A Multicenter Randomized Controlled Study of Interventional Treatment for Operable Stage Ⅱ-Ⅲ Non-small Cell Lung Cancer With Potential Recurrence as Minimal Residual Disease(MRD) Positive

Xuanwu Hospital Capital Medical University

A prospective, multicenter clinical study designed to explore the efficacy of adaptive therapy based on MRD status in patients with stage II-III non-small cell lung cancer(NSCLC) after treatment. Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS).

Study Overview

• Status: Not yet recruiting
• Conditions: DFS
• Intervention / Treatment: Drug: Chemotherapy combined with immunization

• Study Type: Interventional
• Enrollment (Estimated): 213
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaoru Tian; Phone Number: 18618330855; Email: xiaoru9u@163.com
• Study Contact Backup: Name: Yi Zhang, MD,PhD; Email: steven9130@sina.com

Study Locations

• China
  • Eijing
    • Beijing, Eijing, China, 100043
      • Xuanwu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: 18-80 years old
2. gender: men and women can be balanced as far as possible
3. Patients with clinically confirmed stage II-III NSCLC by histopathology have operable conditions
4. no previous exposure to immune-mediated therapy, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 And anti-PD-L2 antibodies
5. ECOG behavior status score 0 ~ 1
6. EGFR or ALK driver gene mutation negative
7. organ function level meets the conditions: 1) Hematological examination indicators: absolute neutrophil count (ANC) ≥1.8×109/L, platelet count ≥ 100×109/L, hemoglobin ≥9 g/dL.

2) Appropriate liver function: total bilirubin ≤ 1.5× upper limit of normal (ULN), aspartate aminotransferase (AST), Alanine aminotransferase (ALT) ≤2.5×ULN 3) Appropriate renal function: serum creatinine ≤1.25×ULN, or creatinine clearance ≥60 mL/min

8. Sign informed consent

Exclusion Criteria:

1. Any other anti-tumor treatment before surgery
2. Patients with previous history of other malignant tumors
3. Have a history of interstitial lung disease, drug-induced interstitial disease or any active interstitial lung disease with clinical evidence
4. CT scan at baseline revealed idiopathic pulmonary fibrosis. 4. Pregnant or lactating women
5. multiple lung cancer patients
6. Patient's organ system status:

1) Prior interstitial lung disease, drug-induced interstitial disease, radiation pneumonia or REN requiring hormone therapy Any clinical evidence of active interstitial lung disease 2) In the investigator's judgment, there is a severe or uncontrollable systemic disease (e.g. unstable or uncompensable) Evidence of respiratory, heart, liver or kidney disease) 3) Any unstable systemic disease (including active infection, grade III hypertension, unstable angina, Congestive heart failure, liver, kidney or metabolic disease) 4) Can not accept oral administration, need intravenous high energy nutrition, prior surgery affecting absorption or live Patients with dynamic peptic ulcer

7. Functional level of patients with various organ lesions:

1. Bone marrow: absolute neutrophil count (ANC) < 1.5×109/L, platelets < 90×109/L or blood V1.1 2024.5.29 Albumin < 9 g/dl
2. Liver: serum bilirubin > 1.5 times the upper limit of normal
3. Serum creatinine > 1.25 times the normal value
4. any other disease, neurological or metabolic disorder, the evidence of physical examination or laboratory test results is reasonable Suspected illness or presence of counterindications of use of related drugs or placing subjects at high levels of treatment-related complications The possibility of risk.

8. No R0 resection [ananatomical lobectomy/total pulmonary resection + systemic lymph node dissection (including at least 3 groups of N1) And 3 groups of N2 lymph nodes), both gross and microscopic incisal margins were negative].

9. Situations considered unsuitable for inclusion by other researchers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: MRD-negative follow-up	Drug: Chemotherapy combined with immunization; MRD positive patients receive chemotherapy ± immune for 4 cycles before adaptive therapy
No Intervention: MRD-positive follow-up
Experimental: MRD-positive adaptive therapy	Drug: Chemotherapy combined with immunization; MRD positive patients receive chemotherapy ± immune for 4 cycles before adaptive therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS	3 years	MRD-positive patients were treated 3 years after intervention

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Study Chair: Yi Zhang, MD,PhD, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: XuanwuH-NSCLC-MINT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No