Use of High Dose Radiation Followed by Chemotherapy and Radiation to Treat Locally Advanced NSCLC

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT03141359
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SBRT — RADIATION
    Primary tumor SBRT
  • Carboplatin — DRUG
    concurrent chemotherapy
  • Paclitaxel — DRUG
    concurrent chemotherapy
  • cis Platinum — DRUG
    concurrent chemotherapy
  • Etoposide — DRUG
    concurrent chemotherapy
  • IMRT — RADIATION
    mediastinal radiation
  • Durvalumab — DRUG
    adjuvant immunotherapy

Study Details

This is a single-arm, single-stage Phase II study designed to evaluate the 1-year PFS rate in subjects with locally-advanced NSCLC (stage II/III) and treated with Stereotactic Body Radiation Therapy (SBRT) followed by concurrent mediastinal chemoradiation with or without consolidation chemotherapy. A total of 60 subjects will be enrolled to this study over a 4 year accrual period.

Key Dates

Start date
May 12, 2017
Status verified
Jan 2026
Primary completion
Jul 12, 2023
Completion
Jul 31, 2027

Study Design

Enrollment
61 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy

Primary Outcome Measure

Number of Participants Progression Free and Surviving at 12 Months [ Time Frame: From date of treatment start to date of progression or death, or censored at 12 months, whichever occurred first. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Levine Cancer InstituteCharlotteNorth Carolina28204-

Find similar trials in Charlotte, NC

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Levine Cancer Institute· Charlotte, NC

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