Non Small Cell Lung CancerNCT04304638
Real-world Treatment Patterns and Clinical Outcomes in EGFR-mutant Unresectable Locally Advanced NSCLC
An observational study of Non Small Cell Lung Cancer and Stage III Non-small-cell Lung Cancer, run by Chinese Academy of Medical Sciences.
Trial summary
The investigators will obtain a cohort of patients from multiple large cancer centers in China and try to unravel the efficacy of "radiotherapy combined with EGFR-TKI", which may provide some evidences for the treatment of stage III-inoperable NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Stage III Non-small-cell Lung Cancer, EGFR Mutation-Related Tumors
- What is being tested?
- radiation or chemo-radiation and EGFR-TKI Inhibitor
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Jun 2020
- 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: stage III patients with EGFR mutation.
Who may be able to join
- histologically confirmed NSCLC with adenocarcinoma
- stage III (AJCC 7th edition)
- inoperable or refuse surgery
- EGFR-TKI mutation, specimen from tissue or blood
Who cannot join
- the pathology was not adenocarcinoma
- stage I,II and IV
- anaplastic lymphoma kinase (ALK) rearrangement
- no follow-up data achievable
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Real-world Treatment Patterns and Clinical Outcomes in Epidermal Growth Factor Receptor(EGFR)-Mutant Unresectable Locally Advanced NSCLC: A Retrospective Multi-center Study
The investigators will obtain a cohort of patients from multiple large cancer centers in China and try to unravel the efficacy of "radiotherapy combined with EGFR-TKI", which may provide some evidences for the treatment of stage III-inoperable NSCLC.
Read the detailed description
The frequency of EGFR mutations in patients with stage III inoperable adenocarcinoma or non-squamous cell carcinoma is 17-31%, which is relatively low. Compared to patients with EGFR wild type, the efficacy of radiotherapy or chemo-radiotherapy may be different in EGFR mutant patients. Some small sample studies showed, compared with patients with EGFR wild type, patients with EGFR mutations have a lower risk of local recurrence and a higher risk of distant metastasis under the standard treatment for stage III lung cancer, which demonstrate the strength of systemic therapy may help. Radiotherapy combined with EGFR-Tyrosine kinase inhibitors(TKI) is a feasible treatment strategy. In view of the low mutation frequency and few prospective research results, the investigators try to explore the survival differences of three treatment strategies used in clinical practice based on the real world data. The investigators will obtain a cohort of patients from multiple large cancer centers in China and try to unravel the efficacy of "radiotherapy combined with EGFR-TKI", which may provide some evidences for the further study.
- Conditions
- Non Small Cell Lung Cancer, Stage III Non-small-cell Lung Cancer, EGFR Mutation-Related Tumors
- Being tested
- radiation or chemo-radiation, EGFR-TKI Inhibitor
- 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.
radiation or chemo-radiationRadiation
standard treatment for stage III lung cancer
EGFR-TKI InhibitorDrug
Also called EGFR-TKI alone
the standard treatment for stage IV lung cancer with EGFR mutation
| Study group | Role | What they receive |
|---|---|---|
| Radiation(Chemo-radiation) | Patients in this group had been treated with definitive radiation/Chemo-radiation followed by no treatment until progression. Receives: Radiation: radiation or chemo-radiation | |
| radiation+EGFR-TKI | Patients in this group had been treated with one of the following three ways: 1) definitive radiation and concurrent EGFR-TKI followed by EGFR-TKI till progression; 2) EGFR-TKI followed by radiation and continue TKI util progression; 3) radiation and TKI thereafter until progression. Receives: Radiation: radiation or chemo-radiation; Drug: EGFR-TKI Inhibitor | |
| EGFR-TKI | Patients in this group had been treated with EGFR-TKI without any other treatment until progression. Receives: Drug: EGFR-TKI Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
median progression-free survival (mPFS)
The time of half patients who are alive and progression-free after the disease diagnose, estimated by the Kaplan-Maier method and using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Tumor scans had been performed at baseline, and every 3 months after the first treatment of EGFR-TKI or the last dose of radiation (whichever occurs first) in 5 years
Secondary outcomes (2)
median overall survival(mOS)
The time of half patients who are alive after the disease diagnose, estimated by the Kaplan-Maier method and using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Tumor scans had been performed at baseline, and every 3 months after the first treatment of EGFR-TKI or the last dose of radiation (whichever occurs first) in 5 years
failure pattern
Rate of disease failure in local, regional and distant sites.
Measured: Tumor scans had been performed at baseline, and every 3 months after the first treatment of EGFR-TKI or the last dose of radiation(whichever occurs first) in 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luhua Wang, Chinese Academy of Medical Sciences
- Investigators
- Luhua Wang, MD, Principal investigator, Cancer center of Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304638
- Sponsor's protocol ID
- CAMS19/216-2000
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bi N, Wang J, Jiang W, Fu X, Zhao L, Yang Z, Qian D, Chen X, Yang H, Wang H, Shan G, Tang W, Ge H, Zhang L, Cao J, Zhu X, Ji Y, Chen M, Hu C, Wang L. Induction and concurrent aumolertinib with radiotherapy for EGFR-mutated stage III NSCLC: results of phase III ADVANCE trial and real-world validation. Signal Transduct Target Ther. 2026 Sep 21;11(1):395. doi: 10.1038/s41392-026-02891-2.
PubMed 42764281
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Treatment Patterns and Clinical Outcomes in Epidermal Growth Factor Receptor(EGFR)-Mutant Unresectable Locally Advanced NSCLC: A Retrospective Multi-center Study
- ClinicalTrials.gov ID
- NCT04304638
- Acronym / sponsor ID
- CAMS19/216-2000
- Conditions
- Non Small Cell Lung Cancer, Stage III Non-small-cell Lung Cancer, EGFR Mutation-Related Tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 11 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.
The investigators will obtain a cohort of patients from multiple large cancer centers in China and try to unravel the efficacy of "radiotherapy combined with EGFR-TKI", which may provide some evidences for the treatment of stage III-inoperable NSCLC.
Detailed description
The frequency of EGFR mutations in patients with stage III inoperable adenocarcinoma or non-squamous cell carcinoma is 17-31%, which is relatively low. Compared to patients with EGFR wild type, the efficacy of radiotherapy or chemo-radiotherapy may be different in EGFR mutant patients. Some small sample studies showed, compared with patients with EGFR wild type, patients with EGFR mutations have a lower risk of local recurrence and a higher risk of distant metastasis under the standard treatment for stage III lung cancer, which demonstrate the strength of systemic therapy may help. Radiotherapy combined with EGFR-Tyrosine kinase inhibitors(TKI) is a feasible treatment strategy. In view of the low mutation frequency and few prospective research results, the investigators try to explore the survival differences of three treatment strategies used in clinical practice based on the real world data. The investigators will obtain a cohort of patients from multiple large cancer centers in China and try to unravel the efficacy of "radiotherapy combined with EGFR-TKI", which may provide some evidences for the further study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radiation(Chemo-radiation) | – | Radiation: radiation or chemo-radiationPatients in this group had been treated with definitive radiation/Chemo-radiation followed by no treatment until progression. |
| radiation+EGFR-TKI | – | Radiation: radiation or chemo-radiation, Drug: EGFR-TKI InhibitorPatients in this group had been treated with one of the following three ways: 1) definitive radiation and concurrent EGFR-TKI followed by EGFR-TKI till progression; 2) EGFR-TKI followed by radiation and continue TKI util progression; 3) radiation and TKI thereafter until progression. |
| EGFR-TKI | – | Drug: EGFR-TKI InhibitorPatients in this group had been treated with EGFR-TKI without any other treatment until progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stage III patients with EGFR mutation.
Key inclusion criteria (4 listed)
- histologically confirmed NSCLC with adenocarcinoma
- stage III (AJCC 7th edition)
- inoperable or refuse surgery
- EGFR-TKI mutation, specimen from tissue or blood
Key exclusion criteria (4 listed)
- the pathology was not adenocarcinoma
- stage I,II and IV
- anaplastic lymphoma kinase (ALK) rearrangement
- no follow-up data achievable
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 |
|---|---|---|
| radiation or chemo-radiationstandard treatment for stage III lung cancer | Radiation | Radiation(Chemo-radiation), radiation+EGFR-TKI |
| EGFR-TKI InhibitorAlso: EGFR-TKI alonethe standard treatment for stage IV lung cancer with EGFR mutation | Drug | EGFR-TKI, radiation+EGFR-TKI |
Primary outcome
median progression-free survival (mPFS)
Time frame: Tumor scans had been performed at baseline, and every 3 months after the first treatment of EGFR-TKI or the last dose of radiation (whichever occurs first) in 5 years
The time of half patients who are alive and progression-free after the disease diagnose, estimated by the Kaplan-Maier method and using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
2 secondary outcomes
median overall survival(mOS)
Time frame: Tumor scans had been performed at baseline, and every 3 months after the first treatment of EGFR-TKI or the last dose of radiation (whichever occurs first) in 5 years
failure pattern
Time frame: Tumor scans had been performed at baseline, and every 3 months after the first treatment of EGFR-TKI or the last dose of radiation(whichever occurs first) in 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Derived from this study: PubMed 42764281Bi N, Wang J, Jiang W, Fu X, Zhao L, Yang Z, Qian D, Chen X, Yang H, Wang H, Shan G, Tang W, Ge H, Zhang L, Cao J, Zhu X, Ji Y, Chen M, Hu C, Wang L. Induction and concurrent aumolertinib with radiotherapy for EGFR-mutated stage III NSCLC: results of phase III ADVANCE trial and real-world validation. Signal Transduct Target Ther. 2026 Sep 21;11(1):395. doi: 10.1038/s41392-026-02891-2.
- 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.
Luhua Wang, MD principal investigator
Cancer center of Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer and Stage III Non-small-cell Lung Cancer, run by Chinese Academy of Medical Sciences.
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 4 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 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Luhua Wang, MD (01087788799, wlhwq@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median progression-free survival (mPFS) (time frame: Tumor scans had been performed at baseline, and every 3 months after the first treatment of EGFR-TKI or the last dose of radiation (whichever occurs first) in 5 years). 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 NCT04304638, which also lists 1 linked publication.
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 11 Mar 2020.