Actively Recruiting

Phase 1
Phase 2
Age: 20Years +
All Genders
NCT03694236

Concurrent Neoadjuvant Chemoradiotherapy Plus Durvalumab (MEDI4736) in Resectable Stage III NSCLC

Led by Yonsei University · Updated on 2026-05-14

39

Participants Needed

1

Research Sites

428 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Combination treatment of Durvalumab with chemoradiotherapy is ongoing for head/neck cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer (NCT02318771) and pancreatic cancer (NCT02305186).Combining Durvalumab with neoadjuvant chemoradiotherapy is a promising strategy to improve clinical outcome in stage III lung cancer. Using serial biopsied and surgically resected fresh tissue through the novel/high-throughput RNA sequencing technologies, we want to identify the change immune signature in tumor microenvironment of NSCLC patients after Durvalumab treatment. With hypothesis that PD-1 inhibitor as a component of neoadjuvant chemoradiotherapy followed by surgery could increase complete pathologic response rate and disease free survival, and overall survival, we suggest adding Durvalumab to neoadjuvant chemoradiation in stage II/III resectable NSCLC. And with immune marker study using FACS, whole exome sequencing, or RNAsequencing, we can find the potential predictive biomarker for anti-PD-L1 blockade. And in this study, we can get "whole" surgical specimen not biopsy sample after Durvalumab treatment so the analysis for immune marker, tumor microenvironment, and various tumor infiltrating immune cells and their changes will be available.

CONDITIONS

Official Title

Concurrent Neoadjuvant Chemoradiotherapy Plus Durvalumab (MEDI4736) in Resectable Stage III NSCLC

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed non-small cell lung cancer (NSCLC)
  • Clinical stage III disease, including N2 stage, as a potential candidate for surgery
  • Signed informed consent obtained prior to any study procedures
  • Age over 20 years at study entry
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and marrow function with specific lab value requirements for hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, and creatinine clearance
  • Life expectancy of at least 6 months
  • Female participants must be of non-reproductive potential or have a negative pregnancy test at study entry
  • Willingness and ability to comply with study protocol, treatments, and visits
Not Eligible

You will not qualify if you...

  • Presence of metastatic lesions or clinical N3 lymph nodes
  • Participation in another investigational study within the past 60 months
  • Involvement in the planning or conduct of this study or previous enrollment in this study
  • Any prior treatment for current NSCLC including chemotherapy, radiotherapy, or surgery
  • Previous treatment with PD-1 or PD-L1 inhibitors, including Durvalumab
  • History of leptomeningeal carcinomatosis
  • Brain metastases or spinal cord compression; MRI or CT required if suspected
  • Receipt of last anti-cancer therapy within 36 months before study drug
  • Mean QTc interval ≥470 ms on ECG
  • Use of immunosuppressive medication within 14 days before Durvalumab, with specific exceptions
  • Concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer
  • History of allogeneic organ transplant
  • Active or prior autoimmune or inflammatory disorders with some exceptions
  • Uncontrolled illnesses including active infections, heart failure, hypertension, arrhythmias, peptic ulcers, bleeding disorders, hepatitis B/C, HIV, or psychiatric/social issues affecting compliance
  • History of other primary malignancy within 5 years except certain treated cancers with low recurrence risk
  • History of primary immunodeficiency
  • Active pulmonary tuberculosis (patients with old tuberculosis allowed)
  • Receipt of live attenuated vaccine within 30 days before study entry or Durvalumab
  • Pregnant or breastfeeding females or patients not using effective birth control
  • History of hypersensitivity to study drugs
  • Past medical history of interstitial lung disease or radiation pneumonitis requiring steroids
  • Inability to comply with study procedures or protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Severance Hospital

Seoul, Seoul, South Korea, 03722

Actively Recruiting

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Research Team

B

Byoung Chul Cho, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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