NCT03871153

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

A Phase II Study of Concurrent Chemoradiation Plus Durvalumab (MEDI4736) Followed by Surgery Followed by Adjuvant Durvalumab (MEDI4736) in Medically Operable Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Greg Durm, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-08-02
• Primary completion: 2021-10-30
• Completion: 2022-03-09
• First posted: 2019-03-12
• Last updated: 2023-11-01
• Results posted: 2023-11-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study