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

NCT04284202 | Unknown Phase 2 DMC

• 1 other identifier: IOT-ARID1A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Event driven, an expected average of 6 months

Secondary Outcomes (1)

• Overall survival(OS)

  An expected average of 24months

Study Arms (1)

PD-1 plus Dasatinib

EXPERIMENTAL

Drug: PD-1 plus Dasatinib

Interventions

PD-1 plus Dasatinib DRUG

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

PD-1 plus Dasatinib

Eligibility Criteria

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

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.
• \. 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Dasatinib

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)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

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: Director of Precision Medicine Center

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: February 25, 2020
• Study Start: March 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)