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

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.

Study Overview

• Status: Unknown
• Conditions: NSCLC Stage IV; PD-1; ARID1A
• Intervention / Treatment: Drug: PD-1 plus Dasatinib

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Qingdao, China
    • The Affiliated Hospital of Qingdao University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PD-1 plus Dasatinib	Drug: PD-1 plus Dasatinib; Toripalimub 240mg injection day1; Dasatinib 100mg po qd day1-day21. 3weeks is 1 cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival	Event driven, an expected average of 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival(OS)	An expected average of 24months

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (ACTUAL): February 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Dasatinib
• Other Study ID Numbers: IOT-ARID1A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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