Locally advanced or metastatic non-small cell lung cancer
Conditions
Interventions
*Biological: PF-08634404
-Solution for infusion
*Biological: Pembrolizumab
-Injection for IV use
*Drug: Chemotherapy Regimen 1
-Injection for IV use
*Drug: Chemotherapy Regimen 2
-Injection for IV use
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: *18 years of age or older at screening. *Have pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer Tumor, lymph nodes, metastasis (TNM) staging system). *Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy *PD-L1 status available based on local testing results *Measurable disease based on RECIST v1.1 per investigator. *Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1 *Expected survival >=12 weeks
Exclusion criteria
Exclusion criteria: Exclusion Criteria: *Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), Repressor of Silencing 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), rearranged during transfection (RET), and mesenchymal-epithelial transition (MET), for which there are available first-line therapies per local standard-of-care (SOC) are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology. *Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter =3 pulmonary disease unrelated to underlying malignancy *History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial/severe venous thromboembolic events. *Major surgery 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. *Prio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Overall Survival [Time Frame: Approximately 39 months] -Overall survival defined as the time from the date of randomization to the date of death due to any cause. *Progression Free Survival (PFS) assessed by blinded independent central review (BICR) [Time Frame: Approximately 32 months] -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. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by BICR [Time Frame: Approximately 32 months] -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 as assessed by Investigator [Time Frame: Approximately 32 months] -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. *Confirmed ORR using RECIST v1.1 as assessed by investigator [Time Frame: Approximately 32 months] -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. *Duration of Response (DoR) as assessed by BICR [Time Frame: Approximately 32 months] -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. *Duration of Response (DoR) as assessed by Investigator [Time Frame: Approximately 32 months] -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. *Number of Participants With Adverse Events (AEs) [Time Frame: Through end of study and up to approximately 39 months] -AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s). *Number of Participants With Clinical Laboratory Abnormalities [Time Frame: through end of study and up to approximately 39 months] -Labora | — |
Countries
Argentina, Australia, Brazil, Canada, China, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Poland, Puerto Rico, Spain, Taiwan, Turkey, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed