Clinical trial NCT04167774: A Study to Evaluate Camrelizumab in Combination With Nb-Paclitaxel in Patients With Advanced or Metastatic NSCLC
Official title: Efficacy and Safety of Camrelizumab Combined With Nb-Paclitaxel in Patients With Recurrent/Metastatic Non-small-cell Lung Cancer After the Failure of Platinum-based Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Immune Checkpoint Inhibitor
nb-Paclitaxel
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2019-11-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the efficacy and safety of Camrelizumab in combination with nb-Paclitaxel in treating patients with recurrent/metastatic non-small-cell lung cancer.

Detailed description: Camrelizumab is a humanized monoclonal antibody against Programmed death 1(PD-1). Albumin-bound paclitaxel is a new nano-paclitaxel drug coated with human albumin. Patients with recurrent/metastatic non-small-cell lung cancer after the failure of platinum-based therapy will received Camrelizumab 200mg((3mg/kg for underweight patients) iv and nb-Paclitaxel 260mg/m2 iv every 3 weeks. The efficacy and safety will be observed.

Eligibility criteria: Inclusion Criteria:

1. Male and Female ≥ 18 years of age
2. Subjects enrolled must have histologically-confirmed or cytologically confirmed diagnosis of stage ⅢB,Ⅳnon-small cell lung cancer（NSCLC）,at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST)
3. Disease progression experienced during or after one prior platinum containing doublet chemotherapy（excluding taxane chemotherapy）
4. Subjects must have had no more than one prior systemic chemotherapeutic regimen Note: a. Replacement of platinum drugs for toxicity is considered as a systemic chemotherapeutic regimen; b.Subjects with recurrent disease \> 6 months after Postoperative adjuvant platinum based chemotherapy, who also subsequently progressed during or after a platinum-doublet regimen given to treat the recurrence, are eligible.
5. Life expectancy ≥ 12 weeks.
6. ECOG performance status of 0 or 1.
7. The main organ's function is normal and it should meet the following criteria:

   Blood routine examination should be complied with (No blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 14 days):
   1. ANC ≥ 1.5×109/L；
   2. PLT ≥ 100×109/L；
   3. HB ≥ 90 g/L；
   4. ALB ≥ 30 g/L
   5. TSH ≤ ULN (however, patients with free Triiodothyronine \[FT3\] or free Thyroxine \[FT4\] levels ≤ ULN may be enrolled)
   6. TBIL ≤ULN；
   7. ALT、AST≤ 1.5 ULN
   8. AKP≤2.5 ULN
   9. Cr≤1.5ULN，endogenous creatinine clearance rate≥60ml/min(Cockcroft-Gault formula);
8. 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.
9. Subjects should be voluntarily participate in clinical studies and informed consent should be signed.

Exclusion Criteria:

1. Subjects have a history of any active autoimmune disease or autoimmune disease including but not limited to the following: autoimmune hepatitis,interstitial pneumonia,uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism which can be included after hormone replacement therapy; Subjects with childhood asthma have been completely alleviated and without any intervention or vitiligo in adulthood can be included. Subjects who need medical intervention with bronchodilators can not be included.
2. Participated in other clinical trials, or finish other clinical trials within 4 weeks.
3. Known history of hypersensitivity to any components of the Camrelizumab formulation，or other monoclonal antibody.
4. Known history of hypersensitivity to paclitaxel or albumin human .
5. Peripheral blood neutrophils \<1500/mm3
6. Subjects with epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation.
7. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least two months prior to the first dose of trial treatment and any Neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment.
8. Clinically significant cardiovascular diseases, including but not limited to congestive heart failure (New York heart association (NYHA) class \> 2), unstable or severe angina, severe acute myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia which need medical intervention.
9. Subjects with congenital or acquired immunodeficiency such as HIV infection, active hepatitis B (HBV DNA ≥ 2000 IU/ml), hepatitis C (hepatitis C antibody is positive).
10. Subjects with other factors that might lead to the termination of the study, such as serious diseases (including mental illness) requiring combined treatment, severe laboratory abnormality, and family or social factors，which will affect the safety of the subjects, or the collection of data and samples. in the opinion of the treating Investigator.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 12 months
Secondary outcomes:
measure: 12-month PFS rate
timeFrame: From date of enrollment up to 12 months
measure: Progression-free Survival (PFS)
timeFrame: Time Frame: Up to approximately 24 months
measure: Overall survival (OS)
timeFrame: Up to approximately 24 months
measure: Duration of Response (DCR)
timeFrame: Up to approximately 24 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 24 months
measure: Incidence of Adverse Events (AEs) in the treatment of Camrelizumab in combination with nb-Paclitaxel
timeFrame: Up to approximately 24 months
Other outcomes:
measure: PD-L1 expression on tumor and immune cells
timeFrame: Up to approximately 24 months
measure: Tumor Mutation Burden (TMB)
timeFrame: Up to approximately 24 months
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The first affiliated hospital of guangzhou medical university
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Xiuyu Cai, MD
role: PRINCIPAL_INVESTIGATOR
References: