A Study to Evaluate Camrelizumab in Combination With Nb-Paclitaxel in Patients With Advanced or Metastatic NSCLC

NCT ID: NCT04167774

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-30
• Study Completion Date: 2022-09-30

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab +nb-Paclitaxel

Participants receive Camrelizumab 200mg(3mg/kg for underweight patients) iv and nb-Paclitaxel 260mg/m2 iv every 3 weeks until disease progression or unacceptable toxicity

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

Camrelizumab will be administered as a 30-minute IV infusion Q3W at a dose of 200mg (3mg/kg for underweight patients).

nb-Paclitaxel

Intervention Type: DRUG

nb-Paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 260mg/m2 for 4-6 cycles.

Interventions

Camrelizumab

Camrelizumab will be administered as a 30-minute IV infusion Q3W at a dose of 200mg (3mg/kg for underweight patients).

Intervention Type: DRUG

nb-Paclitaxel

nb-Paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 260mg/m2 for 4-6 cycles.

Intervention Type: DRUG

Other Intervention Names

Camrelizumab for Injection; Paclitaxel for Injection(Albumin Bound)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xiuyu Cai

Xiuyu Cai，Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiuyu Cai, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

The first affiliated hospital of guangzhou medical university

Guangzhou, Guangdong, China

Site Status: RECRUITING

The First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiuyu Cai, MD

Role: CONTACT

caixy_84@outlook.com

+86-13580569326

Facility Contacts

Xiuyu Cai, MD

Role: primary

caixy_84@outlook.com

Wenhua Liang, MD

Role: primary

Xicheng Wang, MD

Role: primary

Other Identifiers

Compass-001

Identifier Type: -

Identifier Source: org_study_id