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.

NCT06854939 | Not Yet Recruiting

• 1 other identifier: JCOG2111A
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 2-year PFS

  Analyses are planned to be performed 4.5 years after the start of the study.

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

non-small cell lung cancer (NSCLC)

You may qualify if:

• 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):
• \. Stage IB-III (preoperative clinical stage) deemed resectable, with no planned neoadjuvant therapy.
• \. Stage III disease deemed amenable to curative-intent chemoradiotherapy. 3. Stage II-III (preoperative clinical stage) deemed resectable, with planned neoadjuvant therapy.
• \) Age ≥ 18 years at the time of enrollment. 4) The attending physician has determined that tissue and blood samples can be provided.
• \) Written informed consent has been obtained from the patient.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Center, Japan: lead
• Natera, Inc.: collaborator

Study Sites (1)

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected in Streck tubes and EDTA tubes Tissue samples prepared on FFPE slides

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm, Residual; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2029
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

JP (1)