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Chemotherapy
HLX10 + Chemotherapy for Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by Shanghai Henlius Biotech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV (AJCC Edition 8) squamous NSCLC where surgery or radiotherapy cannot be performed
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline until disease progression or death, whichever occurs first (up to approximately 24months)
Awards & highlights
Study Summary
This trial will compare the efficacy and safety of HLX10 + chemotherapy vs chemotherapy in subjects with locally advanced or metastatic squamous NSCLC.
Who is the study for?
This trial is for adults with advanced squamous non-small cell lung cancer (NSCLC) who haven't had prior systemic treatment. They must not have certain gene mutations, their organs should function well, and they need to use contraception. Those with a history of severe drug or alcohol abuse, known allergies to the study drugs, pregnant or breastfeeding women, and those with mixed NSCLC types are excluded.Check my eligibility
What is being tested?
The trial tests HLX10 combined with chemotherapy (carboplatin-nab paclitaxel) against placebo plus the same chemotherapy in patients with stage IIIB/IIIC or IV squamous NSCLC. Participants will be randomly assigned in a 2:1 ratio to either receive HLX10 or placebo alongside standard chemo.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion of HLX10 or placebo, typical chemotherapy-related issues like nausea, hair loss, blood count changes leading to increased infection risk or bleeding tendencies. Organ-specific inflammation due to HLX10 may also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have advanced squamous non-small cell lung cancer that cannot be treated with surgery or radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline until disease progression or death, whichever occurs first (up to approximately 24months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline until disease progression or death, whichever occurs first (up to approximately 24months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
tumor assessment
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AExperimental Treatment2 Interventions
HLX10 + chemotherapy (carboplatin nab paclitaxel)
Group II: BPlacebo Group2 Interventions
Placebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HLX10
2022
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
Shanghai Henlius BiotechLead Sponsor
87 Previous Clinical Trials
15,201 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have specific genetic mutations in your EGFR or ALK genes.You have a history of using drugs or alcohol in a way that caused problems.You are allergic to carboplatin or nab-paclitaxel.You have a specific type of lung cancer called non-squamous non-small cell lung cancer, and you don't have any small cell or neuroendocrine components in your tumor. If your tumor has both squamous and non-squamous components, you may still be eligible.You have had a strong allergic reaction to a specific type of medication called a monoclonal antibody.You have advanced squamous non-small cell lung cancer that cannot be treated with surgery or radiation.
Research Study Groups:
This trial has the following groups:- Group 1: A
- Group 2: B
Awards:
This trial has 1 awards, including:- 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 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can people still sign up for this experiment?
"The clinical trial in question, which was first posted on August 14th 2019 and edited most recently on April 25th 2022, is not looking for participants. However, there are over 3000 other medical trials that are currently seeking patients."
Answered by AI
What is the extent of research surrounding HLX10?
"HLX10 has undergone a lot of testing with 1230 ongoing clinical trials, many of which are in the third stage. Although most trials for HLX10 take place in Shanghai, China, there are 67027 total locations where HLX10 is being tested."
Answered by AI
What is the current status of HLX10's FDA approval process?
"Our team at Power has estimated the safety of HLX10 to be a 3. This is because it is a Phase 3 trial, which means that there is some data supporting efficacy and multiple rounds of data supporting safety."
Answered by AI
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