Actively Recruiting
Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer
Led by Pfizer · Updated on 2026-04-20
40
Participants Needed
3
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well PF-08634404 works when given alone or with chemotherapy . Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing. The study is for adults with Transformed Small Cell Lung Cancer (T-SCLC ). T SCLC is a rare lung cancer that happens when one type of lung cancer changes into a more aggressive type after treatment stops working. To join the study, participants must meet the following conditions: * Are aged 18 years or older * Diagnosed with T-SCLC and have not received treatment for this type of lung cancer (a single cycle of chemotherapy may be permitted) * Prior diagnosis of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer treated with tyrosine kinase inhibitors (TKIs) * Have healthy organs based on medical tests and are in good physical condition After joining the study, adults will be given chemotherapy in addition to the study medicine. After this combination treatment is finished, the study medicine will be continued alone. Adults will receive the treatment through IV infusions (medicine given directly into a vein). All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.
CONDITIONS
Official Title
Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older at the time of informed consent
- Histologically or cytologically confirmed Transformed Small Cell Lung Cancer (T-SCLC) with prior diagnosis of EGFR-mutated non-small cell lung cancer treated with TKIs
- No previous systemic therapy for T-SCLC
- At least one measurable lesion based on RECIST v1.1
- Sufficient tumor tissue available from transformed SCLC diagnosis
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Minimum life expectancy greater than 12 weeks
- Clinical laboratory values within acceptable limits for hematology, liver, and renal function
You will not qualify if you...
- Active or untreated central nervous system disease, including brain, brainstem, spinal cord, or meningeal metastases (except clinically stable treated brain metastases or small untreated asymptomatic brain metastases under specific conditions)
- Leptomeningeal disease
- Significant risk of hemorrhage or fistula including tumor necrosis or invasion of major blood vessels or organs
- History of another malignancy within 3 years except for low-risk cancers
- Unresolved toxicity from prior anti-tumor therapy not recovered to Grade 1 or lower
- History of allogeneic organ or stem cell transplantation
- Active autoimmune disease requiring systemic treatment within past 2 years (except stable or low-risk conditions)
- Interstitial lung disease, pneumonitis, or significant pulmonary diseases including severe asthma or COPD
- Uncontrolled or significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months
- Baseline QTcF greater than 480 msec
- Major surgery or severe trauma within 4 weeks or planned during study
- Significant pleural, pericardial effusion, or ascites requiring repeated drainage
- History of significant bleeding disorders or recent major bleeding
- Significant gastrointestinal conditions like recent perforation or active bleeding
- Active, uncontrolled infections including active tuberculosis, hepatitis B or C, or uncontrolled HIV
- History of immunodeficiency
- Severe hypersensitivity to study drugs or monoclonal antibodies
- Psychiatric illness or medical condition that may interfere with participation
- Prior anti-angiogenic or prohibited anti-tumor/immunomodulatory therapies without required washout
- Use of prohibited medications including high-dose corticosteroids, certain anticoagulants, or live vaccines within specified timeframes
- Recent participation in another investigational study within 30 days or 5 half-lives
- Pregnant or breastfeeding or unwilling to comply with contraception requirements
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Hope and Healing Clinical Research
Hinsdale, Illinois, United States, 60521
Actively Recruiting
2
Hope and Healing Clinical Research
New Lenox, Illinois, United States, 60451
Actively Recruiting
3
Japanese Foundation for Cancer Research
Kotoku, Tokyo, Japan, 135-8550
Not Yet Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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