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NCT Number: NCT06275360

Repositioning Immunotherapy in VetArans With Lung Cancer

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Drug

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)

Other names: Opdivo

Primary outcomes

  1. Progression-free survival

    Time frame: 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.

  2. Treatment Tolerance

    Time frame: 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 outcomes

  1. Adverse Events

    Time frame: 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.

  2. Best overall response rate (BOR)

    Time frame: 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.

  3. Overall survival

    Time frame: Approximately two years after enrollment

    Defined as the time from start of treatment to the date of death from any cause..

Study contacts

Contact information is provided by the study sponsor or research team.

Garth W Strohbehn, MD MSc

CONTACT

[email protected]

(734) 769-7100 ext. 55061

Nithya Ramnath, MD

CONTACT

[email protected]

(734) 769-7100

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Repositioning Immunotherapy in Veterans With Lung Cancer

Acronym: RIVAL

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Feb 23, 2024
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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