Atezolizumab Immunotherapy With or Without Tiragolumab for Patients With Unresectable Stage III NSCLC

Running, not enrolling · Phase 2

Conditions studied: NSCLC

In brief

This is a phase II trial of neoadjuvant and adjuvant atezolizumab with or without tiragolumab in conjunction with chemoradiotherapy for unresectable stage III NSCLC.

Key facts

Study ID: NCT05798663
Run by: Alliance Foundation Trials, LLC.
People needed: 178
Starts: 2023-12-07
Expected to finish: 2026-11-01
Last updated by the study team: 2026-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Newly pathologically proven diagnosis of stage IIIA/B/C (per AJCC 8) NSCLC
Age at least 18 years.
Availability of a representative tumor specimen that is suitable for BOTH determination of PD-L1 status via local testing and, independently, other required correlative study biomarkers. Tissue submission should include:
A representative FFPE tumor specimen in a paraffin block, along with an associated pathology report, which will be sent to the biorepository. If institutional policy prevents the submission of a block, refer to the Correlative Science Manual (CSM) for alternative submission instructions.
If archival tumor tissue is unavailable or is determined to be unsuitable for required testing, tumor tissue must be obtained from a biopsy performed at screening. Questions about biopsy adequacy should be directed to the study team.
Patients may still be eligible after these two points (3a and 3b) have been attempted/considered, at the discretion of the AFT Study Team.
No active autoimmune disease or uncontrolled infection
FEV1 ≥ 1.2L or > 40% predictive
No underlying heart or lung disease precluding treatment per protocol.
Measurable (RECIST v1.1) stage IIIA, IIIB or IIIC disease per AJCC 8.
Patients must be considered unresectable or inoperable. Patients who decline surgery for stage III NSCLC are also eligible. Patients with nodal recurrence after surgery for early-stage NSCLC are eligible if the following criteria are met:
No prior systemic therapy or radiation for this lung cancer
Prior curative-intent surgery at least 3 months prior to the nodal recurrence Note: Patients may be medically unfit for surgery, (e.g., due to general anesthesia risk), but remain fit for chemoradiotherapy. Thus, the criterion does not necessarily have to exclude all patients who are medically unfit for surgery.
Stage III A/B/C disease (per AJCC 8) with minimum diagnostic evaluation to include:
History/physical examination within 4 weeks
Contrast enhanced CT of the chest including upper abdomen (or CT without contrast if contrast is medically contraindicated) within 4 weeks
MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within 6 weeks
PET/CT skull to thigh within 6 weeks If pleural fluid is visible on CT scan, thoracentesis to exclude malignancy should be obtained unless the effusion is too small to tap in which case the patient is eligible.
Patients must be at least 4 weeks from major surgery and must be fully recovered.
Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1); if repeat labs are obtained on or prior to C1D1 they must re-meet eligibility criteria to treat):
ANC ≥ 1500 cells/µL
WBC counts > 2500/ µ L
Lymphocyte count ≥ 500/ µ L
Platelet count ≥ 100,000/ µ L
Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet this criterion).

You may not qualify if…

Active autoimmune disease.
Greater than minimal, exudative, or cytologically positive pleural effusions.
Involved contralateral hilar nodes.
More than 10% unintentional weight loss within the past month.
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; non-invasive conditions such as carcinoma in situ of the breast, localized prostate cancer or thyroid nodules, carcinoma in situ of the oral cavity or cervix are all permissible.
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
Prior radiotherapy to the region of the study cancer that would result in clinically significant overlap of radiation therapy fields.
Prior severe infusion reaction to a monoclonal antibody.
Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration or within 2 weeks of cycle 1 day 1.
Severe active infection, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, HIV testing is required for entry into this protocol due to the immunologic basis for induction treatment.
Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium > ULN).
Prior allogeneic stem cell or solid organ transplantation.
Pregnancy, lactation, or inability or unwillingness to use medically acceptable forms of contraception if pregnancy is a risk.
Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin.
Uncontrolled neuropathy grade 2 or greater regardless of cause.
Any approved or unapproved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:
Hormone-replacement therapy or oral contraceptives
Herbal therapy > 1 week prior to Cycle 1, Day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to Cycle 1, Day 1)
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease.

Where it is running

University of California San Diego Moores Cancer Center — La Jolla, California, United States
Kaiser Permanente Oakland Medical Center — Oakland, California, United States
Kaiser Permanente Roseville Medical Center — Roseville, California, United States
Kaiser Permanente San Francisco Medical Center — San Francisco, California, United States
Kaiser Permanente Santa Clara Medical Center — Santa Clara, California, United States
Kaiser Permanente Vallejo Medical Center — Vallejo, California, United States
Rush University Medical Center — Chicago, Illinois, United States
Washington University Siteman Cancer Center — St Louis, Missouri, United States
Missouri Baptist Medical Center — St Louis, Missouri, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
New Hampshire Oncology - Hematology, PA — Manchester, New Hampshire, United States
Hematology Oncology Associates of Central New York, P.C. — East Syracuse, New York, United States
SUNY Upstate Medical University — Syracuse, New York, United States
Ohio State University — Columbus, Ohio, United States
University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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