A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER
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. 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.
Arms & interventions
- DrugPF-08634404
Concentrate for solution for infusion
- DrugChemotherapy
Injection for intravenous use
Outcome measures
Primary
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.
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
Secondary
Duration of Response (DOR) as assessed by investigator based on RECIST v1.1
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
Time frame: Up to approximately 2 years after completion of study treatment of last study participant
Overall Survival (OS)
Time frame: Up to approximately 2 years after completion of study treatment of last study participant
Number of participants with Laboratory abnormalities
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
Eligibility criteria
Study locations (4)
City of Hope National Medical Center
Duarte, California, 91010
City of Hope Lennar Foundation Cancer Center
Irvine, California, 92618
Hope and Healing Clinical Research
Hinsdale, Illinois, 60521
Hope and Healing Clinical Research
New Lenox, Illinois, 60451