Real World Study on First Line Crizotinib in ROS1 Rearranged Advanced Non-squamous Non-small Cell Lung Cancer
A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ROS1-rearranged Non-squamous Non-small Cell Lung Cancer
1 other identifier
observational
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 23, 2018
CompletedFirst Posted
Study publicly available on registry
August 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedDecember 27, 2023
December 1, 2023
6.4 years
August 23, 2018
December 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PFS
progression survival time
may 2018- may 2019 (1 year)
Secondary Outcomes (2)
ORR
may 2018- may 2019 (1 year)
OS
may 2018- may 2019 (1 year)
Study Arms (1)
Cohorts 1
ROS1 fusion positive NSCLC patients who received crizotinib
Interventions
Eligibility Criteria
ROS1 rearranged Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by NGS
You may qualify if:
- ≥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
You may not qualify if:
- Patients received antitumor treatment before
- Patients with contraindication of chemotherapy
- Pregnant or breast feeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Related Publications (1)
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.
PMID: 34511132DERIVED
Biospecimen
tissue sample and plasma DNA
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongchang Zhang, MD
Hunan Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 23, 2018
First Posted
August 24, 2018
Study Start
August 1, 2018
Primary Completion
December 31, 2024
Study Completion
December 1, 2025
Last Updated
December 27, 2023
Record last verified: 2023-12