The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Important Notice Regarding the Scientific Information You Have Requested
You are being redirected to the scientific presentations section. The information provided here relate to investigational assets. The safety and efficacy of the unapproved assets has not been proven.
Please acknowledge that you understand this before proceeding.
PF-08634404 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Japan, Puerto Rico
for more information at clinicaltrials.gov
EXPERIMENTAL: Phase 2 Single arm
Participants will receive PF-08634404 in combination with chemotherapy
DRUG: PF-08634404
Concentrate for solution for infusion
DRUG: Chemotherapy
Injection for intravenous use
EXPERIMENTAL: Phase 3 Experimental Arm
Participants will receive PF-08634404 in combination with chemotherapy
DRUG: PF-08634404
Concentrate for solution for infusion
DRUG: Chemotherapy
Injection for intravenous use
ACTIVE_COMPARATOR: Phase3 Control Arm
Participants will receive atezolizumab in combination with chemotherapy
BIOLOGICAL: Atezolizumab
Injection for intravenous use
DRUG: Chemotherapy
Injection for intravenous use
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
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.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 2: Number of participants with treatment-emergent adverse events
Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Up to 90 days after the last dose of treatment
Phase 3: 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.
Up to approximately 2 years after completion of study treatment of last study participant
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 PD or death due to any cause.
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
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.
Up to 90 days after the last dose of treatment
Phase 2: Number of Participants who Experience a Dose-Limiting Toxicity (DLT)
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.
Up to 90 days after the last dose of treatment
Pharmacokinetics: Serum concentrations of PF-08634404
Up to 37 days after the last dose of treatment
Incidence of antidrug antibody against PF-08634404
Up to 37 days after the last dose of treatment
Phase 2: Overall Survival
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: PFS using RECIST v1.1 as assessed by blinded independent central review (BICR)
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by BICR per RECIST v1.1, or death due to any cause, whichever occurs first.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: Confirmed ORR using RECIST v1.1 as assessed by BICR
ORR is defined as the proportion of participants in the analysis population having a best overall response (BOR) of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by BICR.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: DOR using RECIST v1.1 as assessed by BICR
The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by BICR assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: Mean scores and Change from baseline in the global health status/quality of life (QoL), function, and symptom scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: Mean scores and Change from Baseline on the EORTC Quality of Life Cancer Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13)
EORTC QLQ-LC13 is a lung cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire, the EORTC QLQ-C30.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: Time to definitive deterioration (TTdD) in the global health status/QoL, function, and symptom scores on the EORTC QLQ-C30
TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.
Up to approximately 2 years after completion of study treatment of last study participant
550
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT07226999
Back
