Symbiotic-Lung-04: 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
ID: NCT07226999
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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.
Concentrate for solution for infusion
Injection for intravenous use
Injection for intravenous use
Treatment Arms Description
Participants will receive PF-08634404 in combination with chemotherapy
Participants will receive PF-08634404 in combination with chemotherapy
Participants will receive atezolizumab in combination with chemotherapy
- 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
Primary Outcome Measures
- 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.
View Secondary Outcome Measures (14)
- 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 progressive disease (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
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.
- Phase 3: Confirmed ORR using RECIST v1.1 as assessed by BICR — Time Frame: 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 — Time Frame: 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.
This trial is recruiting at 82 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 82 Facilities & Contact Sites
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View Official Medical/Scientific Title
A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER