A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor
OSE2101 Trial for NSCLC Patients
Plain English Summary
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor is a Phase 3 clinical trial sponsored by OSE Immunotherapeutics studying Patients With Non-Small Cell Lung Cancer. Tests a new cancer vaccine (OSE2101) against docetaxel for patients with metastatic NSCLC who have stopped responding to immune checkpoint inhibitors. For patients aged 18 and over, HLA-A2 positive, with metastatic NSCLC, and have secondary resistance to immune checkpoint inhibitors. Participation involves regular check-ups and blood tests. Patients will receive either OSE2101 or docetaxel, depending on randomization. Alternative treatments include other chemotherapy options or targeted therapies if available. The trial aims to enroll 363 participants.
Official Summary
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance. Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).
Who Can Participate
Here is what you need to know about eligibility for this trial. Must be HLA-A2 positive, aged 18 and over, with metastatic NSCLC, and have secondary resistance to immune checkpoint inhibitors. Cannot have EGFR, ALK, or ROS1 gene alterations, or be eligible for surgery or radiation. Age ≥ 50 years old and smoker ≥ 15 pack years for squamous NSCLC may not require molecular tests. Must agree to use the NGS HLAA2 assay for HLA-A2 phenotype confirmation. This trial is studying Patients With Non-Small Cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures survival, helping patients understand the potential impact on their life expectancy. The specific primary outcome measures are: OS defined as time from randomization to death (From randomization date through study completion, an average of 3 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 gap in treatment options for patients with metastatic NSCLC who have stopped responding to immune checkpoint inhibitors. 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 Patients With Non-Small Cell Lung Cancer, where improved treatment options are needed.
Investor Insight
The large market size and competitive landscape indicate a high probability of approval, making this a promising investment opportunity. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if you are HLA-A2 positive and have metastatic NSCLC with secondary resistance to immune checkpoint inhibitors. Participation involves regular clinic visits and blood tests. You will receive either OSE2101 or docetaxel. This trial is currently recruiting participants. The trial is being conducted at 20 sites. 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: NONE
- Enrollment: 363 participants
Interventions
- DRUG: OSE2101 — OSE2101 is a peptidic cancer vaccine composed of nine epitopes restricted to HLA-A2 phenotype targeting the tumor associated antigens of P53, HER-2, CEA, MAGE-2 and MAGE-3, and one pan-HLA DR binding epitope (PADRE), all epitopes emulsified in Montanide ISA 51TM adjuvant.
- DRUG: Docetaxel — Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.
- DEVICE: NGS HLAA2 assay — Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files.
Primary Outcomes
- OS defined as time from randomization to death (From randomization date through study completion, an average of 3 years)
Full Eligibility Criteria
Inclusion Criteria: 1. Male or female, aged ≥ 18 years 2. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory 3. Patients with histologically or cytologically squamous or non-squamous documented NSCLC, metastatic stage at study entry, not eligible for definite surgery or radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy; for patients with squamous NSCLC, the molecular tests are not mandatory if age ≥ 50 years old and smoker ≥ 15 pack years; other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; KRAS G12C and BRAF mutations) after Sponsor' agreement. 4. Patients with secondary resistance to ICI; Other inclusion and exclusion criteria will apply per protocol.
Trial Locations
- Clinical Research Advisors, LLC, Beverly Hills, California, United States
- Clinical Research Advisors - Encino, Encino, California, United States
- Clinical Research Advisors - West Hollywood, Los Angeles, California, United States
- Clinical Research Advisors - Korea Town, Los Angeles, California, United States
- SCL Health - Saint Joseph Hospital Cancer Center, Littleton, Colorado, United States
- Lutheran Medical Center - Cancer Centers of Colorado, Wheat Ridge, Colorado, United States
- Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut, United States
- Georgetown Lombardi Comprehensive Cancer Center, Washington D.C., District of Columbia, United States
- Comprehensive Hematology Oncology - Bradenton Clinic, Bradenton, Florida, United States
- Comprehensive Hematology Oncology - Brandon Clinic, Brandon, Florida, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06472245?
NCT06472245 is a Phase 3 INTERVENTIONAL study titled "Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor." It is currently recruiting and is sponsored by OSE Immunotherapeutics. The trial targets enrollment of 363 participants.
What conditions does NCT06472245 study?
This trial investigates treatments for Patients With Non-Small Cell Lung Cancer. The primary condition under study is Patients With Non-Small Cell Lung Cancer.
What treatments are being tested in NCT06472245?
The interventions being studied include: OSE2101 (DRUG), Docetaxel (DRUG), NGS HLAA2 assay (DEVICE). OSE2101 is a peptidic cancer vaccine composed of nine epitopes restricted to HLA-A2 phenotype targeting the tumor associated antigens of P53, HER-2, CEA, MAGE-2 and MAGE-3, and one pan-HLA DR binding epitope (PADRE), all epitopes emulsified in Montanide ISA 51TM adjuvant.
What does Phase 3 mean for NCT06472245?
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 NCT06472245?
This trial is currently "Recruiting." It started on 2024-12-03. The estimated completion date is 2028-12-15.
Who is sponsoring NCT06472245?
NCT06472245 is sponsored by OSE Immunotherapeutics. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06472245?
The trial aims to enroll 363 participants. The trial is currently recruiting and accepting new participants.
How is NCT06472245 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06472245?
The primary outcome measures are: OS defined as time from randomization to death (From randomization date through study completion, an average of 3 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06472245 being conducted?
This trial is being conducted at 20 sites, including Beverly Hills, California; Encino, California; Los Angeles, California; Littleton, Colorado and 16 more sites (United States).
Where can I find official information about NCT06472245?
The official record for NCT06472245 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06472245. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06472245 testing in simple terms?
Tests a new cancer vaccine (OSE2101) against docetaxel for patients with metastatic NSCLC who have stopped responding to immune checkpoint inhibitors. For patients aged 18 and over, HLA-A2 positive, with metastatic NSCLC, and have secondary resistance to immune checkpoint inhibitors.
Why is this trial significant?
This trial addresses a critical gap in treatment options for patients with metastatic NSCLC who have stopped responding to immune checkpoint inhibitors. 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 NCT06472245?
Potential side effects include flu-like symptoms, fatigue, and injection site reactions. Monitor for any unusual symptoms and report them to your healthcare provider. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06472245?
Ask your doctor if you are HLA-A2 positive and have metastatic NSCLC with secondary resistance to immune checkpoint inhibitors. Participation involves regular clinic visits and blood tests. You will receive either OSE2101 or docetaxel. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06472245 signal from an investment perspective?
The large market size and competitive landscape indicate a high probability of approval, making this a promising investment opportunity. 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?
Participation involves regular check-ups and blood tests. Patients will receive either OSE2101 or docetaxel, depending on randomization. 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
More Patients With Non-Small Cell Lung Cancer Trials
View all Patients With Non-Small Cell Lung Cancer clinical trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.