NCT01360554|CompletedPhase 3ResultsDMC

ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer

ARCHER 1009

Archer 1009:a Randomized, Double Blind Phase 3 Efficacy And Safety Study Of Pf-00299804 (Dacomitinib) Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer Following Progression After, Or Intolerance To, At Least One Prior Chemotherapy

Pfizer ClinicalTrials.gov

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2 other identifiers

A74710092010-022656-22

Study Type

interventional

Target

878

Locations

23 countries

Sites

224

Timeline

RegisteredMay 2011

StartedJun 2011

CompletionSep 2015

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

878

participants targeted

Target at P75+ for phase_3 nonsmall-cell-lung-cancer

Timeline

Completed

Started Jun 2011

Geographic Reach

23 countries

224 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.2 years study duration

First Submitted

Initial submission to the registry

April 12, 2011

Completed

1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed

22 days until next milestone

Study Start

First participant enrolled

June 16, 2011

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2013

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2015

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

May 24, 2017

Completed

Last Updated

May 24, 2017

Status Verified

April 1, 2017

Enrollment Period

2.3 years

First QC Date

April 12, 2011

Results QC Date

September 7, 2016

Last Update Submit

April 24, 2017

Conditions

Non-Small Cell Lung Cancer

Keywords

comparative study of PF-00299804 and ErlotinibDouble-Blind Phase 3 trial of TKI

Outcome Measures

Primary Outcomes (2)

Progression-Free Survival (PFS) Per Independent Radiologic Review.
PFS was defined as the time from randomization to the date of disease progression as by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.
Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.
PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.

Secondary Outcomes (15)

PFS Based on Investigator Review.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.
PFS Based on Investigator Review in KRAS-WT Participants.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.
Overall Survival (OS).
From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months.
OS in KRAS-WT Participants.
From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months.
Best Overall Response (BOR) Per Independent Radiologic Review.
From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.
+10 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Blinded active PF-00299804 + blinded placebo comparator (erlotinib)

Drug: Dacomitinib (PF-00299804)Drug: Placebo erlotinib

B

ACTIVE COMPARATOR

Blinded active comparator (erlotinib) + blinded placebo PF-00299804

Drug: Active Comparator (erlotinib)Drug: Placebo PF00299804

Interventions

Dacomitinib (PF-00299804)DRUG

Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing

Active Comparator (erlotinib)DRUG

Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing

Placebo erlotinibDRUG

placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.

Placebo PF00299804DRUG

placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (224)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Northwest Alabama Cancer Center

Florence, Alabama, 35630, United States

Location

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Location

University of South Alabama Medical Center

Mobile, Alabama, 36617, United States

Location

Northwest Alabama Cancer Center

Muscle Shoals, Alabama, 35661, United States

Location

Ironwood physicians P C dba Ironwood Cancer & Research Centers

Chandler, Arizona, 85224, United States

Location

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

Chandler, Arizona, 85224, United States

Location

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

Gilbert, Arizona, 85297, United States

Location

Desert Oncology Associates dba Ironwood Cancer and Research Centers

Mesa, Arizona, 85202, United States

Location

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

Mesa, Arizona, 85206, United States

Location

Highlands Oncology Group PA

Fayetteville, Arkansas, 72703, United States

Location

Highlands Oncology Group, PA

Rogers, Arkansas, 72758, United States

Location

Central Hematology Oncology Medical Group Inc.

Alhambra, California, 91801, United States

Location

UCLA Hematology Oncology-Alhambra

Alhambra, California, 91801, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

St. Jude Heritage Healthcare

Fullerton, California, 92835, United States

Location

Drug Management Only

Los Angeles, California, 90095-1772, United States

Location

Drug Managerrent Only:

Los Angeles, California, 90095-1772, United States

Location

UCLA West Medical Pharmacy

Los Angeles, California, 90095-1772, United States

Location

Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU)