Small Cell Lung Cancer (SCLC)
Conditions
Interventions
*Drug: PF-08634404
-Concentrate for solution for infusion
*Biological: Atezolizumab
-Injection for intravenous use
*Drug: Chemotherapy
-Injection for intravenous use
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: *Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC). *Participants have not received systemic therapy (chemotherapy, radiotherapy, chemoradiation) for ES-SCLC. *Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC *Have at least one measurable lesion as the targeted lesion based on RECIST V1.1. *Eastern Cooperative Oncology Group performance status of 0 or 1. *Adequate organ function
Exclusion criteria
Exclusion criteria: Exclusion Criteria: *known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression *Leptomeningeal disease *Clinically significant risk of hemorrhage or fistula *history of another malignancy within 3 years *active autoimmune diseases requiring systemic treatment within the past 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Phase 2: Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] based on the investigator's assessment [Time Frame: Up to approximately 2 years after completion of study treatment of last study participant] -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. *Phase 2: Number of participants with treatment-emergent adverse events [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. *Phase 3: 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. | — |
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 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 *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. *Phase 2: Number of Participants who Experience a Dose-Limiting Toxicity (DLT) [Time Frame: Up to 90 days after the last dose of treatment] -DLT (any of the prespecified AEs that are attributable to study treatment(s), excluding toxicities clearly due to underlying disease or extraneous causes) rate estimated based on data from DLT-evaluable participants during the DLT evaluation period. *Pharmacokinetics: 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] *Phase 2: Overall Survival [Time Frame: Up to approximately 2 years after completion of study treatment of last study participant] -Overall survival defined as the time from the date of randomization to the date of death due to any cause. *Phase 3: PFS using RECIST v1.1 as assessed by blinded independent central review (BICR) [Time Frame: Up to approximately 2 years after completion of study treatment of last study participant] -Progressio | — |
Countries
Japan, Puerto Rico, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed