JINAN, China, June 8, 2023 /PRNewswire/ — Recently, Qilu Pharmaceutical presented a Trials in Progress poster presentation on QL1706 (iparomlimab/tuvonralimab), an innovative bifunctional antibody for immunotherapy, in two Phase III non-small cell lung carcinoma (NSCLC) clinical studies at the 2023 American Society of Clinical Oncology Annual Meeting (ASCO 2023).
Study One:
Title: DUBHE-L-304: A randomized, double-blind, multicenter Phase III study of platinum-based chemotherapy with or without QL1706 as adjuvant therapy in completely resected stage II-IIIB NSCLC
Abstract Number: TPS8606
Date of Display: June 4, 2023
Nearly 30% of patients with NSCLC are diagnosed with resectable early-stage NSCLC at initial diagnosis. Surgery is the standard treatment for those with early-stage NSCLC, and adjuvant chemotherapy (CT) is commonly used in patients with resectable locally advanced NSCLC. Previous Phase III clinical studies have shown that PD-1/PD-L1 blockers have good efficacy in the adjuvant therapy with NSCLC. However, the use of PD-1/PD-L1 blockers as adjuvant therapy remains ineffective in patients with PD-L1-negative NSCLC.
The DUBHE-L-304 study (NCT05487391) is a double-blind, randomized, placebo-controlled Phase III clinical study. The study plans to enroll 632 patients with completely resected stage II-IIIB NSCLC, without EGFR-sensitive mutations and ALK fusion genes. Patients will receive 16 cycles of either QL1706 or a placebo in combination with 2-4 cycles of adjuvant chemotherapy. The primary endpoints are investigator-assessed disease-free survival (DFS) in the group (PD-L1≥1%) and investigator-assessed DFS in all patients. The study is being conducted in 61 research centers across China. The first patient was enrolled on December 8, 2022.
Study Two:
Title: DUBHE-L-303: A phase III, multicenter, double-blind, randomized, active-controlled study on the efficacy and safety of QL1706 with chemotherapy (CT) as First-line (1L) therapy for PD-L1 negative advanced or metastatic non-small-cell lung cancer (NSCLC)
Abstract Number: TPS9139
Date of Display: June 4, 2023
For patients with locally advanced or metastatic NSCLC with negative driver genes, immune checkpoint inhibitors plus platinum-based chemotherapy have become the standard first-line therapy. Among patients with NSCLC in China, those with PD-L1-negative NSCLC (TPS<1%) account for around 40%-50%. Existing standard treatments are less effective in this group, and there is an unmet need for treatment.
The DUBHE-L-303 study (NCT05690945) is a double-blind, randomized, active-controlled phase III study. The study plans to enroll 650 patients with PD-L1-negative, stage IIIB-IV NSCLC without EGFR/ALK mutations. Patients will receive four cycles of either QL1706 or tislelizumab plus chemotherapy, followed by maintenance treatment with QL1706 or tislelizumab (QL1706 or tislelizumab plus pemetrexed for non-squamous NSCLC). The primary endpoints include investigator-assessed progression-free survival (PFS) (RECIST 1.1) and overall survival (OS). The study is being conducted at 68 research centers across China. The first patient was treated on February 16, 2023.
SOURCE Qilu Pharmaceutical Co., Ltd.
