Back to search results

Symbiotic-Lung-14: PF-08634404 for Transformed Small Cell Lung Cancer

This study is for adults with Transformed Small Cell Lung Cancer (T-SCLC), a rare type of lung cancer that develops after another type of lung cancer changes. Researchers are studying PF-08634404, a kinase inhibitor, to see how well it works when given alone or with chemotherapy. To join, you must be at least 18 years old, have T-SCLC, and not have received prior treatment for it. You must also have had a previous diagnosis of non-small cell lung cancer (NSCLC) with an EGFR mutation that transformed to SCLC after TKI (tyrosine kinase inhibitor) treatment. The study will measure how many participants respond to the treatment and track any side effects. The study plans to enroll 40 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 40 adult participants. It is not specified if it is randomized, blinded, or its phase.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for up to 90 days after their last dose of treatment. The objective response rate will be assessed from the start of treatment until the first documented complete or partial response, for approximately up to 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07476287

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Pfizer
~40 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:PF-08634404Chemotherapy

At a glance

Recruiting sites
21 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Confirmed Objective Response Rate (ORR) as assessed by investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measured over From start of treatment until first documented CR or PR (approximately maximum up to 1 years)
+1 more outcome measured

Conditions

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

Explore related trials

Lung Small Cell CarcinomaSoluble Epidermal Growth Factor Receptor

Where it's being run

30 sites across 23 states
Taiwan4
California2
Illinois2
Tokyo2
Spain2
Brazil1
Beijing Municipality1
Fujian1

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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 trial measures

  • 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.