Durvalumab Followed by Chemoradiation and Consolidation Durvalumab for Stage III Non-small Cell Lung Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rachel Sanborn
Study ID
NCT04364048
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Induction Durvalumab — DRUG
    Induction durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 1 cycle,
  • Chemotherapy — DRUG
    Concurrent chemoradiation will be with platinum-based chemotherapy (cisplatin or carboplatin, with etoposide, taxane, or pemetrexed) selected at the treating physician's discretion. The chemotherapy regimen used should be administered per institutional standards following the prescribing guidelines for each drug
  • Radiation — RADIATION
    Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons per institutional standards. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa). Therapy will be 1.8-2 Gy per day; 5 days per week, excluding holidays per institutional standard as this is a standard of care regimen for this patient population. 54-66 Gy will be delivered.
  • Consolidation durvalumab — DRUG
    Durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 12 cycles

Study Details

Single arm study of induction durvalumab (1500 mg IV) for 1 cycle (every 4 weeks), administered prior to starting concurrent definitive chemoradiation, followed by consolidation durvalumab (1500 mg IV every 4 weeks) for up to 12 cycles. The study will include an initial safety run-in portion. Patients in the safety run-in will be monitored through completion of induction durvalumab, chemoradiation, and 2 cycles of consolidation durvalumab for assessment of safety prior to completion of enrollment.

Key Dates

Start date
Jun 18, 2020
Status verified
Dec 2024
Primary completion
Jun 20, 2023
Completion
Feb 5, 2024

Study Design

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

Arms

  • Experimental: Induction durvalumab, chemoradiation, consolidation durvalumab
    Induction durvalumab at 1500 mg intravenously (IV) on Day 1 of a four week cycle for 1 cycle, followed by concurrent definitive chemoradiation, followed by consolidation durvalumab at 1500 mg IV Day 1 of every 4 week cycle for up to 12 cycles.

Primary Outcome Measure

12-Month Progression Free Survival (PFS) [ Time Frame: From the time of treatment initiation until progression, up to 12 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612-
Cancer Center of KansasWichitaKansas67214-
HealthPartners InstituteMinneapolisMinnesota55440-
Summit Medical Group, P. A.Berkeley HeightsNew Jersey07922-
Providence Portland Medical CenterPortlandOregon97213-

Find similar trials in Chicago, IL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Rush University Medical Center· Chicago, ILCancer Center of Kansas· Wichita, KSHealthPartners Institute· Minneapolis, MNSummit Medical Group, P. A.· Berkeley Heights, NJProvidence Portland Medical Center· Portland, OR

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