Qilu Pharmaceutical Presents Two Phase 3 Clinical Trials of QL1706 in Non-Small Cell Lung Cancer at ASCO 2023

JinanJune 7, 2023PR Newswire -- Recently, at the 2023 American Society of Clinical Oncology Annual Meeting (ASCO 2023), Qilu Pharmaceutical showcased two Phase 3 non-small cell lung cancer (NSCLC) clinical trial posters (Trials in Progress) for its immunotherapy combination antibody QL1706 (Iparomlimab/Tuvonralimab).

Study One:
Title: DUBHE-L-304: A randomized, double-blinded, multicenter phase 3 study of platinum-based chemotherapy with or without QL1706 as adjuvant therapy in completely resected stage II-IIIB NSCLC
Poster Number: TPS8606
Poster Presentation Date: June 4, 2023

In all patients with NSCLC, approximately 30% are diagnosed with resectable early-stage NSCLC at initial diagnosis. For patients with early-stage NSCLC, surgery is the primary treatment method, while adjuvant chemotherapy is commonly used for patients with resectable locally advanced NSCLC. Previous phase 3 clinical studies have shown that PD-1/PD-L1 inhibitors demonstrate promising efficacy in the adjuvant treatment of NSCLC. However, the efficacy of adjuvant therapy with PD-1/PD-L1 inhibitors remains limited in NSCLC patients who are PD-L1 negative.

DUBHE-L-304 Study (NCT05487391) is a double-blind, randomized, placebo-controlled Phase III clinical trial. The study plans to enroll 632 patients with completely resected stage II-IIIB non-small cell lung cancer (NSCLC), without EGFR-sensitive mutations or ALK fusion genes. Patients will receive either QL1706 or placebo for 16 cycles, along with adjuvant chemotherapy for 2-4 cycles. The primary endpoints are investigator-assessed disease-free survival (DFS) in the PD-L1≥1% population and DFS assessed by investigators in the overall population. The study is being conducted across 61 research centers in China, with the first patient enrolled on December 8, 2022.

Study Two:
Title: DUBHE-L-303: A Phase III, Multicenter, Double-Blinded, 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)
Poster Number: TPS9139
Poster Presentation Date: June 4, 2023

For patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are driver gene-negative, the combination of immune checkpoint inhibitors and platinum-based chemotherapy has become the standard first-line treatment. In Chinese NSCLC patients, those with negative PD-L1 expression (TPS<1%) account for approximately 40%-50%. The existing standard treatments have shown limited efficacy in this population, indicating unmet medical needs.

DUBHE-L-303 Study (NCT05690945) is a double-blind, randomized, active-controlled Phase III trial. The study plans to enroll 650 patients with PD-L1-negative, EGFR/ALK mutation-free stage IIIB-IV NSCLC, who will receive four cycles of either QL1706 or tislelizumab combined with chemotherapy, followed by maintenance therapy with QL1706 or tislelizumab (for non-squamous cell carcinoma, maintenance therapy with QL1706 or tislelizumab plus pemetrexed). The primary endpoints are investigator-assessed progression-free survival (PFS) (RECIST 1.1) and overall survival (OS). The study is being conducted across 68 research centers in China, with the first patient enrolled on February 16, 2023.Treatment.