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

NCT ID: NCT04284202

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-12-31

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.

Conditions

NSCLC Stage IV; ARID1A; PD-1

Study Design

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

Study Groups

PD-1 plus Dasatinib

Group Type: EXPERIMENTAL

PD-1 plus Dasatinib

Intervention Type: DRUG

Toripalimub 240mg injection day1; Dasatinib 100mg po qd day1-day21. 3weeks is 1 cycle.

Interventions

PD-1 plus Dasatinib

Toripalimub 240mg injection day1; Dasatinib 100mg po qd day1-day21. 3weeks is 1 cycle.

Intervention Type: DRUG

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.

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

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

zhangxiaochun

Director of Precision Medicine Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Affiliated Hospital of Qingdao University

Qingdao, , China

Countries

China

Facility Contacts

Xiaochun Zhang, MD

Role: primary

zxcgcp@126.com

Na Zhou, MD

Role: backup

zhounabb0912@126.com

Other Identifiers

IOT-ARID1A

Identifier Type: -

Identifier Source: org_study_id