Clinical trial NCT05457049: Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD
Official title: Dynamic Observational Strategy for Stage IB-IIIA Non-Small Cell Lung Cancer Patients After Complete Resection Based on Longitudinal Undetectable Molecular Residual Disease: Prospective, Multicenter, Single-Arm Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer
Keywords: Molecular residual disease
Adjuvant therapy
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stage IB-IIIA NSCLC patients who after complete resection and undetectable landmark MRD.

Brief summary: Molecular residual disease (MRD) has strong relationship with clinical outcome in multiple solid tumors. Here, the investigators try to verify the negative predictive value of undetectable MRD, which is considered as a superior prognostic factor for resected NSCLC patients, and not requiring excessive adjuvant therapy. Stage IB-IIIA resected NSCLC patients with landmark and longitudinal undetectable MRD are enrolled and under close surveillance in this study.

Detailed description: Stage IB-IIIA resected NSCLC patients will undergo two-round MRD tests after operation, first in 3-7 days and second in 1 month after operation. And patients who confirm two-round landmark undetectable MRD will be enrolled. Enrolled patients will be under close MRD and imaging monitoring without any adjuvant therapy.

Eligibility criteria: Inclusion Criteria:

* Stage IB-IIIA non-small cell cancer patients who after complete resection.
* ≥18 years.
* Two-round MRD tests confirm landmark undetectable MRD.
* Expected survival ≥12 weeks.
* Expected survival ≥12 weeks.
* ECOG PS 1-2.
* Willing to accept MRD monitoring every 3 months for a total of 2 years after operation.

Exclusion Criteria:

* 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.).

Primary outcomes:
measure: Two-years disease free survival rates for patients with longitudinal undetectable MRD
timeFrame: 2 year
Secondary outcomes:
measure: Two-years disease free survival rates for patients with six months longitudinal undetectable MRD
timeFrame: 2 year
measure: Two-years disease free survival rates for patients with 12-months longitudinal undetectable MRD
timeFrame: 2 year
measure: Two-years disease free survival rates for patients with 18-months longitudinal undetectable MRD
timeFrame: 2 year
measure: Two-years event-free survival rates for enrolled patients in two years
timeFrame: 2 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
state: Guangdong
Study officials:
References:
citation: Zhang JT, Liu SY, Gao W, Liu SM, Yan HH, Ji L, Chen Y, Gong Y, Lu HL, Lin JT, Yin K, Jiang BY, Nie Q, Liao RQ, Dong S, Guan Y, Dai P, Zhang XC, Yang JJ, Tu HY, Xia X, Yi X, Zhou Q, Zhong WZ, Yang XN, Wu YL. Longitudinal Undetectable Molecular Residual Disease Defines Potentially Cured Population in Localized Non-Small Cell Lung Cancer. Cancer Discov. 2022 Jul 6;12(7):1690-1701. doi: 10.1158/2159-8290.CD-21-1486.