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Real World Study on First Line Crizotinib in ROS1 Rearranged Advanced Non-squamous Non-small Cell Lung Cancer

NCT ID: NCT03646994

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

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2025-12-01

Brief Summary

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This study was designed to explore the efficacy and safety of Crizotinib as a first-line treatment for advanced NSCLC with ROS1 rearrangement positive mutation in the real world, explore the new drug resistance mechanism of ROS1 under Crizotinib treatment and the consistency of plasma and tissue detection driving genes, and finally evaluate the mutation spectrum of plasma dynamic detection driving genes. In predicting the risk of disease progression.

Detailed Description

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This is a research project involving patients in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School of Medicine Central South University. Retrospective study of 40 patients with advanced non-squamous non-small cell lung cancer (NSCLC) using Crizotinib ROS1 rearrangement positive mutation was conducted to observe the efficacy and safety of Crizotinib regimen in the real world.Exploratory research contents are as follows: 1. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the initial diagnosis; 2. Consistency between NGS and plasma gene test (NGS) at the progression of clozotinib treatment; 3. Drug resistance mechanism of clozotinib in ROS1 rearrangement positive NSCLC; 4. Plasma drug resistance. Large panel dynamic driven gene mutation analysis was used to construct disease progression risk model.

Conditions

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Non-small Cell Lung Cancer

Keywords

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Non-small Cell Lung Cancer Crizotinib ROS1 Rearranged

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohorts 1

ROS1 fusion positive NSCLC patients who received crizotinib

Crizotinib

Intervention Type DRUG

Crizotinib Cap 250 mg po bid

Interventions

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Crizotinib

Crizotinib Cap 250 mg po bid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
* ROS1 Arranged Positive
* ROS1 Arranged Detection Method is NGS
* First Diagnosis and Treatment
* Treatment Plan is Kazolinib 250mg po bid

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

Yes

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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Zhang Y, Zhang X, Zhang R, Xu Q, Yang H, Lizaso A, Xu C, Liu J, Wang W, Ou SI, Zhang J, Song Z, Yang N. Clinical and molecular factors that impact the efficacy of first-line crizotinib in ROS1-rearranged non-small-cell lung cancer: a large multicenter retrospective study. BMC Med. 2021 Sep 13;19(1):206. doi: 10.1186/s12916-021-02082-6.

Reference Type DERIVED
PMID: 34511132 (View on PubMed)

Other Identifiers

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CORE

Identifier Type: -

Identifier Source: org_study_id