About the study

This study will evaluate the efficacy and safety of multiple therapies in participants with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status as determined by Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

(All Cohorts):

1. Body weight >/= 30 kg at screening
2. Willingness and ability to use the electronic device(s) or application(s) for the electronic patient-reported outcome (PRO)
3. Whole-body positron emission tomography/computed tomography scan (PET/CT) (from the base of skull to mid-thighs) for the purposes of staging, performed prior and within 42 days of the first dose of cCRT or sCRT
4. Histologically or cytologically documented locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
5. Prior receipt of at least two prior cycles of platinum-based chemotherapy given concurrently with radiotherapy (cCRT); or at least two prior cycles of platinum-based chemotherapy given prior to radiotherapy (sCRT)
6. The RT component in the cCRT or sCRT must have been at a total dose of radiation of 60 (+/-10%) Gy (54 Gy to 66 Gy) administered by intensity-modulated radiotherapy (preferred) or three dimension (3D)-conforming technique
7. No disease progression during or following platinum-based cCRT or sCRT
8. Life expectancy >/= 12 weeks
9. Confirmed availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen
10. Documented tumor PD-L1 status (TC score < 1% vs. >/= 1% vs. unknown) as determined: centrally with the SP263 IHC assay on the confirmed available FFPE tumor specimen; locally, with the SP263 (preferred) or 22C3 IHC assays
11. Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
12. Adequate hematologic and end-organ function
13. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs, as defined by the protocol
14. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm, as defined by the protocol

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.