Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05991895
  4. Details
NCT05991895 Clinical Trial

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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05991895
Other study ID # IRU-RWS-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 24, 2023
Est. completion date July 2026

Study information
Verified date August 2023
Source Shandong Cancer Hospital and Institute
Contact Jinming Yu, PhD
Phone 8613806406293
Email jn7984729@public.jn.sd.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date July 2026
Est. primary completion date July 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Iruplinalkib
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.

Locations
Country Name City State
China Shandong Cancer Hospital and Institute Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Jinming Yu

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events (AEs) 36 months
See also
  Status Clinical Trial Phase
Recruiting NCT06040541 - Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors Phase 1
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Active, not recruiting NCT03667820 - Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC Phase 2
Completed NCT02025114 - Selumetinib in Combination With Gefitinib in NSCLC Patients Phase 1/Phase 2
Recruiting NCT01994057 - A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment
Completed NCT01438307 - Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer Phase 2
Completed NCT01193959 - Pemetrexed in Advanced Non-small Cell Lung Cancer
Recruiting NCT01028729 - A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC) Phase 4
Completed NCT00770588 - Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC) Phase 4
Active, not recruiting NCT05462717 - Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors Phase 1
Completed NCT01951157 - A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients Phase 2
Recruiting NCT01964157 - An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement Phase 2
Active, not recruiting NCT04026412 - A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery Phase 3
Recruiting NCT05585320 - A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT03260491 - HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer Phase 1
Completed NCT05207423 - A Chart Review Study of Adults With Advanced NSCLC
Terminated NCT02608528 - Serial [18F]Fluorodeoxyglucose ([18F]FDG )PET/CT as a Biomarker of Therapeutic Response in Anti-PD1/PDL1 Therapy
Completed NCT01463423 - Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR) N/A
Recruiting NCT02927340 - A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions Phase 2
Recruiting NCT02521051 - Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer Phase 1/Phase 2