Lung AdenocarcinomaPhase 2NCT05675033
Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma
A Phase 2 study testing Serplulimab and Bevacizumab injection in people with Lung Adenocarcinoma and Stage IV Non-small Cell Lung Cancer, run by Fujian Cancer Hospital.
Trial summary
In order to further evaluate the efficacy of immunotherapy combined with antivascular therapy in the real world, we used Serpluimab combined with Bevacizumab and platinum-based chemotherapy in previously untreated EGFR/ALK-negative advanced non-squamous NSCLC patients, to evaluate the efficacy and safety of this… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Adenocarcinoma, Stage IV Non-small Cell Lung Cancer, PD-1 Inhibitor
- What is being tested?
- Serplulimab and Bevacizumab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2023to 10 Jan 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understood this study and voluntarily signed the informed consent form (ICF);
- -≥ 18 years and ≤ 75 years old;
- ECOG score 0-1;
- Non-squamous NSCLC;
- stage IV;
- EGFR and ALK negative;
- Treatment-naive;
- According to RECIST1.1 criteria, there are measurable or evaluable lesions.
Who cannot join
- Tumor histology or cytology confirmed that it was associated with squamous cell carcinoma or small cell lung cancer;
- Patients with severe organ dysfunction were indicated by examination, Exclude subjects with any active, known or suspected autoimmune diseases;
- The estimated survival time is less than 3 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Serplulimab Combined With Anti-VEGF Antibody and Platinum-based Chemotherapy in Treat-naive EGFR/ALK-negative Advanced Lung Adenocarcinoma, a Single Arm Clinical Trail
In order to further evaluate the efficacy of immunotherapy combined with antivascular therapy in the real world, we used Serpluimab combined with Bevacizumab and platinum-based chemotherapy in previously untreated EGFR/ALK-negative advanced non-squamous NSCLC patients, to evaluate the efficacy and safety of this regimen.
- Being tested
- Serplulimab and Bevacizumab injection
- Medical subject headings
- Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serplulimab and Bevacizumab injectionDrug
Also called platinum-based chemotherapy
Serplulimab, 4.5mg/kg, intravenous injection, D1,Q21, until the disease progressed or showed intolerable side effects.
Bevacizumab injection, 7.5mg/kg, intravenous injection, D1, Q21, until the disease progressed or showed intolerable side effects.
Platinum-based chemotherapy: pemetrexed combined with carboplatin, D1-2, Q21, a total of 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| study arm | Other | This is a single arm study. Receives: Drug: Serplulimab and Bevacizumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (3)
ORR
overall response rate
Measured: up to 12 months
DCR
disease control rate
Measured: up to 12 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Measured: up 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 posted9 Jan 2023
- Study start10 Jan 2023 (estimated)
- Primary completion10 Jan 2023 (estimated)
- Study completion10 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675033
- Sponsor's protocol ID
- SCOG004
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2022
- Last updated
- 9 Jan 2023
- 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 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serplulimab Combined With Anti-VEGF Antibody and Platinum-based Chemotherapy in Treat-naive EGFR/ALK-negative Advanced Lung Adenocarcinoma, a Single Arm Clinical Trail
- ClinicalTrials.gov ID
- NCT05675033
- Acronym / sponsor ID
- SCOG004
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 10 Jan 2023 (estimated)
- Primary completion
- 10 Jan 2023 (estimated)
- Study completion
- 10 Jan 2024 (estimated)
- First posted
- 9 Jan 2023 (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.
In order to further evaluate the efficacy of immunotherapy combined with antivascular therapy in the real world, we used Serpluimab combined with Bevacizumab and platinum-based chemotherapy in previously untreated EGFR/ALK-negative advanced non-squamous NSCLC patients, to evaluate the efficacy and safety of this regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study arm | Other | Drug: Serplulimab and Bevacizumab injectionThis is a single arm study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Fully understood this study and voluntarily signed the informed consent form (ICF);
- -≥ 18 years and ≤ 75 years old;
- ECOG score 0-1;
- Non-squamous NSCLC;
- stage IV;
Key exclusion criteria (3 listed)
- Tumor histology or cytology confirmed that it was associated with squamous cell carcinoma or small cell lung cancer;
- Patients with severe organ dysfunction were indicated by examination, Exclude subjects with any active, known or suspected autoimmune diseases;
- The estimated survival time is less than 3 months.
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 |
|---|---|---|
| Serplulimab and Bevacizumab injectionAlso: platinum-based chemotherapySerplulimab, 4.5mg/kg, intravenous injection, D1,Q21, until the disease progressed or showed intolerable side effects. Bevacizumab injection, 7.5mg/kg, intravenous injection, D1, Q21, until the disease progressed or showed intolerable side effects. Platinum-based chemotherapy: pemetrexed combined with carboplatin, D1-2, Q21, a total of 4 cycles. | Drug | study arm |
Primary outcome
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
progression-free survival
3 secondary outcomes
ORR
Time frame: up to 12 months
DCR
Time frame: up to 12 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: up 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 9 Jan 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab and Bevacizumab injection in people with Lung Adenocarcinoma and Stage IV Non-small Cell Lung Cancer, run by Fujian Cancer Hospital.
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 8 inclusion and 3 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 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mei Fang Li, MD (+8615985795022, 362952772@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 9 Jan 2023.