HLX07, nsqNSCLC, High EGFR ExpressionPhase 2NCT05215925
A Study to Evaluate the Efficacy and Safety of HLX07 in nsqNSCLC Patients With High EGFR Expression
A Phase 2 study testing HLX07+carboplatin+pemetrexed, HLX07+docetaxel and HLX07 in people with HLX07, nsqNSCLC, High EGFR Expression, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Combination with Chemotherapy or Monotherapy in Advanced Non-squamous Non-small Cell Lung Cancer (nsqNSCLC) Patients with High EGFR Expression Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HLX07, nsqNSCLC, High EGFR Expression
- What is being tested?
- HLX07+carboplatin+pemetrexed, HLX07+docetaxel and HLX07
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 10 Aug 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
- Age>=18Y
- Good Organ Function
- Expected survival time ≥ 3 months
- Histologically confirmed, advanced/recurrent or metastatic nsqNSCLC
- Measurable lesion according RECISTv1.1 by investigator
- High EGFR expression H score ≥200
- ECOG score 0-1
Who cannot join
- Histologically, squamous NSCLC should be excluded. For tumors with adenocarcinoma and squamous carcinoma, if the adenoid component is dominant and the squamous component is < 5%, the patients meet the inclusion requirements.
- Previous treatment with EGFR inhibitors
- Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
- Active clinical severe infection;
- A history of other malignancies within 5 years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin,etal.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Chest Hospital
Shanghai
baohui han, phD, 021-22200000, hanxkyy@aliyun.com
About this study
Official title: An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Advanced nsqNSCLC Patients With High EGFR Expression
An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Combination with Chemotherapy or Monotherapy in Advanced Non-squamous Non-small Cell Lung Cancer (nsqNSCLC) Patients with High EGFR Expression
- Conditions
- HLX07, nsqNSCLC, High EGFR Expression
- Being tested
- HLX07+carboplatin+pemetrexed, HLX07+docetaxel, HLX07
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX07+carboplatin+pemetrexedDrug
Also called Anti-EGFR Monoclonal Antibody
HLX07 1500mg q3w+carboplatin+pemetrexed
HLX07+docetaxelDrug
HLX07 1500mg q3w+docetaxel
HLX07Drug
HLX07 1500mg q3w
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: HLX07+carboplatin+pemetrexed |
| B | Experimental | Not described Receives: Drug: HLX07+docetaxel |
| C | Experimental | Not described Receives: Drug: HLX07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
Measured: up to 2 years
PFS
Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1
Measured: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
Secondary outcomes (1)
OS
Overall survival
Measured: from the date of first dose until the date of death from any cause，assessed 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 posted31 Jan 2022
- Study start1 Feb 2023 (estimated)
- Primary completion15 Jul 2023 (estimated)
- Study completion10 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HLX07, nsqNSCLC, High EGFR ExpressionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT05215925
- Sponsor's protocol ID
- HLX07-nsqNSCLC201
- Status last verified
- May 2022
- First submitted
- 18 Jan 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Advanced nsqNSCLC Patients With High EGFR Expression
- ClinicalTrials.gov ID
- NCT05215925
- Acronym / sponsor ID
- HLX07-nsqNSCLC201
- Conditions
- HLX07, nsqNSCLC, High EGFR Expression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 10 Aug 2024 (estimated)
- First posted
- 31 Jan 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.
An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Combination with Chemotherapy or Monotherapy in Advanced Non-squamous Non-small Cell Lung Cancer (nsqNSCLC) Patients with High EGFR Expression
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: HLX07+carboplatin+pemetrexed |
| B | Experimental | Drug: HLX07+docetaxel |
| C | Experimental | Drug: HLX07 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age>=18Y
- Good Organ Function
- Expected survival time ≥ 3 months
- Histologically confirmed, advanced/recurrent or metastatic nsqNSCLC
- Measurable lesion according RECISTv1.1 by investigator
Key exclusion criteria (5 listed)
- Histologically, squamous NSCLC should be excluded. For tumors with adenocarcinoma and squamous carcinoma, if the adenoid component is dominant and the squamous component is < 5%, the patients meet the inclusion requirements.
- Previous treatment with EGFR inhibitors
- Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
- Active clinical severe infection;
- A history of other malignancies within 5 years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin,etal.
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 |
|---|---|---|
| HLX07+carboplatin+pemetrexedAlso: Anti-EGFR Monoclonal AntibodyHLX07 1500mg q3w+carboplatin+pemetrexed | Drug | A |
| HLX07+docetaxelHLX07 1500mg q3w+docetaxel | Drug | B |
| HLX07HLX07 1500mg q3w | Drug | C |
Primary outcome
ORR
Time frame: up to 2 years
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
PFS
Time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1
1 secondary outcome
OS
Time frame: from the date of first dose until the date of death from any cause，assessed up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
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+carboplatin+pemetrexed, HLX07+docetaxel and HLX07 in people with HLX07, nsqNSCLC, High EGFR Expression, 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 7 inclusion and 5 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 6 Jul 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 baohui han, phD (021-22200000, hanxkyy@aliyun.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 6 Jul 2022.