NCT07476287From ClinicalTrials.govRecruiting

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

A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER

Small Cell Lung Cancer
Small Cell Lung Cancer ( SCLC )
Transformed Small Cell Lung Cancer
Lung Neoplasms
Carcinoma, Small Cell Lung
Small Cell Cancer Of The Lung

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Pfizer
Enrolment target: 40
Started: 2 July 2026
Main results due: 24 March 2028
Study sites: 57
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(57)

City of Hope National Medical Center
Duarte, California, United States
Recruiting
UC San Diego Medical Center - Encinitas
Encinitas, California, United States
Recruiting
City of Hope Lennar Foundation Cancer Center
Irvine, California, United States
Recruiting
UC San Diego Koman Family Outpatient Pavilion
La Jolla, California, United States
Recruiting
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, United States
Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, United States
Recruiting
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, United States
Recruiting
UC San Diego Medical Center - Bankers Hill
San Diego, California, United States
Recruiting
UC San Diego McGrath Outpatient Pavilion - Hillcrest
San Diego, California, United States
Recruiting
UC San Diego Medical Center- Hillcrest
San Diego, California, United States
Recruiting
UC San Diego Medical Center - Rancho Bernardo
San Diego, California, United States
Recruiting
UC San Diego Medical Center - Vista
Vista, California, United States
Recruiting
Hope and Healing Clinical Research
Hinsdale, Illinois, United States
Recruiting
Hope and Healing Clinical Research
New Lenox, Illinois, United States
Recruiting
MSK Basking Ridge
Basking Ridge, New Jersey, United States
Recruiting
MSK Monmouth
Middletown, New Jersey, United States
Recruiting
MSK Bergen.
Montvale, New Jersey, United States
Recruiting
MSK Commack
Commack, New York, United States
Recruiting
MSK Westchester
East White Plains, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
MSK Nassau
Uniondale, New York, United States
Recruiting
Calvary Connery Centre
Elizabeth Vale, South Australia, Australia
Recruiting
Hospital Beneficência Portuguesa de São Paulo
São Paulo, São Paulo, Brazil
Recruiting
Hospital São Lucas da PUCRS
Porto Alegre, Brazil
Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, China
Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, China
Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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, India
Recruiting
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, India
Recruiting
Sheba Medical Center
Ramat Gan, HA Merkaz, Israel
Recruiting
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Recruiting
Cliniche Gavazzeni S.p.A. - Humanitas Gavazzeni
Bergamo, BERGAMO, Italy
Recruiting
IRCCS Istituto Nazionale dei Tumori Regina Elena
Roma, ROME, Italy
Not yet recruiting
A.O.U. San Luigi Gonzaga
Orbassano, TURIN, Italy
Recruiting
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Recruiting
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Recruiting
Osaka International Cancer Institute(OICI)
Osaka, Osaka, Japan
Recruiting
National Cancer Center - Tsukiji Campus
Chūō, Tokyo, Japan
Recruiting
Japanese Foundation for Cancer Research
Kotoku, Tokyo, Japan
Recruiting
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Catalunya [cataluña], Spain
Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Recruiting
Hospital Universitario Virgen Del Rocio
Seville, SEVILLA, 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

Showing 57 of 57 sites. 54 of the 57 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07476287. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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