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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.
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PF-08634404 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
Global
for more information at clinicaltrials.gov
EXPERIMENTAL: Arm A
Participants will receive PF-08634404 combined with chemotherapy regimen 1, followed by maintenance therapy with PF-08634404.
BIOLOGICAL: PF-08634404
Solution for infusion
DRUG: Chemotherapy Regimen 1
Injection for IV use
ACTIVE_COMPARATOR: Arm B
Participants will receive pembrolizumab combined with chemotherapy regimen 1, followed by maintenance therapy with pembrolizumab.
BIOLOGICAL: Pembrolizumab
Injection for IV use
DRUG: Chemotherapy Regimen 1
Injection for IV use
EXPERIMENTAL: Arm C
Participants will receive PF-08634404 combined with chemotherapy regimen 2, followed by maintenance therapy with PF-08634404 and chemotherapy.
BIOLOGICAL: PF-08634404
Solution for infusion
DRUG: Chemotherapy Regimen 2
Injection for IV use
ACTIVE_COMPARATOR: Arm D
Participants will receive pembrolizumab combined with chemotherapy regimen 2, followed by maintenance therapy with pembrolizumab and chemotherapy.
BIOLOGICAL: Pembrolizumab
Injection for IV use
DRUG: Chemotherapy Regimen 2
Injection for IV use
1. Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC. 2. Previous treatment with immunotherapy 3. Prior radiotherapy \> 30 Gy to the lung \< 6 months of first dose of study intervention 4. Palliative local therapy \< 2 weeks before the first dose of study intervention; 5. Non-specific immunomodulatory therapy \< 2 weeks before the first dose. 6. Prior systemic anti-angiogenic therapy * Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy. * Prior and concomitant therapy: 1. therapeutic oral or parenteral anticoagulants or thrombolytic agents \< 10 days to the first dose. 2. chronic antiplatelet therapy \<7 days to randomization. 3. live or attenuated live vaccine \< 4 weeks to the first dose. 4. current high-dose systemic corticosteroids. 5. prohibited concomitant medication(s) \< 21 days to the first dose. * Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.
Overall Survival
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Approximately 39 months
Progression Free Survival (PFS) assessed by blinded independent central review (BICR)
Progression-free survival 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.
Approximately 32 months
Confirmed objective response rate (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.
Approximately 32 months
Progression Free Survival as assessed by Investigator
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.
Approximately 32 months
Confirmed ORR using RECIST v1.1 as assessed by investigator
ORR is defined as the proportion of participants in the analysis population having a BOR of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by BICR.
Approximately 32 months
Duration of Response (DoR) 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.
Approximately 32 months
Duration of Response (DoR) as assessed by Investigator
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 investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Approximately 32 months
Number of Participants With Adverse Events (AEs)
AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s).
Through end of study and up to approximately 39 months
Number of Participants With Clinical Laboratory Abnormalities
Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing.
through end of study and up to approximately 39 months
Pharmacokinetics (PK): Serum concentrations of PF-08634404
Predose and postdose concentrations of PF-08634404
Through end of study and up to approximately 39 months
Incidence of Anti-Drug Antibody (ADA) against PF-08634404.
Through end of study and up to approximately 39 months
Mean scores and Change from baseline in the global health status/quality of life (QoL) score 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.
Approximately 39 months
Time to definitive deterioration (TTdD) in in the global health status/QoL score 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.
Approximately 39 months
Mean scores and Change from Baseline in dyspnea, cough, and chest pain scores on the EORTC Quality of Life Cancer Questionnaire - Lung Cancer 13 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.
Approximately 39 months
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.
Approximately 39 months
1500
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: