AN INTERVENTIONAL, OPEN-LABEL, PHASE 2 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY OR IN COMBINATION IN ADULT PARTICIPANTS WITH EARLY-STAGE RESECTABLE OR LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER
Summary
This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery. The study is seeking participants who: * Are aged 18 years or older * Have either: * Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery. * Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples. * Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously. * Be in good physical condition and have healthy organs based on medical tests. * Do not have known actionable changes in DNA The study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis: * Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery. * Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor. * Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens. All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.
Arms & interventions
- BiologicalPF-08634404
Concentrate for solution for infusion
- DrugChemotherapy Regimen 1
Injection for intravenous use
- DrugChemotherapy Regimen 2
Injection for intravenous use
Outcome measures
Primary
Number of Participants With Adverse Events (AEs)
AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s).
Time frame: Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)
Part A: Surgical Feasibility Rate
Surgical Feasibility rate is defined by the proportion of participants undergoing surgery and the proportion of participants with wound complications after surgery.
Time frame: Up to approximately 6 months after first dose
Part A: Pathological Complete Response (pCR) rate per International Association for the Study of Lung Cancer (IASLC) guidelines as assessed by central pathology review
pCR rate by central pathology review is defined as the proportion of participants having pCR as assessed by central pathologist. pCR is defined as the absence of residual tumor in surgical specimens
Time frame: Up to approximately 6 months after first dose
Secondary
Part A: Major Pathological Response (MPR) rate per IASLC guidelines as assessed by central pathology review
Time frame: Up to approximately 6 months after first dose
Part A: pCR rate per IASLC guidelines as assessed by investigator
Time frame: Up to approximately 6 months after first dose
Part A: MPR rate per IASLC guidelines as assessed by investigator
Time frame: Up to approximately 6 months after first dose
Part A: Event Free Survival (EFS) per RECIST v1.1 as assessed by investigator
Time frame: Up to approximately 5 years
Part A: Objective Response Rate (ORR) per RECIST v1.1 as assessed by investigator at the completion of neoadjuvant therapy, prior to surgery
Time frame: Up to approximately 5 years
Part B: Disease Free Survival (DFS) per RECIST v1.1 as assessed by investigator
Time frame: Up to approximately 5 years
Part C: Confirmed ORR per RECIST v1.1 as assessed by investigator
Time frame: Up to approximately 5 years
Part C: Progression Free Survival (PFS) per RECIST v1.1 as assessed by investigator
Time frame: Up to approximately 5 years
Overall Survival (OS)
Time frame: Up to approximately 5 years
Rate of circulating tumor DNA (ctDNA) reduction or clearance
Time frame: Part A: Up to 18 months, Part B and Part C: Up to 37 days after the last dose of treatment
Number of participants with Laboratory abnormalities
Time frame: Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)
Pharmacokinetics: Serum concentrations of PF-086344
Time frame: Up to 37 days after the last dose of treatment, prior to surgery
Incidence of antidrug antibody against PF-08634404
Time frame: Up to 37 days after the last dose of treatment, prior to surgery
Eligibility criteria
Study locations (2)
Hope and Healing Clinical Research
Hinsdale, Illinois, 60521
Hope and Healing Clinical Research
New Lenox, Illinois, 60451