NSCLCNCT05701787
Molecular Landscape Analysis and Clinical Implications for NSCLC Patients With Rare Mutations
An observational study of NSCLC and NSCLC Stage IV, run by Shanghai Chest Hospital at 2 sites in China.
Trial summary
Lung cancer is the most common primary cancer of the lung and is responsible for the ever increasing number of cancer-related deaths worldwide. Especially in China, the burden of lung cancer has been rising rapidly due to its large and growing population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, NSCLC Stage IV, NSCLC, Recurrent
- How many people
- 500 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2019to 31 Dec 2029
- 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
- Adult, Older adult
Study population: Participants with NSCLC with rare mutations are with the standard treatment and/or are enrolled in the clinical trials.
Who may be able to join
- Histologically proven diagnosis of NSCLC with rare mutations including EGFR rare mutations, ALK fusion, ROS1 fusion, BRAF V600E, cMET exon 14 skipping, KRAS G12C, RET fusion, NTRK fusion, etc.
- 18 years of age or older
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Xiaomin Niu
Shanghai, Shanghai Municipality, 200030
Xiaomin Niu, 021-22200000, ar_tey@hotmail.com
- Recruiting
Xiaomin Niu
Shanghai, Shanghai Municipality, 200030
Xiaomin Niu, 86 21 2220 0000 ext. 3708, ar_tey@hotmail.com
About this study
Official title: Molecular Landscape Analysis and Clinical and Therapeutic Implications for NSCLC Patients With Rare Mutations
Lung cancer is the most common primary cancer of the lung and is responsible for the ever increasing number of cancer-related deaths worldwide. Especially in China, the burden of lung cancer has been rising rapidly due to its large and growing population. Histologically, approximately 85% of lung cancers are non-small-cell lung cancer (NSCLC).
Molecular targeted therapy has been shown to dramatically improve the quality of life and survival outcomes of NSCLC patients. One of the most important targeted drugs in NSCLC has been the epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs), while there exists some other rare targetable mutation in NSCLC. Emerging evidence underlines that, rather than a single point mutation, some rare mutations present with a wide array of mutations, essentially in NSCLC.
Different rare mutations with NSCLC have divergent clinical and therapeutic implications with a particular distinction. Therefore, there is an unmet need for more effective therapies for NSCLC with rare mutations. In summary, identification of genetic alterations in NSCLC with rare mutations is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with NSCLC with rare mutations to further the characterization of molecular alterations and develop (novel) treatments based on the detection.
- Conditions
- NSCLC, NSCLC Stage IV, NSCLC, Recurrent
- Keywords
- NSCLC, rare mutations, molecular landscape, next-generation sequencing (NGS), targeted therapy, immunotherapy, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records
Measured: 20 years
Disease control rate (DCR)
Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records
Measured: 20 years
Progression-free survival (PFS)
Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records
Measured: 20 years
Secondary outcomes (1)
Overall survival (OS)
Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaomin Niu, Shanghai Chest Hospital
- Investigators
- Xiaomin Niu, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701787
- Sponsor's protocol ID
- THORACIC003
- Status last verified
- Apr 2025
- First submitted
- 18 Jan 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Landscape Analysis and Clinical and Therapeutic Implications for NSCLC Patients With Rare Mutations
- ClinicalTrials.gov ID
- NCT05701787
- Acronym / sponsor ID
- THORACIC003
- Conditions
- NSCLC, NSCLC Stage IV, NSCLC, Recurrent
- Keywords
- NSCLC, rare mutations, molecular landscape, next-generation sequencing (NGS), targeted therapy, immunotherapy, chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Jan 2023 (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 the most common primary cancer of the lung and is responsible for the ever increasing number of cancer-related deaths worldwide. Especially in China, the burden of lung cancer has been rising rapidly due to its large and growing population. Histologically, approximately 85% of lung cancers are non-small-cell lung cancer (NSCLC).
Molecular targeted therapy has been shown to dramatically improve the quality of life and survival outcomes of NSCLC patients. One of the most important targeted drugs in NSCLC has been the epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs), while there exists some other rare targetable mutation in NSCLC. Emerging evidence underlines that, rather than a single point mutation, some rare mutations present with a wide array of mutations, essentially in NSCLC.
Different rare mutations with NSCLC have divergent clinical and therapeutic implications with a particular distinction. Therefore, there is an unmet need for more effective therapies for NSCLC with rare mutations. In summary, identification of genetic alterations in NSCLC with rare mutations is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with NSCLC with rare mutations to further the characterization of molecular alterations and develop (novel) treatments based on the detection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants with NSCLC with rare mutations are with the standard treatment and/or are enrolled in the clinical trials.
Key inclusion criteria (3 listed)
- Histologically proven diagnosis of NSCLC with rare mutations including EGFR rare mutations, ALK fusion, ROS1 fusion, BRAF V600E, cMET exon 14 skipping, KRAS G12C, RET fusion, NTRK fusion, etc.
- 18 years of age or older
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (1 listed)
- None
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
Objective response rate (ORR)
Time frame: 20 years
Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records
Disease control rate (DCR)
Time frame: 20 years
Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records
Progression-free survival (PFS)
Time frame: 20 years
Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records
1 secondary outcome
Overall survival (OS)
Time frame: 20 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 22 May 2025.
- 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.
Xiaomin Niu principal investigator
Shanghai Chest Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC and NSCLC Stage IV, run by Shanghai Chest Hospital at 2 sites 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 3 inclusion and 1 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 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Xiaomin Niu (021-22200000, ar_tey@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 20 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 22 May 2025.