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

NCT ID: NCT06524518

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2029-12-31

Brief Summary

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).

Conditions

DFS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

MRD-negative follow-up

Group Type: SHAM_COMPARATOR

Chemotherapy combined with immunization

Intervention Type: DRUG

MRD positive patients receive chemotherapy ± immune for 4 cycles before adaptive therapy

MRD-positive follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

MRD-positive adaptive therapy

Group Type: EXPERIMENTAL

Chemotherapy combined with immunization

Intervention Type: DRUG

MRD positive patients receive chemotherapy ± immune for 4 cycles before adaptive therapy

Interventions

Chemotherapy combined with immunization

MRD positive patients receive chemotherapy ± immune for 4 cycles before adaptive therapy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi Zhang, MD,PhD

Role: STUDY_CHAIR

Capital Medical University

Locations

Xuanwu Hospital

Beijing, Eijing, China

Countries

China

Central Contacts

Xiaoru Tian

Role: CONTACT

xiaoru9u@163.com

18618330855

Yi Zhang, MD,PhD

Role: CONTACT

steven9130@sina.com

Other Identifiers

XuanwuH-NSCLC-MINT

Identifier Type: -

Identifier Source: org_study_id