Pathologically and radiologically confirmed advanced squamous or non-squamous NSCLC with SD after four cycles of treatment with pembrolizumab as monotherapy or in combination with chemotherapy (carboplatin/cisplatin and pemetrexed/paclitaxel) and suitable for maintenance treatment with pembrolizumab monotherapy.
Patient Framome identification and characterization with demonstrated expressed at least three frameshift mutations (Frames) with combined ³100 amino acids (preferably more than 100 amino acids) completed as part of molecular pre-screening.
Eastern Cooperative Oncology Group (ECOG) £1.
An expected survival of at least 3 months.
Presence of tumor lesion(s) suitable for biopsy and radiological assessment as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Written informed consent according to International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP).
You may not be if
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Any active infection that might according to investigator interfere with FRAME-001 vaccination.
Current use of systemic corticosteroids (or other immunosuppressive agents; \>10mg daily prednisone equivalent). Inhaled, intranasal or topical and physiological replacement doses of up to 10 mg daily prednisone equivalent are permitted.
Live vaccine within 30 days prior to first dose of FRAME-001.
Clareo Health | FRAME-001 Personalized Vaccine in NSCLC
