Potentially Resectable ALK Positive Non-Small Cell Lung CancerPhase 2NCT06282536
Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive NSCLC: A Single Arm, Exploratory Trial
A Phase 2 study testing Iruplinalkib and surgery in people with Potentially Resectable ALK Positive Non-Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
Fusion of anaplastic lymphoma kinase (ALK) is an important driving gene for NSCLC, with an incidence rate of 3-7%. In patients with advanced ALK mutation NSCLC, first-line use of ALK inhibitors significantly improves progression free survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Potentially Resectable ALK Positive Non-Small Cell Lung Cancer
- What is being tested?
- Iruplinalkib and surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 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
- 1. The patient shall sign the Informed Consent Form. 2.Aged 18 ≥ years. 3.Histological or cytological diagnosis of NSCLC by needle biopsy, and evaluated by researchers as stage III-IVA, and diagnosed as ALK positive through genetic testing.
- 4.Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1. 5. According to the MDT evaluation (which should include a thoracic surgeon specializing in tumor surgery), it is considered that the primary NSCLC is potentially completely resectable; 6. At least 1 measurable lesion according to RECIST 1.1. 7.Patients with good function of other main organs (liver, kidney, blood system, etc.) 8.Patients with lung function can tolerate surgery; 9.Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative. 10. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 d
Who cannot join
- 1. Previously received targeted therapy (including TKI or monoclonal antibodies), immunotherapy, or any investigational drug treatment for NSCLC; 2.Pathological confirmation of mixed small cell and non-small cell lung cancer; 3.Patients with a malignancy other than NSCLC within five years prior to the start of this trial，except for cured basal cell carcinoma of the skin, early gastrointestinal (GI) carcinoma excised through endoscopy, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, or any cured cancer deemed to have no impact on the survival of the current NSCLC; 4.Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 5.Patients with congenital or acquired immune dysfunction (such as HIV infected individuals); 6.Received other major surgical treatments (excluding diagnosis) within 4 weeks prior to the start of the study or expected to undergo major surgical treatments during the study period; 7.Participants who are allergic to the test drug or any auxiliary materials; 8.A history of extensive diffuse bilateral interstitial fibrosis in the past or before medication, or a known grade 3 or 4 history of interstitial fibrosis or interstitial lung disease, including pneumonia, allergic pneumonia, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not including local radiation pneumonia or radiation pulmonary fibrosis history;8. Pregnant or lactating women; 9.Any malabsorption; 10.Participants suffering from nervous system diseases or mental diseases that cannot cooperate 11.Other factors that researchers think it is not suitable for enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Shuangyi Li, PhD contact
About this study
Official title: Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive Non-Small Cell Lung Cancer: A Single Arm, Exploratory Trial
Fusion of anaplastic lymphoma kinase (ALK) is an important driving gene for NSCLC, with an incidence rate of 3-7%. In patients with advanced ALK mutation NSCLC, first-line use of ALK inhibitors significantly improves progression free survival. The perioperative research on ALK positive NSCLC was relatively late, and currently most studies mainly focus on early to mid stage ALK positive NSCLC patients. The results of two Phase III clinical trials showed that second-generation ALK targeted drugs, neoadjuvant and/or adjuvant therapy for ALK positive NSCLC, significantly prolonged DFS in patients, including increased pathological response rate, median response duration, and prolonged OS. For ALK positive advanced NSCLC patients who are resistant to second-generation ALK targeted drugs, there is currently limited exploration and there is an urgent need for new exploratory clinical studies.This trial aims to evaluate the effectiveness of Iruplinalkib neoadjuvant therapy for potentially resectable ALK positive non-small cell lung cancer.
- Being tested
- Iruplinalkib, surgery
- Keywords
- Non-Small Cell Lung Cancer, ALK, Iruplinalkib, Potentially Resectable Lung Cancer
- 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.
IruplinalkibDrug
60 mg on days 1-7, if tolerable, 180 mg from day 8 onwards.
surgeryProcedure or surgery
Patients with resectable tumors after neoadjuvant therapy will be treated with surgery.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Therapy With Iruplinalkib | Experimental | In this arm, 20 patients with III-IVA stage, potentially resectable ALK Positive non-small cell lung cancer will receive 4 circles of neoadjuvant Iruplinalkib. And the patients who are resectable after neoadjuvant therapy will be treated with surgery. Postoperative patients receive adjuvant Iruplinalkib therapy up to 2 years/until the disease progressed. Receives: Drug: Iruplinalkib; Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined according to the RECIST v1.1 criteria.
Measured: up to 30 months
Secondary outcomes (8)
Pathologic complete response (PCR) rate
PCR rate is defined as the proportion of participants who have achieved pathologic complete response (on routine hematoxylin and eosin staining, no tumor cell can be found in tumor bed or lymph node) in all participants.
Measured: Up to 30 months
Major pathologic response (MPR) rate
MPR rate is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants.
Measured: Up to 30 months
Overall survival (OS)
It is defined as the time (months) from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
Measured: up to 60 months
Event-free survival (EFS)
Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: up to 60 months
Treatment-related adverse event (TRAE)
TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants.
Measured: Up to 30 months
5-year overall survival (OS)
OS is defined as the time (months) from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
Measured: Up to 72 months
1-year event-free survival (EFS) rate
Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note:
the appearance of one or more new lesions is also considered progression).
Measured: Up to 24 months
Health related quality of life (HRQol)
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 \& LC13, Version 3). EORTC's QLQ-C30 \& LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potentially Resectable ALK Positive Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled patients received Iruplinalkib neoadjuvant therapy.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282536
- Sponsor's protocol ID
- LungMate-018
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The researchers will consider whether IPD is available to other researchers only after the paper is published.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive Non-Small Cell Lung Cancer: A Single Arm, Exploratory Trial
- ClinicalTrials.gov ID
- NCT06282536
- Acronym / sponsor ID
- LungMate-018
- Keywords
- Non-Small Cell Lung Cancer, ALK, Iruplinalkib, Potentially Resectable Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 28 Feb 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.
Fusion of anaplastic lymphoma kinase (ALK) is an important driving gene for NSCLC, with an incidence rate of 3-7%. In patients with advanced ALK mutation NSCLC, first-line use of ALK inhibitors significantly improves progression free survival. The perioperative research on ALK positive NSCLC was relatively late, and currently most studies mainly focus on early to mid stage ALK positive NSCLC patients. The results of two Phase III clinical trials showed that second-generation ALK targeted drugs, neoadjuvant and/or adjuvant therapy for ALK positive NSCLC, significantly prolonged DFS in patients, including increased pathological response rate, median response duration, and prolonged OS. For ALK positive advanced NSCLC patients who are resistant to second-generation ALK targeted drugs, there is currently limited exploration and there is an urgent need for new exploratory clinical studies.This trial aims to evaluate the effectiveness of Iruplinalkib neoadjuvant therapy for potentially resectable ALK positive non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled patients received Iruplinalkib neoadjuvant therapy.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Therapy With Iruplinalkib | Experimental | Drug: Iruplinalkib, Procedure: surgeryIn this arm, 20 patients with III-IVA stage, potentially resectable ALK Positive non-small cell lung cancer will receive 4 circles of neoadjuvant Iruplinalkib. And the patients who are resectable after neoadjuvant therapy will be treated with surgery. Postoperative patients receive adjuvant Iruplinalkib therapy up to 2 years/until the disease progressed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. The patient shall sign the Informed Consent Form. 2.Aged 18 ≥ years. 3.Histological or cytological diagnosis of NSCLC by needle biopsy, and evaluated by researchers as stage III-IVA, and diagnosed as ALK positive through genetic testing.
- 4.Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1. 5. According to the MDT evaluation (which should include a thoracic surgeon specializing in tumor surgery), it is considered that the primary NSCLC is potentially completely resectable; 6. At least 1 measurable lesion according to RECIST 1.1. 7.Patients with good function of other main organs (liver, kidney, blood system, etc.) 8.Patients with lung function can tolerate surgery; 9.Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative. 10. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 d
Key exclusion criteria (1 listed)
- 1. Previously received targeted therapy (including TKI or monoclonal antibodies), immunotherapy, or any investigational drug treatment for NSCLC; 2.Pathological confirmation of mixed small cell and non-small cell lung cancer; 3.Patients with a malignancy other than NSCLC within five years prior to the start of this trial，except for cured basal cell carcinoma of the skin, early gastrointestinal (GI) carcinoma excised through endoscopy, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, or any cured cancer deemed to have no impact on the survival of the current NSCLC; 4.Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 5.Patients with congenital or acquired immune dysfunction (such as HIV infected individuals); 6.Received other major surgical treatments (excluding diagnosis) within 4 weeks prior to the start of the study or expected to undergo major surgical treatments during the study period; 7.Participants who are allergic to the test drug or any auxiliary materials; 8.A history of extensive diffuse bilateral interstitial fibrosis in the past or before medication, or a known grade 3 or 4 history of interstitial fibrosis or interstitial lung disease, including pneumonia, allergic pneumonia, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not including local radiation pneumonia or radiation pulmonary fibrosis history;8. Pregnant or lactating women; 9.Any malabsorption; 10.Participants suffering from nervous system diseases or mental diseases that cannot cooperate 11.Other factors that researchers think it is not suitable for enrollment.
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 |
|---|---|---|
| Iruplinalkib60 mg on days 1-7, if tolerable, 180 mg from day 8 onwards. | Drug | Neoadjuvant Therapy With Iruplinalkib |
| surgeryPatients with resectable tumors after neoadjuvant therapy will be treated with surgery. | Procedure or surgery | Neoadjuvant Therapy With Iruplinalkib |
Primary outcome
Objective response rate (ORR)
Time frame: up to 30 months
ORR is defined according to the RECIST v1.1 criteria.
8 secondary outcomes
Pathologic complete response (PCR) rate
Time frame: Up to 30 months
Major pathologic response (MPR) rate
Time frame: Up to 30 months
Overall survival (OS)
Time frame: up to 60 months
Event-free survival (EFS)
Time frame: up to 60 months
Treatment-related adverse event (TRAE)
Time frame: Up to 30 months
5-year overall survival (OS)
Time frame: Up to 72 months
1-year event-free survival (EFS) rate
Time frame: Up to 24 months
Health related quality of life (HRQol)
Time frame: Up to 36 months
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 28 Feb 2024.
- Individual participant dataSharing planned: Undecided. The researchers will consider whether IPD is available to other researchers only after the paper is published.
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.
Shuangyi Li, PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iruplinalkib and surgery in people with Potentially Resectable ALK Positive Non-Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Peng Zhang, PhD (021-65115006, zhangpeng1121@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 30 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 28 Feb 2024.