Phase 3
Completed N=878
ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT01360554 ↗Enrolled (actual)
878
Serious AEs
39.8%
Results posted
May 2017
Primary outcomePrimary: Progression-Free Survival (PFS) Per Independent Radiologic Review. — 2.6; 2.5 Months — p=0.195
◆ Published Evidence
Highly cited
137citations · ~11 / year
Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): a randomised, double-blind, phase 3 trial.
Summary
This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.
Linked Publications (3)
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Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): a randomised, double-blind, phase 3 trial.
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Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials.
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Targeting Cancer Cachexia: A Mechanistic Evaluation of Anti-GDF-15 Antibody-Based Combination Therapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) Per Independent Radiologic Review. |
2.6; 2.5 | 0.195 |
| PRIMARY Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants. |
2.6; 2.5 | 0.643 |
| SECONDARY PFS Based on Investigator Review. |
1.9; 1.9 | 0.069 |
| SECONDARY PFS Based on Investigator Review in KRAS-WT Participants. |
1.9; 1.9 | 0.728 |
| SECONDARY Overall Survival (OS). |
7.9; 8.3 | 0.638 |
| SECONDARY OS in KRAS-WT Participants. |
8.1; 8.5 | 0.775 |
| SECONDARY Best Overall Response (BOR) Per Independent Radiologic Review. |
6; 8; 46; 27; 163; 182 | — |
| SECONDARY BOR Per Investigator Review. |
2; 3; 57; 42; 136; 136 | — |
| SECONDARY Duration of Response (DR) Based on Independent Radiologic Review. |
9.2; 10.1 | — |
| SECONDARY DR Based on Investigator Review. |
10.4; 9.2 | — |
| SECONDARY Trough Concentrations (Ctrough) of Dacomitinib. |
61.0102; 46.5229; 44.2708; 38.0307 | — |
| SECONDARY Trough Concentrations (Ctrough) of PF-05199265. |
6.3695; 5.8706; 6.4380; 6.5353 | — |
| SECONDARY Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough Patient Reported Disease Symptoms. |
1.0; 1.0 | — |
| SECONDARY Mean and Difference in Mean in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) |
56.4068; 58.3425; 83.8980; 83.0913; 79.1982; 78.4682 | — |
| SECONDARY Mean and Difference in Mean in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30. |
28.5960; 27.3109; 8.2496; 14.1726; 38.8641; 18.6077 | — |
| SECONDARY Mean and Difference in Mean in Lung Cancer Symptom Scores as Assessed by the EORTC QLQ- LC13. |
10.1934; 7.5553; 28.3790; 32.6294; 3.4751; 4.5515 | — |
| SECONDARY Mean and Difference in Mean of the EuroQoL-5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Score |
65.1908; 65.5794 | — |
Eligibility Criteria
Inclusion Criteria
- Evidence of pathologically confirmed, advanced NSCLC (with known histology).
- Prior treatment with at least one and no more than two systemic therapy regimens (at least one must be standard chemotherapy for advanced NSCLC).
- Adequate tissue sample must be submitted prior to randomization for tumor biomarker analyses.
- Adequate renal, hematologic, liver function.
- ECOG PS of 0-2.
- Radiologically measurable disease.
Exclusion Criteria
- Small cell histology.
- Symptomatic brain mets or known leptomeningeal mets.
- Prior therapy with agent known or proposed to be active by action on EGFR tyrosine kinase or other HER family proteins.
- Uncontrolled medical disorders.
Data sourced from ClinicalTrials.gov (NCT01360554) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.