Real-World Study of Iruplinalkib in the Treatment of ALK-... | NCT05991895

Studies
Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer

NCT05991895

Sponsor

Jinming Yu

Status

Recruiting

Last Update Posted

Aug 15, 2023Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Non-small Cell Lung Cancer (NSCLC)

Interventions

Iruplinalkib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2023Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Aug 8, 2023

First Submission Date that Met QC Criteria

Aug 8, 2023

First Posted Date

Aug 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2023

Last Update Posted Date

Aug 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a national multicenter real-world investigation aimed at evaluating the real-world effectiveness and safety of Iruplinalkib in the treatment of ALK-positive NSCLC in China.

The study aims to enroll ALK-positive NSCLC patients who have undergone treatment with Iruplinalkib prior to enrollment. Demographic information, medical history, Iruplinalkib-containing treatment regimens, clinical outcomes, adverse events, and related data will be collected for all enrolled patients.

As this study is a real-world investigation, treatment procedures, visit schedules, and examinations will be based on the routine clinical practice of physicians. The primary sources of data for this study will mainly consist of patients' routine medical records or healthcare documentation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iruplinalkib	Drug	Iruplinalkib is administered orally with approximately fixed dosing times each day. The recommended dosage is once daily, on an empty stomach or with food, at 60 mg per dose for the first 1 to 7 days. If tolerated, the dosage is increased to 180 mg per dose starting from the 8th day.

Measure	Description	Time Frame
Adverse Events (AEs)		36 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients willingly contribute their clinical data for this study
Patients with ALK-positive non-small cell lung cancer
Age ≥ 18 years
Patients who have undergone treatment with Iruplinalkib.

Exclusion Criteria:

Known pregnant or lactating females
Patients with interstitial lung diseases, drug-related pneumonitis, or radiation pneumonitis require ongoing medical intervention.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ALK-positive non-small cell lung cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jinming Yu, PhD	Contact	8613806406293		jn7984729@public.jn.sd.cn
Linlin Wang, PhD	Contact	8613793187739		wanglinlinatjn@163.com

Overall Officials

Name	Affiliation	Role
JinMing Yu, PhD	Shandong Cancer Hospital and Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shandong Cancer Hospital and Institute	Recruiting	Jinan	Shandong		China

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided