Protocol: Alliance – A081801
Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and (810) 762-8038. Thank you!
Eligibility:
- Previously registered to A151216
- Central and/or local testing of EGFR with no EGFR exon 19 deletion of EGFR L858 R mutation (applicable to non-squamous patients only).
- Central and/or local testing of ALK with no ALK rearrangement (failed testing is considered negative) (applicable to non-squamous patients only).
- Central and/or local testing of PD-L1 IHC using one of the following assays: DAKO 22C3, DAKO 28-8, EIL3N or SP263. Note: Local testing results of EGFR and ALK by a local CLIA certified laboratory is acceptable. The report must indicate the result as well as the CLIA number of the laboratory that performed the assay. Local result of PD-L1 by DAKO 22C3, Dako 28-8, EIL3N or SP263 are acceptable for enrollment on A081801. Patients with local results for EGFR, ALK and PD-L1 still need to be registered to A151216 and follow all the submissions requirements but do NOT need to wait for the results to proceed to A081801 registration.
- Completely resected stage IIA, IIB IIIA or IIIB (T3-4N2) NSCLC (squamous or non-squamous) with negative margins. Note: Patients with pathologic N2 disease, completely resected, are eligible. However, patients known to have N2 disease prior to surgery are not eligible; guidelines do not recommend up-front surgery for this population.
- No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis.
- No prior allogeneic tissue/solid organ transplant.
- Age ≥18 years.
- ECOG PS: 0-1