A Phase 3 Study Of PF-00299804, A Pan-HER Inhibitor, Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer

A Randomized, Double-Blind Phase 3 Study Of PF-00299804, A Pan-Her Inhibitor, Vs. Erlotinib For The Treatment Of Advanced Non-Small Cell Lung Cancer Following Progression After, Or Intolerance To, At Least One Prior Chemotherapy - ARCHER 1009

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/03/002486

Enrollment

800

Registered

2012-03-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Non-Small Cell Lung Cancer (NSCLC)

Interventions

Intervention1: A: Experimental Blinded active Dacomitinib (PF-00299804)+ blinded placebo comparator (erlotinib). Dacomitinib (PF-00299804) is provided as 45 mg tablets, + placebo erlotinib, provided

Eligibility

Inclusion criteria

Inclusion criteria: 1. Evidence of pathologically confirmed, advanced NSCLC (with known histology). 2. Prior treatment with at least one and no more than two systemic therapy regimens (at least one must be standard chemotherapy for advanced NSCLC). 3. Adequate tissue sample must be submitted prior to randomization for tumor biomarker analyses. 4. Adequate renal, hematologic, liver function. 5. ECOG PS of 0-2. 6. Radiologically measurable disease.

Exclusion criteria

Exclusion criteria: 1. Small cell histology. 2. Symptomatic brain mets or known leptomeningeal mets. 3. Prior therapy with agent known or proposed to be active by action on EGFR tyrosine kinase or other HER family proteins. 4. Uncontrolled medical disorders.

Design outcomes

Primary

Measure	Time frame
1. Progression Free Survival per Independent Radiologic review in two co-primary populations.Timepoint: 10 months after anticipated LSLV	—

Secondary

Measure	Time frame
1. Overall SurvivalTimepoint: 12 months after anticipated LSLV;2. Progression-Free Survival per InvestigatorTimepoint: 4 months after anticipated LSLV;3. Best Overall ResponseTimepoint: 6 months after anticipated LSLV;4. Duration of ResponseTimepoint: 6 months from LSLV until progression;5. Overall Safety by CTCAE grading at each specified visit, LVEF every 3-6 monthsTimepoint: until resolution of any unresolved treatment-related adverse event for 6 months from LSLV;6. Patient Reported Outcomes of health-related quality of life, diseases symptoms, health statusTimepoint: 6 months from LSLV;7. KRAS mutation status in tissue sample and HER family genotypes from serum samples at baselineTimepoint: baseline, and 12 months from LSLV;8. PK trough concentrationsTimepoint: 12 months from LSLV	—

Measure

Time frame

1. Overall SurvivalTimepoint: 12 months after anticipated LSLV;2. Progression-Free Survival per InvestigatorTimepoint: 4 months after anticipated LSLV;3. Best Overall ResponseTimepoint: 6 months after anticipated LSLV;4. Duration of ResponseTimepoint: 6 months from LSLV until progression;5. Overall Safety by CTCAE grading at each specified visit, LVEF every 3-6 monthsTimepoint: until resolution of any unresolved treatment-related adverse event for 6 months from LSLV;6. Patient Reported Outcomes of health-related quality of life, diseases symptoms, health statusTimepoint: 6 months from LSLV;7. KRAS mutation status in tissue sample and HER family genotypes from serum samples at baselineTimepoint: baseline, and 12 months from LSLV;8. PK trough concentrationsTimepoint: 12 months from LSLV

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Countries

Austria, Belgium, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Japan, Mexico, Poland, Republic of Korea, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States of America

Contacts

Public ContactSwapnali Raut

Representing Pfizer Limited

Swapnali.raut@pfizer.com91-9821415224

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026