Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03663166
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Thoracic Radiotherapy — RADIATION
    2 Gy in 30 fractions directed at all sites of suspected disease
  • Platinum Based Chemotherapy — DRUG
    Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology).
  • ipilimumab — DRUG
    ipilimumab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy
  • Nivolumab — DRUG
    Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.

Study Details

This study is to determine if Stage III NSCLC patients treated with ipilimumab with thoracic radiation therapy followed by nivolumab monotherapy every 4 weeks for up to 12 months show an improved 12-month Progression Free Survival (PFS) rate compared with a 12-month historical PFS rate of 49% among patients treated in a similar fashion with concurrent chemoradiotherapy.

Key Dates

Start date
Nov 20, 2018
Status verified
Feb 2023
Primary completion
Oct 22, 2021
Completion
Oct 22, 2021

Study Design

Enrollment
19 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation and Chemotherapy
    Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and Ipilimumab.
  • Experimental: Nivolumab
    Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression.

Primary Outcome Measure

Unacceptable Toxicity Status at the End of 8-week Safety Observation Period [ Time Frame: At 8 weeks of treatment ]

Locations (3)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
UNC Limeberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Duke UniversityDurhamNorth Carolina27710-

Find similar trials in Tampa, FL

By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FLUNC Limeberger Comprehensive Cancer Center· Chapel Hill, NCDuke University· Durham, NC

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