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

NCT04646837 | Unknown Phase 1

• 1 other identifier: 2020-IMFINZI-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

neoadjuvant immunotherapy; IMFINZI; multiple-omics

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (3)

• Progression free survival

  at 24 months from the first dose of neadjuvant treatment

• Overall survival

  at 3 years from the first dose of neoadjuvant treatment

• Toxicity profile

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

Study Arms (1)

Experimental Arm

EXPERIMENTAL

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; Drug: Albumin Paclitaxel; Drug: Carboplatin/Cisplatin

Interventions

Durvalumab DRUG

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

Also known as: IMFINZI

Experimental Arm

Albumin Paclitaxel DRUG

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

Experimental Arm

Carboplatin/Cisplatin DRUG

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

Experimental Arm

Eligibility Criteria

• Age: 80 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Naixin Liang, Doctor

CONTACT

+86 13701089919; pumchnelson@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 30, 2020
• Study Start: May 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 29, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)