Clinical trial NCT06275360: Repositioning Immunotherapy in VetArans With Lung Cancer
Official title: Repositioning Immunotherapy in Veterans With Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-02-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.


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.

Primary outcomes:
measure: Progression-free survival
timeFrame: Approximately two years after enrollment
measure: Treatment Tolerance
timeFrame: Approximately three years after enrollment
Secondary outcomes:
measure: Adverse Events
timeFrame: Approximately two years after enrollment
measure: Best overall response rate (BOR)
timeFrame: Approximately two years after enrollment
measure: Overall survival
timeFrame: Approximately two years after enrollment
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Omaha
country: United States
facility: Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
state: Nebraska
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA
state: Virginia
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Michael D Green
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Nithya Ramnath, MD
role: PRINCIPAL_INVESTIGATOR
References: