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

Phase 3

Active, not recruiting

• Conditions: Squamous Non Small Cell Lung Cancer
• Interventions: Drug: HLX10; Drug: carboplatin and nab paclitaxel; Drug: Placebo

• Registration Number: NCT04033354
• Lead Sponsor: Shanghai Henlius Biotech

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-19
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-26
• Study Start: 2019-08-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 537

Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Patients with known history of severe hypersensitivity to any monoclonal antibody.
3. Patients with known hypersensitivity to any compositions of carboplatin or nab-paclitaxel.
4. Pregnant or breastfeeding females.
5. Patients with a known history of psychotropic drug abuse or drug addiction; or a history of alcohol abuse.
6. Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	carboplatin and nab paclitaxel	HLX10 + chemotherapy (carboplatin nab paclitaxel)
B	Placebo	Placebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy
B	carboplatin and nab paclitaxel	Placebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy
A	HLX10	HLX10 + chemotherapy (carboplatin nab paclitaxel)

Primary Outcome Measures

Name	Time	Method
tumor assessment	Baseline until disease progression or death, whichever occurs first (up to approximately 24months)	Progression-free survival (PFS) (assessed by the independent radiology review committee \[IRRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)

Trial Locations

Locations (92)

Oncology and Hematology Associates of Southwest Virginia; 🇺🇸 Roanoke, Virginia, United States

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, China

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Daping Hospital; 🇨🇳 Chongqing, Chongqing, China

The Second Affiliated Hospital of Army Medical University,PLA; 🇨🇳 Chongqing, Chongqing, China

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