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Clinical Trials in France / 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 France tracker
Sponsor
Phase
Phase 2
Started
2026-07-02
Last updated
2026-09-28

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-08634404 →Chemotherapy

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 (57)

FacilityCityRegionStatus
City of Hope National Medical Center Duarte California Recruiting
UC San Diego Medical Center - Encinitas Encinitas California Recruiting
City of Hope Lennar Foundation Cancer Center Irvine California Recruiting
UC San Diego Koman Family Outpatient Pavilion La Jolla California Recruiting
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) La Jolla California Recruiting
UC San Diego Moores Cancer Center La Jolla California Recruiting
UC San Diego Sulpizio Cardiovascular Center La Jolla California Recruiting
UC San Diego Medical Center - Bankers Hill San Diego California Recruiting
UC San Diego McGrath Outpatient Pavilion - Hillcrest San Diego California Recruiting
UC San Diego Medical Center- Hillcrest San Diego California Recruiting
UC San Diego Medical Center - Rancho Bernardo San Diego California Recruiting
UC San Diego Medical Center - Vista Vista California Recruiting
Hope and Healing Clinical Research Hinsdale Illinois Recruiting
Hope and Healing Clinical Research New Lenox Illinois Recruiting
MSK Basking Ridge Basking Ridge New Jersey Recruiting
MSK Monmouth Middletown New Jersey Recruiting
MSK Bergen. Montvale New Jersey Recruiting
MSK Commack Commack New York Recruiting
MSK Westchester East White Plains New York Recruiting
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy Long Island City New York Recruiting
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
MSK Nassau Uniondale New York Recruiting
Calvary Connery Centre Elizabeth Vale South Australia Recruiting
Hospital Beneficência Portuguesa de São Paulo São Paulo São Paulo Recruiting
Hospital São Lucas da PUCRS Porto Alegre Brazil Recruiting
Peking Union Medical College Hospital Beijing Beijing Municipality Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
Henan Cancer Hospital Zhengzhou Henan 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
The first Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Not Yet Recruiting
Centre Léon Bérard Lyon France Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital Nord Marseille France Recruiting
Institut Gustave Roussy Villejuif France Not Yet Recruiting
Prince of Wales Hospital Hong Kong Hong Kong Recruiting
Queen Mary Hospital Hong Kong Hong Kong Recruiting
Caritas Hospital and Institute of Health Sciences Kottayam Kerala Recruiting
Rajiv Gandhi Cancer Institute And Research Centre New Delhi National Capital Territory of Delhi Recruiting

+ 17 more sites — see the full list on the official registry below.

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Other trials for the same condition

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 France