NSCLCNCT06924710
Adaptive Therapy for Resected Stage ⅠA2-Ⅱ NSCLC Patients With Undetectable MRD
A study testing Standard Therapy and Adaptive Therapy in people with NSCLC, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
It is a prospective, multicenter, randomized controlled trial to investigate the predictive value of MRD on adjuvant therapy. Stage IA2-II resected NSCLC patients will undergo two-round MRD tests after surgery, first in 3-7 days and second in 1 month after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Standard Therapy and Adaptive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2025to 31 Dec 2029
- Phase
- Interventional
- 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
- Stage IA2-II non-small cell cancer patients who after complete resection.
- Two-round MRD tests confirm landmark undetectable MRD
- Expected survival ≥24 months
- ECOG PS 0-1
- Willing to accept MRD monitoring every 3 months for a total of 2 years after surgery
Who cannot join
- Patients who had previously undergone radiotherapy or chemotherapy or any other anti-tumor therapy
- Patients with a history of other malignancies in the past 5 years
- Any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.) or other conditions that investigators considered would limit the ability of the patient to participate in the study
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
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
Luyan Shen, 86-1581140843, shenluyan@pku.edu.cn
About this study
Official title: A Prospective Multicenter Randomized Controlled Study of Adaptive Therapy in Resected Stage ⅠA2-Ⅱ NSCLC Patients With Undetectable MRD
It is a prospective, multicenter, randomized controlled trial to investigate the predictive value of MRD on adjuvant therapy. Stage IA2-II resected NSCLC patients will undergo two-round MRD tests after surgery, first in 3-7 days and second in 1 month after surgery. And patients who confirm two-round landmark undetectable MRD will be enrolled and randomly assigned to the conventional treatment group or the adaptive therapy group . Patients in the the adaptive therapy group will undergo closely MRD and imaging monitoring without adjuvant therapy if the MRD was negative.
- Conditions
- NSCLC
- Being tested
- Standard Therapy, Adaptive Therapy
- Keywords
- MRD, ctDNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TherapyDrug
For patients with negative EGFR/ALK mutation, adjuvant chemotherapy or adjuvant chemotherapy combined with immunotherapy was administered, for patients with positive EGFR/ALK mutation, targeted therapy was administered.
Adaptive TherapyOther
Patients will be under close MRD and imaging monitoring without adjuvant therapy if the MRD was negative.
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | Active comparator | Patients in this group will be treated following the guidelines. Receives: Drug: Standard Therapy |
| Adaptive Therapy | Experimental | Patients in this group will undergo closely MRD and imaging monitoring without adjuvant therapy if the MRD was negative. Receives: Other: Adaptive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-years disease free survival rates
The 2-year DFS rate of patients in both arms
Measured: 2 years
Secondary outcomes (3)
Use of adjuvant therapy
Differences in adjuvant therapy use between the Adaptive Therapy group (no adjuvant therapy if MRD persistently negative and initiation of adjuvant therapy if MRD positive) and the Standard Treatment Group
Measured: 2 years
Questionnaire on Quality of Life
Differences in the Quality of Life between the Adaptive Therapy group (no adjuvant therapy if MRD persistently negative and initiation of adjuvant therapy if MRD positive) and the Standard Treatment Group, by using Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, V3)
Measured: 2 years
Five-years disease free survival rates
The 5-year DFS rate of patients in both arms
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 posted11 Apr 2025
- Study start6 Apr 2025
- Primary completion15 Jun 2029 (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 Peking University Cancer Hospital & InstituteThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Chest Hospital, Peking University First Hospital, Bethune First Hospital of Jilin University, Beijing Friendship Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Liaoning Cancer Hospital & Institute, Geneplus-Beijing Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Shaohua Ma, M.D., Principal investigator, Peking University Cancer Hospital & Institute, Beijing 100142, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924710
- Sponsor's protocol ID
- 2024KT205
- Other IDs
- ZLRK202524
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Controlled Study of Adaptive Therapy in Resected Stage ⅠA2-Ⅱ NSCLC Patients With Undetectable MRD
- ClinicalTrials.gov ID
- NCT06924710
- Acronym / sponsor ID
- 2024KT205
- Conditions
- NSCLC
- Keywords
- MRD, ctDNA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Tianjin Chest Hospital, Peking University First Hospital, Bethune First Hospital of Jilin University, Beijing Friendship Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Liaoning Cancer Hospital & Institute, Geneplus-Beijing Co. Ltd.
- Study start
- 6 Apr 2025 (actual)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Apr 2025 (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.
It is a prospective, multicenter, randomized controlled trial to investigate the predictive value of MRD on adjuvant therapy. Stage IA2-II resected NSCLC patients will undergo two-round MRD tests after surgery, first in 3-7 days and second in 1 month after surgery. And patients who confirm two-round landmark undetectable MRD will be enrolled and randomly assigned to the conventional treatment group or the adaptive therapy group . Patients in the the adaptive therapy group will undergo closely MRD and imaging monitoring without adjuvant therapy if the MRD was negative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | Active comparator | Drug: Standard TherapyPatients in this group will be treated following the guidelines. |
| Adaptive Therapy | Experimental | Other: Adaptive TherapyPatients in this group will undergo closely MRD and imaging monitoring without adjuvant therapy if the MRD was negative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stage IA2-II non-small cell cancer patients who after complete resection.
- Two-round MRD tests confirm landmark undetectable MRD
- Expected survival ≥24 months
- ECOG PS 0-1
- Willing to accept MRD monitoring every 3 months for a total of 2 years after surgery
Key exclusion criteria (3 listed)
- Patients who had previously undergone radiotherapy or chemotherapy or any other anti-tumor therapy
- Patients with a history of other malignancies in the past 5 years
- Any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.) or other conditions that investigators considered would limit the ability of the patient to participate in the study
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 |
|---|---|---|
| Standard TherapyFor patients with negative EGFR/ALK mutation, adjuvant chemotherapy or adjuvant chemotherapy combined with immunotherapy was administered, for patients with positive EGFR/ALK mutation, targeted therapy was administered. | Drug | Standard Therapy |
| Adaptive TherapyPatients will be under close MRD and imaging monitoring without adjuvant therapy if the MRD was negative. | Other | Adaptive Therapy |
Primary outcome
Two-years disease free survival rates
Time frame: 2 years
The 2-year DFS rate of patients in both arms
3 secondary outcomes
Use of adjuvant therapy
Time frame: 2 years
Questionnaire on Quality of Life
Time frame: 2 years
Five-years disease free survival rates
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 2 Oct 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.
Shaohua Ma, M.D. principal investigator
Peking University Cancer Hospital & Institute, Beijing 100142, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Therapy and Adaptive Therapy in people with NSCLC, run by Peking University Cancer Hospital & Institute 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 5 inclusion and 3 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 2 Oct 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 Luyan Shen, Ph.D. (86-1581140843, shenluyan@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-years disease free survival rates (time frame: 2 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 2 Oct 2025.