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

Sponsor
Peking Union Medical College Hospital
Study ID
NCT04646837
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
80 Years - 80 Years
Healthy Volunteers
Not accepted

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
  • Albumin Paclitaxel — DRUG
    Albumin Paclitaxel 200-260 mg, depending on the patient's physical condition, for 2 cycle
  • Carboplatin/Cisplatin — DRUG
    Carboplatin AUC 6 IV Q3W or Cisplatin 80mg/㎡ for 2 cycle

Study Details

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.

Key Dates

Start date
May 1, 2021
Status verified
Apr 2022
Primary completion
May 1, 2024
Completion
Mar 31, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

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

Central Contacts

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