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Monoclonal Antibodies

Serplulimab + Chemotherapy for Small Cell Lung Cancer

Verified Trial
Phase 3
Recruiting
Research Sponsored by Shanghai Henlius Biotech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
You have full mobility even with current symptoms
You have been newly diagnosed with extensive- stage small cell lung cancer
Must not have
I have recieved treatment for my small cell lung cancer (radiation, chemotherapy, immunotherapy)
I have tested positive for HIV, Hepatitis B, or Hepatitis C.
Timeline
Screening 28 days
Treatment 5 months
Follow Up60 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Verified Trial Data

Study Summary

The trial is studying whether Serplulimab — a drug approved for small cell lung cancer treatment in China — is safer and more effective than the current standard of care for late-stage patients.

Eligible Conditions
  • Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You can move around normally even with your current symptoms.
Select...
You have recently been diagnosed with advanced-stage small cell lung cancer.

Exclusion Criteria

You will be eligible for the trial if you check “No” for criteria below:
Select...
You have already received treatment for your small cell lung cancer, such as radiation, chemotherapy, or immunotherapy.
Select...
You have been diagnosed with HIV, Hepatitis B, or Hepatitis C.
Select...
Have you had any other types of cancer in the last 5 years?
100% of travel, accommodation, and treatment cost is covered.The company running this study will pay for:
Chemotherapy medication & the investigational drug or Atezolizumab (standard of care) depending on which group a patient is assigned to.
Travel, accommodation, and meals required to support your participation in the trial.
Patient Care

Serplulimab Efficacy

Patients demonstrated better survival rates when receiving Serplulimab than chemotherapy alone.

Serplulimab + Chemo

Chemo alone

Overall Survival %

Serplulimab_OS

Duration of survival, month

Serplulimab Efficacy

Serplulimab led to >5x improvement in two year overall survival.

2-Year Overall Survival %

Trial Cards

Timeline

Screening ~ 28 days
Treatment ~ 5 months
Follow Up ~60 months
This trial's timeline: 28 days for screening, 5 months for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess the overall survival of patients
Secondary outcome measures
To assess how long patients respond to the drug without their tumor growing in size
To assess the change in tumor size

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Verified Trial Data
This sponsor has confirmed the contact details & information for their site to make enrollment simpler.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Serplulimab + chemotherapyExperimental Treatment1 Intervention
Serplulimab + chemotherapy (carboplatin-etoposide)
Group II: Atezolizumab + chemotherapyActive Control1 Intervention
Atezolizumab + chemotherapy (carboplatin-etoposide)

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Shanghai Henlius BiotechLead Sponsor
82 Previous Clinical Trials
14,737 Total Patients Enrolled

Media Library

HLX10 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05468489 — Phase 3
Small Cell Lung Cancer Research Study Groups: Serplulimab + chemotherapy, Atezolizumab + chemotherapy
Small Cell Lung Cancer Clinical Trial 2023: HLX10 Highlights & Side Effects. Trial Name: NCT05468489 — Phase 3
HLX10 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05468489 — Phase 3
Small Cell Lung Cancer Patient Testimony for trial: Trial Name: NCT05468489 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can new patients still join the trial?

"That is correct. The most recent information available on clinicaltrials.gov reveals that this trial began seeking patients on October 12th, 2020 and is still recruiting as of today. They are looking for a total of 200 individuals spread out across 6 different locations."

Answered by AI

What are the dangers of HLX10 in combination with other cancer treatments?

"The safety of HLX10 in conjunction with chemotherapy was given a 3 by our team at Power. This is due to the fact that this is a Phase 3 trial, meaning that both efficacy and safety have been supported by rounds of data collection."

Answered by AI

How many different facilities are coordinating this research?

"Presently, there are 6 sites where this study is recruiting patients. The locations of these centres are in Toledo, Tamarac and Orange City as well as other cities 6 additional places. It may be helpful to select the clinic nearest you to reduce travel requirements if you enroll."

Answered by AI

How many individuals are being observed in this clinical trial?

"That is correct, the online information regarding this clinical trial confirms that it is still recruiting patients. This study was first posted on October 12th, 2020 and was updated as recently as October 18th, 2020. The research needs 200 people from 6 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Texas
Florida
Other
How old are they?
18 - 65
65+
What site did they apply to?
Research Site - Springdale
Research Site - Chicago
Research Site - Bethesda
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
2
3+

Why did patients apply to this trial?

I just found out. I want to register. Willing to try a trial. curious if there is somesthing new.
PatientReceived 2+ prior treatments
I have tried drugs that don't work.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What is the process? What does the trial consist of? Do you take patients from Romania?
PatientReceived 1 prior treatment
How long do you have to be at the trial site? Are all expenses covered? WhT if you’re already on a successful treaatment regimen?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Phone Call
Most responsive sites:
  1. Research Site - Florham Park: < 24 hours
  2. Research Site - Bethesda: < 24 hours
  3. Research Site - Covington: < 24 hours
Recent research and studies
clinicaltrials.govStudy
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
2022. "To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05468489.
All > Lung Cancer Glendale > New Jersey
~56 spots leftby Jun 2024
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