Non-small Cell Lung CancerNCT04324164
Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced NSCLC
An observational study of Non-small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
This study aims to explore Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Third-generation EGFR-TKI and EGFR-TKI
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2020to 24 Dec 2027
- 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: Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China
Who may be able to join
- 18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
- Uncommon EGFR Mutant Advanced NSCLC
Who cannot join
- Patients with contraindication of chemotherapy
- Pregnant or breast feeding women
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
Yongchang Zhang
Changsha, Hunan, 410013
Yongchang Zhang, MD, +8613873123436 ext. +8613873123436, zhangyongchang@csu.edu.cn
About this study
Official title: Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China
This study aims to explore Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China
Read the detailed description
inclusion criteria Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer EGFR G719X, exon 20 insert mutation without any anti-cancer treatment history
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Third-generation EGFR-TKI, EGFR-TKI
- 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.
Third-generation EGFR-TKIDrug
Third-generation EGFR-TKI including Osimertinib/Furmonertinib/Almonertinib, etc.
EGFR-TKIDrug
All EGFR-TKI
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Uncommon EGFR exon 19del | patients with uncommon EGFR exon 19del Receives: Drug: Third-generation EGFR-TKI | |
| Cohort 2 EGFR exon 19delins | patients with EGFR exon 19delins Receives: Drug: Third-generation EGFR-TKI | |
| Cohort 3 EGFR exon 18del | patients with EGFR exon 18del Receives: Drug: EGFR-TKI | |
| Cohort 4 Common Uncommon Point Mutations | patients with common uncommon point mutations Receives: Drug: EGFR-TKI | |
| Cohort 5 Rare Uncommon Point Mutations | patients with rare uncommon point mutations Receives: Drug: EGFR-TKI | |
| Cohort 6 Compound Mutations Uncommon With Uncommon | patients with compound mutations uncommon with uncommon Receives: Drug: EGFR-TKI | |
| Cohort 7 Compound Mutations Uncommon With Common | patients with compound mutations uncommon with common Receives: Drug: EGFR-TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
Measured: 5 years
Secondary outcomes (2)
OS
Defined as the time from the start of treatment to the death of the subject due to any cause.
Measured: 5 years
ORR
Defined as the proportion of subjects achieving a complete remission (CR) or partial remission (PR) among all subjects.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start24 Mar 2020
- Primary completion24 Dec 2025 (estimated)
- Study completion24 Dec 2027 (estimated)
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
- 800 participants (estimated)
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
- NCT04324164
- Sponsor's protocol ID
- SONICS
- Status last verified
- Jan 2025
- First submitted
- 25 Mar 2020
- Last updated
- 27 Jan 2025
- 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 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China
- ClinicalTrials.gov ID
- NCT04324164
- Acronym / sponsor ID
- SONICS
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 24 Dec 2025 (estimated)
- Study completion
- 24 Dec 2027 (estimated)
- First posted
- 27 Mar 2020 (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.
This study aims to explore Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China
Detailed description
inclusion criteria Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer EGFR G719X, exon 20 insert mutation without any anti-cancer treatment history
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Uncommon EGFR exon 19del | – | Drug: Third-generation EGFR-TKIpatients with uncommon EGFR exon 19del |
| Cohort 2 EGFR exon 19delins | – | Drug: Third-generation EGFR-TKIpatients with EGFR exon 19delins |
| Cohort 3 EGFR exon 18del | – | Drug: EGFR-TKIpatients with EGFR exon 18del |
| Cohort 4 Common Uncommon Point Mutations | – | Drug: EGFR-TKIpatients with common uncommon point mutations |
| Cohort 5 Rare Uncommon Point Mutations | – | Drug: EGFR-TKIpatients with rare uncommon point mutations |
| Cohort 6 Compound Mutations Uncommon With Uncommon | – | Drug: EGFR-TKIpatients with compound mutations uncommon with uncommon |
| Cohort 7 Compound Mutations Uncommon With Common | – | Drug: EGFR-TKIpatients with compound mutations uncommon with common |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China
Key inclusion criteria (2 listed)
- 18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
Key exclusion criteria (2 listed)
- Patients with contraindication of chemotherapy
- Pregnant or breast feeding women
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 |
|---|---|---|
| Third-generation EGFR-TKIThird-generation EGFR-TKI including Osimertinib/Furmonertinib/Almonertinib, etc. | Drug | Cohort 1 Uncommon EGFR exon 19del, Cohort 2 EGFR exon 19delins |
| EGFR-TKIAll EGFR-TKI | Drug | Cohort 3 EGFR exon 18del, Cohort 4 Common Uncommon Point Mutations, Cohort 5 Rare Uncommon Point Mutations, Cohort 6 Compound Mutations Uncommon With Uncommon, Cohort 7 Compound Mutations Uncommon With Common |
Primary outcome
PFS
Time frame: 5 years
Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
2 secondary outcomes
OS
Time frame: 5 years
ORR
Time frame: 5 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 27 Jan 2025.
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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.
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 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. 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?
Contact Yongchang Zhang, MD (+8613873123436 ext. 7+861383123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 5 years). 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 Jan 2025.