ChineseNCT04137718
Multicenter Observational Study of Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Rare Driver Gene Mutation
An observational study of Chinese and Non-Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
Title: Multicenter observational study for clinicopathological characteristics and clinical efficacy of Chinese Non-Small Cell Lung Cancer (NSCLC) patients With Rare Driver Gene Mutation. Purpose: To observe the status of rare driver gene mutations in NSCLC patients and identify the subtypes of the mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chinese, Non-Small Cell Lung Cancer
- What is being tested?
- nonIntervention
- How many people
- 50,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2019to 20 Oct 2024
- 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: Histologically or cytologically proven diagnosis of NSCLC
Who may be able to join
- Female or male, 18 years of age or older；
- Histologically or cytologically proven diagnosis of NSCLC；
- Able to get tumor tissue gene testing results by lung cancer PCR panel kit carried out in hospital；
- Signed and dated informed consent。
Who cannot join
- Combine with other tumor type
- The investigator judges the situation that may affect the clinical search process and results
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000
Caicun Zhou, 021-65115006
About this study
Official title: Multicenter Observational Study for Clinicopathological Characteristics and Clinical Efficacy of Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Rare Driver Gene Mutation
Title: Multicenter observational study for clinicopathological characteristics and clinical efficacy of Chinese Non-Small Cell Lung Cancer (NSCLC) patients With Rare Driver Gene Mutation.
Purpose: To observe the status of rare driver gene mutations in NSCLC patients and identify the subtypes of the mutations.
By comparing and analyzing the relationship between different subtypes, clinicopathological features and clinical efficacy, to find out the effects on anti-tumor therapy and disease survival.
And ultimately to promote the precise application of clinical specifications for new anti-tumor drugs.
Study type: Observational
Read the detailed description
Inclusion criteria:
- Female or male, 18 years of age or older；
- Histologically or cytologically proven diagnosis of NSCLC；
- Able to get tumor tissue gene testing results by lung cancer Polymerase Chain Reaction(PCR)panel kit carried out in hospital
- Signed and dated informed consent.
Exclusion criteria:
- Combine with other tumor type
- The investigator judges the situation that may affect the clinical search process and results.
Estimated enrollment: 50000 participants.
Outcome measures:
Primary outcome measures：
- The NSCLC rare driver gene mutation frequency and clinicopathological features in 50,000 patients in real world;
- The relationship between rare driver gene subtypes and clinicopathological features (age, gender, smoking history, histological subtype, clinical stage, lymph node metastasis, local metastasis, distant metastasis, brain metastasis) in NSCLC patients.
Secondary outcome measures:
- The relationship between rare driver gene mutation subtypes and disease survival or prognosis (Objective response rate (ORR), Progression-free survival (PFS), and Overall survival (OS)) in NSCLC patients.
Method of Research:
- Pre- entry/screening period (V0)
- Screen the enrolled patients according to the admission criteria. The detection of lung cancer PCR panel kit in the hospital requires the use of tissue samples (including surgical tissue, biopsy tissue under interventional conditions, lymph node biopsy tissue, metastases' tissue, etc.);
- All enrolled samples should be tested Neurotrophic-Tropomyosin Receptor Kinase (NTRK) gene mutation (PCR);
- If a)+b) results show a rare driver gene mutation was detected, participants will be involved into the next step; if a)+b) test results were negative, then 500 cases were selected for next generation sequencing (NGS) detection in this population, and were involved into the next step;
- Baseline period (V1)
- Do further classification of rare driver gene mutation positive samples by Sanger sequencing, and record the test results;
- Follow-up period (V2)
- Record the disease therapeutic regimen and follow-up of the survival status of the enrolled patients;
- Once every 3 months (or according to clinical needs) up to 60 months or death;
- Collect information including follow-up treatment, disease status, and survival status, imaging examination results, laboratory examination results, etc. (see the Case Report Form (CRF) form for details);
- For those who need further molecular testing (such as primary drug resistance), multi-gene analysis using the next generation sequencing (NGS) method;
- Loss of follow-up: If the patient fails to return to the center for a follow-up visit, the center will make two attempts to contact by phone and keep the contact records. If the patient does not respond within 1 month after the second contact, the patient is considered to have lost the interview.
Materials and Methods:
Materials:
The specimen material must be human genomic DNA and total RNA extracted from tumor tissue samples. Before the extraction of DNA and RNA, it is very important to make sure that there is at least 20% tumor cells in the tumor tissue samples.
Methods:
Epidermal Growth Factor Receptor 20 exon insertion (EGFR exon 20-ins) mutation/Activin Receptor-like Kinase (ALK) fusion/ROS proto-oncogene 1 receptor tyrosine kinase (ROS1) fusion/Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) mutation/Neuroblastoma RAS viral oncogene homolog (NRAS) mutation/B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutation/Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation/RET proto-oncogene (RET) fusion/Mesenchymal-Epithelial Transition factor (MET) 14 exon skipping/Erb-b2 Receptor Tyrosine Kinase 2 (ERBB2) mutation/ Neurotrophic-Tropomyosin Receptor Kinase (NTRK) fusion mutation were detected by Fluorogenic Quantitative Polymerase Chain Reaction in Chinese NSCLC.
- DNA/RNA Extraction: The total RNA concentration for gene fusion detection is 10~100 ng/µL in Formalin-Fixed Paraffin-Embedded (FFPE) tissue or 2~30 ng/µL in Fresh tissue. The amount of extracted DNA for gene mutation detection is 1.5~3 ng/µL in FFPE tissue or 0.5~1 ng/µL in Fresh tissue.
- RNA Reverse Transcription.
- Detection of the Target Alterations in RNA and DNA: ALK, ROS1, RET, NTRK Gene fusion and MET 14 exon skipping mutation were detected in RNA. EGFR 20 exon-ins, KRAS, NRAS, BRAF, PIK3CA and ERBB2 mutation were detected in DNA.
- Result Interpretation
- Conditions
- Chinese, Non-Small Cell Lung Cancer
- Being tested
- nonIntervention
- Keywords
- Multicenter, Observational Study, NSCLC, Rare Driver Gene
- 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.
nonInterventionOther
nonIntervention
| Study group | Role | What they receive |
|---|---|---|
| Rare driver gene mutation-positive | Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a rare driver gene mutation positive. Receives: Other: nonIntervention | |
| Rare driver gene mutation-negative | Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction(PCR)panel kit in the hospital requires the use of tissue samples and the results show a rare driver gene mutation negative. Receives: Other: nonIntervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driver gene mutation frequency of Chinese NSCLC patients
Analyze the rare driver gene mutation frequency in NSCLC patients in the real world.
Measured: 2022
Clinicopathological characteristics of Chinese NSCLC patients With Rare Driver Gene Mutation
Observe the clinicopathological features in NSCLC patients with rare gene mutation in the real world.
Measured: 2022
Relationship of Clinicopathological characteristics and Rare Driver Gene Mutation of Chinese NSCLC patients
Analyze the relationship between rare driver gene subtypes and clinicopathological features in NSCLC patients.
Measured: 2022
Secondary outcomes (3)
Objective response rate of Chinese NSCLC patients With Rare Driver Gene Mutation
The relationship between rare driver gene mutation subtypes and objective response rate in NSCLC patients.
Objective response rate(ORR): ORR = (number of subjects with complete response (CR) + partial response (PR)) / total number of subjects × 100%, 95% confidence interval(CI) was calculated using binomial distribution, and the calculation of objective response rate was based on the quadratic confirmed optimal efficacy evaluation.
Measured: 2024
Progression-free survival of Chinese NSCLC patients With Rare Driver Gene Mutation
The relationship between rare driver gene mutation subtypes and progression-free survival in NSCLC patients.
Progression-free survival (PFS): PFS refers to the time (month) between the date of randomization to the first demonstration of disease progression or death (whichever occurs first).
Measured: 2024
Overall survival of Chinese NSCLC patients With Rare Driver Gene Mutation
The relationship between rare driver gene mutation subtypes and overall survival in NSCLC patients.
Overall survival (OS): OS refers to the time of first use of the drug to the time of death. At the end of the study, if the subject is still alive, refer the known "date of last survival of the subject" as the date of censoring.
Measured: 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start25 Oct 2019
- Primary completion20 Oct 2022 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ChineseStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137718
- Sponsor's protocol ID
- LC-IRICA
- Status last verified
- Dec 2019
- First submitted
- 14 Oct 2019
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wen S, Dai L, Wang L, Wang W, Wu D, Wang K, He Z, Wang A, Chen H, Zhang P, Dong X, Dong YA, Wang K, Yao M, Wang M. Genomic Signature of Driver Genes Identified by Target Next-Generation Sequencing in Chinese Non-Small Cell Lung Cancer. Oncologist. 2019 Nov;24(11):e1070-e1081. doi: 10.1634/theoncologist.2018-0572. Epub 2019 Mar 22.
PubMed 30902917Yasuda H, Park E, Yun CH, Sng NJ, Lucena-Araujo AR, Yeo WL, Huberman MS, Cohen DW, Nakayama S, Ishioka K, Yamaguchi N, Hanna M, Oxnard GR, Lathan CS, Moran T, Sequist LV, Chaft JE, Riely GJ, Arcila ME, Soo RA, Meyerson M, Eck MJ, Kobayashi SS, Costa DB. Structural, biochemical, and clinical characterization of epidermal growth factor receptor (EGFR) exon 20 insertion mutations in lung cancer. Sci Transl Med. 2013 Dec 18;5(216):216ra177. doi: 10.1126/scitranslmed.3007205.
PubMed 24353160Du X, Shao Y, Qin HF, Tai YH, Gao HJ. ALK-rearrangement in non-small-cell lung cancer (NSCLC). Thorac Cancer. 2018 Apr;9(4):423-430. doi: 10.1111/1759-7714.12613. Epub 2018 Feb 28.
PubMed 29488330Lin JJ, Shaw AT. Recent Advances in Targeting ROS1 in Lung Cancer. J Thorac Oncol. 2017 Nov;12(11):1611-1625. doi: 10.1016/j.jtho.2017.08.002. Epub 2017 Aug 14.
PubMed 28818606Lee CK, Man J, Lord S, Cooper W, Links M, Gebski V, Herbst RS, Gralla RJ, Mok T, Yang JC. Clinical and Molecular Characteristics Associated With Survival Among Patients Treated With Checkpoint Inhibitors for Advanced Non-Small Cell Lung Carcinoma: A Systematic Review and Meta-analysis. JAMA Oncol. 2018 Feb 1;4(2):210-216. doi: 10.1001/jamaoncol.2017.4427.
PubMed 29270615Zhou F, Zhou C. Lung cancer in never smokers-the East Asian experience. Transl Lung Cancer Res. 2018 Aug;7(4):450-463. doi: 10.21037/tlcr.2018.05.14.
PubMed 30225210Drilon A, Hu ZI, Lai GGY, Tan DSW. Targeting RET-driven cancers: lessons from evolving preclinical and clinical landscapes. Nat Rev Clin Oncol. 2018 Mar;15(3):150. doi: 10.1038/nrclinonc.2017.188. Epub 2017 Nov 28.
PubMed 29182164
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Study for Clinicopathological Characteristics and Clinical Efficacy of Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Rare Driver Gene Mutation
- ClinicalTrials.gov ID
- NCT04137718
- Acronym / sponsor ID
- LC-IRICA
- Conditions
- Chinese, Non-Small Cell Lung Cancer
- Keywords
- Multicenter, Observational Study, NSCLC, Rare Driver Gene
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 20 Oct 2022 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 24 Oct 2019 (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.
Title: Multicenter observational study for clinicopathological characteristics and clinical efficacy of Chinese Non-Small Cell Lung Cancer (NSCLC) patients With Rare Driver Gene Mutation.
Purpose: To observe the status of rare driver gene mutations in NSCLC patients and identify the subtypes of the mutations.
By comparing and analyzing the relationship between different subtypes, clinicopathological features and clinical efficacy, to find out the effects on anti-tumor therapy and disease survival.
And ultimately to promote the precise application of clinical specifications for new anti-tumor drugs.
Study type: Observational
Detailed description
Inclusion criteria:
- Female or male, 18 years of age or older；
- Histologically or cytologically proven diagnosis of NSCLC；
- Able to get tumor tissue gene testing results by lung cancer Polymerase Chain Reaction(PCR)panel kit carried out in hospital
- Signed and dated informed consent.
Exclusion criteria:
- Combine with other tumor type
- The investigator judges the situation that may affect the clinical search process and results.
Estimated enrollment: 50000 participants.
Outcome measures:
Primary outcome measures：
- The NSCLC rare driver gene mutation frequency and clinicopathological features in 50,000 patients in real world;
- The relationship between rare driver gene subtypes and clinicopathological features (age, gender, smoking history, histological subtype, clinical stage, lymph node metastasis, local metastasis, distant metastasis, brain metastasis) in NSCLC patients.
Secondary outcome measures:
- The relationship between rare driver gene mutation subtypes and disease survival or prognosis (Objective response rate (ORR), Progression-free survival (PFS), and Overall survival (OS)) in NSCLC patients.
Method of Research:
- Pre- entry/screening period (V0)
- Screen the enrolled patients according to the admission criteria. The detection of lung cancer PCR panel kit in the hospital requires the use of tissue samples (including surgical tissue, biopsy tissue under interventional conditions, lymph node biopsy tissue, metastases' tissue, etc.);
- All enrolled samples should be tested Neurotrophic-Tropomyosin Receptor Kinase (NTRK) gene mutation (PCR);
- If a)+b) results show a rare driver gene mutation was detected, participants will be involved into the next step; if a)+b) test results were negative, then 500 cases were selected for next generation sequencing (NGS) detection in this population, and were involved into the next step;
- Baseline period (V1)
- Do further classification of rare driver gene mutation positive samples by Sanger sequencing, and record the test results;
- Follow-up period (V2)
- Record the disease therapeutic regimen and follow-up of the survival status of the enrolled patients;
- Once every 3 months (or according to clinical needs) up to 60 months or death;
- Collect information including follow-up treatment, disease status, and survival status, imaging examination results, laboratory examination results, etc. (see the Case Report Form (CRF) form for details);
- For those who need further molecular testing (such as primary drug resistance), multi-gene analysis using the next generation sequencing (NGS) method;
- Loss of follow-up: If the patient fails to return to the center for a follow-up visit, the center will make two attempts to contact by phone and keep the contact records. If the patient does not respond within 1 month after the second contact, the patient is considered to have lost the interview.
Materials and Methods:
Materials:
The specimen material must be human genomic DNA and total RNA extracted from tumor tissue samples. Before the extraction of DNA and RNA, it is very important to make sure that there is at least 20% tumor cells in the tumor tissue samples.
Methods:
Epidermal Growth Factor Receptor 20 exon insertion (EGFR exon 20-ins) mutation/Activin Receptor-like Kinase (ALK) fusion/ROS proto-oncogene 1 receptor tyrosine kinase (ROS1) fusion/Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) mutation/Neuroblastoma RAS viral oncogene homolog (NRAS) mutation/B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutation/Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation/RET proto-oncogene (RET) fusion/Mesenchymal-Epithelial Transition factor (MET) 14 exon skipping/Erb-b2 Receptor Tyrosine Kinase 2 (ERBB2) mutation/ Neurotrophic-Tropomyosin Receptor Kinase (NTRK) fusion mutation were detected by Fluorogenic Quantitative Polymerase Chain Reaction in Chinese NSCLC.
- DNA/RNA Extraction: The total RNA concentration for gene fusion detection is 10~100 ng/µL in Formalin-Fixed Paraffin-Embedded (FFPE) tissue or 2~30 ng/µL in Fresh tissue. The amount of extracted DNA for gene mutation detection is 1.5~3 ng/µL in FFPE tissue or 0.5~1 ng/µL in Fresh tissue.
- RNA Reverse Transcription.
- Detection of the Target Alterations in RNA and DNA: ALK, ROS1, RET, NTRK Gene fusion and MET 14 exon skipping mutation were detected in RNA. EGFR 20 exon-ins, KRAS, NRAS, BRAF, PIK3CA and ERBB2 mutation were detected in DNA.
- Result Interpretation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rare driver gene mutation-positive | – | Other: nonInterventionScreen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a rare driver gene mutation positive. |
| Rare driver gene mutation-negative | – | Other: nonInterventionScreen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction(PCR)panel kit in the hospital requires the use of tissue samples and the results show a rare driver gene mutation negative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically or cytologically proven diagnosis of NSCLC
Key inclusion criteria (4 listed)
- Female or male, 18 years of age or older；
- Histologically or cytologically proven diagnosis of NSCLC；
- Able to get tumor tissue gene testing results by lung cancer PCR panel kit carried out in hospital；
- Signed and dated informed consent。
Key exclusion criteria (2 listed)
- Combine with other tumor type
- The investigator judges the situation that may affect the clinical search process and results
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 |
|---|---|---|
| nonInterventionnonIntervention | Other | Rare driver gene mutation-negative, Rare driver gene mutation-positive |
Primary outcome
Driver gene mutation frequency of Chinese NSCLC patients
Time frame: 2022
Analyze the rare driver gene mutation frequency in NSCLC patients in the real world.
Clinicopathological characteristics of Chinese NSCLC patients With Rare Driver Gene Mutation
Time frame: 2022
Observe the clinicopathological features in NSCLC patients with rare gene mutation in the real world.
Relationship of Clinicopathological characteristics and Rare Driver Gene Mutation of Chinese NSCLC patients
Time frame: 2022
Analyze the relationship between rare driver gene subtypes and clinicopathological features in NSCLC patients.
3 secondary outcomes
Objective response rate of Chinese NSCLC patients With Rare Driver Gene Mutation
Time frame: 2024
Progression-free survival of Chinese NSCLC patients With Rare Driver Gene Mutation
Time frame: 2024
Overall survival of Chinese NSCLC patients With Rare Driver Gene Mutation
Time frame: 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Results publication: PubMed 30902917Wen S, Dai L, Wang L, Wang W, Wu D, Wang K, He Z, Wang A, Chen H, Zhang P, Dong X, Dong YA, Wang K, Yao M, Wang M. Genomic Signature of Driver Genes Identified by Target Next-Generation Sequencing in Chinese Non-Small Cell Lung Cancer. Oncologist. 2019 Nov;24(11):e1070-e1081. doi: 10.1634/theoncologist.2018-0572. Epub 2019 Mar 22.
- Results publication: PubMed 24353160Yasuda H, Park E, Yun CH, Sng NJ, Lucena-Araujo AR, Yeo WL, Huberman MS, Cohen DW, Nakayama S, Ishioka K, Yamaguchi N, Hanna M, Oxnard GR, Lathan CS, Moran T, Sequist LV, Chaft JE, Riely GJ, Arcila ME, Soo RA, Meyerson M, Eck MJ, Kobayashi SS, Costa DB. Structural, biochemical, and clinical characterization of epidermal growth factor receptor (EGFR) exon 20 insertion mutations in lung cancer. Sci Transl Med. 2013 Dec 18;5(216):216ra177. doi: 10.1126/scitranslmed.3007205.
- Results publication: PubMed 29488330Du X, Shao Y, Qin HF, Tai YH, Gao HJ. ALK-rearrangement in non-small-cell lung cancer (NSCLC). Thorac Cancer. 2018 Apr;9(4):423-430. doi: 10.1111/1759-7714.12613. Epub 2018 Feb 28.
- Results publication: PubMed 28818606Lin JJ, Shaw AT. Recent Advances in Targeting ROS1 in Lung Cancer. J Thorac Oncol. 2017 Nov;12(11):1611-1625. doi: 10.1016/j.jtho.2017.08.002. Epub 2017 Aug 14.
- Results publication: PubMed 29270615Lee CK, Man J, Lord S, Cooper W, Links M, Gebski V, Herbst RS, Gralla RJ, Mok T, Yang JC. Clinical and Molecular Characteristics Associated With Survival Among Patients Treated With Checkpoint Inhibitors for Advanced Non-Small Cell Lung Carcinoma: A Systematic Review and Meta-analysis. JAMA Oncol. 2018 Feb 1;4(2):210-216. doi: 10.1001/jamaoncol.2017.4427.
- Results publication: PubMed 30225210Zhou F, Zhou C. Lung cancer in never smokers-the East Asian experience. Transl Lung Cancer Res. 2018 Aug;7(4):450-463. doi: 10.21037/tlcr.2018.05.14.
- Results publication: PubMed 29182164Drilon A, Hu ZI, Lai GGY, Tan DSW. Targeting RET-driven cancers: lessons from evolving preclinical and clinical landscapes. Nat Rev Clin Oncol. 2018 Mar;15(3):150. doi: 10.1038/nrclinonc.2017.188. Epub 2017 Nov 28.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Chinese and Non-Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China 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 4 inclusion and 2 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 2019. 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 Caicun Zhou (86-21-65115006, caicunzhou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driver gene mutation frequency of Chinese NSCLC patients (time frame: 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?
On the ClinicalTrials.gov record for NCT04137718, which also lists 7 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 2019.