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

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 Overview

• Status: Recruiting
• Conditions: Lung Neoplasms; Small Cell Lung Cancer; Carcinoma, Small Cell Lung; Small Cell Lung Cancer ( SCLC ); Transformed Small Cell Lung Cancer; Small Cell Cancer Of The Lung
• Intervention / Treatment: Drug: Chemotherapy; Drug: PF-08634404

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Not yet recruiting
      • Peking Union Medical College Hospital
  • Hubei
    • Wuhan, Hubei, China, 430048
      • Not yet recruiting
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Not yet recruiting
      • Shanghai Chest Hospital
• Israel
  • HA Merkaz
    • Ramat Gan, HA Merkaz, Israel, 5265601
      • Recruiting
      • Sheba Medical Center
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 9103102
      • Recruiting
      • Shaare Zedek Medical Center
• Japan
  • Tokyo
    • Kotoku, Tokyo, Japan, 135-8550
      • Recruiting
      • Japanese Foundation for Cancer Research
• Taiwan
  • Tainan, Taiwan, 704302
    • Not yet recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • Not yet recruiting
    • National Taiwan University Hospital
• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City Of Hope National Medical Center
    • Irvine, California, United States, 92618
      • Recruiting
      • City of Hope Lennar Foundation Cancer Center
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • Recruiting
      • Hope and Healing Clinical Research
    • New Lenox, Illinois, United States, 60451
      • Recruiting
      • Hope and Healing Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-08634404; Participants will receive PF-08634404 in combination with chemotherapy intravenously, followed by maintenance therapy with PF-08634404.	Drug: Chemotherapy; Injection for intravenous use; Drug: PF-08634404; Concentrate for solution for infusion; Other Names: SSGJ-707

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From start of treatment until first documented CR or PR (approximately maximum up to 1 years)
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.	Up to 90 days after the last dose of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to approximately 2 years after completion of study treatment of last study participant
Number of participants with Laboratory abnormalities	Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.	Up to 90 days after the last dose of treatment
Incidence of antidrug antibody against PF-08634404		Up to 37 days after the last dose of treatment
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.	Up to approximately 2 years after completion of study treatment of last study participant
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.	Up to approximately 2 years after completion of study treatment of last study participant
Pharmacokinetics: Predose and postdose Serum concentrations of PF-08634404		Up to 37 days after the last dose of treatment

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): March 19, 2028
• Study Completion (Estimated): March 19, 2031

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Small Cell Lung Cancer; Transformed Small Cell Lung Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Therapeutics; Drug Therapy
• Other Study ID Numbers: C6461014; 2025-524686-24-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No