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

ConditionPotentially Resectable Stage II/IIIa NSCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorYonsei University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed NSCLC

Clinical stage III (including N2 stage and potential candidate for resection)

Written informed consent and any locally-required authorization (IRB) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations

Age > 20 years at time of study entry

Disqualifiers

Patients with metastatic lesions or clinical N3 lymph nodes

Participation in another clinical study with an investigational product during the last 60 months

Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) Previous enrollment in the present study

Any previous treatment (chemotherapy, radiotherapy or surgery) to current disease - NSCLC

Trial design

Design model

Single group

Treatments tested in this trial

  • durvalumab

    Drug

    Neo-adjuvant chemoradiation period The treatment consisted of paclitaxel, carboplatin, duvalumab and radiation. The radiation treatment comprises 45Gy (total 25Fr) and that will be about 5 weeks. Intensity modulated RT (IMRT) or 3D CRT (three-dimensional conformal radiotherapy) will be allowed. Surgery Chest CT and/or PET CT with appropriate other diagnostic method (ex. Bronchoscopy) will be performed before surgery and type of surgery Follow-up period There is every 4 month visit with chest CT and abdominal CT is done at 1,2,5 post-op year. Other diagnostic method can be performed if indicated.

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: durvalumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of patients who experience G3 or more treatment-related adverse events (TRAEs) based on CTCAE 5.0

To evaluate safety and tolerability of neoadjuvant chemoradiation therapy in combination with durvalumab in NSCLC

Time frame
for 5 year

Secondary outcomes

1

Objective response rate (ORR)

Time frame
from date of randomization until the date of first documented progression, assessed up to 5 years
2

DFS (disease free survival)

Time frame
from date of randomization until the date of first documented progression, assessed up to 5 years
3

OS (overall survival)

Time frame
from date of randomization until the date of first documented progression, assessed up to 5 years
4

clinical and pathologic down staging rate

Time frame
from date of randomization until the date of first documented progression, assessed up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yonsei University

Lead sponsor

Source ClinicalTrials.gov
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