Lung CancerPhase 3NCT06323148
Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022)
A Phase 3 study testing Osimertinib and No adjuvant therapy in people with Lung Cancer and EGFR Gene Mutation, run by Fudan University.
Trial summary
This study plans to conduct ctDNA testing on EGFR mutation-positive stage II-IIIA (N1-N2) NSCLC patients after radical surgery (R0 resection). Patients with positive ctDNA testing will receive standard treatment according to clinical guidelines, while patients with negative ctDNA testing will be assessed based on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, EGFR Gene Mutation, Minimal Residual Disease
- What is being tested?
- Osimertinib and No adjuvant therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 31 Mar 2029
- Phase
- Phase 3
- 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
Who may be able to join
- Age greater than 18 years old, both males and females are eligible.
- Histologically confirmed diagnosis of non-small cell lung cancer.
- Diagnosis of stage II-IIIA (N1-N2) non-small cell lung cancer based on the 8th edition TNM staging guidelines combined with radiological evaluation.
- EGFR mutation-positive status confirmed through molecular testing (such as ARMS-PCR or high-throughput sequencing), specifically with mutations 19del or 21L858R.
- Able to undergo R0 surgical resection.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1. Expected survival of more than 12 months.
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- Baseline blood routine and biochemical indicators meeting the following criteria:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
- Lymphocyte count ≥ 0.5 × 10^9/L;
- Platelet count ≥ 100 × 10^9/L;
- Hemoglobin ≥ 9 g/dL.
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 times ULN.
- Patients must provide informed consent, either directly or through their legally authorized representatives, after being informed about the study.
Who cannot join
- Pathological diagnosis of mixed-type lung cancer (including a history of small cell lung cancer or non-adenocarcinoma).
- Received anti-tumor therapy before surgery (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).
- Rx, R1, R2 surgical resection.
- Received blood transfusion during surgery or within 2 weeks before surgery.
- Pregnant or lactating female patients.
- History of other malignant tumors within the past 5 years, except for cases where other malignant tumors have been cured solely through surgery with a disease-free interval of at least 10 years, curable basal cell carcinoma of the skin, and cervical carcinoma in situ.
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- Any unstable systemic diseases (including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction within the past year, severe arrhythmias requiring medication, liver, kidney, or metabolic diseases).
- Evidence of any other diseases, neurological or metabolic functional disorders, physical examination findings, or laboratory findings that would place the subject at high risk of treatment-related complications.
- Other factors deemed by the investigators to potentially affect the study process.
About this study
Official title: Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA
This study plans to conduct ctDNA testing on EGFR mutation-positive stage II-IIIA (N1-N2) NSCLC patients after radical surgery (R0 resection). Patients with positive ctDNA testing will receive standard treatment according to clinical guidelines, while patients with negative ctDNA testing will be assessed based on comprehensive clinical and pathological characteristics. After receiving or not receiving standard adjuvant chemotherapy, patients will be randomly assigned in a 1:1 ratio to either the observation follow-up group (experimental group) or the osimertinib adjuvant treatment group (control group). The aim is to explore whether observation follow-up for patients with negative ctDNA after surgery has a prognosis non-inferior to osimertinib treatment, and to investigate the disease-free survival rate of EGFR mutation-positive stage II-IIIA (N1-N2) NSCLC patients with positive ctDNA after surgery receiving osimertinib adjuvant treatment, providing more precise treatment guidance for adjuvant therapy in this specific type of NSCLC patients with EGFR mutation-positive tumors.
- Conditions
- Lung Cancer, EGFR Gene Mutation, Minimal Residual Disease
- Being tested
- Osimertinib, No adjuvant therapy
- Medical subject headings
- Lung Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
Adjuvant osimertinib for three years after radical surgery
No adjuvant therapyDrug
No adjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| ct-DNA-positive patients receiving no adjuvant osimertinib | Placebo comparator | ct-DNA-positive patients receiving no adjuvant osimertinib Receives: Drug: No adjuvant therapy |
| ct-DNA-positive patients receiving adjuvant osimertinib | Experimental | ct-DNA-positive patients receiving adjuvant osimertinib Receives: Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 3-year Disease-Free Survival (DFS) rate between the observation group and the osimertinib treatment group.
Disease-Free Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323148
- Sponsor's protocol ID
- ECTOP-1022
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- 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 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA
- ClinicalTrials.gov ID
- NCT06323148
- Acronym / sponsor ID
- ECTOP-1022
- Conditions
- Lung Cancer, EGFR Gene Mutation, Minimal Residual Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 21 Mar 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 plans to conduct ctDNA testing on EGFR mutation-positive stage II-IIIA (N1-N2) NSCLC patients after radical surgery (R0 resection). Patients with positive ctDNA testing will receive standard treatment according to clinical guidelines, while patients with negative ctDNA testing will be assessed based on comprehensive clinical and pathological characteristics. After receiving or not receiving standard adjuvant chemotherapy, patients will be randomly assigned in a 1:1 ratio to either the observation follow-up group (experimental group) or the osimertinib adjuvant treatment group (control group). The aim is to explore whether observation follow-up for patients with negative ctDNA after surgery has a prognosis non-inferior to osimertinib treatment, and to investigate the disease-free survival rate of EGFR mutation-positive stage II-IIIA (N1-N2) NSCLC patients with positive ctDNA after surgery receiving osimertinib adjuvant treatment, providing more precise treatment guidance for adjuvant therapy in this specific type of NSCLC patients with EGFR mutation-positive tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ct-DNA-positive patients receiving no adjuvant osimertinib | Placebo comparator | Drug: No adjuvant therapyct-DNA-positive patients receiving no adjuvant osimertinib |
| ct-DNA-positive patients receiving adjuvant osimertinib | Experimental | Drug: Osimertinibct-DNA-positive patients receiving adjuvant osimertinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age greater than 18 years old, both males and females are eligible.
- Histologically confirmed diagnosis of non-small cell lung cancer.
- Diagnosis of stage II-IIIA (N1-N2) non-small cell lung cancer based on the 8th edition TNM staging guidelines combined with radiological evaluation.
- EGFR mutation-positive status confirmed through molecular testing (such as ARMS-PCR or high-throughput sequencing), specifically with mutations 19del or 21L858R.
- Able to undergo R0 surgical resection.
Key exclusion criteria (9 listed)
- Pathological diagnosis of mixed-type lung cancer (including a history of small cell lung cancer or non-adenocarcinoma).
- Received anti-tumor therapy before surgery (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).
- Rx, R1, R2 surgical resection.
- Received blood transfusion during surgery or within 2 weeks before surgery.
- Pregnant or lactating female patients.
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 |
|---|---|---|
| OsimertinibAdjuvant osimertinib for three years after radical surgery | Drug | ct-DNA-positive patients receiving adjuvant osimertinib |
| No adjuvant therapyNo adjuvant therapy | Drug | ct-DNA-positive patients receiving no adjuvant osimertinib |
Primary outcome
The 3-year Disease-Free Survival (DFS) rate between the observation group and the osimertinib treatment group.
Time frame: 3 years
Disease-Free Survival
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 21 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Osimertinib and No adjuvant therapy in people with Lung Cancer and EGFR Gene Mutation, run by Fudan University.
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 14 inclusion and 9 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: opening soon, as of the sponsor's last update on 21 Mar 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
The 3-year Disease-Free Survival (DFS) rate between the observation group and the osimertinib treatment group. (time frame: 3 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 21 Mar 2024.