Repositioning Immunotherapy in VetArans With Lung Cancer

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
VA Office of Research and Development
Study ID
NCT06275360
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Carboplatin, paclitaxel, and nivolumab for three cycles (for squamous cell lung cancer) or Carboplatin, pemetrexed, and nivolumab for three cycles (for lung adenocarcinoma) Followed by radiotherapy (60 Gy in 30 fractions) Followed by adjuvant nivolumab (six cycles)

Study Details

This study is a multicenter Phase II single arm trial to assess the safety and efficacy of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC.

Key Dates

Start date
Mar 1, 2024
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Mar 31, 2030

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemoimmunotherapy followed by radiotherapy
    Nivolumab (Opdivo) + plus platinum-doublet chemotherapy followed by radiotherapy

Primary Outcome Measure

Progression-free survival [ Time Frame: Approximately two years after enrollment ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest HavenConnecticut06516-2770
Michal Rose, MD
203-932-5711
Alicia Roy
2039325711
VA Central Office, Washington, DCWashington D.C.District of Columbia20420-0001
Irina Veytsman, MD
202-745-8000
Ramesh Subrahmanyam
2027458000
Richard L. Roudebush VA Medical Center, Indianapolis, INIndianapolisIndiana46202-2884
Shadia Jalal, MD
317-903-1978
Aleksandra Radovanovich
3177199841
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn ArborMichigan48105-2303
Brittany M Pannecouk, BS
(734) 845-3966
Laura A Randolph, BA
(734) 845-5091
Michael D Green (SUB_INVESTIGATOR)
Nithya Ramnath, MD (PRINCIPAL_INVESTIGATOR)
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NEOmahaNebraska68105-1850
Apar Kishor P Ganti, MD
402-346-8800
Anna Kellogg
4029954143
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030-4211
Daniel Shin, MD
(71-3) -7939
Michael Sustaita
(713) 7947939
Richmond VA Medical Center, Richmond, VARichmondVirginia23249-0001
Bhaumik Patel, MD
804-675-5446

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