WCLC 2025 - Posters & ePosters-P3.18.47 ATTEND: Randomized Phase III Trial of Tislelizumab and Chemotherapy With or Without Diphenhydramine in Advanced Non-Small Cell Lung Cancer

P3.18.47 ATTEND: Randomized Phase III Trial of Tislelizumab and Chemotherapy With or Without Diphenhydramine in Advanced Non-Small Cell Lung Cancer

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Pdf Summary

This prospective randomized Phase III trial (NCT06704620), conducted at Tianjin Medical University Cancer Institute and Hospital, investigates the safety and efficacy of combining diphenhydramine with tislelizumab and chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC). Previous retrospective data suggested that using H1 antihistamines alongside immune checkpoint inhibitors (ICIs) improves survival outcomes, prompting this study to evaluate the strategy prospectively.<br /><br />Eligible patients have histologically or cytologically confirmed stage IIIB–IV NSCLC (AJCC v9), untreated with prior systemic therapy or PD-(L)1 inhibitors, and have an ECOG performance status of 0–1. Key exclusions include known EGFR, ALK, or ROS1 mutations, metastases from other primaries, or contraindications to diphenhydramine.<br /><br />Participants are randomized to receive tislelizumab (200 mg IV every 3 weeks), diphenhydramine (20 mg IM on days 0 to 2 every 3 weeks), and chemotherapy based on histology—carboplatin plus nab-paclitaxel for squamous NSCLC or carboplatin plus pemetrexed for non-squamous NSCLC—for 4 to 6 cycles. Tislelizumab, diphenhydramine, and pemetrexed continue until disease progression or intolerable toxicity.<br /><br />The primary endpoint is progression-free survival (PFS), defined as the time from treatment initiation to radiological progression or death. Secondary endpoints include overall survival (OS) and objective response rate (ORR).<br /><br />This trial aims to build on existing evidence suggesting that histamine and H1 receptor modulation can enhance ICI efficacy in the tumor microenvironment. If successful, the combination could represent a novel, effective first-line therapy for advanced NSCLC, improving survival outcomes by leveraging the immunomodulatory properties of diphenhydramine in conjunction with checkpoint inhibition and chemotherapy.

Asset Subtitle

Liang Liu

Meta Tag

Speaker Liang Liu

Topic Clinical Trials in Progress

Keywords

Phase III trial

diphenhydramine

tislelizumab

chemotherapy

advanced non-small cell lung cancer

immune checkpoint inhibitors

progression-free survival

overall survival

H1 antihistamines

tumor microenvironment