AzTrials
AzTrials

NSCLC Stage IVPhase 2NCT05787613

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

A Phase 2 study testing HLX26, Serplulimab and Chemotherapy drug in people with NSCLC Stage IV, run by Shanghai Henlius Biotech at 3 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC Stage IV
What is being tested?
HLX26, Serplulimab and Chemotherapy drug
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
132 participants
Where
3 sitesChina
Study dates
10 Jul 2023to Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stage IV (AJCC 8th Edition) non-small cell lung cancer confirmed by histology or cytology.
  • No EGFR sensitive mutation or ALK, ROS1 rearrangement.
  • 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.
  • At least one measurable lesion evaluated by the investigator per RECIST v1.1.
  • Subjects must provide qualified tumor tissue samples for the detection of PD-L1 and LAG-3 expression level.
  • Have adequate organ function with expected survival period ≥ 12 weeks and ECOG score of 0 or 1.

Who cannot join

  • Subjects with other histopathological types including small cell lung cancer, neuroendocrine cancer or sarcoma.
  • Have other malignant tumors within 3 years.
  • Pleural effusion, pericardial effusion or ascites that require clinical intervention.
  • Myocardial infarction and poorly controlled arrhythmia occurred within six months before the first administration of the study drug.
  • III - IV cardiac insufficiency per NYHA standard or left ventricular ejection fraction<50%.
  • Patients with active pulmonary tuberculosis.
Show all 11Show fewer
  • 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.
  • 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.
  • 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.
  • 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.
  • Patients with a history of severe allergy to any monoclonal antibody products.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

Other trials in China

About this study

Official title: 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

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

Read the 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.

Conditions
NSCLC Stage IV
Being tested
HLX26, Serplulimab, Chemotherapy drug, Placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX26Drug

    Also called Anti-LAG-3 monoclonal Antibody Injection

    Anti-LAG-3 monoclonal Antibody Injection

  • SerplulimabDrug

    Also called HLX10

    anti-PD-1 humanized monoclonal antibody injection

  • Chemotherapy drugDrug

    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.

  • PlaceboDrug

    placebo

Study groups in NCT05787613
Study groupRoleWhat they receive
HLX26 MTD + serplulimab 300 mg + chemotherapy intravenous infusion Q3WExperimentalIn this group, HLX26 (MTD) in combination with HLX10 (300 mg) and chemotherapy will be intravenously administered every 3 weeks. About 40 subjects will be enrolled in this cohort. Patients will be treated with until disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first). The efficacy of HLX26 (MTD) in combination with Serplulimab and chemotherapy will be evaluated in this group.
Receives: Drug: HLX26; Drug: Serplulimab; Drug: Chemotherapy drug
HLX26 MTD-1 + serplulimab 300 mg + chemotherapy intravenous infusion Q3WExperimentalIn this group, HLX26 (MTD-1) in combination with HLX10 (300 mg) and chemotherapy will be intravenously administered every 3 weeks. About 40 subjects will be enrolled in this cohort. Patients will be treated with until disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first). The efficacy of HLX26 (MTD-1) in combination with Serplulimab and chemotherapy will be evaluated in this group.
Receives: Drug: HLX26; Drug: Serplulimab; Drug: Chemotherapy drug
placebo + serplulimab 300 mg + chemotherapy intravenous infusion Q3WPlacebo comparatorIn this group, placebo in combination with HLX10 (300 mg) and chemotherapy will be intravenously administered every 3 weeks. About 40 subjects will be enrolled in this cohort. Patients will be treated with until disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first). The efficacy of Serplulimab and chemotherapy will be evaluated in this group.
Receives: Drug: Serplulimab; Drug: Chemotherapy drug; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT) (Part 1)

    The DLT of HLX26 in combination with Serplulimab and Chemotherapy within 3 weeks after the first administration in previously untreated NSCLC patients

    Measured: from day1 to day 21

  2. Maximum Tolerated Dose (MTD) (Part 1)

    The MTD of HLX26 in combination with Serplulimab and Chemotherapy within 3 weeks after the first administration in previously untreated NSCLC patients

    Measured: from day1 to day 21

  3. Objective Response Rate (ORR) per RECIST 1.1 as Assessed by IRRC ( Part 2)

    The ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by IRRC.

    Measured: approximately up to 12 months

Secondary outcomes (8)

  1. Progression Free Survival (PFS) per RECIST 1.1 assessed by IRRC and Investigator

    Measured: approximately up to 12 months

  2. Disease Control Rate (DCR) per RECIST 1.1 as Assessed by IRRC and Investigator

    Measured: approximately up to 12 months

  3. Duration of Response (DOR) per RECIST 1.1 assessed by IRRC and Investigator

    Measured: approximately up to 12 months

  4. Objective Response Rate (ORR) per RECIST 1.1 assessed by Investigator

    The ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by investigator.

    Measured: approximately up to 12 months

  5. Overall Survival (OS)

    Measured: approximately up to 36 months

  6. Adverse events

    The incidence of AE, SAE will be detected

    Measured: approximately up to 12 months

  7. Serum concentration of HLX26 and Serplulimab

    The serum concentration of HLX26 (at Cycle 1,2,4 and every 4 cycles from Cycle 8 and thereafter) and Serplulimab (at Cycle 4) will be detected.

    Measured: approximately up to 12 months

  8. Immunogenicity of HLX26

    The incidence of Anti-HLX26 antibody and the incidence of neutralizing antibody will be detected

    Measured: approximately up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2023
  2. Study start10 Jul 2023
  3. Primary completionFeb 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05787613
Sponsor's protocol ID
HLX26HLX10-NSCLC201
Status last verified
Aug 2025
First submitted
3 Mar 2023
Last updated
6 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HLX26, Serplulimab and Chemotherapy drug in people with NSCLC Stage IV, run by Shanghai Henlius Biotech at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (Part 1) (time frame: from day1 to day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05787613.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in