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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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524825-42-00
Enrollment
15
Registered
2026-08-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Detailed description

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

Interventions

DRUGPACLITAXEL
DRUGCARBOPLATIN
DRUGPEMETREXED
DRUGPF-08634404

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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 08634

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 28, 2026