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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 been newly diagnosed with extensive- stage small cell lung cancer
You have full mobility even with current symptoms
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 Up 60 months
Awards & highlights
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.
Who is the study for?
This trial is for US patients newly diagnosed with extensive-stage small cell lung cancer (ES-SCLC) who are fully mobile and have not received prior treatment. Eligible participants must not have other active cancers, except certain cured skin or in situ cancers, and should test negative for HIV, Hepatitis B/C. They cannot join if they've had a solid organ or bone marrow transplant, cervical/bladder/skin cancer, peripheral neuropathy, or brain metastasis.Check my eligibility
What is being tested?
The study compares the efficacy and safety of two treatments: Serplulimab plus chemotherapy (carboplatin-etoposide) versus Atezolizumab plus the same chemotherapy in untreated ES-SCLC patients. Participants will be randomly assigned to either Arm A (Serplulimab group) or Arm B (Atezolizumab control group).See study design
What are the potential side effects?
Potential side effects include reactions related to infusion of drugs like fatigue, digestive issues such as nausea and vomiting; blood disorders that can affect immunity; liver problems; kidney function changes; nerve damage symptoms like numbness; and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been newly diagnosed with extensive-stage small cell lung cancer.
Select...
I can move around freely despite my symptoms.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received treatment for my small cell lung cancer.
Select...
You have been diagnosed with HIV, Hepatitis B, or Hepatitis C.
Select...
I have not had any other cancers 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.
Serplulimab Efficacy
Patients demonstrated better survival rates when receiving Serplulimab than chemotherapy alone.
Serplulimab + Chemo
Chemo alone
Overall Survival %
Duration of survival, month
Serplulimab Efficacy
Serplulimab led to >5x improvement in two year overall survival.
2-Year Overall Survival %
Timeline
Screening ~ 28 days1 visit
Treatment ~ 5 months1 visit
Follow Up ~ 60 months1 visit
Screening ~ 28 days
Treatment ~ 5 months
Follow Up ~60 months
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
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
87 Previous Clinical Trials
15,538 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with cervical cancer.You have been diagnosed with HIV, Hepatitis B, or Hepatitis C.I have been newly diagnosed with extensive-stage small cell lung cancer.I haven't been treated for advanced small cell lung cancer, or it's been 6+ months since my last treatment for early-stage.I have no active cancer and no history of cancer in the last 5 years, except for certain skin, bladder, prostate, cervical, or breast cancers that were treated and cured.I have been diagnosed with bladder cancer.My small cell lung cancer has metastasized.Answer yes if you do not have HIV, Hepatitis B or Hepatitis CI have been diagnosed with skin cancer.I do not have brain metastasis or carcinomatous meningitis.I have been diagnosed with Peripheral Neuropathy.I can move around freely despite my symptoms.You must use birth control during the study.My major organs are working properly.I have been newly diagnosed with extensive-stage small cell lung cancer.I have not received any systemic therapy for my small cell lung cancer.I can move around freely despite having some symptoms.I have had a bone marrow transplant.I have not had any drug treatments for small cell lung cancer.My small cell lung cancer diagnosis is confirmed by lab tests.I have received treatment for my small cell lung cancer.I have not had any other cancers in the last 5 years.I have small cell lung cancer and haven't started treatment, or it's been 6+ months since my last treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab + chemotherapy
- Group 2: Serplulimab + chemotherapy
Awards:
This trial has 3 awards, including:- Verified Trial Data - This sponsor has confirmed the contact details & information for their site to make enrollment simpler.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 28 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 5 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 60 Months after you stop receiving the treatment.
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- Reno
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?
Most responsive sites:
- Research Site - Florham Park: < 24 hours
- Research Site - Bethesda: < 24 hours
- Research Site - Maumee: < 24 hours
Average response time
- < 2 Days
Typically responds via
Email
Phone Call
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