FRAME-001 Personalized Vaccine in NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title: A Phase II Trial of Personalized Tumor Neoantigen Based Vaccine FRAME-001 for Advanced Non-Small Cell Lung Cancer

Status Not yet recruiting

Clinical Trial Summary

Despite encouraging results of programmed cell death protein -1 (PD-1) immune checkpoint inhibitor treatment combined with chemotherapy in advanced non-small cell lung cancer (NSCLC), only the minority of approximately 20% of patients derive durable clinical benefit from such treatment. Patients with stable disease (SD) after four cycles of treatment with PD-1 inhibitor pembrolizumab monotherapy or in combination with chemotherapy (standard of care in advanced NSCLC in the Netherlands) have a low probability of still acquiring a complete response (CR) or durable disease control to such treatment and no other curative standard treatment options are available, emphasizing the need for novel therapeutic approaches. Tumor-specific neopeptides resulting from frameshift mutations in tumor cells, so-called Frames, present potentially potent targets for the immune system and can be utilized in therapeutic anti-cancer vaccination with the intention to synergize in their effect with immune chckpoint inhibitors. Frames are prevalent in NSCLC patients, with 95% of lung tumors harboring one or more Frames. The entire collection of Frames expressed by a tumor is referred to as the Framome. Vaccination against strongly antigenic neopeptides present in a patient's tumor furnishes a perspective of enhancing the therapeutic effect of the immune checkpoint inhibition in NSCLC with expected limited additional toxicities. The current clinical trial is designed to determine immune response, safety, and clinical response of personalized vaccine FRAME-001 based on a patient's Framome and selection of Frame peptides in advanced NSCLC cancer patients after standard first line treatment consisting of immune checkpoint inhibitor pembrolizumab as monotherapy or combined with chemotherapy (carboplatin/cisplatin and pemetrexed/paclitaxel), and who attained SD after four cycles of such therapy. The personalized FRAME-001 vaccine will be administered during maintenance phase of treatment with pembrolizumab monotherapy.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

• NCT number: NCT04998474
• Study type: Interventional
• Source: Frame Pharmaceuticals B.V.
• Contact: Bob Löwenberg, MD
• Phone: 0202374970
• Email: trials@frametherapeutics.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2022
• Completion date: July 2024