Magnetic Resonance-Guided Hypofractionated Adaptive Radiation Therapy With Concurrent Chemotherapy and Consolidation Durvalumab for Inoperable Stage IIB, IIIA, and Select IIIB and IIIC Non-small Cell Lung Cancer

Conditions

• Stage IIB Non-Small Cell Lung Cancer
• Stage IIIA Non-small Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Stage IIIC Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ViewRay MR-Linear Accelerator — DEVICE
  -Radiation will be delivered by this machine
• Radiation therapy — RADIATION
  -60Gy in 15 fractions
• Paclitaxel — DRUG
  -50 mg/m\^2 intravenous
• Carboplatin AUC — DRUG
  -2 mg/mL/min intravenous over 30 minutes
• Durvalumab — BIOLOGICAL
  -10 mg/kg

Study Details

Building upon the clinical experience of the investigators with the magnetic resonance (MR)-guided radiation therapy system and applying principals of hypofractionation toward the current treatment paradigm of concurrent chemoradiation and consolidation immunotherapy for locally advanced non-small cell lung cancer (NSCLC), this prospective, single-arm Phase II clinical trial with safety lead-in will test the feasibility and outcomes of this approach.

Key Dates

Start date

Jun 20, 2019

Status verified

Nov 2025

Primary completion

Sep 28, 2025

Completion

Sep 28, 2025

Study Design

Enrollment

26 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Safety lead-in: Chemoradiation + Durvalumab
  * The first 6 patients enrolled on study will comprise the Safety Lead-In cohort and will be closely monitored for toxicity related specifically to the experimental chemoradiation portion of the study treatment. After these 6 patients have been enrolled, accrual will temporarily be suspended for a minimum of 6 months after completion of chemoradiation to allow for the evaluation of adverse events. * Patients will receive concurrent chemoradiation over the course of 3 weeks (15 fractions of radiation with online adaptive treatment planning at fractions 6, 9, and 12 and weekly carboplatin + paclitaxel). Four to 6 weeks after the end of chemoradiation, durvalumab immunotherapy will administered every 2 weeks or 4 weeks (timeline at the discretion of treating physician) for up to 12 months.
• Experimental: Phase II: Chemoradiation + Durvalumab
  -Patients will receive concurrent chemoradiation over the course of 3 weeks (15 fractions of radiation with online adaptive treatment planning at fractions 6, 9, and 12 and weekly carboplatin + paclitaxel). Four to 6 weeks after the end of chemoradiation, durvalumab immunotherapy will administered every 2 weeks or 4 weeks (timeline at the discretion of the treating physician) for up to 12 months.

Primary Outcome Measure

Safety lead-in only: Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Through 6 months after completion of concurrent chemoradiation (estimated to be 6 months and 3 weeks) ]

Locations (1)

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