A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy (Carboplatin-Nanoparticle Albumin Bound (Nab) Paclitaxel) in Patients With Stage IIIB/IIIC or IV NSCLC

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Squamous Non Small Cell Lung Cancer

In brief

This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10 + chemotherapy vs chemotherapy in subjects with locally advanced or metastatic squamous NSCLC who have not previously received systemic treatment. Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows: Arm A (HLX10 arm): HLX10 + chemotherapy (carboplatin nab paclitaxel) Arm B (placebo arm): Placebo + chemotherapy (carboplatin nab paclitaxel) The three stratification factors for randomization include: PD-L1 expression level (Tumor Proportion Scores \[TPS\]≥50%, 50%\>TPS≥1%, TPS\<1%), Asian population (yes or no), NSCLC stage (stage IIIB/IIIC or stage IV), and carboplatin AUC (5 or 6).

Key facts

Study ID

NCT04033354

Run by

Shanghai Henlius Biotech

People needed

537

Starts

2019-08-14

Expected to finish

2023-12-30

Last updated by the study team

2023-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV (AJCC Edition 8) squamous NSCLC where surgery or radiotherapy cannot be performed.
• No known sensitizing EGFR mutations or ALK, ROS1 gene rearrangements.
• Major organs are functioning well
• Participant must keep contraception
• Patients with prior denosumab use who can agree to switch to bisphosphonate therapy for bone metastases in the study.

You may not qualify if…

• Patients with histologically non-squamous NSCLC. Mixed tumors will be classified according to the primary cell type. Patients do not meet the requirements for enrollment if small cell components and neuroendocrine carcinoma components are present. For non-small cell histology, patients meet the requirements for enrollment if squamous components (e.g., adenosquamous) are present.
• Patients with known history of severe hypersensitivity to any monoclonal antibody.
• Patients with known hypersensitivity to any compositions of carboplatin or nab-paclitaxel.
• Pregnant or breastfeeding females.
• Patients with a known history of psychotropic drug abuse or drug addiction; or a history of alcohol abuse.
• Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.

Where it is running

• Anhui Medical University - The Second Hospital — Hefei, Anhui, China
• Anhui Provincial Hospital — Hefei, Anhui, China
• The First Affiliated Hospital Of Anhui Medical University — Hefei, Anhui, China
• The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China
• Beijing Chaoyang Hospital — Beijing, Beijing Municipality, China
• Beijing Friendship Hospital — Beijing, Beijing Municipality, China
• Peking University First Hospital — Beijing, Beijing Municipality, China
• Daping Hospital — Chongqing, Chongqing Municipality, China
• The Second Affiliated Hospital of Army Medical University,PLA — Chongqing, Chongqing Municipality, China
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China
• Fujian Provincial Cancer Hospital — Fuzhou, Fujian, China
• Fuzhou Pulmonary hospital of Fujian — Fuzhou, Fujian, China
• Gansu Wuwei Tumour Hospital — Wuwei, Gansu, China
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• The Fifth Affiliared Hospital Sun Yat-Sen University — Zhuhai, Guangdong, China
• Liuzhou People's Hospital — Liuzhou, Guangxi, China
• Liuzhou Worker's Hospital — Liuzhou, Guangxi, China
• Guangxi Medical University Affiliated Tumor Hospital — Nanning, Guangxi, China
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China
• The Second Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China
• Affiliated Hospital of Hebei University — Baoding, Hebei, China
• Cangzhou People's Hospital — Cangzhou, Hebei, China
• Tangshan People's Hospital — Tangshan, Hebei, China
• Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital) — Harbin, Heilongjiang, China
• Oncology and Hematology Associates of Southwest Virginia — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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