RECRUITING

Repositioning Immunotherapy in VetArans With Lung Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Repositioning Immunotherapy in Veterans With Lung Cancer

Quick Facts

Study Start:2024-03-01

Study Completion:2030-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06275360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Contact

Michael D Green

CONTACT

(734) 845-3914

Michael.Green4@va.gov

Nithya Ramnath, MD

CONTACT

nithya.ramnath@va.gov

Principal Investigator

Michael D Green

PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System, Ann Arbor, MI

Nithya Ramnath, MD

PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Locations (Sites)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003

United States

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

West Haven, Connecticut, 06516-2770

United States

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303

United States

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, 68105-1850

United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875

United States

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702

United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Michael D Green, PRINCIPAL_INVESTIGATOR, VA Ann Arbor Healthcare System, Ann Arbor, MI
Nithya Ramnath, MD, PRINCIPAL_INVESTIGATOR, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01

Study Completion Date2030-03-31

Study Record Updates

Study Start Date2024-03-01

Study Completion Date2030-03-31

Terms related to this study

Additional Relevant MeSH Terms

Non-Small Cell Lung Cancer