Non-Small Cell Lung Cancer(NSCLC)Phase 2NCT05765877
Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer
A Phase 2 study testing WX-0593 Tablets in people with Non-Small Cell Lung Cancer(NSCLC), run by Pingping Song at 1 site in China.
Trial summary
This is a single-arm, exploratory trial to evaluate the efficacy and safety of neoadjuvant WX-0593 in patients with resectable ALK-positive or ROS1- positive non-small cell lung cancer(NSCLC). 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed non-small cell lung cancer (NSCLC).
- ALK-positive or ROS1-positive NSCLC in Stage IB-IIIA (according to the 8th American Joint Committee on Cancer TNM edition), as assessed by investigator.
- Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialized in oncologic procedures).
- ECOG Performance Status of 0-1.
- At least one measurable lesion according to RECIST 1.1.
- Adequate organ and marrow function.
Who cannot join
- Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug.
- Prior treatment with ALK TKI or ROS1 TKI.
- Prior treatment with local radiotherapy.
- Mixed small cell and NSCLC histology.
- Patients who are candidates to undergo only segmentectomies or wedge resections.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Pingping Song
About this study
Official title: Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer : a Single-arm, Exploratory Trial
This is a single-arm, exploratory trial to evaluate the efficacy and safety of neoadjuvant WX-0593 in patients with resectable ALK-positive or ROS1- positive non-small cell lung cancer(NSCLC).
- Conditions
- Non-Small Cell Lung Cancer(NSCLC)
- Being tested
- WX-0593 Tablets
- 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
60 mg of WX-0593 tablets, once daily for 7 days, followed by 180 mg of WX-0593 tablets, once daily in a 28-days cycle.
| Study group | Role | What they receive |
|---|---|---|
| WX-0593 | Experimental | The treatment will be administrated as neoadjuvant 8 weeks before surgery. After surgical intervention the treatment will be administered up to 2 years. Treatment will be discontinued in case of unacceptable toxicity or disease progression. Receives: Drug: WX-0593 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathologic Response (MPR) Rate
Major pathologic response (MPR) rate is defined as percentage of residual viable tumor cells histologically detected in the resected primary tumor after surgery ≤10%.
Measured: At time of surgery
Secondary outcomes (8)
Pathologic Complete Response (pCR) Rate
Pathologic complete response (pCR) rate is defined as the percentage of participants with absence of residual tumor in lung and lymph nodes.
Measured: At time of surgery
Resectability rate
Resectability rate is defined as the percentage of participants who were able to undergo surgery after neoadjuvant therapy.
Measured: At time of surgery
R0 Resection rate
R0 Resection rate is defined as the percentage of participants who were able to undergo R0 Resection surgery after neoadjuvant therapy.
Measured: At time of surgery
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the percentage of participants who have a complete response (CR) or partial response (PR). Responses are according to RECIST 1.1 as assessed by investigator.
Measured: Prior to surgery
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD). Responses are according to RECIST 1.1 as assessed by investigator.
Measured: Prior to surgery
Event-free survival (EFS)
Event-free survival (EFS) is the length of time after initial administration the participant remains free of recurrence/progression or death, whatever the cause.
Measured: 3 years postoperatively
Disease-free survival (DFS)
Disease-free survival (DFS) is the length of time after surgical resection the participant remains free of recurrence/progression or death, whatever the cause.
Measured: 3 years postoperatively
Overall Survival (OS)
Overall Survival (OS) is the length of time after initial administration the participant remains alive.
Measured: 3 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Mar 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2029 (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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pingping Song
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pingping Song, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765877
- Sponsor's protocol ID
- WX0593-IIT-001
- Status last verified
- Jun 2025
- First submitted
- 1 Mar 2023
- Last updated
- 12 Jun 2025
- 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 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer : a Single-arm, Exploratory Trial
- ClinicalTrials.gov ID
- NCT05765877
- Acronym / sponsor ID
- WX0593-IIT-001
- Conditions
- Non-Small Cell Lung Cancer(NSCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Pingping SongUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 13 Mar 2023 (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.
This is a single-arm, exploratory trial to evaluate the efficacy and safety of neoadjuvant WX-0593 in patients with resectable ALK-positive or ROS1- positive non-small cell lung cancer(NSCLC).
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 | Experimental | Drug: WX-0593 TabletsThe treatment will be administrated as neoadjuvant 8 weeks before surgery. After surgical intervention the treatment will be administered up to 2 years. Treatment will be discontinued in case of unacceptable toxicity or disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed non-small cell lung cancer (NSCLC).
- ALK-positive or ROS1-positive NSCLC in Stage IB-IIIA (according to the 8th American Joint Committee on Cancer TNM edition), as assessed by investigator.
- Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialized in oncologic procedures).
- ECOG Performance Status of 0-1.
- At least one measurable lesion according to RECIST 1.1.
Key exclusion criteria (5 listed)
- Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug.
- Prior treatment with ALK TKI or ROS1 TKI.
- Prior treatment with local radiotherapy.
- Mixed small cell and NSCLC histology.
- Patients who are candidates to undergo only segmentectomies or wedge resections.
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 Tablets60 mg of WX-0593 tablets, once daily for 7 days, followed by 180 mg of WX-0593 tablets, once daily in a 28-days cycle. | Drug | WX-0593 |
Primary outcome
Major Pathologic Response (MPR) Rate
Time frame: At time of surgery
Major pathologic response (MPR) rate is defined as percentage of residual viable tumor cells histologically detected in the resected primary tumor after surgery ≤10%.
8 secondary outcomes
Pathologic Complete Response (pCR) Rate
Time frame: At time of surgery
Resectability rate
Time frame: At time of surgery
R0 Resection rate
Time frame: At time of surgery
Objective Response Rate (ORR)
Time frame: Prior to surgery
Disease Control Rate (DCR)
Time frame: Prior to surgery
Event-free survival (EFS)
Time frame: 3 years postoperatively
Disease-free survival (DFS)
Time frame: 3 years postoperatively
Overall Survival (OS)
Time frame: 3 years postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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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.
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 in people with Non-Small Cell Lung Cancer(NSCLC), run by Pingping Song 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pingping Song (18663776711, SPP128@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathologic Response (MPR) Rate (time frame: At time of surgery). 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 12 Jun 2025.