A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)
New trial tests Tarlatamab combo for first-line extensive stage small-cell lung cancer
Plain English Summary
A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC) is a Phase 3 clinical trial sponsored by Amgen studying Small-cell Lung Cancer, Extensive Stage Small-cell Lung Cancer. This trial tests if adding Tarlatamab to standard chemotherapy (Durvalumab, Carboplatin, Etoposide) helps patients live longer. It is for adults with newly diagnosed extensive stage small-cell lung cancer. Participants will receive either the new combination therapy or the standard chemotherapy alone, assigned randomly. Standard chemotherapy options are available for patients who do not join this trial. The trial aims to enroll 330 participants.
Official Summary
The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 or older with a confirmed diagnosis of extensive stage small-cell lung cancer. Patients must have disease that can be measured on scans and be healthy enough to receive standard chemotherapy. Individuals with active brain metastases, recent blood clots, or certain autoimmune conditions cannot participate. A life expectancy of at least 12 weeks is required. This trial is studying Small-cell Lung Cancer, Extensive Stage Small-cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see if the new combination treatment helps patients live longer overall compared to the standard treatment. The specific primary outcome measures are: Overall Survival (OS) (Up to approximately 3.5 years); Progression free survival (PFS) (Blinded Independent Central Review [BICR] Assessed) (Up to approximately 3.5 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 extensive stage small-cell lung cancer, aiming to improve survival for patients with limited options. 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 Small-cell Lung Cancer, Extensive Stage Small-cell Lung Cancer, where improved treatment options are needed.
Investor Insight
This trial investigates Tarlatamab, a novel therapy, in a large patient population, signaling potential for significant market impact if successful in improving survival for a difficult-to-treat cance 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 this trial is a good fit for you and what the potential benefits and risks are. Participation involves receiving either the new combination or standard chemotherapy, with regular visits for assessments and treatment administration. You will be monitored closely for side effects and your cancer's response to treatment. 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: 330 participants
Interventions
- DRUG: Tarlatamab — Tarlatamab will be administered as an intravenous (IV) infusion.
- DRUG: Durvalumab — Durvalumab will be administered as an IV infusion.
- DRUG: Carboplatin — Carboplatin will be administered as an IV infusion.
- DRUG: Etoposide — Etoposide will be administered as an IV infusion.
Primary Outcomes
- Overall Survival (OS) (Up to approximately 3.5 years)
- Progression free survival (PFS) (Blinded Independent Central Review [BICR] Assessed) (Up to approximately 3.5 years)
Secondary Outcomes
- PFS (Investigator Assessed) (Up to approximately 4 years)
- Objective Response (OR) (Up to approximately 4 years)
- Disease Control (Up to approximately 4 years)
- Duration of Response (DOR) (Up to approximately 4 years)
- PFS Rate (6 months, 1 year, and 2 years)
Full Eligibility Criteria
Inclusion Criteria: * Participant has provided informed consent before initiation of any study-specific activities/procedures. * Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years. * Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV SCLC \[T any, N any, M1 a/b/c\]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. * Measurable disease as defined per RECIST 1.1. * Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment. * Minimum life expectancy ≥ 12 weeks. Exclusion Criteria: * Participants can have no history of other malignancy in the last 2 years. * Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. * They will have no history of severe or life-threatening events to immune-mediated therapy. * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment. * They will have no active autoimmune or inflammatory disorders. * Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection. * Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis. * History of solid organ transplant. * They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months prior to first dose of study treatment.
Trial Locations
- City of Hope Cancer Center Phoenix, Goodyear, Arizona, United States
- Saint Bernards Medical Center, Jonesboro, Arkansas, United States
- Translational Research in Oncology US Inc, Trio Central Pharmacy, Los Angeles, California, United States
- University of California Los Angeles, Santa Monica, California, United States
- Presbyterian Intercommunity Hospital Health Whitter Hospital, Whittier, California, United States
- Colorado West Healthcare System dba Grand Valley Oncology, Grand Junction, Colorado, United States
- Yale New Haven Hospital, New Haven, Connecticut, United States
- Orlando Health Cancer Institute, Kissimmee, Florida, United States
- City of Hope Atlanta, Newnan, Georgia, United States
- University of Illinois Chicago, Chicago, Illinois, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT07005128?
NCT07005128 is a Phase 3 INTERVENTIONAL study titled "A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)." It is currently recruiting and is sponsored by Amgen. The trial targets enrollment of 330 participants.
What conditions does NCT07005128 study?
This trial investigates treatments for Small-cell Lung Cancer, Extensive Stage Small-cell Lung Cancer. The primary condition under study is Small-cell Lung Cancer.
What treatments are being tested in NCT07005128?
The interventions being studied include: Tarlatamab (DRUG), Durvalumab (DRUG), Carboplatin (DRUG), Etoposide (DRUG). Tarlatamab will be administered as an intravenous (IV) infusion.
What does Phase 3 mean for NCT07005128?
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 NCT07005128?
This trial is currently "Recruiting." It started on 2025-08-18. The estimated completion date is 2029-07-15.
Who is sponsoring NCT07005128?
NCT07005128 is sponsored by Amgen. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07005128?
The trial aims to enroll 330 participants. The trial is currently recruiting and accepting new participants.
How is NCT07005128 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07005128?
The primary outcome measures are: Overall Survival (OS) (Up to approximately 3.5 years); Progression free survival (PFS) (Blinded Independent Central Review [BICR] Assessed) (Up to approximately 3.5 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07005128 being conducted?
This trial is being conducted at 20 sites, including Goodyear, Arizona; Jonesboro, Arkansas; Los Angeles, California; Santa Monica, California and 16 more sites (United States).
Where can I find official information about NCT07005128?
The official record for NCT07005128 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07005128. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07005128 testing in simple terms?
This trial tests if adding Tarlatamab to standard chemotherapy (Durvalumab, Carboplatin, Etoposide) helps patients live longer. It is for adults with newly diagnosed extensive stage small-cell lung cancer.
Why is this trial significant?
This trial addresses a critical need for new treatments in extensive stage small-cell lung cancer, aiming to improve survival for patients with limited options. 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 NCT07005128?
Common side effects of chemotherapy can include fatigue, nausea, hair loss, and low blood cell counts. Tarlatamab may cause side effects related to the immune system, such as cytokine release syndrome, which can cause fever, chills, and flu-like symptoms. Other potential risks include nerve damage, skin reactions, and effects on blood pressure. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07005128?
Ask your doctor if this trial is a good fit for you and what the potential benefits and risks are. Participation involves receiving either the new combination or standard chemotherapy, with regular visits for assessments and treatment administration. You will be monitored closely for side effects and your cancer's response to treatment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07005128 signal from an investment perspective?
This trial investigates Tarlatamab, a novel therapy, in a large patient population, signaling potential for significant market impact if successful in improving survival for a difficult-to-treat cance 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 the new combination therapy or the standard chemotherapy alone, assigned randomly. 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.