Back to resultsWX-0593 Combined With Concurrent Chemoradiotherapy in Unresectable Locally Advanced NSCLC
Primary Purpose
Non-small Cell Lung Cancer (NSCLC)
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
WX-0593 Tablets
chemotherapy
Thoracic Radiation Therapy（TRT）
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC) focused on measuring NSCLC, Unresectable , Radiochemotherapy, WX-0593
Eligibility Criteria
Inclusion Criteria:
- Male or female aged 18 years or older;
- Pathologically confirmed NSCLC who present with investigator-assessed previously untreated, unresectable, locally advanced (Stage II、III) disease (according to TMN staging of AJCC version 8);
- Has active mutation of ALK or ROS1;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- Has at least one evaluable lesion (according to RECIST 1.1);
- Have adequate pulmonary function test as a forced expiratory volume in 1 second (FEV1) >50% of predicted normal volume and carbon monoxide lung diffusing capacity (DLCO) >40% of predicted normal value;
- Have adequate organ and marrow function;
- If participant is a woman of childbearing potential (WOCBP), must agree to follow the contraceptive guidance from written informed consent until at least 180 days after the last dose of study treatment. The female participant should have negative serum pregnancy test within 7 days prior to the first dose of study drug, and not breastfeeding;
- A male participant must agree to use contraception from written informed consent until at least 180 days after the last dose of study treatment.
Exclusion Criteria:
- Diagnosed other malignant tumor besides NSCLC within 5 years prior to study entry;
- Mixed small cell and non-small cell lung cancer histology;
- Has received prior therapy with any ALK TKI;
- Has a history of extensive diffuse/bilateral interstitial fibrosis, or grade 3 or 4 pulmonary fibrosis or interstitial lung disease prior to the first dose of study drug.
Has a known history of active tuberculosis; severe infection within 4 weeks prior to study entry;
- History of primary immunodeficiency;
- Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
Sites / Locations
- Shandong Cancer Hospital and InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WX-0593 single arm
Arm Description
Part 1: Participants will receive WX-0593 monotherapy until disease progression or unacceptable toxicity. Part 2: Participants will receive 1 or 2 cycles of WX-0593 monotherapy and subsequently with concurrent chemoradiation, followed by WX-0593 monotherapy until disease progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Develop Grade 3 or Higher drug-related Pneumonitis
Secondary Outcome Measures
Progression Free Survival (PFS)
PFS is defined as the time from the first dose of study drug to the first documented disease progression or death due to any cause, whichever occurs first
Overall Survival (OS)
OS is defined as the time from the first dose of study drug to death due to any cause.
Adverse Events (AEs)
Percentage of participants who experienced one or more AEs.
Disease control rate (DCR)
Objective response rate (ORR)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05351320
Brief Title
WX-0593 Combined With Concurrent Chemoradiotherapy in Unresectable Locally Advanced NSCLC
Official Title
A Phase II Study of WX-0593 Combined With Concurrent Chemoradiotherapy in the Treatment of Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of ALK or ROS1
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2022 (Anticipated)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
May 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jinming Yu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this trial is to evaluate the safety of WX-0593 combined with concurrent chemoradiotherapy in unresectable, locally advanced non-small cell lung cancer (NSCLC) with activating mutation of ALK or ROS1. This trial consists of two parts. In Part 1, approximately 8 patients will be included and receive WX-0593 maintenance until disease progression or unacceptable toxicity. In Part 2, approximately 32 patients will be included and receive WX-0593 monotherapy for 1-2 cycles and subsequently with concurrent chemoradiation, followed by WX-0593 maintenance until disease progression or unacceptable toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer (NSCLC)
Keywords
NSCLC, Unresectable , Radiochemotherapy, WX-0593
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WX-0593 single arm
Arm Type
Experimental
Arm Description
Part 1: Participants will receive WX-0593 monotherapy until disease progression or unacceptable toxicity.
Part 2: Participants will receive 1 or 2 cycles of WX-0593 monotherapy and subsequently with concurrent chemoradiation, followed by WX-0593 monotherapy until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
WX-0593 Tablets
Other Intervention Name(s)
Iruplinalkib
Intervention Description
WX-0593 60 mg, tablets, orally, once daily for 7 days, followed by WX-0593 180 mg, tablets, orally, once daily
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Description
Platinum-based chemotherapy
Intervention Type
Radiation
Intervention Name(s)
Thoracic Radiation Therapy（TRT）
Intervention Description
Five days a week to accept chest radiotherapy, once per day, every time 1.8-2.0 Gy, total dose 54-66 Gy
Primary Outcome Measure Information:
Title
Percentage of Participants Who Develop Grade 3 or Higher drug-related Pneumonitis
Time Frame
within 90 days after radiation therapy
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from the first dose of study drug to the first documented disease progression or death due to any cause, whichever occurs first
Time Frame
24 months
Title
Overall Survival (OS)
Description
OS is defined as the time from the first dose of study drug to death due to any cause.
Time Frame
24 months
Title
Adverse Events (AEs)
Description
Percentage of participants who experienced one or more AEs.
Time Frame
24 months
Title
Disease control rate (DCR)
Time Frame
24 months
Title
Objective response rate (ORR)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female aged 18 years or older;
Pathologically confirmed NSCLC who present with investigator-assessed previously untreated, unresectable, locally advanced (Stage II、III) disease (according to TMN staging of AJCC version 8);
Has active mutation of ALK or ROS1;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
Has at least one evaluable lesion (according to RECIST 1.1);
Have adequate pulmonary function test as a forced expiratory volume in 1 second (FEV1) >50% of predicted normal volume and carbon monoxide lung diffusing capacity (DLCO) >40% of predicted normal value;
Have adequate organ and marrow function;
If participant is a woman of childbearing potential (WOCBP), must agree to follow the contraceptive guidance from written informed consent until at least 180 days after the last dose of study treatment. The female participant should have negative serum pregnancy test within 7 days prior to the first dose of study drug, and not breastfeeding;
A male participant must agree to use contraception from written informed consent until at least 180 days after the last dose of study treatment.
Exclusion Criteria:
Diagnosed other malignant tumor besides NSCLC within 5 years prior to study entry;
Mixed small cell and non-small cell lung cancer histology;
Has received prior therapy with any ALK TKI;
Has a history of extensive diffuse/bilateral interstitial fibrosis, or grade 3 or 4 pulmonary fibrosis or interstitial lung disease prior to the first dose of study drug.
Has a known history of active tuberculosis; severe infection within 4 weeks prior to study entry;
History of primary immunodeficiency;
Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinming Yu, PhD
Phone
8613806406293
Email
jn7984729@public.jn.sd.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Linlin Wang, PhD
Phone
8613793187739
Email
wanglinlinatjn@163.com
Facility Information:
Facility Name
Shandong Cancer Hospital and Institute
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinming Yu, PhD
12. IPD Sharing Statement
Learn more about this trial
WX-0593 Combined With Concurrent Chemoradiotherapy in Unresectable Locally Advanced NSCLC
We'll reach out to this number within 24 hrs