Small-cell Lung CancerPhase 2NCT05354700
A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer
A Phase 2 study testing HLX07, HLX10 and carboplatin and etoposide in people with Small-cell Lung Cancer, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
This study is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide) as first-line treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- HLX07, HLX10 and carboplatin and etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2023to 29 May 2024
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system)
- No prior systemic therapy for ES-SCLC
- Major organs are functioning well
- Participant must keep contraception
Who cannot join
- Histologically or cytologically confirmed mixed SCLC
- Known history of severe allergy to any monoclonal antibody
- Known hypersensitivity to carboplatin or etoposide
- Pregnant or breastfeeding females
- Patients with a known history of psychotropic drug abuse or drug addiction
- Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment
Trial locations and contacts
1 site in 1 country.
China1 site
Jilin Cancer Hospital
Changchun, Jilin, 130000
Ying Cheng, MD, 0431-85872600, jl.cheng@163.com
About this study
Official title: An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy in Patients With Extensive Small Cell Lung Cancer (ES-SCLC)
This study is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide) as first-line treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).
- Conditions
- Small-cell Lung Cancer
- Being tested
- HLX07, HLX10, carboplatin and etoposide
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX07Drug
HLX07 is a recombinant humanized anti-EGFR monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.
HLX10Drug
HLX10 is a recombinant humanized anti-PD-1 monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.
carboplatin and etoposideDrug
chemotherapeutics
| Study group | Role | What they receive |
|---|---|---|
| HLX07+HLX10+Chemotherapy | Experimental | HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide) Receives: Drug: HLX07; Drug: HLX10; Drug: carboplatin and etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate by investigator assessment per RECIST 1.1
Measured: up to 2 years
PFS
Progression-free survival by investigator assessment per RECIST v1.1
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start29 Mar 2023 (estimated)
- Primary completion29 Mar 2024 (estimated)
- Study completion29 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354700
- Sponsor's protocol ID
- HLX07-SCLC201
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy in Patients With Extensive Small Cell Lung Cancer (ES-SCLC)
- ClinicalTrials.gov ID
- NCT05354700
- Acronym / sponsor ID
- HLX07-SCLC201
- Conditions
- Small-cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2023 (estimated)
- Primary completion
- 29 Mar 2024 (estimated)
- Study completion
- 29 May 2024 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide) as first-line treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLX07+HLX10+Chemotherapy | Experimental | Drug: HLX07, Drug: HLX10, Drug: carboplatin and etoposideHLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system)
- No prior systemic therapy for ES-SCLC
- Major organs are functioning well
- Participant must keep contraception
Key exclusion criteria (6 listed)
- Histologically or cytologically confirmed mixed SCLC
- Known history of severe allergy to any monoclonal antibody
- Known hypersensitivity to carboplatin or etoposide
- Pregnant or breastfeeding females
- Patients with a known history of psychotropic drug abuse or drug addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX07HLX07 is a recombinant humanized anti-EGFR monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc. | Drug | HLX07+HLX10+Chemotherapy |
| HLX10HLX10 is a recombinant humanized anti-PD-1 monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc. | Drug | HLX07+HLX10+Chemotherapy |
| carboplatin and etoposidechemotherapeutics | Drug | HLX07+HLX10+Chemotherapy |
Primary outcome
ORR
Time frame: up to 2 years
Objective response rate by investigator assessment per RECIST 1.1
PFS
Time frame: Up to 2 years
Progression-free survival by investigator assessment per RECIST v1.1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX07, HLX10 and carboplatin and etoposide in people with Small-cell Lung Cancer, 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 4 inclusion and 6 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 4 May 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuhui Hu, MD (18618313742, Xuhui_Hu@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 2 years). 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?
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 4 May 2022.