Clinical trial NCT04646837: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: neoadjuvant immunotherapy
IMFINZI
multiple-omics
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2020-11-30
Enrollment: 20
Sex: ALL
Minimum age (years): 80
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

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)

Primary outcomes:
measure: MPR
timeFrame: At the date of tumor assessment after surgery, estimated at approximately 24 weeks post-baseline
Secondary outcomes:
measure: Progression free survival
timeFrame: at 24 months from the first dose of neadjuvant treatment
measure: Overall survival
timeFrame: at 3 years from the first dose of neoadjuvant treatment
measure: Toxicity profile
timeFrame: from the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: