NSCLC, Stage I, II, IIIMRDSEEKERNCT06854939
A Prospective Study Investigating the Relationship Between Minimal Residual Disease Detection, Monitoring Frequency, and Prognosis in Non-small Cell Lung Cancer Patients Eligible for Curative Treatment.
An observational study of NSCLC, Stage I, II, III, run by National Cancer Center, Japan at 1 site in Japan.
Trial summary
Adding immune checkpoint inhibitors or molecularly targeted drugs as adjuvant therapy to curative treatments-such as surgery or chemoradiotherapy-for stage I-III non-small cell lung cancer (NSCLC) has been established as a standard of care and has improved treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Stage I, II, III
- How many people
- 350 participants
- Where
- 1 siteJapan
- Study dates
- 1 Mar 2025to 30 Sep 2029
- How long will I take part?
- 18 Months
- 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: non-small cell lung cancer (NSCLC)
Who may be able to join
- A histopathologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- The diagnosis (by cytology or biopsy) must be one of the following: "adenocarcinoma," "squamous cell carcinoma," "non-small cell carcinoma consistent with adenocarcinoma," "non-small cell carcinoma consistent with squamous cell carcinoma," or "non-small cell carcinoma not otherwise specified (NOS)." If the histological subtype differs between cytology and biopsy specimens, the subtype determined by the biopsy specimen shall be used.
- At the time of enrollment, diagnoses of "squamous cell carcinoma" or "non-small cell carcinoma consistent with squamous cell carcinoma" are classified as squamous cell carcinoma, whereas "adenocarcinoma," "non-small cell carcinoma consistent with adenocarcinoma," and "non-small cell carcinoma NOS" are classified as non-squamous cell carcinoma.
- Meets one of the following criteria (1-3):
- 1. Stage IB-III (preoperative clinical stage) deemed resectable, with no planned neoadjuvant therapy.
- 2. Stage III disease deemed amenable to curative-intent chemoradiotherapy. 3. Stage II-III (preoperative clinical stage) deemed resectable, with planned neoadjuvant therapy.
- 3) Age ≥ 18 years at the time of enrollment. 4) The attending physician has determined that tissue and blood samples can be provided.
- 5) Written informed consent has been obtained from the patient.
Who cannot join
- Presence of active multiple primary malignancies (defined as synchronous multiple cancers/tumors or metachronous multiple cancers/tumors with a disease-free interval of 3 years or less). However, even if the disease-free interval is less than 3 years, a history of clinical stage I prostate cancer or a completely resected cancer with any of the pathological stages specified below is not considered "active multiple primary malignancies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site
National Cancer Center Hospital
Chuo-ku, Tokyo
Hidehito Horinouchi, MD, PhD, +813-3542-2511, hhorinou@ncc.go.jp
Ken Masuda, MD, +813-3542-2511, kenmasud@ncc.go.jp
About this study
Official title: Prospective Observational Study Using Personalized Minimal Residual Disease Assay (Signatera) to Evaluate the Kinetics and Detection Rate in Patients with Non-small Cell Lung Cancer
Adding immune checkpoint inhibitors or molecularly targeted drugs as adjuvant therapy to curative treatments-such as surgery or chemoradiotherapy-for stage I-III non-small cell lung cancer (NSCLC) has been established as a standard of care and has improved treatment outcomes. However, there is currently no adequate method to determine which patients should receive these adjuvant therapies. Identifying those with a good prognosis without adjuvant therapy could reduce the risk of adverse events, lessen the burden of clinic visits, and reduce healthcare costs.
Among various approaches, ctDNA-based MRD (minimal residual disease) analysis is highly anticipated and has already been introduced into clinical practice for hematologic malignancies. However, solid tumors' development as a companion diagnostic has been limited, and regulatory approval is mainly being considered based on performance evaluation data. In this study, we will conduct a performance evaluation of MRD analysis using Signatera™ in patients with stage I-III NSCLC while also collecting other prognostic factors based on clinicopathological information and survival data.
- Conditions
- NSCLC, Stage I, II, III
- Keywords
- Signatera™, minimal residual disease, MRD, lung cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm, Residual, Lung Neoplasms
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 |
|---|---|---|
| Neoadjuvant therapy group | Resectable preoperative clinical stage II-III disease (with planned neoadjuvant therapy) | |
| Adjuvant therapy group | Resectable preoperative clinical stage IB-III disease (with no planned neoadjuvant therapy) | |
| Surgery-alone group | Resectable preoperative clinical stage IB-III disease (with no planned neoadjuvant therapy) | |
| Chemoradiotherapy group | Unresectable clinical stage III disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year PFS
Measured: Analyses are planned to be performed 4.5 years after the start of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC, Stage I, II, IIIStudies 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
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Japan
- Sponsor type
- Other government
- Collaborators
- Natera, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854939
- Sponsor's protocol ID
- JCOG2111A
- Acronym
- MRDSEEKER
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 3 Mar 2025
- 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 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Using Personalized Minimal Residual Disease Assay (Signatera) to Evaluate the Kinetics and Detection Rate in Patients with Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06854939
- Acronym / sponsor ID
- MRDSEEKER / JCOG2111A
- Conditions
- NSCLC, Stage I, II, III
- Keywords
- Signatera™, minimal residual disease, MRD, lung cancer, NSCLC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- National Cancer Center, JapanOther government
- Collaborators
- Natera, Inc.
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 3 Mar 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.
Adding immune checkpoint inhibitors or molecularly targeted drugs as adjuvant therapy to curative treatments-such as surgery or chemoradiotherapy-for stage I-III non-small cell lung cancer (NSCLC) has been established as a standard of care and has improved treatment outcomes. However, there is currently no adequate method to determine which patients should receive these adjuvant therapies. Identifying those with a good prognosis without adjuvant therapy could reduce the risk of adverse events, lessen the burden of clinic visits, and reduce healthcare costs.
Among various approaches, ctDNA-based MRD (minimal residual disease) analysis is highly anticipated and has already been introduced into clinical practice for hematologic malignancies. However, solid tumors' development as a companion diagnostic has been limited, and regulatory approval is mainly being considered based on performance evaluation data. In this study, we will conduct a performance evaluation of MRD analysis using Signatera™ in patients with stage I-III NSCLC while also collecting other prognostic factors based on clinicopathological information and survival data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therapy group | – | –Resectable preoperative clinical stage II-III disease (with planned neoadjuvant therapy) |
| Adjuvant therapy group | – | –Resectable preoperative clinical stage IB-III disease (with no planned neoadjuvant therapy) |
| Surgery-alone group | – | –Resectable preoperative clinical stage IB-III disease (with no planned neoadjuvant therapy) |
| Chemoradiotherapy group | – | –Unresectable clinical stage III disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- non-small cell lung cancer (NSCLC)
Key inclusion criteria (8 listed)
- A histopathologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- The diagnosis (by cytology or biopsy) must be one of the following: "adenocarcinoma," "squamous cell carcinoma," "non-small cell carcinoma consistent with adenocarcinoma," "non-small cell carcinoma consistent with squamous cell carcinoma," or "non-small cell carcinoma not otherwise specified (NOS)." If the histological subtype differs between cytology and biopsy specimens, the subtype determined by the biopsy specimen shall be used.
- At the time of enrollment, diagnoses of "squamous cell carcinoma" or "non-small cell carcinoma consistent with squamous cell carcinoma" are classified as squamous cell carcinoma, whereas "adenocarcinoma," "non-small cell carcinoma consistent with adenocarcinoma," and "non-small cell carcinoma NOS" are classified as non-squamous cell carcinoma.
- Meets one of the following criteria (1-3):
- 1. Stage IB-III (preoperative clinical stage) deemed resectable, with no planned neoadjuvant therapy.
Key exclusion criteria (1 listed)
- Presence of active multiple primary malignancies (defined as synchronous multiple cancers/tumors or metachronous multiple cancers/tumors with a disease-free interval of 3 years or less). However, even if the disease-free interval is less than 3 years, a history of clinical stage I prostate cancer or a completely resected cancer with any of the pathological stages specified below is not considered "active multiple primary malignancies.
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
2-year PFS
Time frame: Analyses are planned to be performed 4.5 years after the start of the study.
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 3 Mar 2025.
- 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.
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 NSCLC, Stage I, II, III, run by National Cancer Center, Japan at 1 site in Japan.
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 8 inclusion and 1 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 3 Mar 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 Japan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year PFS (time frame: Analyses are planned to be performed 4.5 years after the start of the study.). 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 3 Mar 2025.