Repositioning Immunotherapy in VetArans With Lung Cancer

NCT06275360 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: SPLP-002-23F
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  Defined as the time from start of treatment to radiographic/clinical progression (per irRECIST1.1), or death from any cause, whichever occurs first.

  Approximately two years after enrollment

• Treatment Tolerance

  Proportion of patients able to complete prescribed treatment course (all planned cycles of systemic therapy and all fractions of radiotherapy).

  Approximately three years after enrollment

Secondary Outcomes (3)

• Adverse Events

  Approximately two years after enrollment

• Best overall response rate (BOR)

  Approximately two years after enrollment

• Overall survival

  Approximately two years after enrollment

Study Arms (1)

Chemoimmunotherapy followed by radiotherapy

EXPERIMENTAL

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

Drug: Nivolumab

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)

Also known as: Opdivo

Chemoimmunotherapy followed by radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (7)

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

West Haven, Connecticut, 06516-2770, United States

RECRUITING

VA Central Office, Washington, DC

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

RECRUITING

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

RECRUITING

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

RECRUITING

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

Omaha, Nebraska, 68105-1850, United States

RECRUITING

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

RECRUITING

Richmond VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Nithya Ramnath, MD

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nithya Ramnath, MD

CONTACT

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

Garth W Strohbehn, MD MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 23, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 31, 2030
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)