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Real World Study of First Line Crizotinib for ALK Rearranged Non-squamous Non-small Cell Lung Cancer

NCT ID: NCT03647111

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-12-01

Brief Summary

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This study aims to explore the efficacy and safety of Crizotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world.

Detailed Description

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According to the study of P11014 and P1029, Crizotinib is a first-line therapy for advanced non squamous non small cell lung cancer with positive ALK rearrangement.This study aims to explore the efficacy and safety of clozotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world. Among them, ALK positive was based on NGS test results, exploring the new drug resistance mechanism of ALK under clozotinib treatment mode and consistency between plasma and tissue detection driving genes, and finally assessing the role of plasma dynamic detection driving gene mutation spectrum in predicting disease progression risk. A retrospective study of 120 patients with advanced NSCLC using clozotinib ALK positive mutation was conducted to observe the efficacy and safety of clozotinib regimen in the real world.

Conditions

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Non-small Cell Lung Cancer

Keywords

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Non-small Cell Lung Cancer ALK rearranged Crizotinib

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohorts 1

Crizotinib

Intervention Type DRUG

Crizotinib 250mg po bid

Interventions

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Crizotinib

Crizotinib 250mg po bid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥18，Pathologically proven ALK positive mutation in advanced non squamous non small cell lung cancer
* ALK rearrangement detection method is NGS and Ventana
* Primary treatment of first diagnosis

Exclusion Criteria

* Patients received antitumor treatment before
* Patients with contraindication of chemotherapy
* Pregnant or breast feeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hunan Province Tumor Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yongchang Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yongchang Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Hunan Cancer Hospital

Locations

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Hunan Cancer Hospital

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongchang Zhang, MD

Role: CONTACT

Phone: +8613873123436

Email: [email protected]

Nong Yang, MD

Role: CONTACT

Phone: +8613873123436

Email: [email protected]

Facility Contacts

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Yongchang Zhang, MD

Role: primary

Nong Yang, MD

Role: backup

References

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Zhou Y, Song L, Xu Q, Zeng L, Jiang W, Yang N, Zhang Y. Investigation on the survival implications of PD-L1 expression status in ALK- rearranged advanced non-small cell lung cancer treated with first-line crizotinib. Lung Cancer. 2022 May;167:58-64. doi: 10.1016/j.lungcan.2022.04.002. Epub 2022 Apr 6.

Reference Type DERIVED
PMID: 35405360 (View on PubMed)

Zhang Y, Zeng L, Zhou C, Li Y, Wu L, Xia C, Jiang W, Hu Y, Liao D, Xiao L, Liu L, Yang H, Xiong Y, Guan R, Lizaso A, Mansfield AS, Yang N. Detection of Nonreciprocal/Reciprocal ALK Translocation as Poor Predictive Marker in Patients With First-Line Crizotinib-Treated ALK-Rearranged NSCLC. J Thorac Oncol. 2020 Jun;15(6):1027-1036. doi: 10.1016/j.jtho.2020.02.007. Epub 2020 Feb 27.

Reference Type DERIVED
PMID: 32112982 (View on PubMed)

Other Identifiers

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RECURE

Identifier Type: -

Identifier Source: org_study_id