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

Last updated: November 20, 2019
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT04167774
Compass-001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and Female ≥ 18 years of age

  2. Subjects enrolled must have histologically-confirmed or cytologically confirmeddiagnosis of stage ⅢB,Ⅳnon-small cell lung cancer(NSCLC),at least one measurablelesion according to the Response Evaluation Criteria in Solid Tumors (RECIST)

  3. Disease progression experienced during or after one prior platinum containing doubletchemotherapy(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 systemicchemotherapeutic regimen; b.Subjects with recurrent disease > 6 months afterPostoperative adjuvant platinum based chemotherapy, who also subsequently progressedduring or after a platinum-doublet regimen given to treat the recurrence, areeligible.

  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 ofhematopoietic factors and no use of drugs for correction within 14 days):

  8. ANC ≥ 1.5×109/L;

  9. PLT ≥ 100×109/L;

  10. HB ≥ 90 g/L;

  11. ALB ≥ 30 g/L

  12. TSH ≤ ULN (however, patients with free Triiodothyronine [FT3] or free Thyroxine [FT4] levels ≤ ULN may be enrolled)

  13. TBIL ≤ULN;

  14. ALT、AST≤ 1.5 ULN

  15. AKP≤2.5 ULN

  16. Cr≤1.5ULN,endogenous creatinine clearance rate≥60ml/min(Cockcroft-Gault formula);

  17. Women of childbearing age must undergo a serological pregnancy test within 7 daysbefore the first dose with negative results and willing to use a medically approvedand effective contraceptive method (e.g. intrauterine device, contraceptive pill orcondom) during the study and within two months after the last dose. For male subjectswhose partners are women of childbearing age, they should be sterilized surgically oragree to use effective contraceptive methods during the study and within two monthsafter the last dose.

  18. Subjects should be voluntarily participate in clinical studies and informed consentshould be signed.

Exclusion

Exclusion Criteria:

  1. Subjects have a history of any active autoimmune disease or autoimmune diseaseincluding but not limited to the following: autoimmune hepatitis,interstitialpneumonia,uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis,myocarditis, nephritis, hyperthyroidism, hypothyroidism which can be included afterhormone replacement therapy; Subjects with childhood asthma have been completelyalleviated 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,orother 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/oranaplastic lymphoma kinase (ALK) translocation.

  7. Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis. Subjects with previously treated brain metastases may participate providedthey are stable (without evidence of progression by imaging for at least two monthsprior to the first dose of trial treatment and any Neurologic symptoms have returnedto baseline), have no evidence of new or enlarging brain metastases, and are not usingsteroids for at least 14 days prior to trial treatment.

  8. Clinically significant cardiovascular diseases, including but not limited tocongestive heart failure (New York heart association (NYHA) class > 2), unstable orsevere 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, activehepatitis 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 asserious diseases (including mental illness) requiring combined treatment, severelaboratory abnormality, and family or social factors,which will affect the safety ofthe subjects, or the collection of data and samples. in the opinion of the treatingInvestigator.

Study Design

Total Participants: 62
Study Start date:
July 30, 2019
Estimated Completion Date:
September 30, 2022

Study 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.

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

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

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • The first affiliated hospital of guangzhou medical university

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

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