Non-Squamous Non-Small Cell Lung CancerPhase 2NCT06334757
Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure
A Phase 2 study testing Serplulimab, Bevacizumab Biosimilar HLX04 and Pemetrexed in people with Non-Squamous Non-Small Cell Lung Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Serplulimab Plus Bevacizumab and chemotherapy in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer
- What is being tested?
- Serplulimab, Bevacizumab Biosimilar HLX04 and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2023to 30 Jun 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent before any trial-related processes;
- Age ≥ 18 years and ≤70 years male or females;
- Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer [AJCC] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;
- Patients with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment
- EGFR-TKI resistance, confirmed by RECIST 1.1
- The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
Who cannot join
- History of severe allergies to any study drug
- Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other stimulatory or inhibitory agents of T cell receptors
- Previous exposure to VEGF inhibitor for anti-cancer treatment
- Patients with untreated symptomatic brain metastases. Patients with treated brain metastases will be allowed if brain imaging obtained greater than 4 weeks from trial enrollment reveals stable disease.
- Has received a live-virus vaccination within 28 days of planned treatment start
- Interstitial lung disease or pneumonitis requiring oral or IV glucocorticoids Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
zhen he, 13523530961
About this study
Official title: A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Serplulimab Plus Bevacizumab and Chemotherapy for EGFRm+ Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure
The purpose of this study is to evaluate the efficacy and safety of Serplulimab Plus Bevacizumab and chemotherapy in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients.
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Being tested
- Serplulimab, Bevacizumab Biosimilar HLX04, Pemetrexed, Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
Also called HLX10
300 mg，IV，Q3W
Bevacizumab Biosimilar HLX04Drug
Also called HLX04
7.5 mg/kg，Q3W
PemetrexedDrug
500 mg/m2，IV，Q3W
CarboplatinDrug
AUC=5，IV，Q3W
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab+Bevacizumab+Pemetrexed+Carboplatin | Experimental | Using Serplulimab in combination with bevacizumab, carboplatin and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors. Receives: Drug: Serplulimab; Drug: Bevacizumab Biosimilar HLX04; Drug: Pemetrexed; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR(Overall Response Rate)
The proportion of subjects who have a complete response (CR) or a partial response (PR)
Measured: From start of treatment to 12 months
Secondary outcomes (3)
PFS(Progression Free Survival)
Time from enrollment to first disease progression assessed by investigator or death due to any cause
Measured: From start of treatment to 24 months
OS(Overall Survival)
Time from enrollment to the death of the subject due to any cause
Measured: From start of treatment to 24 months
AE(Adverse Event)
incidece of adverse drug event
Measured: From start of treatment to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start8 May 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334757
- Sponsor's protocol ID
- HLX10IIT22
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2024
- Last updated
- 28 Mar 2024
- 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 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Serplulimab Plus Bevacizumab and Chemotherapy for EGFRm+ Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure
- ClinicalTrials.gov ID
- NCT06334757
- Acronym / sponsor ID
- HLX10IIT22
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 8 May 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 28 Mar 2024 (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.
The purpose of this study is to evaluate the efficacy and safety of Serplulimab Plus Bevacizumab and chemotherapy in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab+Bevacizumab+Pemetrexed+Carboplatin | Experimental | Drug: Serplulimab, Drug: Bevacizumab Biosimilar HLX04, Drug: Pemetrexed, Drug: CarboplatinUsing Serplulimab in combination with bevacizumab, carboplatin and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed written informed consent before any trial-related processes;
- Age ≥ 18 years and ≤70 years male or females;
- Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer [AJCC] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;
- Patients with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment
- EGFR-TKI resistance, confirmed by RECIST 1.1
Key exclusion criteria (6 listed)
- History of severe allergies to any study drug
- Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other stimulatory or inhibitory agents of T cell receptors
- Previous exposure to VEGF inhibitor for anti-cancer treatment
- Patients with untreated symptomatic brain metastases. Patients with treated brain metastases will be allowed if brain imaging obtained greater than 4 weeks from trial enrollment reveals stable disease.
- Has received a live-virus vaccination within 28 days of planned treatment start
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 |
|---|---|---|
| SerplulimabAlso: HLX10300 mg，IV，Q3W | Drug | Serplulimab+Bevacizumab+Pemetrexed+Carboplatin |
| Bevacizumab Biosimilar HLX04Also: HLX047.5 mg/kg，Q3W | Drug | Serplulimab+Bevacizumab+Pemetrexed+Carboplatin |
| Pemetrexed500 mg/m2，IV，Q3W | Drug | Serplulimab+Bevacizumab+Pemetrexed+Carboplatin |
| CarboplatinAUC=5，IV，Q3W | Drug | Serplulimab+Bevacizumab+Pemetrexed+Carboplatin |
Primary outcome
ORR(Overall Response Rate)
Time frame: From start of treatment to 12 months
The proportion of subjects who have a complete response (CR) or a partial response (PR)
3 secondary outcomes
PFS(Progression Free Survival)
Time frame: From start of treatment to 24 months
OS(Overall Survival)
Time frame: From start of treatment to 24 months
AE(Adverse Event)
Time frame: From start of treatment to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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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 Serplulimab, Bevacizumab Biosimilar HLX04 and Pemetrexed in people with Non-Squamous Non-Small Cell Lung Cancer, run by Henan Cancer Hospital 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 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 28 Mar 2024. 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 zhen he (+86 13523530961, 13523530961@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR(Overall Response Rate) (time frame: From start of treatment to 12 months). 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 28 Mar 2024.