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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Concentrate for solution for infusion
Injection for intravenous use
Hope and Healing Clinical Research
Hinsdale, Illinois, United States
RECRUITINGHope and Healing Clinical Research
New Lenox, Illinois, United States
RECRUITINGJapanese Foundation for Cancer Research
Kotoku, Tokyo, Japan
NOT_YET_RECRUITINGConfirmed 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.
Time frame: 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.
Time frame: Up to 90 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.
Time frame: Up to approximately 2 years after completion of study treatment of last study participant
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
Time frame: 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.
Time frame: 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.
Time frame: Up to 90 days after the last dose of treatment
Pharmacokinetics: Predose and postdose Serum concentrations of PF-08634404
Time frame: Up to 37 days after the last dose of treatment
Incidence of antidrug antibody against PF-08634404
Time frame: Up to 37 days after the last dose of treatment
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