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

March 28, 2023 updated by: Peking Union Medical College Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Naixin Liang, Doctor
        • Principal Investigator:
          • Shanqing Li, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm
Durvalumab 1000 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IB-IIIA NSCLC adult patients followed by adjuvant treatment for 1 year with Durvalumab 1000 mg IV Q3W for 4 months and Durvalumab 15000mg Q4W for 8 months
Drug: Durvalumab
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
Other Names:
  • IMFINZI
Drug: Albumin Paclitaxel
Albumin Paclitaxel 200-260 mg, depending on the patient's physical condition, for 2 cycle
Drug: Carboplatin/Cisplatin
Carboplatin AUC 6 IV Q3W or Cisplatin 80mg/㎡ for 2 cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MPR
Time Frame: At the date of tumor assessment after surgery, estimated at approximately 24 weeks post-baseline
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
At the date of tumor assessment after surgery, estimated at approximately 24 weeks post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: at 24 months from the first dose of neadjuvant treatment
The progression free survival is the time until the patients disease progresses
at 24 months from the first dose of neadjuvant treatment
Overall survival
Time Frame: at 3 years from the first dose of neoadjuvant treatment
Time when the patient is still alive
at 3 years from the first dose of neoadjuvant treatment
Toxicity profile
Time Frame: from the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment
Toxicities caused by the drug during the study
from the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 26, 2020

First Posted (Actual)

November 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-IMFINZI-001

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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