The Research Plan of Taiwan Precision Medicine: Lung Cancer

Taiwan Precision Medicine Study for Lung Cancer

NCT: NCT04849481 · Status: RECRUITING · Phase: N/A · Sponsor: National Health Research Institutes, Taiwan · Started: 2021-06-23 · Est. Completion: 2030-12-31

Plain English Summary

The Research Plan of Taiwan Precision Medicine is a Not Applicable clinical trial sponsored by National Health Research Institutes, Taiwan studying Non-small-cell Lung Cancer. This study analyzes the genetic makeup of non-small cell lung cancer (NSCLC) in Taiwanese patients. It is for individuals diagnosed with advanced NSCLC, including those who haven't responded to standard treatments. Participation involves providing tumor tissue for genetic testing and regular follow-ups. Alternatives may include standard chemotherapy, targeted therapies, or immunotherapy based on genetic profiles. The trial aims to enroll 550 participants.

Official Summary

Non-small-cell lung cancer (NSCLC) is one of the top three most common cancers in Taiwan. Targetable driver mutations in NSCLC are more prevalent in Asian population compared to those in Western population, which offers chances to apply suitable targeted therapies worldwide. For patients who failed to the treatment of tyrosine kinase inhibitors (TKIs), the genetic mutations from next-generation sequencing (NGS) reports can serve as the reference of treatment selection. Moreover, the expression of PD-1/PD-L1 serves as a helpful indicator for the response of immune checkpoint inhibitors (ICIs). On the other hand, patients with wild-type EGFR/ALK mutations and PD-L1-negative NSCLC who received chemotherapy had relative poorer survival than those received suitable targeted therapies and ICIs. To further elucidate the underlying molecular genomic aberrations, as well as the clinical demographics and therapeutic outcomes in above subpopulations, it is necessary to have a national, multi-centers and population-focused research project to collect data completely. Tumor tissue will be collected from advanced NSCLC patients with wild-type EGFR/ALK or with EGFR/ALK mutation after resistant to TKIs for next-generation sequencing analysis in a platform of data storage and sharing. The purpose of the precision medicine project is to establish tumor molecular profiling of specific NSCLC populations in Taiwan, to facilitate patients to have corresponding potential targeted therapeutics and suitable clinical trials, and to extend the median overall survival.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 20 and older with specific types of lung cancer (adenocarcinoma, squamous cell, etc.). Patients with advanced NSCLC who have either not started treatment or have failed up to two previous treatments. Individuals with specific genetic mutations (EGFR, ALK) may have different treatment history requirements. Exclusion: inability to provide medical history, no tumor tissue available, or poor compliance. This trial is studying Non-small-cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The study will map key genetic characteristics of lung tumors to help doctors understand why some treatments stop working and to discover new ways to fight the cancer. The specific primary outcome measures are: To perform large-scale NGS analysis for specific populations, create a map containing important genetic characteristics to help understand the mechanisms of drug resistance, and find novel treatment strategies. (2021/05~2030/12). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is crucial for understanding lung cancer in the Asian population, aiming to identify new targeted treatments for patients who haven't responded to current therapies. This research targets Non-small-cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This observational study aims to build a comprehensive molecular profile of NSCLC in Taiwan, potentially guiding future targeted therapy development and clinical trial design in a significant cancer m The large enrollment target of 550 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific types of lung cancer included and if your condition fits the study criteria. Understand that providing tumor tissue for genetic analysis is a key part of the study. Be prepared for regular follow-up appointments to monitor your health and treatment response. This trial is currently recruiting participants. The trial is being conducted at 13 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Primary Outcomes

Full Eligibility Criteria

Inclusion Criteria

1. Ages 20 and above.
2. Pathological reports showed adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous carcinoma, and sacromatoid carcinoma.
3. For patients with squamous cell carcinoma, only never smokers and light smokers (less than 10 cigarettes per day) are indicated.
4. For patients with advanced EGFR (-) and ALK (-) adenocarcinoma or other histological types regardless of EGFR/ALK status, treatment-naïve or failure to ≤ two lines of systemic treatment is allowed.
5. For patients with advanced EGFR (+) or ALK (+) adenocarcinoma, failure to ≤ two lines of systemic treatment, including tyrosine kinase inhibitor is allowed.
6. For patients with advanced EGFR exon 20 insertion/mutation (excluding T790M mutation) adenocarcinoma, failure to ≤ four lines of systemic treatment, including tyrosine kinase inhibitor is allowed.
7. Reacquisition of tumor tissue after the failure of previous systemic treatment
8. Willingness to provide the residual biopsy/operative slides.
9. Life expectancy more than 3 months.
10. Patients fully understand the protocol with the willingness to have regular follow-up.
11. For patients with advanced EGFR exon 20 insertion/mutation (excluding T790M mutation) adenocarcinoma: if the patient had died before 2022/07/31, the waiver of Informed Consent Form(s) is allowed under the permission of Independent Ethics Committee/Institutional Review Board (IEC/IRB). Exclusion Criteria

1.Inability to cooperate by providing a complete medical history. 2.No available tumor tissues for genetic testing. 3.Undesirable compliance.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT04849481?

NCT04849481 is a Not Applicable OBSERVATIONAL study titled "The Research Plan of Taiwan Precision Medicine." It is currently recruiting and is sponsored by National Health Research Institutes, Taiwan. The trial targets enrollment of 550 participants.

What conditions does NCT04849481 study?

This trial investigates treatments for Non-small-cell Lung Cancer. The primary condition under study is Non-small-cell Lung Cancer.

What does Not Applicable mean for NCT04849481?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT04849481?

This trial is currently "Recruiting." It started on 2021-06-23. The estimated completion date is 2030-12-31.

Who is sponsoring NCT04849481?

NCT04849481 is sponsored by National Health Research Institutes, Taiwan. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT04849481?

The trial aims to enroll 550 participants. The trial is currently recruiting and accepting new participants.

How is NCT04849481 designed?

This is a observational study.

What are the primary outcomes being measured in NCT04849481?

The primary outcome measures are: To perform large-scale NGS analysis for specific populations, create a map containing important genetic characteristics to help understand the mechanisms of drug resistance, and find novel treatment strategies. (2021/05~2030/12). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT04849481 being conducted?

This trial is being conducted at 13 sites, including Chiayi City; Dalin; Kaohsiung City; Taichung and 9 more sites (Taiwan).

Where can I find official information about NCT04849481?

The official record for NCT04849481 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04849481. This government database provides the most up-to-date and detailed information about the trial.

What is NCT04849481 testing in simple terms?

This study analyzes the genetic makeup of non-small cell lung cancer (NSCLC) in Taiwanese patients. It is for individuals diagnosed with advanced NSCLC, including those who haven't responded to standard treatments.

Why is this trial significant?

This trial is crucial for understanding lung cancer in the Asian population, aiming to identify new targeted treatments for patients who haven't responded to current therapies.

What are the potential risks of participating in NCT04849481?

The primary risk is related to the reacquisition of tumor tissue, which may involve minor discomfort or bleeding. Potential side effects are generally related to the underlying cancer and previous treatments, not the study itself. There's a risk that genetic testing may not reveal actionable mutations or new treatment options. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT04849481?

Ask your doctor about the specific types of lung cancer included and if your condition fits the study criteria. Understand that providing tumor tissue for genetic analysis is a key part of the study. Be prepared for regular follow-up appointments to monitor your health and treatment response. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT04849481 signal from an investment perspective?

This observational study aims to build a comprehensive molecular profile of NSCLC in Taiwan, potentially guiding future targeted therapy development and clinical trial design in a significant cancer m This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves providing tumor tissue for genetic testing and regular follow-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.