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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Adults will receive the treatment through IV infusions (medicine given directly into a vein)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests PF-08634404 with chemotherapy, medicines that kill cancer cells or stop their growth, and then PF-08634404 alone. It is for adults whose lung cancer changed into small cell lung cancer after treatment with targeted medicines.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 or older.
- Tests show small cell lung cancer that changed from non-small cell lung cancer with an EGFR gene change after treatment with medicines called TKIs.
- You have not had treatment for the changed cancer. One round of chemotherapy may be allowed.
- You have at least one tumor that can be measured.
- Enough tumor tissue from when the cancer changed is available for testing.
- You can do daily activities with little or no trouble.
- You are expected to live more than 12 weeks.
- Your blood counts, liver tests, and kidney tests meet the study’s limits.
Who can't join
- You have active or untreated cancer in the brain or spinal cord, or cancer in their lining. Some stable, treated brain tumors or very small tumors without symptoms may be allowed.
- You have a serious risk of bleeding or an abnormal opening between organs, or serious stomach or bowel problems.
- You have serious lung disease, or certain serious or uncontrolled heart, blood vessel, liver, kidney, or other health problems.
- You have an uncontrolled infection, a weak immune system, a past organ or donor stem cell transplant, or an immune disease needing whole-body treatment in the past 2 years. Some exceptions apply.
- You had another cancer within 3 years, except your earlier lung cancer or certain low-risk cancers, or still have significant side effects from past cancer treatment.
- You recently had major surgery or a severe injury, plan major surgery during the study, or have fluid around your lungs, heart, or belly that needs repeated draining.
- You have a severe allergy to study treatment, another condition that makes joining unsafe, or recent use of treatments, medicines, vaccines, or another study treatment that the study does not allow.
- You are pregnant or breastfeeding, or are not willing to follow the study’s birth control rules.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (23)
CA
- City of Hope National Medical Center · Duarte, CA 91010More trials in Duarte
- UC San Diego Medical Center - Encinitas · Encinitas, CA 92024More trials in Encinitas
- City of Hope Lennar Foundation Cancer Center · Irvine, CA 92618More trials in Irvine
- UC San Diego Koman Family Outpatient Pavilion · La Jolla, CA 92037More trials in La Jolla
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) · La Jolla, CA 92037More trials in La Jolla
- UC San Diego Moores Cancer Center · La Jolla, CA 92037More trials in La Jolla
- UC San Diego Sulpizio Cardiovascular Center · La Jolla, CA 92037More trials in La Jolla
- UC San Diego Medical Center - Bankers Hill · San Diego, CA 92101More trials in San Diego
- UC San Diego McGrath Outpatient Pavilion - Hillcrest · San Diego, CA 92103More trials in San Diego
- UC San Diego Medical Center- Hillcrest · San Diego, CA 92103More trials in San Diego
- UC San Diego Medical Center - Rancho Bernardo · San Diego, CA 92127More trials in San Diego
- UC San Diego Medical Center - Vista · Vista, CA 92081More trials in Vista
IL
- Hope and Healing Clinical Research · Hinsdale, IL 60521More trials in Hinsdale
- Hope and Healing Clinical Research · New Lenox, IL 60451More trials in New Lenox
NJ
- MSK Basking Ridge · Basking Ridge, NJ 07920More trials in Basking Ridge
- MSK Monmouth · Middletown, NJ 07748More trials in Middletown
- MSK Bergen. · Montvale, NJ 07645More trials in Montvale
NY
- MSK Commack · Commack, NY 11725More trials in Commack
- MSK Westchester · Harrison, NY 10604More trials in Harrison
- Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy · Long Island City, NY 11101More trials in Long Island City
- Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). · New York, NY 10021More trials in New York
- Memorial Sloan Kettering Cancer Center · New York, NY 10065More trials in New York
- MSK Nassau · Uniondale, NY 11553More trials in Uniondale