A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer
- Conditions
- Small Cell Lung Cancer (SCLC)
- Interventions
- Registration Number
- NCT07226999
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 550
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 2 Single arm PF-08634404 Participants will receive PF-08634404 in combination with chemotherapy Phase 2 Single arm Chemotherapy Participants will receive PF-08634404 in combination with chemotherapy Phase 3 Experimental Arm PF-08634404 Participants will receive PF-08634404 in combination with chemotherapy Phase 3 Experimental Arm Chemotherapy Participants will receive PF-08634404 in combination with chemotherapy Phase3 Control Arm Atezolizumab Participants will receive atezolizumab in combination with chemotherapy Phase3 Control Arm Chemotherapy Participants will receive atezolizumab in combination with chemotherapy
- Primary Outcome Measures
Name Time Method 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 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 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) 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 Outcome Measures
Name Time Method Duration of Response (DOR) as assessed by Investigator based on RECIST v1.1 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 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 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) 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 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 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) Up to approximately 2 years after completion of study treatment of last study participant 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.
Phase 3: Confirmed ORR using RECIST v1.1 as assessed by BICR Up to approximately 2 years after completion of study treatment of last study participant 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.
Phase 3: DOR using RECIST v1.1 as assessed by BICR Up to approximately 2 years after completion of study treatment of last study participant 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.
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) Up to approximately 2 years after completion of study treatment of last study participant 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.
Phase 3: Mean scores and Change from Baseline on the EORTC Quality of Life Cancer Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13) Up to approximately 2 years after completion of study treatment of last study participant 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.
Phase 3: Time to definitive deterioration (TTdD) in the global health status/QoL, function, and symptom scores on the EORTC QLQ-C30 Up to approximately 2 years after completion of study treatment of last study participant TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.
Phase 3: TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13 Up to approximately 2 years after completion of study treatment of last study participant TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.