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Clinical Trials in the USA / NCT07476287
Recruiting Phase 2

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

NCT07476287 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 2
Started
2026-07-02
Last updated
2026-08-17

Condition(s) studied

Small Cell Lung CancerSmall Cell Lung Cancer ( SCLC )Transformed Small Cell Lung CancerLung NeoplasmsCarcinoma, Small Cell LungSmall Cell Cancer Of The Lung

Investigational drug(s) / intervention(s)

PF-08634404Chemotherapy

PF-08634404: Concentrate for solution for infusion

Chemotherapy: Injection for intravenous use

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion 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. Exclusion Criteria: 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. Participants with untreated asymptomatic brain metastases of longest diameter \<1 cm are permitted if all of the following criteria are met: absence of neurological symptoms, no need for corticosteroids, and brain metastasis has no evidence of edema or hemorrhagic features. * 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 fistula * 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

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
City of Hope National Medical Center Duarte California Recruiting
City of Hope Lennar Foundation Cancer Center Irvine California Recruiting
Hope and Healing Clinical Research Hinsdale Illinois Recruiting
Hope and Healing Clinical Research New Lenox Illinois Recruiting
Hospital São Lucas da PUCRS Porto Alegre Brazil Recruiting
Peking Union Medical College Hospital Beijing Beijing Municipality Recruiting
Fujian Cancer Hospital Fuzhou Fujian Not Yet Recruiting
Henan Cancer Hospital Zhengzhou Henan Not Yet Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
Shanghai Chest Hospital Shanghai Shanghai Municipality Recruiting
Institut Gustave Roussy Villejuif VAL DE Marne Not Yet Recruiting
Centre Léon Bérard Lyon France Not Yet Recruiting
Queen Mary Hospital Hong Kong Hong Kong Not Yet Recruiting
Sheba Medical Center Ramat Gan HA Merkaz Recruiting
Shaare Zedek Medical Center Jerusalem Jerusalem Recruiting
IRCCS Istituto Nazionale dei Tumori Regina Elena Roma ROME Not Yet Recruiting
A.O.U. San Luigi Gonzaga Orbassano Turin Not Yet Recruiting
Cliniche Gavazzeni S.p.A. - Humanitas Gavazzeni Bergamo Italy Not Yet Recruiting
Kansai Medical University Hospital Hirakata Osaka Recruiting
National Cancer Center - Tsukiji Campus Chūō Tokyo Recruiting
Japanese Foundation for Cancer Research Kotoku Tokyo Recruiting
Osaka International Cancer Institute(OICI) Osaka Japan Recruiting
Institut Català d'Oncologia - L'Hospitalet L'Hospitalet de Llobregat Catalunya [cataluña] Not Yet Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Hospital Universitario Virgen Del Rocio Seville Spain Recruiting
National Cheng Kung University Hospital Tainan Taiwan Recruiting
National Taiwan University Hospital Taipei Taiwan Recruiting
National Taiwan University Cancer Center (NTUCC) Taipei Taiwan Recruiting
Taipei Veterans General Hospital Taipei Taiwan Recruiting

More Pfizer trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07476287 on ClinicalTrials.gov ↗ ← All trials in the USA