Active — Not RecruitingPhase 2

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

United States178 participantsStarted 2023-12-07

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

To determine the progression-free survival (PFS) of patients treated with neoadjuvant, concurrent and adjuvant atezolizumab with or without tiragolumab.

Timeframe: 2 years

Trial details

NCT IDNCT05798663

SponsorAlliance Foundation Trials, LLC.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

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