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Neoadjuvant Immunoradiation for Resectable Non-Small Cell Lung Cancer

NCT03237377 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-10-14

Study results available
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Summary

This is a pilot study of neoadjuvant 'immunoradiation' (durvalumab or durvalumab plus tremelimumab) administered every 4 weeks for 2 doses, concurrently with standard thoracic radiation (RT) (45Gy in 25 fractions), with one dose of immunotherapy alone delivered in the pre-surgical window, prior to surgical resection, for patients with stage IIIA NSCLC that is deemed resectable with a lobectomy by a thoracic surgeon. If preliminary safety of the durvalumab/thoracic RT combination is established, a second cohort investigating the combination of durvalumab/tremelimumab/thoracic RT prior to surgical resection will be opened. After surgical resection, patients may receive standard adjuvant chemotherapy, as deemed appropriate by the treating investigator.

Conditions

Interventions

DRUG

Durvalumab

1500mg via IV infusion every 4 weeks for up to 3 doses/cycles

DRUG

Tremelimumab

75mg via IV infusion every 4 weeks

RADIATION

Thoracic Radiation

5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction

PROCEDURE

lobectomy

patients may proceed to surgery post drug and radiation intervention for lung lobectomy

DRUG

Standard of care adjuvant chemotherapy

patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Patrick Forde, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-12
Primary Completion
2021-11-04
Completion
2024-05-23
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03237377 on ClinicalTrials.gov