Mechanism of Response to IMFINZI Neoadjuvant Therapy in Non-small Cell Lung Cancer Patients Based on Multiple-omics Models

Peking Union Medical College Hospital20 enrolled

Overview

A single-center prospective exploratory single-arm neoadjuvant therapy study, based on a prospective cohort study, according to patients' blood and tumor samples before and after neoadjuvant treatment, WES, GEP gene expression profiling, TCR sequencing and ctDNA dynamic monitoring were used to explore the intratumoral immune consequences of PD-1 monoclonal antibody administration and identify potential Response biomarker.

To explore the safety and immunobiological effects of 2 cycles of duvalumab combined with albumin paclitaxel + cisplatin/carboplatin for patients with stage IB-IIIA non-small cell lung cancer; use whole exome sequencing , GEP gene expression profile detection based on NanoString platform and other methods to predict the efficacy of IMFINZI neoadjuvant therapy, looking for potential biomarkers; study the impact of neoadjuvant therapy of I drug on the tumor microenvironment at multiple levels such as genome, transcriptome, PD-1/PD-L1 protein transcription and expression, T cell TCR immune groupthe library and T cell subsets, and provide comprehensive exploratory research evidence for finding the biomarker for the neoadjuvant anti-PD-L1 therapy of lung cancer .

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small Cell Lung Cancer

Interventions

DurvalumabDRUG

Durvalumab 1000 mg IV Q3W for 2 cycle + Followed by adjuvant treatment for 1 year with Durvalumab 1000 mg IV Q3W for 4 months and Durvalumab 1500mg Q4W for 8 months

Albumin PaclitaxelDRUG

Albumin Paclitaxel 200-260 mg, depending on the patient's physical condition, for 2 cycle

Carboplatin/CisplatinDRUG

Carboplatin AUC 6 IV Q3W or Cisplatin 80mg/㎡ for 2 cycle

Eligibility

Sex: ALLMin age: 80 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18-80 years old * Male or female (no fertility requirement) * Meet NCCN lung cancer diagnostic criteria * No radical mastectomy, radiotherapy, chemotherapy, targeted therapy and immunotherapy * Resectable stage Ib-IIIa non-small cell lung cancer (NSCLC) patients confirmed by imaging and biopsy; clear lung histopathological sample results have been obtained during screening, and all molecular biological tests can be completed. * Patients without serious comorbidities, including but not limited to basic cardiovascular and cerebrovascular diseases, and patients whose clinical conditions allow to tolerate thoracic surgery * Female and male subjects of childbearing age must use appropriate contraceptive measures during the study period and 6 months after the last study medication. Female subjects of childbearing age must have a negative pregnancy test * Pathologically confirmed as lung adenocarcinoma or squamous cell carcinoma Exclusion Criteria: * Patients with unstable vital signs, need vasoactive drugs, or need intensive care unit (ICU) support * Patients with active infections (including infections such as bacteria, fungi, viruses, tuberculosis, and various types of hepatitis) within 3 months before the first study medication * Symptoms and signs of severe or uncontrolled liver, kidney, gastrointestinal, endocrine, lung, heart, neuropsychiatric, or brain disease * Patients with a history of autoimmune diseases (inflammation or insufficiency of glands such as thyroid, pituitary, adrenal gland, etc., immunological diseases with positive autoantibodies) * Is participating in other drug trials * One month before the enrollment plan to receive immunotherapy, he had used any anti-systemic antibiotic therapy, hormone therapy, immunosuppressive therapy, etc. * The pathology is small cell lung cancer or other neuroendocrine tumors or sarcomas, rare tumors or lung adenocarcinoma/squamous cell carcinoma containing the above components. * The patient has a history of malignant tumors other than lung cancer * Patients with sensitive gene mutations in EGFR (E19del/E21 L858R) and ALK (various types of fusion mutations)

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

MPR

Major pathologic response is defined as the presence of 10% or less of vital tumor cells in the sections of the primary lesion and/or mediastinal lymph nodes presenting focal microscopic disease after surgery

Time frame: At the date of tumor assessment after surgery, estimated at approximately 24 weeks post-baseline

Secondary Outcomes

Progression free survival

The progression free survival is the time until the patients disease progresses

Time frame: at 24 months from the first dose of neadjuvant treatment

Overall survival

Time when the patient is still alive

Time frame: at 3 years from the first dose of neoadjuvant treatment

Toxicity profile

Toxicities caused by the drug during the study

Time frame: from the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment

Central Contacts

Naixin Liang, Doctor

CONTACT

+86 13701089919 pumchnelson@163.com

Data from ClinicalTrials.gov

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