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NCT Number: NCT06524518

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

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).

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Key information

Conditions

DFS

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Xuanwu Hospital

Beijing, Eijing, 100043, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-80 years old
  • gender: men and women can be balanced as far as possible
  • Patients with clinically confirmed stage II-III NSCLC by histopathology have operable conditions
  • 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
  • ECOG behavior status score 0 ~ 1
  • EGFR or ALK driver gene mutation negative
  • 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.
  • 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
  • Sign informed consent

Exclusion criteria

  • Any other anti-tumor treatment before surgery
  • Patients with previous history of other malignant tumors
  • Have a history of interstitial lung disease, drug-induced interstitial disease or any active interstitial lung disease with clinical evidence
  • CT scan at baseline revealed idiopathic pulmonary fibrosis. 4. Pregnant or lactating women
  • multiple lung cancer patients
  • Patient's organ system status:
  • 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
  • Functional level of patients with various organ lesions:
  • 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
  • Liver: serum bilirubin > 1.5 times the upper limit of normal
  • Serum creatinine > 1.25 times the normal value
  • 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.
  • 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].
  • Situations considered unsuitable for inclusion by other researchers

Treatment and study plan

Chemotherapy combined with immunization

Drug

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

Primary outcomes

  1. DFS

    Time frame: MRD-positive patients were treated 3 years after intervention

    3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoru Tian

CONTACT

[email protected]

18618330855

Yi Zhang, MD,PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

Xuanwu Hospital Capital Medical University

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Jul 29, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.