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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Confirmed Objective Response Rate (ORR) as assessed by investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) — From start of treatment until first documented CR or PR (approximately maximum up to 1 years)
Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response. ORR using RECIST v1.1 as assessed by investigator. - Number of Participants with Adverse Events (AEs) — Up to 90 days after the last dose of treatment
Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Trial sites (61)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Harrison | 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 |
| Westmead Hospital | Westmead | New South Wales | Not Yet Recruiting |
| Calvary Connery Centre | Elizabeth Vale | South Australia | Recruiting |
| Warringal Private Hospital | Heidelberg | Victoria | Not Yet Recruiting |
| Hospital Beneficência Portuguesa de São Paulo | São Paulo | São Paulo | Recruiting |
| Hospital São Lucas da PUCRS | Porto Alegre | Brazil | Recruiting |
| Centro Paulista de Oncologia Clínica | São Paulo | Brazil | Not Yet 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 | 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 |
+ 21 more sites — see the full list on the official registry below.
More Pfizer trials in Israel
Other trials for the same condition
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 Israel