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

NCT04167774 | Unknown Phase 2

• 1 other identifier: Compass-001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 3

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Immune Checkpoint Inhibitor; nb-Paclitaxel

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  Up to approximately 12 months

Secondary Outcomes (6)

• 12-month PFS rate

  From date of enrollment up to 12 months

• Progression-free Survival (PFS)

  Time Frame: Up to approximately 24 months

• Overall survival (OS)

  Up to approximately 24 months

• Duration of Response (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

Other Outcomes (2)

• PD-L1 expression on tumor and immune cells

  Up to approximately 24 months

• Tumor Mutation Burden (TMB)

  Up to approximately 24 months

Study Arms (1)

Camrelizumab +nb-Paclitaxel

EXPERIMENTAL

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

Drug: Camrelizumab; Drug: nb-Paclitaxel

Interventions

Camrelizumab DRUG

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

Also known as: Camrelizumab for Injection

Camrelizumab +nb-Paclitaxel

nb-Paclitaxel DRUG

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

Also known as: Paclitaxel for Injection(Albumin Bound)

Camrelizumab +nb-Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female ≥ 18 years of age
• 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)
• Disease progression experienced during or after one prior platinum containing doublet chemotherapy（excluding taxane chemotherapy）
• 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.
• Life expectancy ≥ 12 weeks.
• ECOG performance status of 0 or 1.
• 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):
• ANC ≥ 1.5×109/L；
• PLT ≥ 100×109/L；
• HB ≥ 90 g/L；
• ALB ≥ 30 g/L
• TSH ≤ ULN (however, patients with free Triiodothyronine \[FT3\] or free Thyroxine \[FT4\] levels ≤ ULN may be enrolled)
• TBIL ≤ULN；
• ALT、AST≤ 1.5 ULN

You may not qualify if:

• 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.
• Participated in other clinical trials, or finish other clinical trials within 4 weeks.
• Known history of hypersensitivity to any components of the Camrelizumab formulation，or other monoclonal antibody.
• Known history of hypersensitivity to paclitaxel or albumin human .
• Peripheral blood neutrophils \<1500/mm3
• Subjects with epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation.
• 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.
• 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.
• 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).
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (3)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

The first affiliated hospital of guangzhou medical university

Guangzhou, Guangdong, 510000, China

RECRUITING

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

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

camrelizumab; Injections; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Xiuyu Cai, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuyu Cai, MD

CONTACT

+86-13580569326; caixy_84@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xiuyu Cai，Principal investigator

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 19, 2019
• Study Start: July 30, 2019
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 22, 2019

Record last verified: 2019-11

Locations

CN (3)