An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)
Study to Test Trastuzumab Deruxtecan for Lung Cancer
Plain English Summary
A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations is a Phase 3 clinical trial sponsored by AstraZeneca studying Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Tests Trastuzumab Deruxtecan as a first-line treatment for lung cancer with HER2 mutations. For patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and HER2 exon 19 or 20 mutations. Participation involves receiving Trastuzumab Deruxtecan or standard of care chemotherapy and regular check-ups. Alternative treatments include standard chemotherapy options like cisplatin, carboplatin, and pemetrexed. The trial aims to enroll 454 participants.
Official Summary
DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible patients are at least 18 years old, have NSCLC with HER2 mutations, and have not received prior treatment for their cancer. Patients must have measurable disease and adequate organ function, and must be able to provide tumor tissue for testing. Excluded are those with untreated brain metastases, active autoimmune disorders, or recent myocardial infarction. Patients with other targetable mutations like EGFR or those with severe lung-specific illnesses are also excluded. This trial is studying Locally Advanced or Metastatic Non-Small Cell Lung Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures focus on progression-free survival, which means how long patients can go without their cancer getting worse. The specific primary outcome measures are: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (Until progression or death, assessed up to approximately 12 months). 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 is crucial as it aims to fill a treatment gap for patients with HER2-mutated lung cancer, offering a potentially more effective option. 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 Locally Advanced or Metastatic Non-Small Cell Lung Cancer, where improved treatment options are needed.
Investor Insight
The market for targeted therapies for HER2-mutated lung cancer is growing, and this trial could lead to faster approval and wider access. 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 have HER2 mutations in your lung cancer and if you are eligible for this study. Participation involves regular check-ups, blood tests, and possibly scans to monitor your health and the effectiveness of the treatment. 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: 454 participants
Interventions
- DRUG: Trastuzumab Deruxtecan — Trastuzumab Deruxtecan administered by intravenous infusion
- DRUG: Cisplatin — Investigator's choice of platinum chemotherapy (cisplatin) administered by intravenous infusion
- DRUG: Carboplatin — Investigator's choice of platinum chemotherapy (carboplatin) administered by intravenous infusion
- DRUG: Pembrolizumab — Pembrolizumab administered by intravenous infusion
- DRUG: Pemetrexed — Pemetrexed administered by intravenous infusion
Primary Outcomes
- Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (Until progression or death, assessed up to approximately 12 months)
Secondary Outcomes
- Overall Survival (OS) (Until death, assessed up to approximately 28 months.)
- Progression Free Survival (PFS) by investigator assessment (Until progression, assessed up to approximately 12 months)
- Objective Response Rate (ORR) (Until progression, assessed up to approximately 12 months)
- Duration of Response (DoR) (Until progression, assessed up to approximately 12 months)
- Time to second progression or death (PFS2) (Assessed up to approximately 20 months)
Full Eligibility Criteria
Inclusion Criteria: * Participants at least 18 years of age * Locally advanced and unresectable NSCLC, not amenable to curative therapy, or metastatic disease * Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA * Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease * Left ventricular ejection fraction (LVEF) ≥ 50% * Measurable disease assessed by Investigator based on RECIST 1.1 * Protocol-defined adequate organ function including cardiac, renal, hepatic function * ECOG 0-1 * Having tumour tissue available for central testing Exclusion Criteria: * Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy) * Any untreated brain metastases, including asymptomatic or clinically inactive brain metastases * Active autoimmune or inflammatory disorders * Medical history of myocardial infarction within 6 months prior to randomization * History of non-infectious pneumonitis/ILD, current or suspected ILD * Lung-specific intercurrent clinical significant severe illness * Contraindication to platinum-based doublet chemotherapy or pembrolizumab
Trial Locations
- Research Site, Anchorage, Alaska, United States
- Research Site, Los Alamitos, California, United States
- Research Site, Los Angeles, California, United States
- Research Site, Orange, California, United States
- Research Site, San Francisco, California, United States
- Research Site, Santa Monica, California, United States
- Research Site, Silver Spring, Maryland, United States
- Research Site, Boston, Massachusetts, United States
- Research Site, Ann Arbor, Michigan, United States
- Research Site, Basking Ridge, New Jersey, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT05048797?
NCT05048797 is a Phase 3 INTERVENTIONAL study titled "A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations." It is currently active, not recruiting and is sponsored by AstraZeneca. The trial targets enrollment of 454 participants.
What conditions does NCT05048797 study?
This trial investigates treatments for Locally Advanced or Metastatic Non-Small Cell Lung Cancer. The primary condition under study is Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
What treatments are being tested in NCT05048797?
The interventions being studied include: Trastuzumab Deruxtecan (DRUG), Cisplatin (DRUG), Carboplatin (DRUG), Pembrolizumab (DRUG), Pemetrexed (DRUG). Trastuzumab Deruxtecan administered by intravenous infusion
What does Phase 3 mean for NCT05048797?
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 NCT05048797?
This trial is currently "Active, Not Recruiting." It started on 2021-10-28. The estimated completion date is 2027-07-30.
Who is sponsoring NCT05048797?
NCT05048797 is sponsored by AstraZeneca. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05048797?
The trial aims to enroll 454 participants. The trial status is active, not recruiting.
How is NCT05048797 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT05048797?
The primary outcome measures are: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (Until progression or death, assessed up to approximately 12 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05048797 being conducted?
This trial is being conducted at 20 sites, including Anchorage, Alaska; Los Alamitos, California; Los Angeles, California; Orange, California and 16 more sites (United States, Austria).
Where can I find official information about NCT05048797?
The official record for NCT05048797 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05048797. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05048797 testing in simple terms?
Tests Trastuzumab Deruxtecan as a first-line treatment for lung cancer with HER2 mutations. For patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and HER2 exon 19 or 20 mutations.
Why is this trial significant?
This trial is crucial as it aims to fill a treatment gap for patients with HER2-mutated lung cancer, offering a potentially more effective option. 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 NCT05048797?
Key risks include potential side effects from chemotherapy and the need for regular monitoring of heart function. Side effects may include nausea, fatigue, and changes in blood counts, but the study team will manage these closely. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05048797?
Ask your doctor if you have HER2 mutations in your lung cancer and if you are eligible for this study. Participation involves regular check-ups, blood tests, and possibly scans to monitor your health and the effectiveness of the treatment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05048797 signal from an investment perspective?
The market for targeted therapies for HER2-mutated lung cancer is growing, and this trial could lead to faster approval and wider access. 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 receiving Trastuzumab Deruxtecan or standard of care chemotherapy and regular check-ups. 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.
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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.