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Small Cell Lung CancerPhase 2NCT07476287

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 study testing PF-08634404 and Chemotherapy in people with Small Cell Lung Cancer and Small Cell Lung Cancer ( SCLC ), run by Pfizer at 61 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08634404 and Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
61 sitesin 12 countries
Study dates
2 Jul 2026to 24 Mar 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 29Show fewer
  • 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

Trial locations and contacts

61 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

61 sites in 12 countries

United States23 sites, 23 recruiting

  • MSK Basking Ridge

    Basking Ridge, New Jersey, 07920

    Recruiting

  • MSK Commack

    Commack, New York, 11725

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010

    Recruiting

  • UC San Diego Medical Center - Encinitas

    Encinitas, California, 92024

    Recruiting

  • MSK Westchester

    Harrison, New York, 10604

    Recruiting

  • Hope and Healing Clinical Research

    Hinsdale, Illinois, 60521

    Recruiting

  • City of Hope Lennar Foundation Cancer Center

    Irvine, California, 92618

    Recruiting

  • UC San Diego Koman Family Outpatient Pavilion

    La Jolla, California, 92037

    Recruiting

  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

    La Jolla, California, 92037

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037

    Recruiting

  • UC San Diego Sulpizio Cardiovascular Center

    La Jolla, California, 92037

    Recruiting

  • Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

    Long Island City, New York, 11101

    Recruiting

  • MSK Monmouth

    Middletown, New Jersey, 07748

    Recruiting

  • MSK Bergen.

    Montvale, New Jersey, 07645

    Recruiting

  • Hope and Healing Clinical Research

    New Lenox, Illinois, 60451

    Recruiting

  • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

    New York, New York, 10021

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • UC San Diego Medical Center - Bankers Hill

    San Diego, California, 92101

    Recruiting

  • UC San Diego McGrath Outpatient Pavilion - Hillcrest

    San Diego, California, 92103

    Recruiting

  • UC San Diego Medical Center- Hillcrest

    San Diego, California, 92103

    Recruiting

  • UC San Diego Medical Center - Rancho Bernardo

    San Diego, California, 92127

    Recruiting

  • MSK Nassau

    Uniondale, New York, 11553

    Recruiting

  • UC San Diego Medical Center - Vista

    Vista, California, 92081

    Recruiting

Other trials in United States

China7 sites, 7 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Recruiting

  • The first Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330200

    Recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430048

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Recruiting

Other trials in China

Japan6 sites, 6 recruiting

  • National Cancer Center - Tsukiji Campus

    Chūō, Tokyo, 104-0045

    Recruiting

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

    Recruiting

  • Okayama University Hospital

    Kita, Okayama-ken, 700-8558

    Not yet recruiting

  • Japanese Foundation for Cancer Research

    Kotoku, Tokyo, 135-8550

    Recruiting

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

    Recruiting

  • Osaka International Cancer Institute(OICI)

    Osaka, 541-8567

    Recruiting

Other trials in Japan

Taiwan4 sites, 4 recruiting

  • National Cheng Kung University Hospital

    Tainan, 704302

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Recruiting

  • National Taiwan University Cancer Center (NTUCC)

    Taipei, 106

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

Other trials in Taiwan

Australia3 sites, 3 recruiting

  • Calvary Connery Centre

    Elizabeth Vale, South Australia, 5112

    Recruiting

  • Warringal Private Hospital

    Heidelberg, Victoria, 3084

    Not yet recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Not yet recruiting

Other trials in Australia

Brazil3 sites, 3 recruiting

  • Hospital São Lucas da PUCRS

    Porto Alegre, 90610-000

    Recruiting

  • Hospital Beneficência Portuguesa de São Paulo

    São Paulo, São Paulo, 01321-001

    Recruiting

  • Centro Paulista de Oncologia Clínica

    São Paulo, 01452-000

    Not yet recruiting

Other trials in Brazil

France3 sites, 3 recruiting

  • Centre Léon Bérard

    Lyon, 69373

    Recruiting

  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord

    Marseille, 13915

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Not yet recruiting

Other trials in France

Italy3 sites, 3 recruiting

  • Cliniche Gavazzeni S.p.A. - Humanitas Gavazzeni

    Bergamo, 24125

    Recruiting

  • A.O.U. San Luigi Gonzaga

    Orbassano, Turin, 10043

    Recruiting

  • IRCCS Istituto Nazionale dei Tumori Regina Elena

    Roma, ROME, 00144

    Not yet recruiting

Other trials in Italy

Spain3 sites, 3 recruiting

  • Institut Català d'Oncologia - L'Hospitalet

    L'Hospitalet de Llobregat, Catalunya [cataluña], 08908

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    Recruiting

Other trials in Spain

Hong Kong2 sites, 2 recruiting

  • Prince of Wales Hospital

    Hong Kong

    Recruiting

  • Queen Mary Hospital

    Hong Kong

    Recruiting

Other trials in Hong Kong

India2 sites, 2 recruiting

  • Caritas Hospital and Institute of Health Sciences

    Kottayam, Kerala, 686630

    Recruiting

  • Rajiv Gandhi Cancer Institute And Research Centre

    New Delhi, National Capital Territory of Delhi, 110085

    Recruiting

Other trials in India

Israel2 sites, 2 recruiting

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 9103102

    Recruiting

  • Sheba Medical Center

    Ramat Gan, HA Merkaz, 5265601

    Recruiting

Other trials in Israel

About this study

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

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:

Read more
  • 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.

Being tested
PF-08634404, Chemotherapy
Keywords
Transformed Small Cell Lung Cancer, Small Cell Lung Cancer
Medical subject headings
Small Cell Lung Carcinoma, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08634404Drug

    Also called SSGJ-707

    Concentrate for solution for infusion

  • ChemotherapyDrug

    Injection for intravenous use

Study groups in NCT07476287
Study groupRoleWhat they receive
PF-08634404ExperimentalParticipants will receive PF-08634404 in combination with chemotherapy intravenously, followed by maintenance therapy with PF-08634404.
Receives: Drug: PF-08634404; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed Objective Response Rate (ORR) as assessed by investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    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.

    Measured: From start of treatment until first documented CR or PR (approximately maximum up to 1 years)

  2. Number of Participants with Adverse Events (AEs)

    Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.

    Measured: Up to 90 days after the last dose of treatment

Secondary outcomes (6)

  1. Duration of Response (DOR) as assessed by investigator based on RECIST v1.1

    DOR is defined as the time from the first documentation of objective response (CR or PR) to the date of first documentation of disease progression (PD) or death due to any cause.

    Measured: Up to approximately 2 years after completion of study treatment of last study participant

  2. Progression Free Survival (PFS) as assessed by investigator based on RECIST v1.1

    PFS is defined as the time from the date of randomization to the date of first documented disease progression, per RECIST v1.1, or death to any cause, whichever occurs first

    Measured: Up to approximately 2 years after completion of study treatment of last study participant

  3. Overall Survival (OS)

    OS is defined as the time from the date of randomization to the date of death due to any cause. OS is secondary outcome measure in Phase 2 portion of the study.

    Measured: Up to approximately 2 years after completion of study treatment of last study participant

  4. Number of participants with Laboratory abnormalities

    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.

    Measured: Up to 90 days after the last dose of treatment

  5. Pharmacokinetics: Predose and postdose Serum concentrations of PF-08634404

    Measured: Up to 37 days after the last dose of treatment

  6. Incidence of antidrug antibody against PF-08634404

    Measured: Up to 37 days after the last dose of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2026
  2. Study start2 Jul 2026
  3. Primary completion24 Mar 2028 (estimated)
  4. Study completion24 Mar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07476287
Sponsor's protocol ID
C6461014
Other IDs
2025-524686-24-00, 2025
Status last verified
Oct 2026
First submitted
13 Mar 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-08634404 and Chemotherapy in people with Small Cell Lung Cancer and Small Cell Lung Cancer ( SCLC ), run by Pfizer at 61 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, China, Japan, Taiwan, Australia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed Objective Response Rate (ORR) as assessed by investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (time frame: From start of treatment until first documented CR or PR (approximately maximum up to 1 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07476287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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