therapy (e.g., use of disease modifying
drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose.
Substitution therapy (e.g., thyroxine, insulin, or physiologic corticosteroids for
adrenal or pituitary insufficiency, etc.) is not considered systemic therapy;
6. Diagnosis of immunodeficiency or ongoing systemic glucocorticoid therapy or any other
form of immunosuppressive therapy within 7 days prior to the first dose of the study;
physiologic doses of glucocorticoids (= 10 mg/day of prednisone or equivalent drugs)
are allowed;
7. History of noninfectious pneumonitis requiring glucocorticoid therapy within 1 year
prior to the first dose or current interstitial lung disease;
8. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody
positive);
9. Untreated active hepatitis B; Note: subjects with hepatitis B who meet the following
criteria are also eligible for inclusion:
1. HBV viral load must be < 500 IU/ml prior to the first dose, and anti-HBV therapy
should be administered at the discretion of the investigator throughout the study
to avoid viral reactivation;
2. For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-),
prophylactic anti-HBV therapy is not required, but viral reactivation needs to be
closely monitored;
10. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher
than the lower limit of detection);
11. Pregnant and lactating women;
12. Known allergy to Camrelizumab, Pemetrexed, Carboplatin, or any of their excipients;
13. Malignancies other than NSCLC within 5 years prior to enrollment, except adequately
treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin
carcinoma, localized prostatic carcinoma after radical surgery, and ductal carcinoma
in situ after radical surgery.
14. Subjects with active pulmonary tuberculosis (TB) are excluded. Suspected active TB
need to be excluded by chest x-ray, sputum examination and clinical symptoms and
signs.
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