Non-small Cell Lung Cancer (NSCLC)Phase 2NCT05351320
WX-0593 Combined With Concurrent Chemoradiotherapy in Unresectable Locally Advanced NSCLC
A Phase 2 study testing WX-0593 Tablets, chemotherapy and Thoracic Radiation Therapy（TRT） in people with Non-small Cell Lung Cancer (NSCLC), run by Jinming Yu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- WX-0593 Tablets, chemotherapy and Thoracic Radiation Therapy（TRT）
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2022to 30 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Jinming Yu, PhD
About this study
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
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.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- WX-0593 Tablets, chemotherapy, Thoracic Radiation Therapy（TRT）
- Keywords
- NSCLC, Unresectable , Radiochemotherapy, WX-0593
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WX-0593 TabletsDrug
Also called Iruplinalkib
WX-0593 60 mg, tablets, orally, once daily for 7 days, followed by WX-0593 180 mg, tablets, orally, once daily
chemotherapyDrug
Platinum-based chemotherapy
Thoracic Radiation Therapy（TRT）Radiation
Five days a week to accept chest radiotherapy, once per day, every time 1.8-2.0 Gy, total dose 54-66 Gy
| Study group | Role | What they receive |
|---|---|---|
| WX-0593 single arm | Experimental | 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. Receives: Drug: WX-0593 Tablets; Drug: chemotherapy; Radiation: Thoracic Radiation Therapy（TRT） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Develop Grade 3 or Higher drug-related Pneumonitis
Measured: within 90 days after radiation therapy
Secondary outcomes (5)
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
Measured: 24 months
Overall Survival (OS)
OS is defined as the time from the first dose of study drug to death due to any cause.
Measured: 24 months
Adverse Events (AEs)
Percentage of participants who experienced one or more AEs.
Measured: 24 months
Disease control rate (DCR)
Measured: 24 months
Objective response rate (ORR)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start30 Apr 2022 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinming Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinming Yu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351320
- Sponsor's protocol ID
- FL006-IIT-002
- Status last verified
- Apr 2022
- First submitted
- 24 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05351320
- Acronym / sponsor ID
- FL006-IIT-002
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- NSCLC, Unresectable , Radiochemotherapy, WX-0593
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jinming YuUniversity, hospital or other
- Study start
- 30 Apr 2022 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WX-0593 single arm | Experimental | Drug: WX-0593 Tablets, Drug: chemotherapy, Radiation: Thoracic Radiation Therapy（TRT）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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WX-0593 TabletsAlso: IruplinalkibWX-0593 60 mg, tablets, orally, once daily for 7 days, followed by WX-0593 180 mg, tablets, orally, once daily | Drug | WX-0593 single arm |
| chemotherapyPlatinum-based chemotherapy | Drug | WX-0593 single arm |
| Thoracic Radiation Therapy（TRT）Five days a week to accept chest radiotherapy, once per day, every time 1.8-2.0 Gy, total dose 54-66 Gy | Radiation | WX-0593 single arm |
Primary outcome
Percentage of Participants Who Develop Grade 3 or Higher drug-related Pneumonitis
Time frame: within 90 days after radiation therapy
5 secondary outcomes
Progression Free Survival (PFS)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months
Adverse Events (AEs)
Time frame: 24 months
Disease control rate (DCR)
Time frame: 24 months
Objective response rate (ORR)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WX-0593 Tablets, chemotherapy and Thoracic Radiation Therapy（TRT） in people with Non-small Cell Lung Cancer (NSCLC), run by Jinming Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinming Yu, PhD (8613806406293, jn7984729@public.jn.sd.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Develop Grade 3 or Higher drug-related Pneumonitis (time frame: within 90 days after radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.