MedTrace Logo

Chemoradiation Plus Durvalumab Followed by Surgery Followed by Adjuvant Durvalumab in Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer

NCT03871153 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-11-01

Study results available
· View outcomes & findings →

Summary

This is an open label, multi-institutional, single arm Phase II trial. All patients will be treated with Carboplatin, Paclitaxel, Durvalumab and Radiation. All patients with non-PD after induction therapy who remain surgical candidates will undergo surgical resection 4-12 weeks following induction therapy.

After surgical resection, all patients who remain eligible will be treated with adjuvant Durvalumab every 4 weeks for 6 cycles beginning 4-12 weeks after surgical resection.

Conditions

  • Non Small Cell Lung Cancer
  • Stage III Non-small-cell Lung Cancer

Interventions

DEVICE

Durvalumab

Neoadjuvant Durvalumab 750 mg IV on Days 1, 15 and 29 Adjuvant Durvalumab 12 weeks after undergoing surgical resection 1,500 mg IV on Day 1

DRUG

Paclitaxel

Paclitaxel 45 mg/m2 IV Days 1, 8, 15, 22, 29 and +/- 36

DRUG

Carboplatin

Carboplatin AUC of 2 IV Days 1, 8, 15, 22, 29 +/- 36

RADIATION

Radiation

1.8-2.0 Gy per day (5 days/week) for a total of 45-61.2 Gy over 5-6 weeks. Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons. Proton therapy is also allowed. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa).

PROCEDURE

Surgical Resection

Patients will undergo repeat imaging between 4 and 12 weeks after completing neoadjuvant therapy. Those without evidence of progressive disease and found to be a surgical candidate by a thoracic surgeon will undergo surgical resection between 4 and 12 weeks after neoadjuvant therapy.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Indiana University School of Medicine

    collaborator OTHER

  • Greg Durm, MD

    lead OTHER

Principal Investigators

  • Greg A Durm, MD · Indiana University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-02
Primary Completion
2021-10-30
Completion
2022-03-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT03871153 on ClinicalTrials.gov