Lung Cancer Clinical Trial

Repositioning Immunotherapy in VetArans With Lung Cancer

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT06275360

Recruitment Status:

Recruiting

Sponsor:

VA Office of Research and Development

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There are 7 Locations for this study

See Locations Near You

VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles California, 90073, United States More Info
Daniel Shin, MD
Contact
310-478-3711
[email protected]
Michelle Treadwell
Contact
3104783711
[email protected]
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven Connecticut, 06516, United States More Info
Michal Rose, MD
Contact
203-932-5711
[email protected]
Alicia Roy
Contact
2039325711
[email protected]
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor Michigan, 48105, United States More Info
Brittany M Pannecouk, BS
Contact
734-845-3966
[email protected]
Laura A Randolph, BA
Contact
(734) 845-5091
[email protected]
Michael D Green
Principal Investigator
Nithya Ramnath, MD
Principal Investigator
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha Nebraska, 68105, United States More Info
Apar Kishor P Ganti, MD
Contact
402-346-8800
[email protected]
Anna Kellogg
Contact
4029954143
[email protected]
Durham VA Medical Center, Durham, NC
Durham North Carolina, 27705, United States More Info
Michael Kelley, MD
Contact
919-286-0411
[email protected]
Maya Robinson
Contact
9192866926
[email protected]
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland Ohio, 44106, United States More Info
Charles Nock, MD
Contact
216-791-3800
[email protected]
Margaret Titkin
Contact
2167913800
[email protected]
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond Virginia, 23249, United States More Info
Bhaumik Patel, MD
Contact
804-675-5446
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT06275360

Recruitment Status:

Recruiting

Sponsor:


VA Office of Research and Development

How clear is this clinincal trial information?

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