Clinical trial · Interventional
Repositioning Immunotherapy in VetArans With Lung Cancer
Repositioning Immunotherapy in Veterans With Lung Cancer
NCT06275360CI-TRIAL-00104339RIVALrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemoimmunotherapy followed by radiotherapy
- description
- Nivolumab (Opdivo) + plus platinum-doublet chemotherapy followed by radiotherapy
- interventionNames
- Drug: Nivolumab
Primary outcomes (2)
- measure
- Progression-free survival
- timeFrame
- Approximately two years after enrollment
- description
- Defined as the time from start of treatment to radiographic/clinical progression (per irRECIST1.1), or death from any cause, whichever occurs first.
- measure
- Treatment Tolerance
- timeFrame
- Approximately three years after enrollment
- description
- Proportion of patients able to complete prescribed treatment course (all planned cycles of systemic therapy and all fractions of radiotherapy).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.