This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with extensive-stage small cell lung cancer (ES-SCLC), a fast-growing type of lung cancer that has spread widely in the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have extensive-stage small cell lung cancer confirmed by lab tests. * Have not received chemotherapy or radiation for this type of lung cancer. * Be in good physical condition and have healthy organs based on medical tests. The study has two parts: * In the first part, researchers will check how safe the study medicine is and how well people tolerate it when given with chemotherapy. * In the second part, they will compare study medicine plus chemotherapy to another approved treatment (atezolizumab plus chemotherapy) to see which works better. Participants will receive the treatment through IV infusions (medicine given directly into a vein). The treatment will be given in repeated time periods called cycles. Some participants will continue receiving the study medicine alone after the initial treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
550
Concentrate for solution for infusion
Injection for intravenous use
Injection for intravenous use
Highlands Oncology Group
Fayetteville, Arkansas, United States
RECRUITINGHighlands Oncology Group
Rogers, Arkansas, United States
RECRUITINGHighlands Oncology Group
Springdale, Arkansas, United States
RECRUITINGBRCR Coral Springs
Coral Springs, Florida, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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 progressive disease (PD) or death due to any cause.
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
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
Time frame: 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.
Time frame: 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.
Time frame: Up to 90 days after the last dose of treatment
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
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Time frame: 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 PD assessed by BICR per RECIST v1.1, or death due to any cause, whichever occurs first.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 2 years after completion of study treatment of last study participant
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BRCR Global - Coral Springs
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RECRUITINGMid Florida Hematology and Oncology Center
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RECRUITINGBRCR Global - Tamarac
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RECRUITINGClario
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