Small Cell Lung Cancer
Conditions
Interventions
*Drug: PF-08634404
-Concentrate for solution for infusion
-Other Names:
#SSGJ-707
*Drug: Chemotherapy
-Injection for intravenous use
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | 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) [Time Frame: 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) [Time Frame: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| *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] -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. *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] -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 *Overall Survival (OS) [Time Frame: Up to approximately 2 years after completion of study treatment of last study participant] -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. *Number of participants with Laboratory abnormalities [Time Frame: Up to 90 days after the last dose of treatment] -Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. *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] | — |
Countries
Japan, Will be provided
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed