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New treatment option for Small Cell Lung Cancer
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
ClinicalTrials.gov ID: NCT07476287
What this study is testing
What is PF-08634404?
PF-08634404 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell lung cancer.
Also referred to as SSGJ-707.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 .
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female participants aged ≥18 years at the time of informed consent.
- Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC...
- Participants have not received systemic therapy for T-SCLC.
- Have at least one measurable lesion as the target lesion based on RECIST v1.1.
- Have sufficient tumor tissue from the diagnosis of transformed SCLC available.
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically...
- Leptomeningeal disease
- Clinically significant risk of hemorrhage or fistula, including tumor necrosis/cavitation, invasion or compression of major blood vessels, airways...
- History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or...
- Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities...
See the full eligibility criteria
- Male or female participants aged ≥18 years at the time of informed consent.
- Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following the treatment with TKI(s).
- Participants have not received systemic therapy for T-SCLC.
- Have at least one measurable lesion as the target lesion based on RECIST v1.1.
- Have sufficient tumor tissue from the diagnosis of transformed SCLC available.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Have a minimum life expectancy of \>12 weeks.
- Clinical laboratory values at screening within acceptable limits, as defined in the protocol, including: 1) Hematology, 2) Liver function and 3) Renal function.
- Participants are excluded from the study if any of the following criteria apply:
- Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically stable brain metastases may be eligible per protocol criteria...
- Leptomeningeal disease
- Clinically significant risk of hemorrhage or fistula, including tumor necrosis/cavitation, invasion or compression of major blood vessels, airways, or critical organs, or risk of tracheoesophageal or pleuroesophageal...
- History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or death (eg, adequately treated carcinoma in situ, nonmelanoma skin cancer)
- Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities deemed stable)
- History of allogeneic organ or hematopoietic stem cell transplantation
- Active autoimmune disease requiring systemic treatment within the past 2 years (Stable replacement therapy and selected low-risk autoimmune conditions are permitted per protocol)
- Interstitial lung disease (ILD), pneumonitis, or significant pulmonary disease, including:
- Prior or current non-infectious pneumonitis requiring systemic therapy
- DLCO \<50% predicted
- Severe asthma, COPD, pulmonary embolism, or autoimmune lung involvement
- Uncontrolled or clinically significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months prior to first dose
- Baseline QTcF \>480 msec
- Major surgery or severe trauma within 4 weeks prior to first dose, or planned major surgery during the study
- Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- History of significant bleeding disorders or recent major bleeding events
- Clinically significant gastrointestinal conditions, including recent perforation, fistula, obstruction, or active bleeding
- Active, uncontrolled, or symptomatic infection, including:
- Active TB
- Active hepatitis B or C
- Uncontrolled HIV infection
- History of immunodeficiency
- Severe hypersensitivity or allergic reactions to study intervention components or monoclonal antibodies
- Psychiatric illness or medical condition, including recent suicidal ideation or behavior, that may increase risk or interfere with study participation
- Prior anti-angiogenic therapy or other prohibited anti-tumor or immunomodulatory therapies per protocol-specified washout periods
- Use of prohibited concomitant medications, including high-dose systemic corticosteroids, certain anticoagulants, or live vaccines within protocol-specified timeframes
- Recent participation in another investigational study (within 30 days or 5 half-lives, whichever is longer)
- Pregnant or breastfeeding participants, or unwillingness to comply with contraception requirements
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- Hinsdale, Illinois, United States
- New Lenox, Illinois, United States
- Beijing, Beijing Municipality, China
- Wuhan, Hubei, China
- Shanghai, Shanghai Municipality, China
- Ramat Gan, HA Merkaz, Israel
- Jerusalem, Jerusalem, Israel
- Kotoku, Tokyo, Japan
- Tainan, Taiwan
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; Hinsdale, Illinois, United States; New Lenox, Illinois, United States; Beijing, Beijing Municipality, China; Wuhan, Hubei, China and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.