Repositioning Immunotherapy in VetArans With Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

— RIVAL  

Official title:

Repositioning Immunotherapy in Veterans With Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06275360
• Other study ID #: SPLP-002-23F
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2024
• Est. completion date: March 31, 2030

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: Michael D Green
• Phone: (734) 845-3914
• Email: Michael.Green4[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 31, 2030
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Nivolumab
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)

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio
United States	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	Hunter Holmes McGuire VA Medical Center, Richmond, VA	Richmond	Virginia
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

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Adverse Events	Frequency of adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria 5.0 classified by body system, grade, and attribution.	Approximately two years after enrollment
Secondary	Best overall response rate (BOR)	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.	Approximately two years after enrollment
Secondary	Overall survival	Defined as the time from start of treatment to the date of death from any cause..	Approximately two years after enrollment