Small Cell Lung Cancer (SCLC)
Conditions
Keywords
small cell lung cancer, extensive stage small cell lung cancer, first-line
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.
Interventions
DRUGPF-08634404
Concentrate for solution for infusion
BIOLOGICALAtezolizumab
Injection for intravenous use
DRUGChemotherapy
Injection for intravenous use
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Phase 2 is open-label, whereas Phase 3 is double-blind, randomized design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Japan, Puerto Rico, United States
Contacts
Primary ContactPfizer CT.gov Call Center
Outcome results
None listed