Recruiting
Phase 2

Immunotherapy

Sponsor:

VA Office of Research and Development

Code:

NCT06275360

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nivolumab

Study Details

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT06275360

Start date

Mar 1, 2024

Status verified date

Feb, 2026

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Chemoimmunotherapy followed by radiotherapy

Nivolumab (Opdivo) + plus platinum-doublet chemotherapy followed by radiotherapy

Interventions

Nivolumab

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)

Primary outcome measure

  • Progression-free survival [ Time Frame: Approximately two years after enrollment ]
  • Treatment Tolerance [ Time Frame: Approximately three years after enrollment ]

Central Contacts and Locations

Central contacts

Nithya Ramnath, MD

(734) 769-7100nithya.ramnath@va.gov

Garth W Strohbehn, MD MSc

(734) 769-7100garth.strohbehn@va.gov

Locations

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Recruiting

West Haven, Connecticut, United States, 06516-2770

Contacts

Michal Rose, MD

203-932-5711Michal.Rose@va.gov

Alicia Roy

2039325711Alicia.Roy@va.gov

VA Central Office, Washington, DC

Recruiting

Washington D.C., District of Columbia, United States, 20420-0001

Contacts

Irina Veytsman, MD

202-745-8000Irina.Veytsman@va.gov

Ramesh Subrahmanyam

2027458000Ramesh.Subrahmanyam@va.gov

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Recruiting

Indianapolis, Indiana, United States, 46202-2884

Contacts

Shadia Jalal, MD

317-903-1978SHADIA.JALAL@va.gov

Aleksandra Radovanovich

3177199841Aleksandra.Radovanovich@va.gov

VA Ann Arbor Healthcare System, Ann Arbor, MI

Recruiting

Ann Arbor, Michigan, United States, 48105-2303

Contacts

Brittany M Pannecouk, BS

(734) 845-3966brittany.pannecouk@va.gov

Laura A Randolph, BA

(734) 845-5091Laura.Randolph@va.gov

Principal Investigator:

Nithya Ramnath, MD

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Recruiting

Omaha, Nebraska, United States, 68105-1850

Contacts

Apar Kishor P Ganti, MD

402-346-8800Aparkishor.Ganti@va.gov

Anna Kellogg

4029954143Anna.Kellogg@va.gov

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

Daniel Shin, MD

(71-3) -7939Daniel.Shin@va.gov

Michael Sustaita

(713) 7947939Michael.Sustaita@va.gov

Richmond VA Medical Center, Richmond, VA

Recruiting

Richmond, Virginia, United States, 23249-0001

Contacts

Bhaumik Patel, MD

804-675-5446Bhaumik.Patel@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-03-02.