 |
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.
