Trial Title:
Repositioning Immunotherapy in VetArans With Lung Cancer
NCT ID:
NCT06275360
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Nivolumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Carboplatin, paclitaxel, and nivolumab for three cycles followed by radiotherapy followed
by nivolumab (for squamous cell lung cancer) OR Carboplatin, pemetrexed, and nivolumab
for three cycles followed by radiotherapy followed by nivolumab (for lung adenocarcinoma)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nivolumab
Description:
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)
Arm group label:
Chemoimmunotherapy followed by radiotherapy
Other name:
Opdivo
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants must be more than 18 years of age.
- Patient must have a performance status of 0-1 (ECOG Performance Scale).
- Patient must be a candidate for concurrent chemoradiation.
- Unresectable Stage III NSCLC as assessed by investigator or multidisciplinary tumor
board assessment
- PD-L1 tumor expression greater than or equal to 1%
- Presence of measurable disease according to RECIST v1.1
- Adequate organ function
- Available tissue (archival FFPE preferred) with adequate tumor content ( 20% tumor
cellularity).
Exclusion Criteria:
- Active autoimmune disease that has requires immunosuppressive therapy in the
previous year.
- Uncontrolled primary or acquired immunodeficiency (including HIV)
- Baseline corticosteroid usage (>10 mg prednisone or equivalent daily) aside from
supportive medication use.
- Tumor with known EGFR, ALK, ROS1, MET or RET mutations/fusions.
- Presence of significant comorbidities precluding participation in a clinical study
as determined by investigator.
- Prior thoracic radiotherapy or prior systemic treatment for stage IIIB/IV NSCLC
- Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the trial, starting with informed consent through 180 days
after the last dose of trial treatment.
- Has a known history of active TB (Bacillus Tuberculosis)
- Has known active Hepatitis B or Hepatitis C.
- Has received a live vaccine within 30 days of enrollment.
- Known diagnosis of Interstitial Lung Disease
- Inability to provide informed consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Address:
City:
West Los Angeles
Zip:
90073-1003
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Daniel Shin, MD
Phone:
310-478-3711
Email:
Daniel.Shin@va.gov
Contact backup:
Last name:
Michelle Treadwell
Phone:
3104783711
Phone ext:
45003
Email:
Michelle.Treadwell@va.gov
Facility:
Name:
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Address:
City:
West Haven
Zip:
06516-2770
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michal Rose, MD
Phone:
203-932-5711
Phone ext:
2832
Email:
Michal.Rose@va.gov
Contact backup:
Last name:
Alicia Roy
Phone:
2039325711
Phone ext:
3006
Email:
Alicia.Roy@va.gov
Facility:
Name:
VA Ann Arbor Healthcare System, Ann Arbor, MI
Address:
City:
Ann Arbor
Zip:
48105-2303
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brittany M Pannecouk, BS
Phone:
734-845-3966
Email:
brittany.pannecouk@va.gov
Contact backup:
Last name:
Laura A Randolph, BA
Phone:
(734) 845-5091
Email:
Laura.Randolph@va.gov
Investigator:
Last name:
Michael D Green
Email:
Principal Investigator
Investigator:
Last name:
Nithya Ramnath, MD
Email:
Principal Investigator
Facility:
Name:
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Address:
City:
Omaha
Zip:
68105-1850
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Apar Kishor P Ganti, MD
Phone:
402-346-8800
Phone ext:
3846
Email:
Aparkishor.Ganti@va.gov
Contact backup:
Last name:
Anna Kellogg
Phone:
4029954143
Email:
Anna.Kellogg@va.gov
Facility:
Name:
Durham VA Medical Center, Durham, NC
Address:
City:
Durham
Zip:
27705-3875
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Michael Kelley, MD
Phone:
919-286-0411
Phone ext:
172199
Email:
Michael.Kelley6@va.gov
Contact backup:
Last name:
Maya Robinson
Phone:
9192866926
Email:
Maya.Robinson@va.gov
Facility:
Name:
Louis Stokes VA Medical Center, Cleveland, OH
Address:
City:
Cleveland
Zip:
44106-1702
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Charles Nock, MD
Phone:
216-791-3800
Phone ext:
64825
Email:
Charles.Nock@va.gov
Contact backup:
Last name:
Margaret Titkin
Phone:
2167913800
Phone ext:
36241
Email:
MargaretTiktin@va.gov
Facility:
Name:
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Address:
City:
Richmond
Zip:
23249-0001
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Bhaumik Patel, MD
Phone:
804-675-5446
Email:
Bhaumik.Patel@va.gov
Start date:
March 1, 2024
Completion date:
March 31, 2030
Lead sponsor:
Agency:
VA Office of Research and Development
Agency class:
U.S. Fed
Source:
VA Office of Research and Development
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06275360
