Repositioning Immunotherapy in VetArans With Lung Cancer (RIVAL)

VA Office of Research and Development

Status and phase

Enrolling

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Nivolumab

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT06275360

SPLP-002-23F

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.