Non-Small Cell Lung CancerEarly Phase 1NCT06436885
An Exploratory Study of Efficacy and Safety of Iruplinalkib Tablets in Patients With ROS1 Positive Non-small Cell Lung Cancer
A Early Phase 1 study testing Iruplinalkib tablets in people with Non-Small Cell Lung Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This is a single-arm, open, multicenter exploratory clinical trial to observe and evaluate the efficacy and safety of Iruplinalkib Tablets in patients with ROS1 positive non-small cell lung cancer. 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?
- Iruplinalkib tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2024to 31 Dec 2025
- Phase
- Early Phase 1
- 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
- Volunteer to join the study and sign the informed consent
- ≥18 years old
- Histologically or cytologically confirmed stage III unresectable or stage IV ROS1 positive non-small cell lung cancer
- The ECOG performance status is 0-2
- At least one measurable lesion according to RECIST 1.1
- Can swallow pills normally
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- No brain metastases, or asymptomatic brain metastases, or symptomatic brain metastases that are stable for >4 weeks after treatment
- The function of vital organs meets the following requirements (no blood component, cell growth factor drugs are allowed within 14 days before the first medication):
- Absolute neutrophil count ≥1.5×109/L Platelet ≥100×109/L Hemoglobin ≥90 g/L Serum albumin ≥30 g/L Serum total bilirubin ≤1.5×ULN ALT and AST≤ 2.5 x ULN; if liver metastasis exists, ALT and AST≤5ULN AKP≤ 2.5×ULN Serum creatinine ≤1.5×ULN International Standardized Ratio (INR) ≤1.5×ULN (not receiving anticoagulation therapy)
- Non-surgical sterilization or female patients of reproductive age who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 3 months after the end of the study treatment period; Serum or urine HCG tests must be negative for women of childbearing age who have been sterilized without surgery within 7 days prior to the first dose. And must be non-lactation period; For male patients whose partner is a woman of reproductive age, effective contraception should be used during the trial and within 3 months after the last dose of the trial drug
Who cannot join
- Patients who are participating in another clinical study or are receiving another investigational drug, or who received the investigational device within 4 weeks prior to the first treatment of our investigational drug. Patients may be included in this study if they are participating in a non-interventional clinical trial
- Mixed small cell and NSCLC histology
- Known history or evidence of interstitial lung disease or active non-infectious pneumonia
- Have had other malignancies within the past 5 years or at the same time (except cured basal cell carcinoma of the skin and cervical carcinoma in situ)
- Prior surgery or immunotherapy must be completed at least 4 weeks, and radiotherapy must be completed at least 2 weeks before the investigational drug begins
- Have high blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); Allow the above parameters to be achieved through the use of antihypertensive therapy; A history of hypertensive crisis or hypertensive encephalopathy
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- Have clinical symptoms or diseases of heart that are not well controlled, such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc>450ms (male); QTc>470ms (Female)
- Patients with pleural effusion, ascites, or pericardial effusion requiring drainage can be enrolled if their symptoms are assessed to be stable after drainage
- Congenital or acquired immune deficiency (such as HIV infection); Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥2000 IU/ml, or hepatitis C virus antibody positive
- Live vaccine was administered within 4 weeks prior to or possibly during the study period
- The presence of active gastrointestinal (GI) disease or other conditions that significantly interfere with the absorption, distribution, metabolism, or excretion of the investigational drug
- Known allergy to the investigational drug or its excipients
- According to the investigator's judgment, the patient has other factors that may affect the study results or lead to the forced termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious laboratory abnormalities, and family or social factors, which will affect the safety of the patient.
Trial locations and contacts
1 site in 1 country.
Jie Liu contact
China1 site, 1 recruiting
- Recruiting
Henan cancer hospital
Zhengzhou, Henan
Yanqiu Zhao, 13938252350, 13938252350@163.com
About this study
This is a single-arm, open, multicenter exploratory clinical trial to observe and evaluate the efficacy and safety of Iruplinalkib Tablets in patients with ROS1 positive non-small cell lung cancer.
Read the detailed description
Iruplinalkib Tablets should be administered orally at a roughly fixed time each day. Once daily, on an empty stomach or with food, 60mg per dose for days 1 to 7, 180 mg per dose from day 8 if tolerated. Swallow the tablet whole, do not crush, divide or chew the tablet.
The primary end point was objective response rate
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Iruplinalkib tablets
- Keywords
- non-small cell lung cancer, ROS1, Iruplinalkib 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.
Iruplinalkib tabletsDrug
Also called Qi Xin Ke
Iruplinalkib tablets should be administered orally at a roughly fixed time each day. Once daily, on an empty stomach or with food, 60mg per dose for days 1 to 7, 180 mg per dose from day 8 if tolerated. Swallow the tablet whole, do not crush, divide or chew the tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Iruplinaakib tablets should be administered orally at a roughly fixed time each day. Once daily, on an empty stomach or with food, 60mg per dose for days 1 to 7, 180 mg per dose from day 8 if tolerated. Swallow the tablet whole, do not crush, divide or chew the tablet Receives: Drug: Iruplinalkib tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start28 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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 CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yanqiu Zhao, Henan Cancer Hospital
- Investigators
- Yanqiu Zhao, Study chair, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436885
- Sponsor's protocol ID
- QLMA-NSCLC-IIT-001
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Efficacy and Safety of Iruplinalkib Tablets in Patients With ROS1 Positive Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06436885
- Acronym / sponsor ID
- QLMA-NSCLC-IIT-001
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, ROS1, Iruplinalkib Tablets
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 May 2024 (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, open, multicenter exploratory clinical trial to observe and evaluate the efficacy and safety of Iruplinalkib Tablets in patients with ROS1 positive non-small cell lung cancer.
Detailed description
Iruplinalkib Tablets should be administered orally at a roughly fixed time each day. Once daily, on an empty stomach or with food, 60mg per dose for days 1 to 7, 180 mg per dose from day 8 if tolerated. Swallow the tablet whole, do not crush, divide or chew the tablet.
The primary end point was objective response rate
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Iruplinalkib tabletsIruplinaakib tablets should be administered orally at a roughly fixed time each day. Once daily, on an empty stomach or with food, 60mg per dose for days 1 to 7, 180 mg per dose from day 8 if tolerated. Swallow the tablet whole, do not crush, divide or chew the tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Volunteer to join the study and sign the informed consent
- ≥18 years old
- Histologically or cytologically confirmed stage III unresectable or stage IV ROS1 positive non-small cell lung cancer
- The ECOG performance status is 0-2
- At least one measurable lesion according to RECIST 1.1
Key exclusion criteria (13 listed)
- Patients who are participating in another clinical study or are receiving another investigational drug, or who received the investigational device within 4 weeks prior to the first treatment of our investigational drug. Patients may be included in this study if they are participating in a non-interventional clinical trial
- Mixed small cell and NSCLC histology
- Known history or evidence of interstitial lung disease or active non-infectious pneumonia
- Have had other malignancies within the past 5 years or at the same time (except cured basal cell carcinoma of the skin and cervical carcinoma in situ)
- Prior surgery or immunotherapy must be completed at least 4 weeks, and radiotherapy must be completed at least 2 weeks before the investigational drug begins
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 |
|---|---|---|
| Iruplinalkib tabletsAlso: Qi Xin KeIruplinalkib tablets should be administered orally at a roughly fixed time each day. Once daily, on an empty stomach or with food, 60mg per dose for days 1 to 7, 180 mg per dose from day 8 if tolerated. Swallow the tablet whole, do not crush, divide or chew the tablet | Drug | Treatment group |
Primary outcome
Objective Response Rate
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
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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.
Jie Liu contact
Yanqiu Zhao study chair
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Iruplinalkib tablets in people with Non-Small Cell Lung Cancer, run by Henan Cancer Hospital 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 10 inclusion and 13 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 31 May 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Yanqiu Zhao (13938252350, 13938252350@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: up to 24 months). 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 31 May 2024.