Back to resultsTreatment of Non-small Cell Lung Cancer With PD-1 Monoclonal Antibody Combined With Donafenib Toluene Sulfonate
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
donafenib tablets
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring non-small cell lung cancer
Eligibility Criteria
Inclusion Criteria:
1、18 years age or older ,male or female
2、Histologically or cytologically confirmed diagnosis of local advanced or metastatic NSCLC
3、Previously received with two or more systemic Antitumor treatments (Chemotherapy or targeted therapy). Chemotherapy treatments must include a two-drug regimen containing platinum, patients with EGFR TKI drug resistance and unknow T790M mutation, after AZD9291 treatment patients with T790M mutation could be enrolled
4、At least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
5、Asymptomatic patients with uncontrolled brain metastases or brain metastases involving the pia mater
6、Patients must have recovered from all toxicities related to prior anticancer therapies to ≤ 2 (CTCAE v5.0). AE of Neurology must be ≤ 1
7、Life expectancy ≥ 12 weeks
8、ECOG performance status 0-1
Exclusion Criteria:
- Small cell lung cancer (including small lung cancer mixed with non-small cell lung cancer)
- Patients at risk of bleeding treated with antiangiogenic drugs
- Subjects who are using immunosuppressive agents, or systemic, or absorbable topical hormone therapy for immunosuppressive purposes (dose >10mg/ dprednisone or other therapeutic hormones) and who continue to use it for 2 weeks prior to enrollment
- Patients with active, known or suspected autoimmune diseases, including tuberculosis, HIV infection, active hepatitis, etc.
- Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severe impairment of lung function, etc
- Women who are pregnant or lactating, or who are unwilling to use contraception during the trial
Sites / Locations
- The First Affiliated Hospital of College of Medicine Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
donafenib tablets 1
donafenib tablets 2
Arm Description
This is the dose group was given once a day. donafenib tablets 1 100mg qd dose group
This is the dose group was given twice a day. donafenib tablets 2 100mg bid dose group
Outcomes
Primary Outcome Measures
safety assessments
safety assessments
Secondary Outcome Measures
Effective evaluation
progression-free survival (PFS)
Overall response rate
Disease control rate
Full Information
NCT ID
NCT04059874
First Posted
August 5, 2019
Last Updated
August 15, 2019
Sponsor
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04059874
Brief Title
Treatment of Non-small Cell Lung Cancer With PD-1 Monoclonal Antibody Combined With Donafenib Toluene Sulfonate
Official Title
To Assess the Safety and Efficacy of Third-line and Above Therapy of Patients With Local Advanced or Metastatic NSCLC With Combined Treatment With Launched Recombinant Humanized Anti-PD-1 Monoclonal Antibody and Donafenib Tosilate
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the safety and efficacy of third-line and above therapy of patients with local advanced or metastatic non-small cell lung cancer (NSCLC) with combined treatment with launched recombinant humanized anti-PD-1 monoclonal antibody and Donafenib Tosilate
Detailed Description
Donafenib has a multi-target and dual anti-tumor effect, similar to sorafenib toluene sulfonate, and its effect is similar to that of sorafenib toluene sulfonate. Donafenib has the potential to be effective in the treatment of cancer, including advanced non-small cell lung cancer. PD-1 inhibitor has become a new therapy for advanced non-small cell lung cancer because of its strong specificity, definite efficacy, small side effects and long time of tumor control.
This is a single-center, open, single-arm, exploratory phase Ib trial. There were two dosages of donafenib (100mg qd and 100mg bid, respectively). Three to six subjects were enrolled in the dosages of 100mg qd. The investigators determined that the dosages of 100mg bid were well tolerated
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
This is a single-center, open, single-arm, exploratory phase Ib trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
donafenib tablets 1
Arm Type
Experimental
Arm Description
This is the dose group was given once a day. donafenib tablets 1 100mg qd dose group
Arm Title
donafenib tablets 2
Arm Type
Experimental
Arm Description
This is the dose group was given twice a day. donafenib tablets 2 100mg bid dose group
Intervention Type
Drug
Intervention Name(s)
donafenib tablets
Intervention Description
donafenib tablets 100mg qd dose group and donafenib tablets 100mg bid dose group
Primary Outcome Measure Information:
Title
safety assessments
Description
safety assessments
Time Frame
From signing ICF to 30 days after the end of treatment
Secondary Outcome Measure Information:
Title
Effective evaluation
Description
progression-free survival (PFS)
Time Frame
Continue treatment until the end of treatment，an average of 12 months
Title
Overall response rate
Time Frame
Continue treatment until the end of treatment，an average of 12 months
Title
Disease control rate
Time Frame
Continue treatment until the end of treatment，an average of 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1、18 years age or older ,male or female
2、Histologically or cytologically confirmed diagnosis of local advanced or metastatic NSCLC
3、Previously received with two or more systemic Antitumor treatments (Chemotherapy or targeted therapy). Chemotherapy treatments must include a two-drug regimen containing platinum, patients with EGFR TKI drug resistance and unknow T790M mutation, after AZD9291 treatment patients with T790M mutation could be enrolled
4、At least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
5、Asymptomatic patients with uncontrolled brain metastases or brain metastases involving the pia mater
6、Patients must have recovered from all toxicities related to prior anticancer therapies to ≤ 2 (CTCAE v5.0). AE of Neurology must be ≤ 1
7、Life expectancy ≥ 12 weeks
8、ECOG performance status 0-1
Exclusion Criteria:
Small cell lung cancer (including small lung cancer mixed with non-small cell lung cancer)
Patients at risk of bleeding treated with antiangiogenic drugs
Subjects who are using immunosuppressive agents, or systemic, or absorbable topical hormone therapy for immunosuppressive purposes (dose >10mg/ dprednisone or other therapeutic hormones) and who continue to use it for 2 weeks prior to enrollment
Patients with active, known or suspected autoimmune diseases, including tuberculosis, HIV infection, active hepatitis, etc.
Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severe impairment of lung function, etc
Women who are pregnant or lactating, or who are unwilling to use contraception during the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianying Zhou, MD
Phone
13505719970
Email
drzjy@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianya Zhou, MD
Phone
13858123060
Email
zhoujianya@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianying Zhou, MD
Organizational Affiliation
First Affiliated Hospital of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of College of Medicine Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianying Zhou, MD
Phone
13505719970
Email
drzjy@163.com
First Name & Middle Initial & Last Name & Degree
Jianya Zhou, MD
Phone
13858123060
Email
zhoujianya@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share date of the trial
Learn more about this trial
Treatment of Non-small Cell Lung Cancer With PD-1 Monoclonal Antibody Combined With Donafenib Toluene Sulfonate
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