Non-small Cell Lung CancerNCT03647111
Real World Study of First Line Crizotinib for ALK Rearranged Non-squamous Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Crizotinib
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients who diagnosed ALK positive mutation in advanced non squamous non small cell lung cancer treated by Crizotinib.
Who may be able to join
- ≥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
- The treatment was Crizotinib 250mg po bid Exclusion Criteria
- Patients received antitumor treatment before
- Patients with contraindication of chemotherapy
- Pregnant or breast feeding women
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Yongchang Zhang, MD, +86 731 89762323, zhangyongchang@csu.edu.cn
Nong Yang, MD, +86 731 89762321, yangnong0217@163.com
About this study
Official title: A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ALK Rearranged Advanced Non Squamous Non-small Cell Lung Cancer
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.
Read the detailed description
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
- Non-small Cell Lung Cancer
- Being tested
- Crizotinib
- Keywords
- Non-small Cell Lung Cancer, ALK rearranged, Crizotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrizotinibDrug
Crizotinib 250mg po bid
| Study group | Role | What they receive |
|---|---|---|
| Cohorts 1 | Not described Receives: Drug: Crizotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: Approximately 1 years
Secondary outcomes (1)
OS
Overall survival
Measured: Approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Yongchang Zhang, MD, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647111
- Sponsor's protocol ID
- RECURE
- Status last verified
- Dec 2023
- First submitted
- 23 Aug 2018
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35405360Zhang 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.
PubMed 32112982
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ALK Rearranged Advanced Non Squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03647111
- Acronym / sponsor ID
- RECURE
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small Cell Lung Cancer, ALK rearranged, Crizotinib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohorts 1 | – | Drug: Crizotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients who diagnosed ALK positive mutation in advanced non squamous non small cell lung cancer treated by Crizotinib.
Key inclusion criteria (7 listed)
- ≥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
- The treatment was Crizotinib 250mg po bid Exclusion Criteria
- Patients received antitumor treatment before
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrizotinibCrizotinib 250mg po bid | Drug | Cohorts 1 |
Primary outcome
PFS
Time frame: Approximately 1 years
Progression free survival
1 secondary outcome
OS
Time frame: Approximately 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Derived from this study: PubMed 35405360Zhou 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.
- Derived from this study: PubMed 32112982Zhang 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.
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongchang Zhang, MD principal investigator
Hunan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongchang Zhang, MD (+8613873123436 ext. +8613873123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Approximately 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03647111, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.