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Non-small Cell Lung CancerPhase 2NCT04641754

A Study Evaluates the Safety and Efficacy of WX-0593 in 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, run by Qilu Pharmaceutical Co., Ltd. at 41 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the study is to evaluate safety and efficacy of WX-0593 oral tablets in 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
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
176 participants
Where
41 sitesChina
Study dates
7 Mar 2019to Mar 2021
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

  • ≥18 years.
  • Female or male;
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Expected survival no less than 12 weeks.
  • Patient should have at least one measurable lesion (RECIST 1.1); Lesions previously treated with radiotherapy can be considered target lesions only if there is a clear evidence of progression after radiotherapy.
  • Histologically or cytologically confirmed advanced ALK-positive NSCLC in upper first-class hospitals，or histologically or cytologically confirmed advanced ROS1-positive NSCLC in a central laboratory. Admission of ROS1-positive patients will be based on the positive test results confirmed by the central laboratory or by the local-approved method.
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  • Patients with ALK-positive NSCLC who had been progressive disease after at least 12 weeks of continuous treatment with crizotinib .
  • Patients with ROS1-positive NSCLC who failed in standard treatment (eg.resistant /intolerance of crizotinib or chemotherapy).
  • Patients with ROS1-positive NSCLC who cannot accept chemotherapy.
  • ROS1-positive NSCLC patients who could not afford crizotinib treatment.
  • Patients with or without asymptomatic CNS metastases, or symptomatic brain metastasis after treatment stabilized for more than 4 weeks, and with stopping systemic sex hormone therapy for more than 2 weeks.
  • Organ functions should meet the following requirements (Blood components, cell growth factors, drugs that stimulate the growth of WBC or platelets, or drugs used to correct anemia are not permitted within 14 days prior to the laboratory examination): ANC≥1.5*10^9/L PLT≥90*10^9/L,Hb≥90 g/L, Total Bilirubin （TBIL）≤1.5*Upper Limit of Normal（ULN） ( Gilbert's Syndrome TBIL ≤3.0*ULN and DBIL≤1.5*ULN )，Alanine Transaminase （ALT）and Aspartate Aminotransferase （AST）≤2.5*ULN. For liver metastasis patients, ALT and AST≤5*ULN, Cr≤1.5*ULN, LVEF≥50%.
  • Any surgery, prior radiotherapy (except for palliative radiotherapy)/procedures must be completed at least 4 weeks prior to starting the treatment with study drug. Palliative radiotherapy must be completed within 48 hours prior to starting treatment.
  • Subject understands and voluntarily provides informed consent.

Who cannot join

  • Received any prior ALK inhibitors other than crizotinib.
  • Patients with brain meningeal metastasis.
  • Any clinically significant cardiovascular disease within 6 months prior to the first dose of the investigational drug, including but not limited to: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident (including transient ischemic attack).
  • Two consecutive corrected QT interval (QTc) > 480 ms through ECG examination during screening, patients with NCI-CTCAE v4.03 Grade ≥2 arrhythmia, Grade ≥2 heart failure, atrial fibrillation and ventricular fibrillation of any grade, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
  • Concomitant use of medications that may cause QTc prolongation or induce Torsades de pointes within 14 days prior to the first dose of the investigational drug or during treatment.
  • Continuous use of corticosteroids for more than 30 days, or require chronic use of corticosteroids or other immunosuppressants.
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  • Past history of a large area of diffuse/interstitial pulmonary fibrosis, or known history of Grade 3 or 4 interstitial pulmonary fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonitis, interstitial lung disease, obliterative bronchiolitis, or pulmonary fibrosis, but does not include local radiation pneumonitis or radiation-induced pulmonary fibrosis.
  • Patients with Grade > 1 nausea, vomiting, or diarrhea (CTCAE 4.03), other GI dysfunction or GI disease that may potentially affect drug absorption (such as ulcerative disease or malabsorption syndrome).
  • Subject received other clinical trial treatment within 1 month prior to the first dose of the investigational drug (if the medication received is a marketed drug, then refer to exclusion criteria #11).
  • Patients who are HBsAg-positive and/or HBcAb positive and HBV DNA >10^3 copies/mL, or HCV antibody-positive, or syphilis antibody- positive or known HIV infected.
  • No more than 2 weeks between the most recent use of another anti-cancer treatment (half life ≤3 days) and the first dose of the investigational drug, or the most recent use of another anti-cancer treatment (half life > 3 days) is less than 4 weeks. Patients previously treated with crizotinib could take WX-0593 tables after 1 week from the last dose.
  • Patients who cannot suspend the use of a strong CYP3A4 inducer or inhibitor at least 1 weeks prior to this study and during the study. These drugs include but are not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, rifapentine, tipranavir, ritonavir, St. John's wart, and ketoconazole.
  • Patients who cannot suspend the use of a CYP3A4 substrate at least 1 weeks prior to this study and during the study, and the therapeutic index is low.
  • Pregnant or lactating female patients or a positive pregnancy test at baseline for females of childbearing potential.
  • Childbearing potential female patients who are unwilling to use effective contraceptive measures during the entire course of the study and within 6 months after the end of the study, or male patients who plan to have children.
  • Concurrent diseases that may seriously affect patient safety or impact patient completion of the study as determined by the investigator (such as clinically uncontrolled hypertension (blood pressure > 160/110 mmHg), severe diabetes, or thyroid disease).
  • Drug or alcohol abuse. Alcohol abuse refers to drinking 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 100mL of wine.
  • History of definitive neurological or mental disorder, including epilepsy or dementia.
  • Patients with other malignant tumors within 3 years prior to screening (except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, thyroid carcinoma in situ, and papillary thyroid carcinoma).
  • Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.

Trial locations and contacts

41 sites in 1 country.

Shunjiang Yu, CMO contact

0531-83129659

shunjiang.yu@qilu-pharma.com

Yuankai Shi, M.D contact

010-67781331

syuankaipumc@126.com

41 sites in 1 country

China41 sites, 41 recruiting

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Yuankai Shi, M.D., 86-010-87788293, syuankaipumc@126.com

    Recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100039

    Recruiting

  • Thoracic Oncology I Department, Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Thoracic Oncology II Department, Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Recruiting

  • Beijing Chest Hospital

    Beijing, Beijing Municipality, 101149

    Recruiting

  • General Department, Beijing Chest Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 132000

    Recruiting

  • Hunan Tumor Hospital

    Changsha, Hunan, 410006

    Recruiting

  • Army Medical Center of PLA

    Chongqing, Chongqing Municipality, 400042

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Recruiting

  • Cancer Center of Guangzhou Medical University

    Guangzhou, Guangdong, 510095

    Recruiting

  • Hangzhou first people's Hospital

    Hangzhou, Zhejiang, 310006

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

    Recruiting

  • Oncology Department, Anhui Cancer Hospital

    Hefei, Anhui, 233004

    Recruiting

  • Respiratory Department, Anhui Cancer Hospital

    Hefei, Anhui, 233004

    Recruiting

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010000

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Recruiting

  • Jinan Central Hospital

    Jinan, Shandong, 250013

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100

    Recruiting

  • Gansu Cancer Hospital

    Lanzhou, Gansu, 620100

    Recruiting

  • Liuzhou People's Hospital

    Liuzhou, Guangxi, 545006

    Recruiting

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637000

    Recruiting

  • Nanjing Chest Hospital

    Nanjing, Jiangsu, 210029

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266555

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiangzhuang, Hebei, 050019

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030013

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

    Recruiting

  • Cancer Hospital Affiliated to Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430070

    Recruiting

  • The Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu, 214062

    Recruiting

  • Tangdu Hospital

    Xi’an, Shanxi, 710038

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

    Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Recruiting

Other trials in China

About this study

Official title: Phase II Clinical Study to Evaluate the Efficacy and Safety of WX-0593 in Patients With Crizotinib-resistant ALK -Positive, or Crizotinib-resistant/Crizotinib-naive ROS1-positive Non-small Cell Lung Cancer (NSCLC)

The purpose of the study is to evaluate safety and efficacy of WX-0593 oral tablets in ALK -positive, or ROS1-positive non-small cell lung cancer (NSCLC)

Read the detailed description

The clinical study is a single-arm, phase II, open label, multicenter design in patients with crizotinib-resistant ALK -positive, or crizotinib-resistant/crizotinib-naive ROS1-positive 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

    Also called FL-006

    tablets, 60 mg→180mg, quaque die（QD）

Study groups in NCT04641754
Study groupRoleWhat they receive
WX-0593 TabletsExperimental60 mg of WX-0593 tablets, once daily for 7 days, followed by 180 mg of WX-0593 tablets, once daily in a 21-days cycle.
Receives: Drug: WX-0593 Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed Objective Response Rate (ORR) Assessed By An Independent Review Committee

    ORR is defined the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR) per an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.

    Measured: From frist administration of WX-0593 to the date that the last patients observed for 18 weeks.

Secondary outcomes (9)

  1. Confirmed Objective Response Rate (ORR) Assessed By Investigators

    ORR is defined the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR) per Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.

    Measured: From frist administration of WX-0593 to the date that the last patients observed for 18 weeks.

  2. Progression-free survival (PFS)

    PFS defined as the time from baseline to first observed disease progression or death from any cause.

    Measured: From frist administration of WX-0593 until firstly recorded disease progression or death (whichever occurs earlier), or to the date that the last patients observed for 18 weeks.

  3. Disease Control Rate (DCR)

    DCR is the percentage of patients with best response of CR, PR or Stable Disease (SD).

    Measured: From frist administration of WX-0593 to the date that the last patients observed for 18 weeks.

  4. Duration of Response (DOR)

    The DOR is defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date on which progressive disease (PD) is first noted or date of death.

    Measured: From frist administration of WX-0593 to the date that the last patients observed for 18 weeks .

  5. Time to Progression (TTP)

    Time to Progression

    Measured: From frist administration of WX-0593 to the date that the last patients observed for 18 weeks.

  6. Confirmed Intracranial Objective Response Rate (iORR)

    Confirmed iORR is defined as the proportion of the participants who have achieved CR or PR in the brain per a modification of RECIST version 1.1, after the initiation of study treatment, in participants with intracranial brain metastases at baseline.

    Measured: From frist administration of WX-0593 to the date that the last patients observed for 18 weeks.

  7. Overall Survival (OS)

    OS is the time from the start of study treatment to the date of death.

    Measured: From frist administration of WX-0593 until death due to any cause, withdraws informed consent, is lost to follow-up or refuses phone visits, or study completion（up to 2.5 years）

  8. Incidence of Adverse Events

    Incidence of All Adverse Events, Serious Adverse Events and Treatment-Emergent Adverse Events by CTCAE v4.03

    Measured: the date of written informed consent signed until at least 28 days after the last dose of study drug was administered.

  9. Cssmin

    Minimum value of steady plasma-drug concentration for WX-0593

    Measured: Pre-dose on Cycle 1 Day 1, Cycle 1 Day 7, Cycle 1 Day 21, Cycle 2 Day 21, and Cycle 4 Day 21 (each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2020
  2. Study start7 Mar 2019
  3. Primary completionDec 2020 (estimated)
  4. Study completionMar 2021 (estimated)

Resources

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
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04641754
Sponsor's protocol ID
WX0593-003
Status last verified
Nov 2020
First submitted
11 Nov 2020
Last updated
24 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shi Y, Chen J, Zhang H, Zhang Z, Zhang Y, Wang Z, Zhang S, Zhao J, Liu C, Wang X, Zhao Y, Hu C, Yang L, Hao X, Wang L, Liu Y, Yu Y, Zhao J, Wang M, Zhang L, Sun S, Hu Y, Gu K, Hang X, Shan J, Zhang Y, Tan B, Yang W, Yang R, Si M, Geng H, Li H, Kang X. Efficacy and safety of iruplinalkib (WX-0593) in ALK-positive crizotinib-resistant advanced non-small cell lung cancer patients: a single-arm, multicenter phase II study (INTELLECT). BMC Med. 2023 Feb 24;21(1):72. doi: 10.1186/s12916-023-02738-5.

    PubMed 36829154

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, run by Qilu Pharmaceutical Co., Ltd. at 41 sites 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 14 inclusion and 20 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites 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 Shunjiang Yu, CMO (0531-83129659, shunjiang.yu@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed Objective Response Rate (ORR) Assessed By An Independent Review Committee (time frame: From frist administration of WX-0593 to the date that the last patients observed for 18 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04641754, which also lists 1 linked publication.

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 24 Nov 2020.

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