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.

Authors

null

Yuming Zhu

Department of Medical Oncology,Shanghai Pulmonary Hospital, Shanghai, China

Yuming Zhu , Tao Jiang , Lianghua Fang , Tao Zhang , Xiaoyan Kang , Caicun Zhou

Organizations

Department of Medical Oncology,Shanghai Pulmonary Hospital, Shanghai, China, Department of Thoracic Surgery, The Second Hospital Affiliated to Air Force Medical University, Xi'an, Shannxi, China, Medicine Department, Qilu Pharmaceutical Co., Ltd., Jinan, China, Statistics and Statistical Programming Department, Qilu Pharmaceutical Co., Ltd., Jinan, China, Department of Medical Oncology, Shanghai Pulmonary Hospital, Shanghai, China

Research Funding

Pharmaceutical/Biotech Company
Qilu Pharmaceutical Co., Ltd.

Background: Adjuvant atezolizumab is approved for PD-L1 positive stage II-IIIA NSCLC in USA and China. To date, there are few clinical studies on dual immune checkpoint inhibitors in adjuvant settings of NSCLC. QL1706, a MabPair product, is a novel bifunctional antibody containing a mixture of anti-PD-1 IgG4 and anti-CTLA-4 IgG1 antibodies. QL1706 monotherapy has demonstrated good safety and promising antitumor activity in advanced solid tumors in a phase Ia/Ib study with 518 patients, including 146 NSCLC patients. Meanwhile, in NSCLC patients with negative oncogene drivers, QL1706 plus 2 cycles of chemotherapy as first line treatment resulted in an ORR of 58.6% (17/29) and the mPFS was 6.97 months. Furthermore, in the EGFR mutant NSCLC patients who previously were treated with EGFR-TKI, QL1706 plus platinum-based chemotherapy and bevacizumab showed promising efficacy with an ORR of 64.5% (20/31). This study is designed to investigate the efficacy and safety of QL1706 or placebo plus platinum doublet chemotherapy as adjuvant treatment in stage II-IIIB NSCLC. Methods: In this phase Ⅲ, randomized, double-blind, placebo-controlled, multicenter study, 632 eligible pts, who is completely resected stage Ⅱ-ⅢB NSCLC (AJCC 8th) with negative EGFR, ALK etc, will be enrolled. Pts will be randomized 1:1 to receive QL1706 (5 mg/kg) or placebo plus chemotherapy, administered every 3 weeks (Q3W). The regimen of vinorelbine/paclitaxel plus cisplatin/carboplatin is chosen for squamous NSCLC, while pemetrexed/vinorelbine plus cisplatin/carboplatin for non-squamous NSCLC. Randomization will be stratified by PD-L1 TPS (ie, < 1%, ≥1%), disease stage (stage II, III) and predominant tumor histology (ie, squamous vs non-squamous). The primary endpoint is disease-free survival (DFS) per investigators in PD-L1 TPS ≥1% pts and in all randomized pts, which will be tested hierarchically. An interim analysis is to occur when about 70% DFS events achieved in pts with PD-L1≥1%. Enrollment began in Nov, 2022. ClinicalTrials.gov NCT05487391. Clinical trial information: NCT05487391.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Local-Regional Non–Small Cell Lung Cancer

Clinical Trial Registration Number

NCT05487391

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr TPS8606)

DOI

10.1200/JCO.2023.41.16_suppl.TPS8606

Abstract #

TPS8606

Poster Bd #

229b

Abstract Disclosures