C6461010 - 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

Condition studied

Early-Stage Resectable or Locally Advanced Unresectable Non-Small Cell Lung Cancer

Investigational medicinal product(s)

Every trial of PF-08634404, Pemetrexed, Paclitaxel and Carboplatin across our registers →

Eligibility

Primary endpoint

PART A: • AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.; • Proportion of participants undergoing surgery;• Proportion of participants with wound complications after surgery; • pCR rate per IASLC guidelines as assessed by central pathology review, PART B: • AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention., PART C: • AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.

Endpoint detail

PART A: • MPR rate per IASLC guidelines as assessed by central pathology review; • pCR rate per IASLC guidelines as assessed by investigator; • MPR rate per IASLC guidelines as assessed by investigator, PART A: • EFS per RECIST v1.1 as assessed by investigator; • OS; • ORR per RECIST v1.1 as assessed by investigator at the completion of neoadjuvant therapy, prior to surgery, PART A: • Rate of ctDNA reduction or clearance, PART A: • Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), PART A: • Predose and/or postdose concentrations of PF 08634404, PART A: • Incidence of ADA against PF 08634404., PART B: • DFS per RECIST v1.1 as assessed by investigator; • OS, PART B: • Rate of ctDNA reduction or clearance, PART B: • Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), PART B: • Predose and/or postdose concentrations of PF 08634404., PART B: • Incidence of ADA against PF 08634404., PART C: • Confirmed ORR per RECIST v1.1 as assessed by investigator; • PFS per RECIST v1.1 as assessed by investigator; • OS, PART C: • Rate of ctDNA reduction or clearance, PART C: • Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), PART C: • Predose and/or postdose concentrations of PF 08634404, PART C: • Incidence of ADA against PF-08634404