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

Primary Purpose

Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Durvalumab
Albumin Paclitaxel
Carboplatin/Cisplatin
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring neoadjuvant immunotherapy, IMFINZI, multiple-omics

Eligibility Criteria

80 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression free survival
The progression free survival is the time until the patients disease progresses
Overall survival
Time when the patient is still alive
Toxicity profile
Toxicities caused by the drug during the study

Full Information

First Posted
November 10, 2020
Last Updated
March 28, 2023
Sponsor
Peking Union Medical College Hospital
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04646837
Brief Title
Mechanism of Response to IMFINZI Neoadjuvant Therapy in Non-small Cell Lung Cancer Patients Based on Multiple-omics Models
Official Title
Mechanism of Response to IMFINZI Neoadjuvant Therapy in Non-small Cell Lung Cancer Patients Based on Multiple-omics Models
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
neoadjuvant immunotherapy, IMFINZI, multiple-omics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
IMFINZI
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Albumin Paclitaxel
Intervention Description
Albumin Paclitaxel 200-260 mg, depending on the patient's physical condition, for 2 cycle
Intervention Type
Drug
Intervention Name(s)
Carboplatin/Cisplatin
Intervention Description
Carboplatin AUC 6 IV Q3W or Cisplatin 80mg/㎡ for 2 cycle
Primary Outcome Measure Information:
Title
MPR
Description
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 Outcome Measure Information:
Title
Progression free survival
Description
The progression free survival is the time until the patients disease progresses
Time Frame
at 24 months from the first dose of neadjuvant treatment
Title
Overall survival
Description
Time when the patient is still alive
Time Frame
at 3 years from the first dose of neoadjuvant treatment
Title
Toxicity profile
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
80 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naixin Liang, Doctor
Phone
+86 13701089919
Email
pumchnelson@163.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naixin Liang, Doctor
Phone
13701089919
Email
pumchnelson@163.com
First Name & Middle Initial & Last Name & Degree
Naixin Liang, Doctor
First Name & Middle Initial & Last Name & Degree
Shanqing Li, Doctor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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