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CarcinomaPhase 3NCT03952403

A Study of HLX10 in Combination With Carboplatin Plus (+) Pemetrexed With or Without HLX04 Compared With Carboplatin+Pemetrexed in 1L Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

A Phase 3 study testing HLX10, an engineered anti-PD-1 antibody, HLX04, a bevacizumab biosimilar and Carboplatin in people with Carcinoma and Non-Small-Cell Lung, run by Shanghai Henlius Biotech at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study involves a two-part design. Part 1 is designed to evaluate the safety and tolerability of the 4 drug (HLX10+HLX04+carboplatin+pemetrexed). Part 2 is a randomized, open-label study, which will evaluate the safety and efficacy of HLX10 in combination with carboplatin+pemetrexed with or without… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
HLX10, an engineered anti-PD-1 antibody, HLX04, a bevacizumab biosimilar and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
643 participants
Where
1 siteChina
Study dates
2 Dec 2019to 15 Mar 2024
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Histologically or cytologically confirmed, Stage IIIB/IIIC or IV non-squamous NSCLC
  • Participants with no EGFR, ALK and ROS1 mutation.
  • Participants with no prior treatment for Stage IIIB/IIIC or IV non-squamous NSCLC
  • Measurable disease as defined by RECIST v1.1
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Adequate hematologic and end organ function

Who cannot join

  • Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
  • Active central nervous system metastases
  • Prior treatment with cluster of differentiation immune checkpoint blockade therapies or Bevacizumab
  • Has received a surgical operation within 4 weeks from the initial drug administration
  • Active or suspected autoimmune diseases. Subjects in a stable state with no need for systemic immunosuppressant therapy are allowed to enroll.
  • Currently having or have had interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis and severe impaired pulmonary function that may interfere with the detection and management of suspected drug-related pulmonary toxicity
Show all 14Show fewer
  • Any active infection requiring systemic anti-infective therapy within 14 days prior to study drug administration
  • Uncontrollable active infection(s)
  • History of immunodeficiency, including HIV antibody positive
  • active hepatitis B; or hepatitis C virus infections
  • Has bleeding tendency
  • History of severe cardiovascular diseases
  • Known gastrointestinal diseases as follows, Gastrointestinal perforation, abdominal fistula or abdominal abscess within 6 months before signing the informed consent; History of poorly controlled or recurrent inflammatory bowel disease; Active peptic ulcers, or > moderate esophageal varices
  • Pregnant or breastfeeding female

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital Chinese Academy of Medical Sciences (CAMS)

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: A Three Arm, Randomized, Double-Blind, Multicenter, Phase 3 Study of HLX10(Anti-PD-1 Antibody) in Combination With Carboplatin Plus (+) Pemetrexed With or Without HLX04(Avastin Biosimilar) Compared With Carboplatin+Pemetrexed in 1L Stage IIIB/IIIC or IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

This study involves a two-part design. Part 1 is designed to evaluate the safety and tolerability of the 4 drug (HLX10+HLX04+carboplatin+pemetrexed). Part 2 is a randomized, open-label study, which will evaluate the safety and efficacy of HLX10 in combination with carboplatin+pemetrexed with or without HLX04(biosimilar of avastin) compared with treatment with carboplatin+pemetrexed in 1st line Stage IIIB/IIIC or IV non-squamous NSCLC. Participants will be randomized in a 1:1:1 ratio to Arm A (HLX10+HLX04+Carboplatin+Pemetrexed), Arm B (HLX10+HLX04 placebo+Carboplatin+Pemetrexed), or Arm C (HLX10 placebo + HLX04 placebo+Carboplatin+Pemetrexed).

Being tested
HLX10, an engineered anti-PD-1 antibody, HLX04, a bevacizumab biosimilar, Carboplatin, Pemetrexed
Medical subject headings
Carcinoma

What participants receive

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

  • HLX10, an engineered anti-PD-1 antibodyDrug

    HLX10 will be administered as IV infusion at a dose of 4.5mg/kg on Day 1 of each 21-day cycle until loss of clinical benefit or up to 2 year.

  • HLX04, a bevacizumab biosimilarDrug

    HLX04 will be administered as IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, death or up to 2 year.

  • CarboplatinDrug

    Carboplatin will be administered at area under the concentration-time curve (AUC) 5 on Day 1 of each 21-day cycle for 4 cycles, or until loss of clinical benefit whichever occurs first.

  • PemetrexedDrug

    Pemetrexed will be administered as IV infusion at a dose of 500 milligrams per square meter (mg/m2) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, death or up to 2 year.

Study groups in NCT03952403
Study groupRoleWhat they receive
Part 1-Cohort 1 (HLX10+HLX04+Carboplatin+Pemetrexed)ExperimentalParticipants will receive IV infusion of HLX10 and HLX04 on Day 1 of each 21-day cycle followed by IV infusion of Carboplatin and Pemetrexed on Day 1 of each 21-day cycle for 4 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of HLX10 until loss of clinical benefit and HLX04 and Pemetrexed until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Receives: Drug: HLX10, an engineered anti-PD-1 antibody; Drug: HLX04, a bevacizumab biosimilar; Drug: Carboplatin; Drug: Pemetrexed
Part 2-Arm A (HLX10+HLX04+Carboplatin+Pemetrexed)ExperimentalParticipants will receive IV infusion of HLX10 and HLX04 on Day 1 of each 21-day cycle followed by IV infusion of Carboplatin and Pemetrexed on Day 1 of each 21-day cycle for 4 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of HLX10 until loss of clinical benefit and HLX04 and Pemetrexed until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Receives: Drug: HLX10, an engineered anti-PD-1 antibody; Drug: HLX04, a bevacizumab biosimilar; Drug: Carboplatin; Drug: Pemetrexed
Part 2-Arm B (HLX10+HLX04 placebo+Carboplatin+Pemetrexed)ExperimentalParticipants will receive IV infusion of HLX10 and HLX04 placebo on Day 1 of each 21-day cycle followed by IV infusion of Carboplatin and Pemetrexed on Day 1 of each 21-day cycle for 4 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of HLX10 until loss of clinical benefit and Pemetrexed until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Receives: Drug: HLX10, an engineered anti-PD-1 antibody; Drug: Carboplatin; Drug: Pemetrexed
Part 2-Arm C (HLX10 placebo+HLX04 placebo+Carboplatin+Pemetrexed)Active comparatorParticipants will receive IV infusion of HLX10 placebo and HLX04 placebo on Day 1 of each 21-day cycle followed by IV infusion of Carboplatin and Pemetrexed on Day 1 of each 21-day cycle for 4 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion Pemetrexed until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Receives: Drug: Carboplatin; Drug: Pemetrexed

What is being measured

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

  1. Part 1 Safety and tolerability of study treatment

    Measured: baseline to 21 days

  2. Part 2-Progression Free Survival (PFS) as Determined by the IRRC using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    Measured: Baseline until disease progression or death, whichever occurs first (up to approximately 24months)

Secondary outcomes (12)

  1. Part 2-Overall survival (OS), as a major secondary endpoint

    Measured: Baseline until death (up to approximately 36 months)

  2. Part 1 and 2-Incidence rates of AEs and SAEs

    Measured: Baseline up to approximately 36months

  3. Part 1-Overall survival (OS)

    Measured: Baseline up to approximately 36months

  4. Part 1 and Part 2-PFS (assessed by the investigator according to RECIST v1.1) in Part 1 and 2; PFS (assessed by IRRC according to RECIST v1.1) in Part 1

    Measured: Baseline until disease progression or death, whichever occurs first (up to approximately 36months)

  5. Part 1 and 2-Objective response rate (ORR, assessed by IRRC and investigator according to RECIST v1.1 criteria)

    Measured: Baseline up to approximately 36 months

  6. Part 1 and 2-Duration of response (DOR, assessed by IRRC and investigator according to RECIST v1.1 criteria)

    Measured: Baseline up to approximately 36 months

  7. Part 2-PFS2 (assessed by IRRC)

    Measured: Baseline up to approximately 36months

  8. Part 1 and 2-Pharmacokinetics (PK): serum HLX10 concentration

    Measured: Baseline up to approximately 36 months

  9. Part 1 and 2-Immunogenicity evaluation: positive anti-drug antibody (ADA) rate

    Measured: Baseline up to approximately 36 months

  10. Part 1 and 2-PD-L1 expression level

    Measured: Baseline

  11. Part 1 and 2-Microsatellite instability(MSI)

    Measured: Baseline

  12. Part 1 and 2-Tumor mutation burden(TMB)

    Measured: Baseline

Timeline

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

  1. First posted16 May 2019
  2. Study start2 Dec 2019
  3. Primary completion1 Oct 2023 (estimated)
  4. Study completion15 Mar 2024 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
643 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03952403
Sponsor's protocol ID
HLX10-002-NSCLC301
Status last verified
Aug 2023
First submitted
6 May 2019
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hao X, Wang L, Hao Y, Hu Y, Chen C, Chen B, Huang Y, Zang A, Wang Y, Chen Z, Zhuang W, Shi J, Ren X, Nie L, Yu G, Luo F, Mao Y, Wang X, Li B, Bai Y, Shi J, Ni H, Hou X, Yu H, Li J, Wang Q, Zhu J, Shi Y; ASTRUM-002 Study Group. Serplulimab Plus Chemotherapy, with or without HLX04, versus Chemotherapy as First-Line Treatment for Nonsquamous NSCLC: Final Survival Analysis of the Phase III ASTRUM-002 Study. Cancer Commun (Lond). 2026 Jun 10;46:0034. doi: 10.34133/cancomm.0034. eCollection 2026.

    PubMed 42282892

  • Wang L, Hao X, Hao Y, Hu Y, Chen C, Chen B, Huang Y, Zang A, Wang Y, Chen Z, Zhuang W, Shi J, Ren X, Nie L, Yu G, Luo F, Mao Y, Wang X, Li B, Bai Y, Shi J, Ni H, Yu H, Li J, Wang Q, Zhu J, Shi Y; ASTRUM-002 Study Group. First-line serplulimab plus chemotherapy with or without HLX04 versus chemotherapy in locally advanced or metastatic non-squamous non-small-cell lung cancer (ASTRUM-002): a randomised, double-blind, multicentre phase 3 trial. Lancet Respir Med. 2026 Feb;14(2):117-128. doi: 10.1016/S2213-2600(25)00263-2. Epub 2025 Dec 4.

    PubMed 41354044

  • Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322.

    PubMed 40932107

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HLX10, an engineered anti-PD-1 antibody, HLX04, a bevacizumab biosimilar and Carboplatin in people with Carcinoma and Non-Small-Cell Lung, run by Shanghai Henlius Biotech at 1 site 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 14 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: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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?

Part 1 Safety and tolerability of study treatment (time frame: baseline to 21 days). The study lists 2 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 NCT03952403, which also lists 3 linked publications.

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 8 Aug 2023.

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