Non-small Cell Lung CancerNCT05450081
Association Between the Results of Specific Genetic Tests and the Efficacy of Targeted Therapies in Patients
An observational study of Non-small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
Our study aimed to evaluate the correlation between test reagent specific gene test results and the efficacy of relevant targeted drugs in patients with non-small cell lung cancer, and to support the continued registration of test reagents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2022to 1 Oct 2023
- 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: Patients with non-small cell lung cancer who have previously received single-agent K therapy
Who may be able to join
- 1)≥18，advanced non-small cell lung cancer confirmed by histopathology, and were previously or currently treated with gefitinib tablets (as the first-line treatment) or osimertinib (first-generation TKI resistance treatment) or crizotinib capsules monotherapy were evaluated for efficacy.
- 2) Able to provide FFPE samples with a storage life of 5 years: Large specimen 5 pieces in each case; 10 puncture specimens in each case
Who cannot join
- 1) Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells >20%);
- 2) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;
- 3) Maintenance treatment when the disease does not progress after other anti-tumor treatments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trials to Evaluate the Association Between the Results of Specific Genetic Tests and the Efficacy of Targeted Therapies in Patients With Non-small Cell Lung Cancer
Our study aimed to evaluate the correlation between test reagent specific gene test results and the efficacy of relevant targeted drugs in patients with non-small cell lung cancer, and to support the continued registration of test reagents.
- Conditions
- Non-small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival time
Measured: October 2022-December 2022
ORR
Objective response rate
Measured: October 2022-December 2022
Consistency
he consistency of efficacy between specified kit and 22C3
Measured: October 2022-December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start30 Jun 2022
- Primary completion31 Mar 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 140 participants (actual)
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
- NCT05450081
- Sponsor's protocol ID
- ART
- Status last verified
- Dec 2023
- First submitted
- 29 Jun 2022
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Clinical Trials to Evaluate the Association Between the Results of Specific Genetic Tests and the Efficacy of Targeted Therapies in Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05450081
- Acronym / sponsor ID
- ART
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 8 Jul 2022 (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.
Our study aimed to evaluate the correlation between test reagent specific gene test results and the efficacy of relevant targeted drugs in patients with non-small cell lung cancer, and to support the continued registration of test reagents.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-small cell lung cancer who have previously received single-agent K therapy
Key inclusion criteria (2 listed)
- 1)≥18，advanced non-small cell lung cancer confirmed by histopathology, and were previously or currently treated with gefitinib tablets (as the first-line treatment) or osimertinib (first-generation TKI resistance treatment) or crizotinib capsules monotherapy were evaluated for efficacy.
- 2) Able to provide FFPE samples with a storage life of 5 years: Large specimen 5 pieces in each case; 10 puncture specimens in each case
Key exclusion criteria (3 listed)
- 1) Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells >20%);
- 2) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;
- 3) Maintenance treatment when the disease does not progress after other anti-tumor treatments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFS
Time frame: October 2022-December 2022
Progression free survival time
ORR
Time frame: October 2022-December 2022
Objective response rate
Consistency
Time frame: October 2022-December 2022
he consistency of efficacy between specified kit and 22C3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
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 2 inclusion and 3 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: October 2022-December 2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.