Non-small Cell Lung CancerRAISENCT06477055
The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 2 sites in China.
Trial summary
This study was a multicenter, real-world observational study aimed at characterizing the genomic landscape of recurrence in patients with EGFR-sensitizing mutation-positive early-stage (clinical stage IB-IIIA) non-small cell lung cancer who received adjuvant osimertinib after surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 43 participants
- Where
- 2 sitesChina
- Study dates
- 2 Dec 2025to 21 Apr 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This multicenter, retrospective, real-world study includes patients with resected stage IB-IIIA NSCLC harboring EGFR-sensitizing mutations (exon 19 deletion or exon 21 L858R) who received adjuvant osimertinib. A total of 60 patients are enrolled and classified into two cohorts based on recurrence timing: Cohort 1 comprises 30 patients with recurrence more than 6 months after completing 3 years of adjuvant osimertinib; Cohort 2 comprises 30 patients with recurrence during adjuvant osimertinib treatment. Genomic profiling data of recurrence, obtained from next-generation sequencing of tissue and/or blood samples, are collected and analyzed. All data are extracted from electronic medical records.
Who may be able to join
- Informed consent signed;
- Age ≥ 18 years;
- Histologically confirmed diagnosis of non-squamous non-small cell lung cancer;
- Patients with stage IB-IIIA (TNM 8#) NSCLC undergo confirmed radical R0 resection;
- Confirmed EGFR sensitive-mutations (exon 19 deletions, 21 L858R point mutations) prior to adjuvant osimertinib therapy;
- Recurrence after/on Osimertinib treatment according to RECIST 1.1;
- NGS gene test report (tumor or blood sample) at the time of recurrence;
Who cannot join
- Patients with stage I-III NSCLC whose surgical resection cannot be confirmed;
- Received adjuvant therapy other than that specified in the ADAURA study;
- No NGS test report at recurrence;
- History of other malignant tumors within 2 years;
- Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has treatment-related complications High risk etc.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hunan Provincal Tumor Hospital
Changsha, Hunan, 410013
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: A Multicenter, Real-World, Observational Study: Genomic Landscape of Recurrence in Early-Stage (Clinical Stage IB-IIIA) Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Sensitizing Mutations After Adjuvant Osimertinib Treatment
This study was a multicenter, real-world observational study aimed at characterizing the genomic landscape of recurrence in patients with EGFR-sensitizing mutation-positive early-stage (clinical stage IB-IIIA) non-small cell lung cancer who received adjuvant osimertinib after surgery.
Read the detailed description
This is a multicenter, real-world, retrospective observational study designed to investigate the genomic landscape of recurrence in patients with early-stage (clinical stage IB-IIIA) non-small cell lung cancer harboring EGFR-sensitizing mutations who received adjuvant osimertinib. A total of 60 patients with resectable EGFR-sensitizing mutation-positive NSCLC (exon 19 deletion or exon 21 L858R) are expected to be included and classified into two cohorts. Cohort 1 consists of 30 patients with recurrence more than 6 months after completing 3 years of adjuvant osimertinib, and Cohort 2 consists of 30 patients with recurrence during adjuvant osimertinib treatment. Genomic profiling data of recurrence, obtained from next-generation sequencing of tissue and/or blood samples, are collected and analyzed.
The primary endpoint is to evaluate the genomic landscape of recurrence during or after adjuvant osimertinib treatment in patients with resectable NSCLC harboring EGFR-sensitizing mutations. The secondary endpoints are to explore the genomic profiles of recurrence in subgroups with different recurrence patterns (local recurrence versus distant metastasis) during or after adjuvant osimertinib treatment, and to describe the treatment patterns used in real-world clinical practice after disease progression. The exploratory endpoints are to investigate changes in the genomic profile between baseline and recurrence and to explore the mechanisms underlying tumor progression.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- EGFR, Osimertinib
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | consists of 30 patients who experienced a recurrence more than 6 months after completing 3 years of adjuvant osimertinib. | |
| Cohort 2 | consists of 30 patients with recurrence during adjuvant osimertinib treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence gene profiles
To assess the recurrence gene profiles of adjuvant Osimertinib therapy
Measured: From January 2021 to March 2026, assessed retrospectively from medical records.
Secondary outcomes (2)
Recurrence gene profiles in patients with different recurrence types (local /distant)
To explore of subgroups recurrence gene profiles of different recurrence types (local /distant) after adjuvant Osimertinib therapy
Measured: From January 2021 to March 2026, assessed retrospectively from medical records
Subsequent treatment patterns
To describe the diverse treatment patterns (Osi or other EGFR TKIs，± chemo) in real clinical practice after the disease progressed
Measured: FromJanuary 2021 to March 2026, assessed retrospectively from medical records
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start2 Dec 2025
- Primary completion21 Apr 2026
- Study completion21 Apr 2026
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
- 43 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477055
- Sponsor's protocol ID
- 2024-IIT0612
- Acronym
- RAISE
- Status last verified
- Apr 2026
- First submitted
- 19 Jun 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Real-World, Observational Study: Genomic Landscape of Recurrence in Early-Stage (Clinical Stage IB-IIIA) Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Sensitizing Mutations After Adjuvant Osimertinib Treatment
- ClinicalTrials.gov ID
- NCT06477055
- Acronym / sponsor ID
- RAISE / 2024-IIT0612
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- EGFR, Osimertinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 27 Jun 2024 (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 was a multicenter, real-world observational study aimed at characterizing the genomic landscape of recurrence in patients with EGFR-sensitizing mutation-positive early-stage (clinical stage IB-IIIA) non-small cell lung cancer who received adjuvant osimertinib after surgery.
Detailed description
This is a multicenter, real-world, retrospective observational study designed to investigate the genomic landscape of recurrence in patients with early-stage (clinical stage IB-IIIA) non-small cell lung cancer harboring EGFR-sensitizing mutations who received adjuvant osimertinib. A total of 60 patients with resectable EGFR-sensitizing mutation-positive NSCLC (exon 19 deletion or exon 21 L858R) are expected to be included and classified into two cohorts. Cohort 1 consists of 30 patients with recurrence more than 6 months after completing 3 years of adjuvant osimertinib, and Cohort 2 consists of 30 patients with recurrence during adjuvant osimertinib treatment. Genomic profiling data of recurrence, obtained from next-generation sequencing of tissue and/or blood samples, are collected and analyzed.
The primary endpoint is to evaluate the genomic landscape of recurrence during or after adjuvant osimertinib treatment in patients with resectable NSCLC harboring EGFR-sensitizing mutations. The secondary endpoints are to explore the genomic profiles of recurrence in subgroups with different recurrence patterns (local recurrence versus distant metastasis) during or after adjuvant osimertinib treatment, and to describe the treatment patterns used in real-world clinical practice after disease progression. The exploratory endpoints are to investigate changes in the genomic profile between baseline and recurrence and to explore the mechanisms underlying tumor progression.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –consists of 30 patients who experienced a recurrence more than 6 months after completing 3 years of adjuvant osimertinib. |
| Cohort 2 | – | –consists of 30 patients with recurrence during adjuvant osimertinib treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This multicenter, retrospective, real-world study includes patients with resected stage IB-IIIA NSCLC harboring EGFR-sensitizing mutations (exon 19 deletion or exon 21 L858R) who received adjuvant osimertinib. A total of 60 patients are enrolled and classified into two cohorts based on recurrence timing: Cohort 1 comprises 30 patients with recurrence more than 6 months after completing 3 years of adjuvant osimertinib; Cohort 2 comprises 30 patients with recurrence during adjuvant osimertinib treatment. Genomic profiling data of recurrence, obtained from next-generation sequencing of tissue and/or blood samples, are collected and analyzed. All data are extracted from electronic medical records.
Key inclusion criteria (7 listed)
- Informed consent signed;
- Age ≥ 18 years;
- Histologically confirmed diagnosis of non-squamous non-small cell lung cancer;
- Patients with stage IB-IIIA (TNM 8#) NSCLC undergo confirmed radical R0 resection;
- Confirmed EGFR sensitive-mutations (exon 19 deletions, 21 L858R point mutations) prior to adjuvant osimertinib therapy;
Key exclusion criteria (5 listed)
- Patients with stage I-III NSCLC whose surgical resection cannot be confirmed;
- Received adjuvant therapy other than that specified in the ADAURA study;
- No NGS test report at recurrence;
- History of other malignant tumors within 2 years;
- Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has treatment-related complications High risk etc.
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
Recurrence gene profiles
Time frame: From January 2021 to March 2026, assessed retrospectively from medical records.
To assess the recurrence gene profiles of adjuvant Osimertinib therapy
2 secondary outcomes
Recurrence gene profiles in patients with different recurrence types (local /distant)
Time frame: From January 2021 to March 2026, assessed retrospectively from medical records
Subsequent treatment patterns
Time frame: FromJanuary 2021 to March 2026, assessed retrospectively from medical records
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Non-small Cell Lung Cancer, run by Hunan Province Tumor 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence gene profiles (time frame: From January 2021 to March 2026, assessed retrospectively from medical records.). 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 21 Jul 2026.