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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Albumin Paclitaxel; Drug: Durvalumab; Drug: Carboplatin/Cisplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04646837

2020-IMFINZI-001

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 20 estimated patients

Sex: All

Ages: 80 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Experimental Arm

Experimental group

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

Treatment:

Drug: Carboplatin/Cisplatin

Drug: Durvalumab

Drug: Albumin Paclitaxel