A Study of HLX10 in Combination With Carboplatin Plus (+) Pemetrexed With or Without HLX04 Compared With Carboplatin+Pemetrexed in 1L Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
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ClinicalTrials.gov Identifier: NCT03952403 |
Recruitment Status :
Recruiting
First Posted : May 16, 2019
Last Update Posted : May 12, 2020
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Condition or disease | Intervention/treatment | Phase |
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Carcinoma Non-Small-Cell Lung | Drug: HLX10, an engineered anti-PD-1 antibody Drug: HLX04, a bevacizumab biosimilar Drug: Carboplatin Drug: Pemetrexed | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 636 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | December 2, 2019 |
Estimated Primary Completion Date : | June 24, 2022 |
Estimated Study Completion Date : | September 22, 2022 |

Arm | Intervention/treatment |
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Experimental: Part 1-Cohort 1 (HLX10+HLX04+Carboplatin+Pemetrexed)
Participants 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.
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Drug: HLX10, an engineered anti-PD-1 antibody
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. Drug: HLX04, a bevacizumab biosimilar 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. Drug: Carboplatin 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. Drug: Pemetrexed 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. |
Experimental: Part 2-Arm A (HLX10+HLX04+Carboplatin+Pemetrexed)
Participants 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.
|
Drug: HLX10, an engineered anti-PD-1 antibody
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. Drug: HLX04, a bevacizumab biosimilar 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. Drug: Carboplatin 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. Drug: Pemetrexed 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. |
Experimental: Part 2-Arm B (HLX10+Carboplatin+Pemetrexed)
Participants will receive IV infusion of HLX10 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.
|
Drug: HLX10, an engineered anti-PD-1 antibody
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. Drug: Carboplatin 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. Drug: Pemetrexed 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. |
Active Comparator: Part 2-Arm C (Carboplatin+Pemetrexed)
Participants will receive 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.
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Drug: Carboplatin
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. Drug: Pemetrexed 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. |
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: baseline to 21 days ]
- Part 2-Progression Free Survival (PFS) as Determined by the IRRC using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 24months) ]
- Part 1 and 2-Incidence rates of AEs and SAEs [ Time Frame: Baseline up to approximately 27months ]
- Part 1 and 2-Overall Survival (OS) [ Time Frame: Baseline until death (up to approximately 36 months) ]
- Part 1-PFS (assessed by the investigator according to RECIST v1.1) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 36months) ]
- Part 1 and 2-Objective response rate (ORR, assessed by IRRC and investigator according to RECIST v1.1 criteria) [ Time Frame: Baseline up to approximately 24 months ]
- Part 1 and 2-Duration of response (DOR, assessed by IRRC and investigator according to RECIST v1.1 criteria) [ Time Frame: Baseline up to approximately 36 months ]
- Part 1 and 2-Pharmacokinetics (PK): serum HLX10 concentration [ Time Frame: Baseline up to approximately 25 months ]
- Part 1 and 2-Immunogenicity evaluation: positive anti-drug antibody (ADA) rate [ Time Frame: Baseline up to approximately 25 months ]
- Part 1 and 2-PD-L1 expression level [ Time Frame: Baseline ]
- Part 1 and 2-Microsatellite instability(MSI) [ Time Frame: Baseline ]
- Part 1 and 2-Tumor mutation burden(TMB) [ Time Frame: Baseline ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952403
Contact: Xia Zhang | +86 150 6880 5856 | Xia_Zhang@henlius.com | |
Contact: Peipei Zai | +86 155 2206 7076 | peipei_zhai@henlius.com |
China, Beijing | |
Cancer Hospital Chinese Academy of Medical Sciences (CAMS) | Recruiting |
Beijing, Beijing, China, 100000 | |
Contact: Yuankai Shi, MD syuankai@cicams.ac.cn |
Principal Investigator: | Yankai Shi, professor | Cancer Hospital Chinese Academy of Medical Sciences (CAMS) |
Responsible Party: | Shanghai Henlius Biotech |
ClinicalTrials.gov Identifier: | NCT03952403 |
Other Study ID Numbers: |
HLX10-002-NSCLC301 |
First Posted: | May 16, 2019 Key Record Dates |
Last Update Posted: | May 12, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Bevacizumab Carboplatin Pemetrexed |
Antibodies Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |