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PD-1 Combined With Dasatinib for as Third-line Treatment for ARID1A Mutation Advanced NSCLC

Primary Purpose

NSCLC Stage IV, ARID1A, PD-1

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PD-1 plus Dasatinib
Sponsored by
The Affiliated Hospital of Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC Stage IV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- 1. Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures 2. over 18 years old 3. Metastatic (stage IV) NSCLCwith ARID1A mutation underwent 2 lines of prior treatment.

4. World Health Organization (WHO) performance status 0-2 5. Adequate bone marrow reserve and organ function as demonstrated by complete blood count, biochemistry in blood and urine at baseline 6. ECG recording at baseline showing absence of any cardiac abnormality as per exclusion criterion #5 7. Female patients of childbearing potential must be using adequate contraceptive measures must not be breast feeding, and must have a negative pregnancy test prior to start of dosing.

Exclusion Criteria:

- 1. Subjects with known EGFR and ALK mutations are excluded. 2. Subjects with untreated CNS metastases are excluded 3. Subjects with an active, known or suspected autoimmune disease. 4. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody or any other antibody targeting T cell co-regulatory pathways.

5. Prior therapy with Dasatinib 6. Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.

Sites / Locations

  • The Affiliated Hospital of Qingdao University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD-1 plus Dasatinib

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Overall survival(OS)

Full Information

First Posted
February 23, 2020
Last Updated
February 24, 2020
Sponsor
The Affiliated Hospital of Qingdao University
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1. Study Identification

Unique Protocol Identification Number
NCT04284202
Brief Title
PD-1 Combined With Dasatinib for as Third-line Treatment for ARID1A Mutation Advanced NSCLC
Official Title
PD-1 Combined With Dasatinib for as Third-line Treatment for ARID1A Mutation Advanced NSCLC
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Hospital of Qingdao University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evalute the efficacy and safety of PD-1 antibody combined with Dasatinib as third-line therapy for NSCLC patients with ARID1A mutation until disease progression or intolerable toxicity or patients withdrawal of consent. The target sample size is 30+individuals. The primary endpoint of this study is PFS、ORR、OS and the secondary endpoint is toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC Stage IV, ARID1A, PD-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PD-1 plus Dasatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PD-1 plus Dasatinib
Intervention Description
Toripalimub 240mg injection day1; Dasatinib 100mg po qd day1-day21. 3weeks is 1 cycle.
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
Event driven, an expected average of 6 months
Secondary Outcome Measure Information:
Title
Overall survival(OS)
Time Frame
An expected average of 24months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 1. Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures 2. over 18 years old 3. Metastatic (stage IV) NSCLCwith ARID1A mutation underwent 2 lines of prior treatment. 4. World Health Organization (WHO) performance status 0-2 5. Adequate bone marrow reserve and organ function as demonstrated by complete blood count, biochemistry in blood and urine at baseline 6. ECG recording at baseline showing absence of any cardiac abnormality as per exclusion criterion #5 7. Female patients of childbearing potential must be using adequate contraceptive measures must not be breast feeding, and must have a negative pregnancy test prior to start of dosing. Exclusion Criteria: - 1. Subjects with known EGFR and ALK mutations are excluded. 2. Subjects with untreated CNS metastases are excluded 3. Subjects with an active, known or suspected autoimmune disease. 4. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody or any other antibody targeting T cell co-regulatory pathways. 5. Prior therapy with Dasatinib 6. Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.
Facility Information:
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaochun Zhang, MD
Email
zxcgcp@126.com
First Name & Middle Initial & Last Name & Degree
Na Zhou, MD
Email
zhounabb0912@126.com
First Name & Middle Initial & Last Name & Degree
Xiaochun Zhang, MD
First Name & Middle Initial & Last Name & Degree
Chuantao Zhang, MD
First Name & Middle Initial & Last Name & Degree
Helei Hou, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PD-1 Combined With Dasatinib for as Third-line Treatment for ARID1A Mutation Advanced NSCLC

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