Camrelizumab With AC in Patients With Brain Metastases of Driven Gene-negative,NSCLC

• Status: Recruiting
• Trial end date: 2023-07-15
• Target enrollment: 0
• Participant gender: All

Summary

The primary hypothesis is that camrelizumab in combination with pemetrexed/ carboplatin will present a better efficacy for treatment of first line metastatic non-squamous non-small cell lung cancer and minimize the risk of toxicity

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Carboplatin; Pemetrexed

Criteria

Inclusion Criteria:

1. Histological or cytological diagnosis of non-squamous non-small cell lung cancer（NSCLC）

2. Subjects with asymptomatic brain metastasis or the symptoms of intracranial hypertension were relieved after dehydration treatment, and kept clinically stable for ≥ 2 weeks. Subjects who need hormone dehydration treatment, hormone therapy should be stopped 3 days before the first dose of the investigational drugs;

3. MRI confirmed brain parenchyma metastasis, ≥ 3 brain lesions, or 1-2 brain lesions but not suitable for local treatment or refused local treatment. At least one brain measurable lesion ≥ 5mm using RECIST 1.1 criteria.,

4. Subjects have not received prior systemic treatment for metastatic NSCLC.

5. Tumor tissue biomarkers examination should be complied with: 1) Subjects should not have a previously detected sensitizing EGFR mutation or ALK fusion oncogene. 2) Subjects should have sufficient tissue samples for PD-L1 detection (IHC,DAKO 22C3 pharmDx).

6. age:18~75years

7. ECOG performance status of 0 or 1.

8. Life expectancy ≥ 3 months.

9. Blood routine examination should be complied with (No blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 7 days):

1. ANC ≥ 1.5×109/L；

2. PLT ≥ 100×109/L；

3. HB ≥ 90 g/L；

10. Has adequate organ function,Biochemical tests must meet the following criteria:

TBIL ≤ 1.5ULN； ALT、AST≤ 2.5 ULN (If abnormal liver function is caused by liver metastasis, ALT、AST< 5ULN; Cr≤1.5ULN，endogenous creatinine clearance rate≥60ml/min(Cockcroft-Gault formula);

11. Blood coagulation must meet the following criteria: INR≤1.5 and APTT≤1.5 ULN；

12. Women of childbearing age must undergo a serological pregnancy test within 7 days before the first dose with negative results and willing to use a medically approved and effective contraceptive method (e.g. intrauterine device, contraceptive pill or condom) during the study and within two months after the last dose. For male subjects whose partners are women of childbearing age, they should be sterilized surgically or agree to use effective contraceptive methods during the study and within two months after the last dose.

13. Subjects should be able to follow the research and follow-up procedures;

14. Subjects should be voluntarily participate in clinical studies and informed consent should be signed.

Exclusion Criteria:

1. Subjects with predominantly squamous cell histology NSCLC, or SCLC.

2. brain metastases with hemorrhage;

3. Participated in other clinical trials, or finish other clinical trials within 4 weeks.

4. Subjects have received prior systemic treatment for metastatic NSCLC；

5. Subjects have received solid organ or blood system transplantation;

6. active autoimmune diseases requiring systemic treatment (such as the use of disease remission drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapy (such as thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy;

7. systemic glucocorticoid therapy or any other form of immunosuppressive therapy is being given within 7 days before the first administration of the study; physiological doses of glucocorticoids are allowed (prednisone or equivalent for ≤ 10 mg/ days);

8. within 1 year before the first administration, there was a history of non-infectious pneumonia or interstitial lung disease requiring glucocorticoid treatment;

9. Subjects with congenital or acquired immunodeficiency such as HIV infection, active hepatitis B (HBV DNA ≥ 200 IU/ml), hepatitis C (hepatitis C antibody is positive).

10. Women who are pregnant or lactating

11. Known history of hypersensitivity to any components of the Camrelizumab formulation，or other monoclonal antibody.

12. Known history of hypersensitivity to pemetrexed, carboplatin or any of its excipients;

13. A prior malignancy other than NSCLC, except carcinoma in situ of the cervix or non-melanoma skin cancer, adequately treated low grade [Gleason score <6] localized prostate cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence-