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

Henlius Pharmaceuticals

Status and phase: Active, not recruiting; Phase 3

Conditions: Squamous Non Small Cell Lung Cancer

Treatments: Drug: HLX10; Drug: Placebo; Drug: carboplatin and nab paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04033354

HLX10-004-NSCLC303

Details and patient eligibility

About

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).

Enrollment: 537 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

537 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

HLX10 + chemotherapy (carboplatin nab paclitaxel)

Treatment:

Drug: HLX10

Drug: carboplatin and nab paclitaxel

B

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: carboplatin and nab paclitaxel