Trial Title:
A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients
NCT ID:
NCT05787613
Condition:
NSCLC Stage IV
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
HLX26
Description:
Anti-LAG-3 monoclonal Antibody Injection
Arm group label:
HLX26 MTD + serplulimab 300 mg + chemotherapy intravenous infusion Q3W
Arm group label:
HLX26 MTD-1 + serplulimab 300 mg + chemotherapy intravenous infusion Q3W
Other name:
Anti-LAG-3 monoclonal Antibody Injection
Intervention type:
Drug
Intervention name:
Serplulimab
Description:
anti-PD-1 humanized monoclonal antibody injection
Arm group label:
HLX26 MTD + serplulimab 300 mg + chemotherapy intravenous infusion Q3W
Arm group label:
HLX26 MTD-1 + serplulimab 300 mg + chemotherapy intravenous infusion Q3W
Arm group label:
placebo + serplulimab 300 mg + chemotherapy intravenous infusion Q3W
Other name:
HLX10
Intervention type:
Drug
Intervention name:
Chemotherapy drug
Description:
non-squamous NSCLC patients will receive Pemetrexed 500mg/m2, IV, Q3W. Carboplatin AUC
5mg/mL/min, IV, Q3W, up to 4 cycles.squamous NSCLC patients will receive
Albumin-paclitaxel 100mg/m2, IV, Q1W or paclitaxel 175mg/m2, IV, Q3W and carboplatin AUC
5 mg/mL/min, IV, Q3W, up to 4 cycles.
Arm group label:
HLX26 MTD + serplulimab 300 mg + chemotherapy intravenous infusion Q3W
Arm group label:
HLX26 MTD-1 + serplulimab 300 mg + chemotherapy intravenous infusion Q3W
Arm group label:
placebo + serplulimab 300 mg + chemotherapy intravenous infusion Q3W
Intervention type:
Drug
Intervention name:
Placebo
Description:
placebo
Arm group label:
placebo + serplulimab 300 mg + chemotherapy intravenous infusion Q3W
Summary:
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3
Monoclonal Antibody Injection) Combined With Serplulimab (Anti-PD-1 Humanized Monoclonal
Antibody Injection) and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung
Cancer (NSCLC) Patients
Detailed description:
This study is a phase II study to evaluate the efficacy, safety and tolerability of HLX26
in combination with Serplulimab and chemotherapy in the treatment of patients with
Non-small cell lung cancer.
The trial was divided into period 1 (safety run-in phase) and period 2 (dose expansion
phase).
The first phase is an open-label study, patients will receive varying doses (800 mg, 600
mg or lower) of HLX26 combined with a fixed dose (300 mg) of serplulimab and
chemotherapy, administered by intravenous infusion every 3 weeks. Observation period of
DLT lasts for 3 weeks after the first administration of HLX26. Safety review committee
(SRC) will responsible for the safety of combination treatment. After confirmation of the
safety, the efficacy of HLX26 combined with Serplulimab and chemotherapy will be
evaluated in period 2.
The second phase (dose expansion phase) is a randomized, double-blind, placebo-controlled
study to evaluate the safety and efficacy of 2 dose levels of HLX26 combined with
fixed-dose (300 mg) of serplulimab and chemotherapy in patients with NSCLC. If the
tolerability observation of the 600mg dose group is completed in the first phase, the SRC
will review the safety data obtained from the study and decide whether to enter into the
second phase; if 2 of the 6 subjects in the 600mg dose group in the first phase occur DLT
event, we will continue to explore the safe dose of HLX26 and enroll another 3-6
subjects. Once the maximum tolerated dose (MTD) is found, two doses, MTD and MTD-1, will
be selected to enter the dose expansion phase. (The SRC will review the safety and
tolerability results obtained in the study to determine the MTD, and will select the dose
of MTD-1 below the MTD and within the effective dose range). In the second stage, there
are 3 groups and 40 people in each group. The interactive network/voice response system
(IWRS) is used to randomly assign qualified subjects to the following three groups in a
1:1:1 allocation ratio:
> Group A: HLX26 MTD intravenous infusion + serplulimab 300 mg intravenous infusion, Q3W;
chemotherapy
> Group B: HLX26 MTD-1 intravenous infusion + serplulimab 300 mg intravenous infusion,
Q3W; chemotherapy
> Group C: placebo + serplulimab 300 mg intravenous infusion, Q3W; chemotherapy
The chemotherapy will be decided by investigator per patients' pathological type.
nsqNSCLC patients will receive pemetrexed and carboplatin as chemotherapy and sqNSCLC
patients will receive nab-paclitaxel or paclitaxel and carboplatin.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Stage IV (AJCC 8th Edition) non-small cell lung cancer confirmed by histology or
cytology.
2. No EGFR sensitive mutation or ALK, ROS1 rearrangement.
3. Have not received systemic treatment for stage IV disease. For patients who have
received adjuvant or neoadjuvant treatment, if the adjuvant/neoadjuvant treatment
has been completed for at least 6 months, they are allowed to be enrolled.
4. At least one measurable lesion evaluated by the investigator per RECIST v1.1.
5. Subjects must provide qualified tumor tissue samples for the detection of PD-L1 and
LAG-3 expression level.
6. Have adequate organ function with expected survival period ≥ 12 weeks and ECOG score
of 0 or 1.
Key Exclusion Criteria:
1. Subjects with other histopathological types including small cell lung cancer,
neuroendocrine cancer or sarcoma.
2. Have other malignant tumors within 3 years.
3. Pleural effusion, pericardial effusion or ascites that require clinical
intervention.
4. Myocardial infarction and poorly controlled arrhythmia occurred within six months
before the first administration of the study drug.
5. III - IV cardiac insufficiency per NYHA standard or left ventricular ejection
fraction<50%.
6. Patients with active pulmonary tuberculosis.
7. Patients with previous or current interstitial pneumonia, pneumoconiosis, radiation
pneumonitis, drug-related pneumonitis, or severe pulmonary function impairment that
may interfere with the detection and management of suspected drug-related pulmonary
toxicity.
8. Patients who have known active autoimmune diseases or suspected auto-immue disease.
Patients in stable condition and do not require systemic immunosuppressant therapy
are allowed to be enrolled.
9. Require systemic treatment with corticosteroids (> 10 mg/day prednisone or
equivalent) or other immunosuppressive agents within 14 days prior to the first dose
of the study products or during the study.
10. Patients who have received any T-cell costimulatory agents or immune checkpoint
blockade therapy, including but not limited to cytotoxic T lymphocyte-associated
antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1 inhibitors.
11. Patients with a history of severe allergy to any monoclonal antibody products.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Affiliated Hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Bi CHEN
Phone:
0
Email:
chenbi207@126.com
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Jialei WANG
Phone:
0
Email:
luwangjialei@126.com
Investigator:
Last name:
Jialei WANG
Email:
Principal Investigator
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Shun Lu
Phone:
0
Email:
shun_lu@hotmail.com
Investigator:
Last name:
Shun Lu
Email:
Principal Investigator
Start date:
July 10, 2023
Completion date:
July 2027
Lead sponsor:
Agency:
Shanghai Henlius Biotech
Agency class:
Industry
Source:
Shanghai Henlius Biotech
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05787613
