Trial · NCT01360554

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

NCT01360554, Phase 3, Completed, Pfizer; results first posted 2017-05-24

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer. Trials, record NCT01360554. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01360554

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer
NCT number: NCT01360554
Status: Completed
Phases: Phase 3
Enrollment: 878 participants, actual
Lead sponsor: Pfizer
Conditions: Non-Small Cell Lung Cancer
Interventions: Dacomitinib (PF-00299804), Active Comparator (erlotinib), Placebo erlotinib, Placebo PF00299804
First posted: 2011-05-25
Last updated: 2017-05-24
Other registries' IDs: eudract:2010-022656-22
Results first posted: 2017-05-24

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-Free Survival (PFS) Per Independent Radiologic 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 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.
Primary	Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (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.	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.
Secondary	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 was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's 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.
Secondary	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.	PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's 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.
Secondary	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 was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up).
Secondary	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.	OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up). Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.
Secondary	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.	The BOR was the best response per RECIST (version 1.1) criteria as assessed by independent assessment recorded from randomization until disease progression. Per RECIST version 1.1: Complete Response (CR): disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis\<10 mm) and no appearance of new unequivocal malignant lesions; Partial Response (PR): \>=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; Progressive Disease (PD): \>=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.
Secondary	BOR Per Investigator 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.	The BOR was the best response per RECIST (version 1.1) criteria as assessed by investigator assessment recorded from randomization until disease progression. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis\<10 mm) and no appearance of new unequivocal malignant lesions; PR: \>=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: \>=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.
Secondary	Duration of Response (DR) Based on Independent Radiologic Review.	From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.	DR was defined as the time from first documentation of response assessed by independent review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis\<10 mm) and no appearance of new unequivocal malignant lesions; PR: \>=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: \>=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.
Secondary	DR Based on Investigator Review.	From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.	DR was defined as the time from first documentation of response assessed by investigator review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis\<10 mm) and no appearance of new unequivocal malignant lesions; PR: \>=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: \>=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-Free Survival (PFS) Per Independent Radiologic 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.	The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.	Months	MEDIAN
PRIMARY	Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (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.	ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.	Months	MEDIAN
SECONDARY	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.	The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.	Months	MEDIAN
SECONDARY	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.	ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.	Months	MEDIAN
SECONDARY	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.	The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.	Months	MEDIAN
SECONDARY	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.	ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.	Months	MEDIAN
SECONDARY	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.	The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.	Participants	NUMBER
SECONDARY	BOR Per Investigator 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.	The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.	Participants	NUMBER
SECONDARY	Duration of Response (DR) Based on Independent Radiologic Review.	From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.	DR was analyzed for a subgroup of participants in the ITT population, who had an objective tumor response.	Months	MEDIAN
SECONDARY	DR Based on Investigator Review.	From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.	DR was analyzed for a subgroup of participants in the ITT population, who had an objective tumor response.	Months	MEDIAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group100

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression-Free Survival (PFS) Per Independent Radiologic Review.	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	2.6	95% Confidence Interval 1.9 to 2.8	Months
Progression-Free Survival (PFS) Per Independent Radiologic Review.	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	2.5	95% Confidence Interval 1.9 to 2.8	Months
Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	2.6	95% Confidence Interval 1.9 to 2.9	Months
Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	2.5	95% Confidence Interval 1.9 to 3.0	Months
PFS Based on Investigator Review.	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	1.9	95% Confidence Interval 1.9 to 2.6	Months
PFS Based on Investigator Review.	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	1.9	95% Confidence Interval 1.8 to 2.1	Months
PFS Based on Investigator Review in KRAS-WT Participants.	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	1.9	95% Confidence Interval 1.8 to 2.7	Months
PFS Based on Investigator Review in KRAS-WT Participants.	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	1.9	95% Confidence Interval 1.8 to 2.6	Months
Overall Survival (OS).	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	7.9	95% Confidence Interval 6.8 to 9.0	Months
Overall Survival (OS).	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	8.3	95% Confidence Interval 7.4 to 9.7	Months

1 to 10 of 100Source ClinicalTrials.gov

See all 100 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	439
Overall Study	STARTED	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	439
Overall Study	Treated	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	436
Overall Study	Treated	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	436
Overall Study	COMPLETED	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	0
Overall Study	COMPLETED	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	0
Overall Study	NOT COMPLETED	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	439
Overall Study	NOT COMPLETED	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	439

Source ClinicalTrials.gov

Adverse events552

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	35	436
other	Anaemia	Blood and lymphatic system disorders	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	43	436
other	Tachycardia	Cardiac disorders	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	5	436
other	Tachycardia	Cardiac disorders	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	10	436
other	Dry eye	Eye disorders	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	16	436
other	Dry eye	Eye disorders	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	5	436
other	Abdominal pain	Gastrointestinal disorders	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	21	436
other	Abdominal pain	Gastrointestinal disorders	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	19	436
other	Abdominal pain upper	Gastrointestinal disorders	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	21	436
other	Abdominal pain upper	Gastrointestinal disorders	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	20	436

1 to 10 of 552Source ClinicalTrials.gov

See all 552 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)
Total, all-cause mortality	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)
Total, other adverse events	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	424	436
Total, other adverse events	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	417	436
Total, serious adverse events	Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)	178	436
Total, serious adverse events	Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)	169	436

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25439691	DERIVED	PubMed
26768165	DERIVED	PubMed
42126170	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) vs Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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