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Monoclonal Antibodies

Serplulimab + Chemotherapy for Small Cell Lung Cancer

Verified Trial
Phase 3
Recruiting
Led By Jinming Yu, MD
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 limited-stage small cell lung cancer
You are completely mobile even with current symptoms
Must not have
I have tested positive for HIV, Hepatitis B, or Hepatitis C
I have received treatment for my small cell lung cancer (radiation, chemotherapy, immunotherapy)
Timeline
Screening 28 days
Treatment 12 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 (Atezolizumab).

Who is the study for?
This trial is for adults newly diagnosed with limited-stage small cell lung cancer who haven't had any treatment yet. They should be able to carry out daily activities, not have HIV or hepatitis, and no other cancers in the last 5 years except certain cured skin or localized cancers.Check my eligibility
What is being tested?
The study tests if Serplulimab combined with chemotherapy and radiotherapy works better than just chemo and radiotherapy for this type of lung cancer. It's a phase III trial where patients are randomly assigned to either the drug or a placebo without knowing which one they get.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation by Serplulimab, such as inflammation in various organs, fatigue, nausea from chemotherapy, and skin irritation from radiotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been newly diagnosed with early-stage small cell lung cancer.
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I can move around freely despite my symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have tested positive for HIV, Hepatitis B, or Hepatitis C.
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I have undergone treatment for small cell lung cancer.
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My small cell lung cancer has spread to other parts of my body.
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I have had another type of cancer besides small cell lung 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 ~ 12 months
Follow Up ~60 months
This trial's timeline: 28 days for screening, 12 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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Serplulimab + carboplatin/cisplatin-etoposide + radiotherapyExperimental Treatment4 Interventions
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab 300 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
Group II: placebo + carboplatin/cisplatin-etoposide + radiotherapyPlacebo Group4 Interventions
Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus placebo every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thoracic radiotherapy
2018
Completed Phase 2
~70

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
15,256 Total Patients Enrolled
Jinming Yu, MDPrincipal InvestigatorShandong Cancer Hospital & Institute-department
2 Previous Clinical Trials
1,124 Total Patients Enrolled
Ying ChengPrincipal InvestigatorJilin Provincial Tumor Hospital
10 Previous Clinical Trials
1,549 Total Patients Enrolled

Media Library

HLX10 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05353257 — Phase 3
Small Cell Lung Cancer Research Study Groups: Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy, placebo + carboplatin/cisplatin-etoposide + radiotherapy
Small Cell Lung Cancer Clinical Trial 2023: HLX10 Highlights & Side Effects. Trial Name: NCT05353257 — Phase 3
HLX10 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05353257 — Phase 3
Small Cell Lung Cancer Patient Testimony for trial: Trial Name: NCT05353257 — Phase 3

Frequently Asked Questions

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

Has the FDA cleared HLX10 + carboplatin/cisplatin-etoposide + radiotherapy for patient use?

"This proposed treatment, HLX10 + carboplatin/cisplatin-etoposide + radiotherapy, has received a score of 3 for safety. This is due to the fact that this is a Phase 3 trial, which means that efficacy has been supported by some data and safety has been corroborated by multiple rounds of testing."

Answered by AI

Are investigators still signing up people for this experiment?

"This study appears to be actively recruiting patients according to the clinicaltrials.gov website. The trial was first posted on May 17th, 2022 and was most recently updated on October 28th, 2022."

Answered by AI

Who else is applying?

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

Why did patients apply to this trial?

i want to live. Nothing is working. I need help, money. small cell lung cancer.
PatientReceived 2+ prior treatments
I am looking at all options.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What does this do? How long does screening take? Is this a Phase 1 trial? Is this open label? What new drug is being tested?
PatientReceived 2+ prior treatments
How many site visits required and how long would I need to be there, if I qualify? Nearest site is over 500 miles . What is total compensation and is it paid in increments or lump sum. Will some of lab work be done nearby? Will I need to stay overnight at official site?
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Research Site - Redlands: < 24 hours
  2. The Center for Cancer and Blood Disorders: < 24 hours
  3. Research Site - Chicago: < 24 hours
Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
~124 spots leftby Dec 2024