- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06282536
Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive NSCLC: A Single Arm, Exploratory Trial
Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive Non-Small Cell Lung Cancer: A Single Arm, Exploratory Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Peng Zhang, PhD
- Phone Number: 021-65115006
- Email: zhangpeng1121@tongji.edu.cn
Study Contact Backup
- Name: Shuangyi Li, PhD
- Email: dr.frederic.lee@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neoadjuvant Therapy With Iruplinalkib
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.
|
Patients with resectable tumors after neoadjuvant therapy will be treated with surgery.
60 mg on days 1-7, if tolerable, 180 mg from day 8 onwards.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: up to 30 months
|
ORR is defined according to the RECIST v1.1 criteria.
|
up to 30 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: up to 60 months
|
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.
|
up to 60 months
|
Pathologic complete response (PCR) rate
Time Frame: Up to 30 months
|
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.
|
Up to 30 months
|
Major pathologic response (MPR) rate
Time Frame: Up to 30 months
|
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.
|
Up to 30 months
|
Treatment-related adverse event (TRAE)
Time Frame: Up to 30 months
|
TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants.
|
Up to 30 months
|
Event-free survival (EFS)
Time Frame: up to 60 months
|
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).
|
up to 60 months
|
5-year overall survival (OS)
Time Frame: Up to 72 months
|
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.
|
Up to 72 months
|
Health related quality of life (HRQol)
Time Frame: Up to 36 months
|
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.
|
Up to 36 months
|
1-year event-free survival (EFS) rate
Time Frame: Up to 24 months
|
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). |
Up to 24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LungMate-018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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