Repositioning Immunotherapy in VetArans With Lung Cancer
- Registration Number
- NCT06275360
- Lead Sponsor
- VA Office of Research and Development
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
- 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).
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemoimmunotherapy followed by radiotherapy Nivolumab Nivolumab (Opdivo) + plus platinum-doublet chemotherapy followed by radiotherapy
- Primary Outcome Measures
Name Time Method Progression-free survival Approximately two years after enrollment Defined as the time from start of treatment to radiographic/clinical progression (per irRECIST1.1), or death from any cause, whichever occurs first.
Treatment Tolerance Approximately three years after enrollment Proportion of patients able to complete prescribed treatment course (all planned cycles of systemic therapy and all fractions of radiotherapy).
- Secondary Outcome Measures
Name Time Method Overall survival Approximately two years after enrollment Defined as the time from start of treatment to the date of death from any cause..
Adverse Events Approximately two years after enrollment Frequency of adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria 5.0 classified by body system, grade, and attribution.
Best overall response rate (BOR) Approximately two years after enrollment Defined as the proportion of participants who achieve a confirmed either a best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by central review.
Trial Locations
- Locations (7)
Durham VA Medical Center, Durham, NC
🇺🇸Durham, North Carolina, United States
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
🇺🇸Omaha, Nebraska, United States
Louis Stokes VA Medical Center, Cleveland, OH
🇺🇸Cleveland, Ohio, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
🇺🇸Ann Arbor, Michigan, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
🇺🇸West Haven, Connecticut, United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
🇺🇸West Los Angeles, California, United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
🇺🇸Richmond, Virginia, United States