A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
New drug PF-08634404 tested with chemo for advanced small cell lung cancer
Plain English Summary
Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer is a Phase 3 clinical trial sponsored by Pfizer studying Small Cell Lung Cancer (SCLC). This study tests a new drug, PF-08634404, combined with standard chemotherapy for adults with extensive-stage small cell lung cancer. It is for patients aged 18 and older with this specific type of lung cancer who have not yet received chemotherapy or radiation for it. Participation involves receiving the study drug and chemotherapy through IV infusions, with potential for continued study drug treatment. Alternative treatments include standard chemotherapy, and for comparison, atezolizumab plus chemotherapy. The trial aims to enroll 550 participants.
Official Summary
This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with extensive-stage small cell lung cancer (ES-SCLC), a fast-growing type of lung cancer that has spread widely in the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have extensive-stage small cell lung cancer confirmed by lab tests. * Have not received chemotherapy or radiation for this type of lung cancer. * Be in good physical condition and have healthy organs based on medical tests. The study has two parts: * In the first part, researchers will check how safe the study medicine is and how well people tolerate it when given with chemotherapy. * In the second part, they will compare study medicine plus chemotherapy to another approved treatment (atezolizumab plus chemotherapy) to see which works better. Participants will receive the treatment through IV infusions (medicine given directly into a vein). The treatment will be given in repeated time periods called cycles. Some participants will continue receiving the study medicine alone after the initial treatment.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 or older with confirmed extensive-stage small cell lung cancer. Patients must not have received prior chemotherapy or radiation for this stage of lung cancer. Individuals should be in good general health with healthy organ function. Those with active brain metastases or leptomeningeal disease cannot participate. This trial is studying Small Cell Lung Cancer (SCLC), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures, like how often the tumor shrinks (Objective Response Rate) and how long patients live (Overall Survival), will show if the new drug combination is effective in treating t The specific primary outcome measures are: Phase 2: Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] based on the investigator's assessment (Up to approximately 2 years after completion of study treatment of last study participant); Phase 2: Number of participants with treatment-emergent adverse events (Up to 90 days after the last dose of treatment); Phase 3: Overall Survival (OS) (Up to approximately 2 years after completion of study treatment of last study participant). 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, a fast-growing and aggressive form of the disease. 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 (SCLC), where improved treatment options are needed.
Investor Insight
This Phase 3 trial by Pfizer, a major pharmaceutical company, signals a significant investment in a competitive oncology market, with a moderate probability of approval if primary outcomes are met. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 550 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of PF-08634404 and chemotherapy. Understand how often you will need to visit the clinic for infusions and monitoring. Discuss any other health conditions or medications you are taking with your study team. 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: QUADRUPLE
- Enrollment: 550 participants
Interventions
- DRUG: PF-08634404 — Concentrate for solution for infusion
- BIOLOGICAL: Atezolizumab — Injection for intravenous use
- DRUG: Chemotherapy — Injection for intravenous use
Primary Outcomes
- Phase 2: Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] based on the investigator's assessment (Up to approximately 2 years after completion of study treatment of last study participant)
- Phase 2: Number of participants with treatment-emergent adverse events (Up to 90 days after the last dose of treatment)
- Phase 3: Overall Survival (OS) (Up to approximately 2 years after completion of study treatment of last study participant)
Secondary Outcomes
- Duration of Response (DOR) as assessed by Investigator based on RECIST v1.1 (Up to approximately 2 years after completion of study treatment of last study participant)
- Progression Free Survival (PFS) as assessed by investigator based on RECIST v1.1 (Up to approximately 2 years after completion of study treatment of last study participant)
- Number of participants with Laboratory abnormalities (Up to 90 days after the last dose of treatment)
- Phase 2: Number of Participants who Experience a Dose-Limiting Toxicity (DLT) (Up to 90 days after the last dose of treatment)
- Pharmacokinetics: Serum concentrations of PF-08634404 (Up to 37 days after the last dose of treatment)
Full Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC). * Participants have not received systemic therapy (chemotherapy, radiotherapy, chemoradiation) for ES-SCLC. * Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC * Have at least one measurable lesion as the targeted lesion based on RECIST V1.1. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Adequate organ function Exclusion Criteria: * known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression * Leptomeningeal disease * Clinically significant risk of hemorrhage or fistula * history of another malignancy within 3 years * active autoimmune diseases requiring systemic treatment within the past 2 years
Trial Locations
- Highlands Oncology Group, Fayetteville, Arkansas, United States
- Highlands Oncology Group, Rogers, Arkansas, United States
- Highlands Oncology Group, Springdale, Arkansas, United States
- BRCR Coral Springs, Coral Springs, Florida, United States
- BRCR Global - Coral Springs, Coral Springs, Florida, United States
- Mid Florida Hematology and Oncology Center, Orange City, Florida, United States
- BRCR Global - Tamarac, Tamarac, Florida, United States
- Texas Oncology - Gulf Coast, Beaumont, Texas, United States
- Texas Oncology - San Antonio, Fredericksburg, Texas, United States
- Texas Oncology - Gulf Coast, Houston, Texas, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT07226999?
NCT07226999 is a Phase 3 INTERVENTIONAL study titled "Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer." It is currently recruiting and is sponsored by Pfizer. The trial targets enrollment of 550 participants.
What conditions does NCT07226999 study?
This trial investigates treatments for Small Cell Lung Cancer (SCLC). The primary condition under study is Small Cell Lung Cancer (SCLC).
What treatments are being tested in NCT07226999?
The interventions being studied include: PF-08634404 (DRUG), Atezolizumab (BIOLOGICAL), Chemotherapy (DRUG). Concentrate for solution for infusion
What does Phase 3 mean for NCT07226999?
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 NCT07226999?
This trial is currently "Recruiting." It started on 2025-12-09. The estimated completion date is 2034-03-11.
Who is sponsoring NCT07226999?
NCT07226999 is sponsored by Pfizer. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07226999?
The trial aims to enroll 550 participants. The trial is currently recruiting and accepting new participants.
How is NCT07226999 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 NCT07226999?
The primary outcome measures are: Phase 2: Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] based on the investigator's assessment (Up to approximately 2 years after completion of study treatment of last study participant); Phase 2: Number of participants with treatment-emergent adverse events (Up to 90 days after the last dose of treatment); Phase 3: Overall Survival (OS) (Up to approximately 2 years after completion of study treatment of last study participant). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07226999 being conducted?
This trial is being conducted at 20 sites, including Fayetteville, Arkansas; Rogers, Arkansas; Springdale, Arkansas; Coral Springs, Florida and 16 more sites (United States, Australia).
Where can I find official information about NCT07226999?
The official record for NCT07226999 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07226999. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07226999 testing in simple terms?
This study tests a new drug, PF-08634404, combined with standard chemotherapy for adults with extensive-stage small cell lung cancer. It is for patients aged 18 and older with this specific type of lung cancer who have not yet received chemotherapy or radiation for it.
Why is this trial significant?
This trial addresses a critical need for new treatments in extensive-stage small cell lung cancer, a fast-growing and aggressive form of the disease. 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 NCT07226999?
Common risks include side effects from chemotherapy and the new drug, such as fatigue, nausea, and potential effects on blood counts. There is a risk of infusion-related reactions or allergic responses to the study medications. Potential for serious side effects affecting organs like the liver or kidneys, or an increased risk of bleeding. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07226999?
Ask your doctor about the potential benefits and risks of PF-08634404 and chemotherapy. Understand how often you will need to visit the clinic for infusions and monitoring. Discuss any other health conditions or medications you are taking with your study team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07226999 signal from an investment perspective?
This Phase 3 trial by Pfizer, a major pharmaceutical company, signals a significant investment in a competitive oncology market, with a moderate probability of approval if primary outcomes are met. 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 the study drug and chemotherapy through IV infusions, with potential for continued study drug treatment. 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.