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ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

Primary Purpose

Non-small Cell Lung Cancer With EGFR-Activating Mutations

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dacomitinib (PF-00299804)

Gefitinib

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer With EGFR-Activating Mutations focused on measuring first-line, locally advanced or metastatic, non-small cell lung cancer, epidermal growth factor receptor, EGFR, ARCHER, mutation, dacomitinib, PF-00299804

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Evidence of histo or cytopathology confirmed, advanced NSCLC (with known histology) with the presence of EGFR-activating mutation (exon 19 deletion or the L858R mutation in exon 21).
It is acceptable for subjects with the presence of the exon 20 T790M mutation together with either EGFR-activating mutation (exon 19 deletion or the L858R mutation in exon 21) to be included in this study
No prior treatment with systemic therapy for locally advanced or metastatic NSCLC. Minimum of 12 months disease free interval between completion of neoadjuvant/adjuvant systemic therapy and recurrence of NSCLC
Adequate tissue sample must be available for central analyses.
Adequate renal, hematologic, liver function.
ECOG PS of 0-1.
Radiologically measurable disease.

Exclusion Criteria:

Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer.
Any other mutation other than exon 19 deletion or L858R in exon 21, with or without the presence of the exon 20 T790M mutation.
Any history of brain metastases or leptomeningeal metastases.
Any previous anti-cancer systemic treatment of early, locally advanced, or metastatic NSCLC.
Any surgery(not including minor procedures such as lymph node biopsy), palliative radiotherapy or pleurodesis within 2 weeks of baseline assessments
Any clinically significant gastrointestinal abnormalities that may impair intake, transit or absorption of the study drug.
Current enrollment in another therapeutic clinical study.
History of, or currently suspected, diffuse non-infectious pneumonitis or interstitial lung disease
Uncontrolled medical disorders.
Prior malignancy and concurrent malignancy except for non melanoma skin cancer or in-situ cervical cancer with no evidence of active disease.
Use of narrow therapeutic index drugs that are CYP2D6 substrates from screening to randomization.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dacomitinib (PF-00299804)

gefitinib

Arm Description

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

Gefitinib is provided as 250 mg tablets, continuous oral daily dosing.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) Based on Independent Radiologic Central (IRC) Review

PFS: time from randomization to date of progression of disease (PD) as determined by IRC review as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause, whichever occurred first. PD: >=20% increase in sum of diameters of target lesions (TLs), referring smallest sum on study, sum must be an absolute increase of >=5 mm, appearance of >=1 new lesions; unequivocal progression of existing non TLs. Overall tumor burden increased sufficiently to merit discontinuation of therapy. In presence of stable disease (did not achieve partial response, complete response or PD) or partial response (>=30% decrease under baseline of sum of diameters of all target measurable lesions, short diameter used in the sum for target nodes, longest diameter used in sum for all other target lesions) in target disease; for new lesions: appearance of any new unequivocal malignant lesion indicated PD.

Secondary Outcome Measures

Progression Free Survival (PFS) Based on Investigator Assessment

PFS: time from randomization to date of PD as determined by investigator assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause, whichever occurred first. PD for target lesions: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm; for non-target lesions: unequivocal progression of pre-existing lesions. Overall tumor burden increased sufficiently to merit discontinuation of therapy. In presence of stable disease (did not achieve partial response, complete response or PD) or partial response (>=30% decrease under baseline of sum of diameters of all target measurable lesions, short diameter used in the sum for target nodes, longest diameter used in sum for all other target lesions) in target disease; for new lesions: appearance of any new unequivocal malignant lesion indicated PD.

Number of Participants With Best Overall Response (BOR) Based on IRC Review

BOR for CR/PR:>=1 objective status (OBS) of CR/PR documented before PD; SD:>=1 OBS of stable documented >=8 weeks (wks) post treatment & before PD, not qualifying as CR/PR; PD:OBS of PD within 12 wks treatment, not qualifying as CR/PR/SD; indeterminate:PD not documented within 12 wks post treatment & no other response category applies. RECIST v1.1, CR:disappearance of all target lesions (TLs), non TLs;any pathological lymph nodes (LN) must reduce in short axis to <10 mm; normalization of tumour marker level, for non TL all LN must be non-pathological in size (<10 mm short axis); PR:>=30% decrease in sum of diameters of TLs, referring baseline sum diameters. SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referring smallest sum diameters on study. PD:>=20% increase in sum of diameters of TLs, referring smallest sum on study, sum must be an absolute increase of >=5 mm, appearance of >=1 new lesions;unequivocal progression of existing non TLs.

Number of Participants With Best Overall Response (BOR) Based on Investigator Assessment

Objective Response Rate (ORR) Based on IRC Review

Percentage of participants with a BOR of either CR or PR based on IRC review recorded from the start of treatment until disease progression based on RECIST v1.1. CR: disappearance of all target lesions (TLs), non TLs; any pathological lymph nodes (LN) must reduce in short axis to <10 mm; normalization of tumour marker level, for non TL all LN must be non-pathological in size (<10 mm short axis); PR:>=30% decrease in sum of diameters of TLs, referring baseline sum diameters. PD:>=20% increase in sum of diameters of TLs, referring smallest sum on study, sum must be an absolute increase of >=5 mm, appearance of >=1 new lesions; unequivocal progression of existing non TLs.

Objective Response Rate (ORR) Based on Investigator Assessment

Percentage of participants with a BOR of either CR or PR based on investigator assessment recorded from the start of treatment until disease progression based on RECIST v1.1. CR: disappearance of all target lesions (TLs), non TLs; any pathological lymph nodes (LN) must reduce in short axis to <10 mm; normalization of tumour marker level, for non TL all LN must be non-pathological in size (<10 mm short axis); PR:>=30% decrease in sum of diameters of TLs, referring baseline sum diameters. PD:>=20% increase in sum of diameters of TLs, referring smallest sum on study, sum must be an absolute increase of >=5 mm, appearance of >=1 new lesions; unequivocal progression of existing non TLs.

Duration of Response (DoR)

DoR was defined as time from first documentation of objective response(CR or PR, whichever occurred first)to date of PD/death from any cause, whichever occurred first. CR: disappearance of all target lesions (TLs), non TLs; any pathological lymph nodes (LN) must reduce in short axis to <10 mm; normalization of tumour marker level, for non TL all LN must be non-pathological in size (<10 mm short axis); PR:>=30% decrease in sum of diameters of TLs, referring baseline sum diameters. PD:>=20% increase in sum of diameters of TLs, referring smallest sum on study, sum must be an absolute increase of >=5 mm, appearance of >=1 new lesions; unequivocal progression of existing non TLs. DoR was recorded based on IRC review and investigator's assessment and summarized for subgroup of participants with objective disease response.

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non- serious adverse events.

Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 4.0: Biochemistry and Haematology

Parameters included anaemia, activated partial thromboplastin time, haemoglobin, international normalized ratio, lymphocyte count, lymphopenia, neutrophils (absolute), platelets, prothrombin time and white blood cells. Biochemistry parameters included alanine aminotransferase (increased), alkaline phosphatase (increased), aspartate aminotransferase (increased), bilirubin (total), creatinine (increased), hypercalcaemia, hyperglycaemia, hyperkalaemia, hypermagnesaemia, hypernatraemia, hypoalbuminaemia, hypocalcaemia, hypoglycaemia, hypokalaemia, hypomagnesaemia, hyponatraemia. Test abnormalities were graded by AEs according to the Common Terminology Criteria for Adverse Events(NCI CTCAE) version 4.0 as Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening; Grade 5=death related to AE. Only categories with at least 1 participant with abnormality are reported in this outcome measure.

Number of Participants With Laboratory Test Abnormalities: Urinalysis

Urinalysis parameter included urine protein, urine blood/haemoglobin, urine glucose and urine sediment. Test abnormalities was defined as deviation from normal range (higher or lower). Normal range of 24-hour urine protein test: less than 150 mg of protein per day, urine glucose: 0 to 0.8 mmol/L (millimole per liter), urine protein: 0 to 20 mg/dL (milligrams per deciliter). Urine blood/haemoglobin abnormality was defined as presence and absence of blood/haemoglobin in urine of participants. Urine sediment abnormality was defined as the presence of any bacteria, casts, crystals, and epithelial cells. Only categories with at least 1 participant with abnormality are reported in this outcome measure.

Number of Participants With Clinically Significant Abnormalities in Vital Signs

Criteria for vital signs abnormalities: systolic pulse rate less than (<) 50 beats per minute (bpm) or greater than (>)130 bpm and maximum increase or decrease from baseline in pulse rate of 30 bpm. Systolic blood pressure of maximum increase from baseline (MIB) >=40 millimeters of mercury (mmHg), maximum decrease from baseline (MDB) in systolic blood pressure =<60 mmHg. Diastolic blood pressure of MIB >=20 mmHg and MDB in diastolic blood pressure >40 and =<20 mm Hg. Only categories with at least 1 participant with abnormality are reported in this outcome measure.

Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)

ECG parameters included corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria for abnormality: absolute value 450 - <480 msec, 480 - <500 msec, >=500. The number of participants with potentially clinically significant ECG findings at any visit were reported.

Number of Participants With Maximum Relative Decrease From Baseline >20% in Left Ventricular Ejection Fraction (LVEF)

An ejection fraction (EF) was the volumetric fraction of blood ejected from a ventricle of the heart with each heartbeat; it was a measure of the pumping efficiency of the heart. The EF of the left heart, known as the left ventricular ejection fraction, was a measure of the efficiency of pumping into the body's systemic circulation.

Health Related Quality of Life (HRQOL): Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough

HRQOL was measured by standardized questionnaires (European Organization for Research and Treatment of Cancer (EORTC)) quality of life questionnaires (OLQ-C30) and its lung cancer module (QLQ-LC13). TTD in pain (chest, arm/shoulder), dyspnea, fatigue or cough was defined as time between baseline and first occurrence of increase in score of 10 points or greater from baseline in any of these 4 symptoms for at least two consecutive cycles. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment for pain, dyspnea, fatigue or cough.

Overall Mean Scores of Euro Quality of Life-5 Dimension Visual Analog Scale (EQ-5D VAS)

The Euro Quality of Life-5 dimension (EQ-5D) is a brief self-administered, validated reliable generic health status instrument. EQ-5D general health status can also be measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

Maximum Observed Plasma Concentration (Cmax) of Dacomitinib and Its Metabolite PF-05199265

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Dacomitinib and Its Metabolite PF-05199265

Area Under the Plasma Concentration-Time Curve From Time Zero (0) to End of Dosing Interval (AUCtau) of Dacomitinib and Its Metabolite PF-05199265

Averaged Plasma Concentration at Steady State (Cavg) of Dacomitinib and Its Metabolite PF-05199265

Minimum Observed Plasma Concentration (Cmin) of Dacomitinib and Its Metabolite PF-05199265

Fluctuation Coefficient Between Trough and Peak Plasma Concentration (DF) of Dacomitinib and Its Metabolite PF-05199265

Fluctuation coefficient between trough and peak plasma concentration was determined as Cmax-Ctrough divided by Cavg, where Cmax was the maximum observed concentration within the dosing interval, Ctrough was the observed concentration prior to dose administration and Cavg was averaged plasma concentration at steady state.

Apparent Clearance (CL) of Dacomitinib

Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes).

Pre-dose Plasma Concentrations (Ctrough) of Dacomitinib and Its Metabolite PF-05199265

Trough plasma concentration was defined as the measured concentration at the end of a dosing interval at steady state (taken directly before next administration).

Full Information

NCT ID

NCT01774721

First Posted

January 21, 2013

Last Updated

February 10, 2022

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01774721

Brief Title

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

Official Title

ARCHER 1050: A RANDOMIZED, OPEN-LABEL, PHASE 3, EFFICACY AND SAFETY STUDY OF DACOMITINIB (PF-00299804) VERSUS GEFITINIB FOR THE FIRST LINE TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER IN SUBJECTS WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) ACTIVATING MUTATION(S)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

May 9, 2013 (Actual)

Primary Completion Date

July 29, 2016 (Actual)

Study Completion Date

January 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a multinational, multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of treatment with dacomitinib (PF-00299804) to treatment with gefitinib in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal growth factor receptor EGFR-activating mutation (s). Analyses of primary objective (Progression Free Survival) will be done as defined in the protocol.

Detailed Description

452 patients were randomized in a 1:1 ratio between dacomitinib (PF-00299804 ) vs. gefitinib.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer With EGFR-Activating Mutations

Keywords

first-line, locally advanced or metastatic, non-small cell lung cancer, epidermal growth factor receptor, EGFR, ARCHER, mutation, dacomitinib, PF-00299804

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Masking

None (Open Label)

Allocation

Randomized

Enrollment

452 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dacomitinib (PF-00299804)

Arm Type

Experimental

Arm Description

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

Arm Title

gefitinib

Arm Type

Active Comparator

Arm Description

Gefitinib is provided as 250 mg tablets, continuous oral daily dosing.

Intervention Type

Drug

Intervention Name(s)

Dacomitinib (PF-00299804)

Other Intervention Name(s)

Dacomitinib

Intervention Description

Dacomitinib (PF-00299804) 45 mg tablets, continuous oral daily dosing.

Intervention Type

Drug

Intervention Name(s)

Gefitinib

Other Intervention Name(s)

Iressa

Intervention Description

Gefitinib 250 mg tablets, continuous oral daily dosing.

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS) Based on Independent Radiologic Central (IRC) Review

Description

Time Frame

Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS) Based on Investigator Assessment

Description

Time Frame

Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)

Title

Number of Participants With Best Overall Response (BOR) Based on IRC Review

Description

Time Frame

Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)

Title

Number of Participants With Best Overall Response (BOR) Based on Investigator Assessment

Description

Time Frame

Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)

Title

Objective Response Rate (ORR) Based on IRC Review

Description

Time Frame

Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)

Title

Objective Response Rate (ORR) Based on Investigator Assessment

Description

Time Frame

Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)

Title

Duration of Response (DoR)

Description

Time Frame

Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)

Title

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

From baseline up to 28-35 days after last dose of study drug (up to 48 months)

Title

Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 4.0: Biochemistry and Haematology

Description

Time Frame

From baseline up to 28-35 days after last dose of study drug (up to 48 months)

Title

Number of Participants With Laboratory Test Abnormalities: Urinalysis

Description

Time Frame

From baseline up to 28-35 days after last dose of study drug (up to 48 months)

Title

Number of Participants With Clinically Significant Abnormalities in Vital Signs

Description

Time Frame

From baseline up to 28-35 days after last dose of study drug (up to 48 months)

Title

Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)

Description

Time Frame

From baseline up to 28-35 days after last dose of study drug (up to 48 months)

Title

Number of Participants With Maximum Relative Decrease From Baseline >20% in Left Ventricular Ejection Fraction (LVEF)

Description

Time Frame

From baseline up to 7 days of Cycle 4 (up to 91 days)

Title

Health Related Quality of Life (HRQOL): Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough

Description

Time Frame

Baseline until the end of treatment (up to 48 months)

Title

Overall Mean Scores of Euro Quality of Life-5 Dimension Visual Analog Scale (EQ-5D VAS)

Description

Time Frame

From Cycle 1 Day 1 up to 48 months

Title

Maximum Observed Plasma Concentration (Cmax) of Dacomitinib and Its Metabolite PF-05199265

Time Frame

Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)

Title

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Dacomitinib and Its Metabolite PF-05199265

Time Frame

Pre-dose and 2, 4, 6, 8, and 24 hours post-dose (sample collection time points had window of +/- 10% of nominal time) on Cycle 2 Day 1 (Day 29)

Title

Area Under the Plasma Concentration-Time Curve From Time Zero (0) to End of Dosing Interval (AUCtau) of Dacomitinib and Its Metabolite PF-05199265

Time Frame

Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)

Title

Averaged Plasma Concentration at Steady State (Cavg) of Dacomitinib and Its Metabolite PF-05199265

Time Frame

Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)

Title

Minimum Observed Plasma Concentration (Cmin) of Dacomitinib and Its Metabolite PF-05199265

Time Frame

Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)

Title

Fluctuation Coefficient Between Trough and Peak Plasma Concentration (DF) of Dacomitinib and Its Metabolite PF-05199265

Description

Time Frame

Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)

Title

Apparent Clearance (CL) of Dacomitinib

Description

Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes).

Time Frame

Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)

Title

Pre-dose Plasma Concentrations (Ctrough) of Dacomitinib and Its Metabolite PF-05199265

Description

Trough plasma concentration was defined as the measured concentration at the end of a dosing interval at steady state (taken directly before next administration).

Time Frame

Pre-dose on Day 1 of Cycle 2, 3, 4, 5 and 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Evidence of histo or cytopathology confirmed, advanced NSCLC (with known histology) with the presence of EGFR-activating mutation (exon 19 deletion or the L858R mutation in exon 21). It is acceptable for subjects with the presence of the exon 20 T790M mutation together with either EGFR-activating mutation (exon 19 deletion or the L858R mutation in exon 21) to be included in this study No prior treatment with systemic therapy for locally advanced or metastatic NSCLC. Minimum of 12 months disease free interval between completion of neoadjuvant/adjuvant systemic therapy and recurrence of NSCLC Adequate tissue sample must be available for central analyses. Adequate renal, hematologic, liver function. ECOG PS of 0-1. Radiologically measurable disease. Exclusion Criteria: Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer. Any other mutation other than exon 19 deletion or L858R in exon 21, with or without the presence of the exon 20 T790M mutation. Any history of brain metastases or leptomeningeal metastases. Any previous anti-cancer systemic treatment of early, locally advanced, or metastatic NSCLC. Any surgery(not including minor procedures such as lymph node biopsy), palliative radiotherapy or pleurodesis within 2 weeks of baseline assessments Any clinically significant gastrointestinal abnormalities that may impair intake, transit or absorption of the study drug. Current enrollment in another therapeutic clinical study. History of, or currently suspected, diffuse non-infectious pneumonitis or interstitial lung disease Uncontrolled medical disorders. Prior malignancy and concurrent malignancy except for non melanoma skin cancer or in-situ cervical cancer with no evidence of active disease. Use of narrow therapeutic index drugs that are CYP2D6 substrates from screening to randomization.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

City

Beijing

Country

China

City

Changchun

Country

China

City

Changsha

Country

China

City

Chengdu

Country

China

City

Chongqing

Country

China

City

Fuzhou

Country

China

City

Guangzhou

Country

China

City

Hangzhou

Country

China

City

Hefei

Country

China

City

Nanning

Country

China

City

Shanghai

Country

China

City

Shenyang

Country

China

City

Tianjin

Country

China

City

Wuhan

Country

China

City

Wuxi

Country

China

City

Hong Kong

Country

Hong Kong

City

Shatin

Country

Hong Kong

City

Catania

Country

Italy

City

Lecco

Country

Italy

City

Livorno

Country

Italy

City

Meldola

Country

Italy

City

Milano

Country

Italy

City

Napoli

Country

Italy

City

Perugia

Country

Italy

City

Ravenna

Country

Italy

City

Roma

Country

Italy

City

Trento

Country

Italy

City

Viterbo

Country

Italy

City

Hokkaido

State/Province

Asahikawa

Country

Japan

City

Kashiwa

State/Province

Chiba

Country

Japan

City

Matsuyama

State/Province

Ehime

Country

Japan

City

Yokohama

State/Province

Kanagawa

Country

Japan

City

Tokyo

State/Province

Koto-ku

Country

Japan

City

Osakasayama

State/Province

Osaka

Country

Japan

City

Sakai

State/Province

Osaka

Country

Japan

City

Sunto-gun

State/Province

Shizouka

Country

Japan

City

Chuo-Ku

State/Province

Tokyo

Country

Japan

City

Seoul

Country

Korea, Republic of

City

Gdansk

Country

Poland

City

Olsztyn

Country

Poland

City

Poznan

Country

Poland

City

Warszawa

Country

Poland

City

Avila

Country

Spain

City

Barcelona

Country

Spain

City

Bilbao

Country

Spain

City

Caceres

Country

Spain

City

Cordoba

Country

Spain

City

Las Palmas

Country

Spain

City

Madrid

Country

Spain

City

Malaga

Country

Spain

City

San Sebastian

Country

Spain

City

Seville

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

34120312

Citation

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Results Reference

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PubMed Identifier

33721611

Citation

Cheng Y, Mok TS, Zhou X, Lu S, Zhou Q, Zhou J, Du Y, Yu P, Liu X, Hu C, Lu Y, Zhang Y, Lee KH, Nakagawa K, Linke R, Wong CH, Tang Y, Zhu F, Wilner KD, Wu YL. Safety and efficacy of first-line dacomitinib in Asian patients with EGFR mutation-positive non-small cell lung cancer: Results from a randomized, open-label, phase 3 trial (ARCHER 1050). Lung Cancer. 2021 Apr;154:176-185. doi: 10.1016/j.lungcan.2021.02.025. Epub 2021 Feb 23.

Results Reference

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PubMed Identifier

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Citation

Mok TS, Cheng Y, Zhou X, Lee KH, Nakagawa K, Niho S, Chawla A, Rosell R, Corral J, Migliorino MR, Pluzanski A, Noonan K, Tang Y, Pastel M, Wilner KD, Wu YL. Updated Overall Survival in a Randomized Study Comparing Dacomitinib with Gefitinib as First-Line Treatment in Patients with Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations. Drugs. 2021 Feb;81(2):257-266. doi: 10.1007/s40265-020-01441-6.

Results Reference

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PubMed Identifier

31313942

Citation

Corral J, Mok TS, Nakagawa K, Rosell R, Lee KH, Migliorino MR, Pluzanski A, Linke R, Devgan G, Tan W, Quinn S, Wang T, Wu YL. Effects of dose modifications on the safety and efficacy of dacomitinib for EGFR mutation-positive non-small-cell lung cancer. Future Oncol. 2019 Aug;15(24):2795-2805. doi: 10.2217/fon-2019-0299. Epub 2019 Jul 17.

Results Reference

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PubMed Identifier

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Citation

Nagano T, Tachihara M, Nishimura Y. Dacomitinib, a second-generation irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) to treat non-small cell lung cancer. Drugs Today (Barc). 2019 Apr;55(4):231-236. doi: 10.1358/dot.2019.55.4.2965337.

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29864379

Citation

Mok TS, Cheng Y, Zhou X, Lee KH, Nakagawa K, Niho S, Lee M, Linke R, Rosell R, Corral J, Migliorino MR, Pluzanski A, Sbar EI, Wang T, White JL, Wu YL. Improvement in Overall Survival in a Randomized Study That Compared Dacomitinib With Gefitinib in Patients With Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations. J Clin Oncol. 2018 Aug 1;36(22):2244-2250. doi: 10.1200/JCO.2018.78.7994. Epub 2018 Jun 4. Erratum In: J Clin Oncol. 2020 Nov 1;38(31):3725.

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PubMed Identifier

28958502

Citation

Wu YL, Cheng Y, Zhou X, Lee KH, Nakagawa K, Niho S, Tsuji F, Linke R, Rosell R, Corral J, Migliorino MR, Pluzanski A, Sbar EI, Wang T, White JL, Nadanaciva S, Sandin R, Mok TS. Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol. 2017 Nov;18(11):1454-1466. doi: 10.1016/S1470-2045(17)30608-3. Epub 2017 Sep 25.

Results Reference

derived

PubMed Identifier

26768165

Citation

Ramalingam SS, O'Byrne K, Boyer M, Mok T, Janne PA, Zhang H, Liang J, Taylor I, Sbar EI, Paz-Ares L. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials. Ann Oncol. 2016 Mar;27(3):423-9. doi: 10.1093/annonc/mdv593. Epub 2016 Jan 13. Erratum In: Ann Oncol. 2016 Jul;27(7):1363.

Results Reference

derived

Learn more about this trial

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

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