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UCDCC#270: Avelumab and Stereotactic Ablative Radiotherapy in Non-responding and Progressing NSCLC Patients

NCT03158883 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-10-20

No results posted yet for this study

Summary

This is a pilot, single center, open-label study to examine the ORR, safety, and toxicity of avelumab in combination with SAR in non-responding and progressing NSCLC patients previously treated with a PD-1 Inhibitor.

Conditions

  • Metastatic Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

Avelumab

Avelumab: 10 mg/kg administered by IV infusion q2w (1 cycle = 14 \[±2\] days).

RADIATION

Stereotactic ablative radiotherapy (SAR)

SAR: the prescription dose will be 50 Gy over 5 fractions of 10 Gy each on an every 2 day basis (i.e., 2-3 treatments per week, with a minimum of 40 hours and a maximum of 96 hours between treatments) and completed within 1.5-2 weeks. SAR treatment will not be repeated.

Sponsors & Collaborators

  • EMD Serono

    collaborator INDUSTRY

  • Megan Daly, MD

    lead OTHER

Principal Investigators

  • Megan Daly, MD · University of California, Davis

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-17
Primary Completion
2020-04-09
Completion
2020-06-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03158883 on ClinicalTrials.gov