HLX17 vs Keytruda for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to compare a new treatment, HLX17, with Keytruda in patients who have undergone surgery for certain types of cancer: non-small cell lung cancer, melanoma, or renal cell carcinoma. Researchers seek to determine if HLX17 is as effective and safe as Keytruda. This study targets individuals who have had surgery to completely remove their cancer and are at risk of recurrence. Participants should not have other active cancers or severe heart or lung issues. The trial involves regular treatments over several months to monitor the response.
As a Phase 1 trial, the research focuses on understanding how the treatment works in people, and participants will be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received certain treatments like pembrolizumab or other immune checkpoint inhibitors before joining the study. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that HLX17 is as safe as Keytruda. Studies comparing the two treatments reported similar safety results, indicating that patients generally tolerated HLX17 well, just like Keytruda. No unusual or unexpected side effects appeared with HLX17 compared to Keytruda.
Keytruda has FDA approval for various cancers, indicating its general safety. Although HLX17 is still under testing, its comparison to a well-known treatment like Keytruda is promising.
This trial is in an early phase, focusing on the safety of HLX17. Early trials carefully monitor for any side effects. So far, HLX17 appears well-tolerated, similar to the FDA-approved Keytruda.12345Why are researchers excited about this trial's treatments?
Researchers are excited about HLX17 because it offers a fresh approach to treating lung cancer. Unlike traditional therapies like chemotherapy, HLX17 is an experimental treatment that aims to enhance the body's immune response against cancer cells, potentially providing a more targeted and less toxic option. Another key feature is its flexible treatment duration, tailored individually based on disease progression or side effects, which might offer patients a more personalized treatment experience. This could revolutionize lung cancer care by providing a treatment that better fits individual patient needs and potentially improves outcomes.
What evidence suggests that this trial's treatments could be effective for lung cancer?
This trial will compare HLX17 with Keytruda for lung cancer treatment. Research has shown that HLX17 closely resembles Keytruda, functioning similarly in the body. Biosimilars are designed to mimic the original drugs they are based on. Studies on Keytruda have demonstrated its effectiveness in treating several types of cancer, including non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma (RCC). Keytruda has been proven to extend patient survival and shrink tumors. Since HLX17 is designed to be like Keytruda, it holds promise for similar success. Although direct data on HLX17 is limited, it is being developed to achieve the same positive results as Keytruda.12678
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with resected non-small cell lung cancer, melanoma, or renal cell carcinoma at high risk of recurrence. Participants must have a BMI between 18 and 30, weigh between 50 and 85 kg, expect to live at least another 12 weeks, have good organ function without recent blood transfusions or certain treatments. They should not be breastfeeding and agree to use effective contraception or abstain from sex.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive HLX17 or US-sourced Keytruda® on Day 1 of each 3-week cycle
Crossover Treatment
Participants in the US-sourced Keytruda® group switch to HLX17 after 8 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HLX17
- Keytruda
Trial Overview
The study compares HLX17 with US-sourced Keytruda® in patients who've had surgery for specific cancers. It's randomized and double-blind, meaning neither the researchers nor participants know who gets which drug. The goal is to see if HLX17 matches Keytruda® in pharmacokinetics (how the body processes the drug), effectiveness, safety, and immune response.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Subjects will receive HLX17 (200 mg) on Day 1 of each 3-week cycle, until 12 months after the randomization (nearly 17 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first).
Subjects will receive US-sourced Keytruda® (200 mg) on Day 1 of each 3-week cycle, for a total of 8 cycles (24 weeks). After 8 cycles, all subjects in the US-sourced Keytruda® group will receive HLX17 200 mg on Day 1 of each 3-week cycle until 12 months after the randomization (nearly 17 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shanghai Henlius Biotech
Lead Sponsor
Dr. Jason Zhu
Shanghai Henlius Biotech
Chief Executive Officer since 2023
MBA from Yale University
Dr. Jun Zhu
Shanghai Henlius Biotech
Chief Medical Officer
MD from an unspecified institution
Citations
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3.
biosimilardevelopment.com
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