Lung Cancer, Non-small CellPRECISENCT05598528
Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)
An observational study of Lung Cancer, Non-small Cell and EGFR Gene Mutation, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), especially the 3rd-generation EGFR-TKIs have demonstrated strong antitumor effects in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell, EGFR Gene Mutation, EGFR-TKI Resistant Mutation
- What is being tested?
- Genomic profiles detection and circulating tumor DNA detection
- Type of treatment
- Injection or infusion
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2021to 31 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Stage IIIB-IV EGFR-positive lung patients receiving 3rd generation EGFR-TKIs (Osimertinib 80mg/Qd or Almonertinib 110mg/Qd or Furmonertinib 80mg/Qd) as first-line therapy.
Who may be able to join
- Age >18 years;
- Histological or cytopathological diagnosed NSCLC;
- According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is unresectable IIIB-IV or recurrence and metastasis after surgery;
- At least one measurable lesion can be evaluated according to the Response Evaluation Criteria In Solid Tumours v1.1 (RECIST1.1) criteria;
- Positive EGFR mutation confirmed by tissue or cytology (pleural fluid, cerebrospinal fluid, etc.);
- Use of third-generation EGFR-TKIs approved by the NMPA for NSCLC as first-line therapy;
- Cooperate with the provision of clinicopathological data, imaging data, sample collection, and follow-up required for the research process, and agree to use the test data for subsequent research and product development;
- Agree to participate in this study and sign an informed consent form.
Who cannot join
- Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form;
- Pregnant and lactating women;
- Other malignant neoplastic diseases within 3 years;
- Patients who have undergone other clinical drug trials;
- Received systemic anti-tumor therapy within 2 years;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Oncology, The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011
Fang Wu, MD, PhD, +86 13574858332, wufang4461@csu.edu.cn
About this study
Official title: A Multicenter Clinical Study to Explore the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)
Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), especially the 3rd-generation EGFR-TKIs have demonstrated strong antitumor effects in EGFR-positive patients.
However, approximately 20% of EGFR-positive were primarily resistant to 3rd generation EGFR-TKIs, i.e., clinical non-response or disease progression in the short term.
This study aimed to clarify the molecular indicators that predict the benefits of 3-rd EGFR-TKIs as first-line therapy in NSCLCpatients with EGFR-positive. Further, to clarify their primary drug resistance mechanisms, which is of great significance for the treatment and clinical decision-making of NSCLC disease.
- Conditions
- Lung Cancer, Non-small Cell, EGFR Gene Mutation, EGFR-TKI Resistant Mutation, Primary Resistance, Circulating Tumor DNA
- Being tested
- Genomic profiles detection, circulating tumor DNA detection
- 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.
Genomic profiles detectionOther
The Paraffin-embedded tumor tissue at diagnosis is collected and assessed by Next- generation gene sequencing
circulating tumor DNA detectionOther
The Plasma at diagnosis and at 1-month treatment are collected and assessed by Next-generation gene sequencing
| Study group | Role | What they receive |
|---|---|---|
| EGFR-positive lung patients recieving 3rd generation EGFR-TKIs as first-line therapy | Stage III-IV EGFR-positive lung patients receiving 3rd generation EGFR-TKIs (Osimertinib 80mg/Qd or Almonertinib 110mg/Qd or Furmonertinib 80mg/Qd) as first-line therapy. Receives: Other: Genomic profiles detection; Other: circulating tumor DNA detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: 2 years
Progression-free survival (PFS)
Time from the beginning of treatment to the first disease progression (PD) in patients with advanced NSCLC
Measured: 3 years
Differences in genomic profiles of tumor tissues and ctDNA clearance of third-generation EGFR-TKIs sensitive and primary drug-resistant NSCLC.
The patients who don't achieve partial response or progress within 6 months are defined as the primary resistant group. The genomic profiles and ctDNA clearance detected by Next-generation gene sequencing will be compared between the primary drug-resistant group and sensitive-drug group.
Measured: 3 years
Secondary outcomes (2)
Overall survival (OS)
Overall survival (OS) is defined as the duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status
Measured: 5 years
Disease Control Rate (DCR)
The proportion of patients with a complete response or partial response or stable desease to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start28 Sep 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-small CellStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 210 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, Shanghai Chest Hospital, West China Hospital, Hunan Cancer Hospital, The Third Xiangya Hospital of Central South University, The First Affiliated Hospital of Xiamen University, Second Affiliated Hospital, Zhejiang University, School of Medicine, China-Japan Friendship Hospital, Fudan University, First Affiliated Hospital of Kunming Medical University, Loudi Central Hospital, ZhuZhou Central Hospital, Xiangtan Central Hospital, First People's Hospital of Chenzhou, Yueyang Central Hospital, Yongzhou Central Hospital, The First Affiliated Hospital of University of South China, Hunan Provincial People's Hospital, Hunan Shaoyang Central Hospital, Yiyang Central Hospital, Changsha Central Hospital, The First People's Hospital of Guiyang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Renmin Hospital of Wuhan University, The First People's Hospital of Changde City, Zhuzhou Second Hospital, Changsha First Hospital, Hengyang Central Hospital, Huaihua first people's Hospital, The First People's Hospital of Xiangtan, University of South China Affiliated Nanhua Hospital, Xiangxi Autonomous Prefecture People's Hospital, People's Hospital of Zhangjiajie, Second People's Hospital Of Huaihua, Hunan Academy of Traditional Chinese Medicine Affiliated Hospital, Changsha Third Hospital, Changde Hospital, Xiangya School of Medicine, Central South University, Hunan Provincial Straight Hospital of Traditional Chinese Medicine, Liuyang Hospital of traditional Chinese Medicine, Second People's Hospital of Hunan, First Affiliated Hospital of Guangxi Medical University, Guiyang Public Health Treatment Center, The Affiliated Bethune Hospital of Shanxi Medical University, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Tongji Hospital, The First Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Fang Wu, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598528
- Sponsor's protocol ID
- XYEYY20220928
- Acronym
- PRECISE
- Status last verified
- Nov 2024
- First submitted
- 25 Oct 2022
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study to Explore the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)
- ClinicalTrials.gov ID
- NCT05598528
- Acronym / sponsor ID
- PRECISE / XYEYY20220928
- Conditions
- Lung Cancer, Non-small Cell, EGFR Gene Mutation, EGFR-TKI Resistant Mutation, Primary Resistance, Circulating Tumor DNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, Shanghai Chest Hospital, West China Hospital, Hunan Cancer Hospital, The Third Xiangya Hospital of Central South University, The First Affiliated Hospital of Xiamen University, Second Affiliated Hospital, Zhejiang University, School of Medicine, China-Japan Friendship Hospital, Fudan University, First Affiliated Hospital of Kunming Medical University, Loudi Central Hospital, ZhuZhou Central Hospital, Xiangtan Central Hospital, First People's Hospital of Chenzhou, Yueyang Central Hospital, Yongzhou Central Hospital, The First Affiliated Hospital of University of South China, Hunan Provincial People's Hospital, Hunan Shaoyang Central Hospital, Yiyang Central Hospital, Changsha Central Hospital, The First People's Hospital of Guiyang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Renmin Hospital of Wuhan University, The First People's Hospital of Changde City, Zhuzhou Second Hospital, Changsha First Hospital, Hengyang Central Hospital, Huaihua first people's Hospital, The First People's Hospital of Xiangtan, University of South China Affiliated Nanhua Hospital, Xiangxi Autonomous Prefecture People's Hospital, People's Hospital of Zhangjiajie, Second People's Hospital Of Huaihua, Hunan Academy of Traditional Chinese Medicine Affiliated Hospital, Changsha Third Hospital, Changde Hospital, Xiangya School of Medicine, Central South University, Hunan Provincial Straight Hospital of Traditional Chinese Medicine, Liuyang Hospital of traditional Chinese Medicine, Second People's Hospital of Hunan, First Affiliated Hospital of Guangxi Medical University, Guiyang Public Health Treatment Center, The Affiliated Bethune Hospital of Shanxi Medical University, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Tongji Hospital, The First Affiliated Hospital of Nanchang University
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Oct 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.
Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), especially the 3rd-generation EGFR-TKIs have demonstrated strong antitumor effects in EGFR-positive patients.
However, approximately 20% of EGFR-positive were primarily resistant to 3rd generation EGFR-TKIs, i.e., clinical non-response or disease progression in the short term.
This study aimed to clarify the molecular indicators that predict the benefits of 3-rd EGFR-TKIs as first-line therapy in NSCLCpatients with EGFR-positive. Further, to clarify their primary drug resistance mechanisms, which is of great significance for the treatment and clinical decision-making of NSCLC disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGFR-positive lung patients recieving 3rd generation EGFR-TKIs as first-line therapy | – | Other: Genomic profiles detection, Other: circulating tumor DNA detectionStage III-IV EGFR-positive lung patients receiving 3rd generation EGFR-TKIs (Osimertinib 80mg/Qd or Almonertinib 110mg/Qd or Furmonertinib 80mg/Qd) as first-line therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage IIIB-IV EGFR-positive lung patients receiving 3rd generation EGFR-TKIs (Osimertinib 80mg/Qd or Almonertinib 110mg/Qd or Furmonertinib 80mg/Qd) as first-line therapy.
Key inclusion criteria (8 listed)
- Age >18 years;
- Histological or cytopathological diagnosed NSCLC;
- According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is unresectable IIIB-IV or recurrence and metastasis after surgery;
- At least one measurable lesion can be evaluated according to the Response Evaluation Criteria In Solid Tumours v1.1 (RECIST1.1) criteria;
- Positive EGFR mutation confirmed by tissue or cytology (pleural fluid, cerebrospinal fluid, etc.);
Key exclusion criteria (5 listed)
- Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form;
- Pregnant and lactating women;
- Other malignant neoplastic diseases within 3 years;
- Patients who have undergone other clinical drug trials;
- Received systemic anti-tumor therapy within 2 years;
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 |
|---|---|---|
| Genomic profiles detectionThe Paraffin-embedded tumor tissue at diagnosis is collected and assessed by Next- generation gene sequencing | Other | EGFR-positive lung patients recieving 3rd generation EGFR-TKIs as first-line therapy |
| circulating tumor DNA detectionThe Plasma at diagnosis and at 1-month treatment are collected and assessed by Next-generation gene sequencing | Other | EGFR-positive lung patients recieving 3rd generation EGFR-TKIs as first-line therapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: 2 years
The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Progression-free survival (PFS)
Time frame: 3 years
Time from the beginning of treatment to the first disease progression (PD) in patients with advanced NSCLC
Differences in genomic profiles of tumor tissues and ctDNA clearance of third-generation EGFR-TKIs sensitive and primary drug-resistant NSCLC.
Time frame: 3 years
The patients who don't achieve partial response or progress within 6 months are defined as the primary resistant group. The genomic profiles and ctDNA clearance detected by Next-generation gene sequencing will be compared between the primary drug-resistant group and sensitive-drug group.
2 secondary outcomes
Overall survival (OS)
Time frame: 5 years
Disease Control Rate (DCR)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
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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.
Department of Oncology, The Second Xiangya Hospital, Central South University
Changsha, China
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 Lung Cancer, Non-small Cell and EGFR Gene Mutation, run by Second Xiangya Hospital of Central South University 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 2 years). 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 2 Dec 2024.