A Randomized, Double-blind, Multicenter Phase 3 Clinical Trial of Ivonescimab Versus Placebo, Combined With Docetaxel in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) That Has Progressed on or After PD-(L)1 Inhibitor-based Therapy
Trial tests Ivonescimab plus chemotherapy for advanced lung cancer after prior treatment.
Plain English Summary
Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer is a Phase 3 clinical trial sponsored by Akeso studying Non-Small Cell Lung Cancer. This trial tests if Ivonescimab, when added to standard chemotherapy (docetaxel), is more effective than placebo plus chemotherapy for advanced lung cancer. It is for patients with non-small cell lung cancer (NSCLC) that has spread and has not responded to previous treatments like chemotherapy and immunotherapy. Participants will receive either Ivonescimab with docetaxel or a placebo with docetaxel, with regular check-ups and tests. Alternative treatments include other chemotherapy regimens, targeted therapies, or palliative care, depending on the patient's specific situation and previous treatments. The trial aims to enroll 536 participants.
Official Summary
This is a Phase 3 Randomized, double-blind, Multicenter Study of Ivonescimab Combined with Docetaxel Versus Placebo Combined with Docetaxel in Patients with Locally advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) that has progressed on or after PD-(L)1 inhibitor-based therapy. The purpose of this study is to evaluate the efficacy and safety of ivonescimab versus placebo, combined with docetaxel in patients with advanced NSCLC.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 to 75 years with a confirmed diagnosis of NSCLC. Patients must have cancer that has spread and has progressed after receiving platinum-based chemotherapy and PD-1/L1 inhibitors. Individuals must have a good general health status (ECOG performance status 0 or 1) and a life expectancy of at least 3 months. People with other types of lung cancer (small cell), recent other cancers, known genetic mutations, or certain autoimmune or heart conditions may not be eligible. This trial is studying Non-Small Cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
Overall Survival (OS) measures how long patients live after starting the treatment, indicating if the new combination therapy helps patients live longer. The specific primary outcome measures are: Overall Survival (OS) (approximately 5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a critical need for new treatments in advanced lung cancer that no longer responds to existing immunotherapies, potentially offering a new option for patients with limited alterna As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Non-Small Cell Lung Cancer, where improved treatment options are needed.
Investor Insight
This trial targets a significant unmet need in a large market for advanced NSCLC, with Ivonescimab aiming to improve outcomes in a difficult-to-treat patient population, suggesting potential for futur Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 536 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of Ivonescimab and docetaxel, and how this trial compares to other available treatments. Participation involves regular clinic visits for infusions, blood tests, scans to monitor your cancer, and reporting any side effects. You will be randomly assigned to receive either the study drug combination or a placebo with chemotherapy, and neither you nor your doctor will know which you are receiving until the study is over. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 536 participants
Interventions
- DRUG: Ivonescimab, docetaxel — Patients will receive ivonescimab and docetaxel as an IV injection
- DRUG: Placebo, docetaxel — Patients will receive placebo and docetaxel as an IV injection
Primary Outcomes
- Overall Survival (OS) (approximately 5 years)
Secondary Outcomes
- Progression Free Survival (PFS) (approximately 3 years)
- Adverse Event (AE) (From the patient signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first)
Full Eligibility Criteria
Inclusion Criteria: * Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). * Age ≥ 18 years old and ≤ 75 years old at the time of randomization. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Expected life expectancy of at least 3 months. * Histologically or cytologically confirmed diagnosis of NSCLC. * Locally advanced or metastatic NSCLC (American Joint Committee on Cancer \[AJCC\] 8th edition). * Previously received systemic platinum-based chemotherapy and PD-1/L1 inhibitors. * At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Adequate organ function. Exclusion Criteria: * Histologic or cytopathologic evidence of the presence of small cell lung carcinoma. * Other malignancies within 3 years prior to randomization. * Known actionable genomic alterations. * Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors. * Previous treatment with docetaxel. * History of severe bleeding tendency or coagulation dysfunction. * Active autoimmune disease requiring systemic therapy within 2 years prior to randomization. * History of myocarditis, cardiomyopathy, and malignant arrhythmia.
Trial Locations
- Shanghai East Hospital, Shanghai, Shanghai Municipality, China
Frequently Asked Questions
What is clinical trial NCT06928389?
NCT06928389 is a Phase 3 INTERVENTIONAL study titled "Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer." It is currently recruiting and is sponsored by Akeso. The trial targets enrollment of 536 participants.
What conditions does NCT06928389 study?
This trial investigates treatments for Non-Small Cell Lung Cancer. The primary condition under study is Non-Small Cell Lung Cancer.
What treatments are being tested in NCT06928389?
The interventions being studied include: Ivonescimab, docetaxel (DRUG), Placebo, docetaxel (DRUG). Patients will receive ivonescimab and docetaxel as an IV injection
What does Phase 3 mean for NCT06928389?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06928389?
This trial is currently "Recruiting." It started on 2025-07-08. The estimated completion date is 2030-06.
Who is sponsoring NCT06928389?
NCT06928389 is sponsored by Akeso. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06928389?
The trial aims to enroll 536 participants. The trial is currently recruiting and accepting new participants.
How is NCT06928389 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06928389?
The primary outcome measures are: Overall Survival (OS) (approximately 5 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06928389 being conducted?
This trial is being conducted at 1 site, including Shanghai, Shanghai Municipality (China).
Where can I find official information about NCT06928389?
The official record for NCT06928389 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06928389. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06928389 testing in simple terms?
This trial tests if Ivonescimab, when added to standard chemotherapy (docetaxel), is more effective than placebo plus chemotherapy for advanced lung cancer. It is for patients with non-small cell lung cancer (NSCLC) that has spread and has not responded to previous treatments like chemotherapy and immunotherapy.
Why is this trial significant?
This trial addresses a critical need for new treatments in advanced lung cancer that no longer responds to existing immunotherapies, potentially offering a new option for patients with limited alterna As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06928389?
Common side effects may include fatigue, nausea, hair loss, decreased white blood cell count (increasing infection risk), and skin rash. More serious risks can include severe allergic reactions, lung inflammation, or problems with blood clotting. As this is a blinded study, participants may receive a placebo, which means they might not receive the active study drug. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06928389?
Ask your doctor about the potential benefits and risks of Ivonescimab and docetaxel, and how this trial compares to other available treatments. Participation involves regular clinic visits for infusions, blood tests, scans to monitor your cancer, and reporting any side effects. You will be randomly assigned to receive either the study drug combination or a placebo with chemotherapy, and neither you nor your doctor will know which you are receiving until the study is over. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06928389 signal from an investment perspective?
This trial targets a significant unmet need in a large market for advanced NSCLC, with Ivonescimab aiming to improve outcomes in a difficult-to-treat patient population, suggesting potential for futur This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will receive either Ivonescimab with docetaxel or a placebo with docetaxel, with regular check-ups and tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.