Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO (ARCHER 1042)

ARCHER 1042: A PHASE 2 STUDY OF DACOMITINIB IN ADVANCED NON-SMALL CELL LUNG CANCER (POST-CHEMOTHERAPY OR SELECT FIRST LINE PATIENTS) TO EVALUATE PROPHYLACTIC INTERVENTION ON DERMATOLOGIC AND GASTROINTESTINAL ADVERSE EVENTS AND PATIENT REPORTED OUTCOMES

To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1 mutation, HER-2 mutation or HER-2 amplification).

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Dacomitinib; Drug: Dacomitinib; Drug: Doxycycline; Drug: Probiotic; Drug: Alclometasone cream

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Yonsei University Health System
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • Fullerton, California, United States, 92835
      • St. Jude Heritage Healthcare
    • Irvine, California, United States, 92604
      • UCLA Hematology Oncology
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • La Jolla, California, United States, 92037
      • UC San Diego Medical Center - La Jolla
    • La Jolla, California, United States, 92037
      • UC San Diego Moores Cancer Center - Investigational Drug Services
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 90095
      • Regulatory Management Only: TRIO-US Central Administration
    • Los Angeles, California, United States, 90095
      • UCLA Hematology Oncology
    • Los Angeles, California, United States, 90095
      • Drug Management Only: UCLA West Medical Pharmacy
    • Los Angeles, California, United States, 90095
      • Westwood Bowyer Clinic
    • Los Angeles, California, United States, 90095-7349
      • Drug Management Only: UCLA West Medical Pharmacy
    • Los Angeles, California, United States, 90095
      • Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharm.D.
    • Los Angeles, California, United States, 90095
      • Drug Managment Only: UCLA West Medical Pharmacy
    • Los Angeles, California, United States, 90095
      • Regulatory Management Only TRIO-US Central Administration
    • Pasadena, California, United States, 91105
      • UCLA/Pasadena Healthcare
    • San Diego, California, United States, 92103
      • UC San Diego Medical Center - Hillcrest
    • San Luis Obispo, California, United States, 93401
      • Coastal Integrative Cancer Care
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic
    • Santa Barbara, California, United States, 93150
      • Cancer Center of Santa Barbara with Sansum Clinic
    • Santa Maria, California, United States, 93454
      • Central Coast Medical Oncology Corporation
    • Santa Monica, California, United States, 90404
      • UCLA Hematology Oncology
    • Santa Monica, California, United States, 90404
      • UCLA Santa Monica Medical Center & Orthopaedic Hospital
    • Solvang, California, United States, 93463
      • Cancer Center of Santa Barbara with Sansum Clinic
    • South Pasadena, California, United States, 91030
      • City of Hope South Pasadena Cancer Center
    • Valencia, California, United States, 91355
      • UCLA/Santa Clarita Valley Cancer Center
    • Westlake Village, California, United States, 91361
      • UCLA Cancer Center
  • Colorado
    • Denver, Colorado, United States, 80205
      • Kaiser Permanente Colorado - Franklin
    • Grand Junction, Colorado, United States, 81501
      • St. Mary's Hospital Regional Cancer Center
    • Lafayette, Colorado, United States, 80026
      • Kaiser Permanente Colorado - Rock Creek
    • Lonetree, Colorado, United States, 80124
      • Kaiser Permanente Colorado - Lonetree
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital
    • Hollywood, Florida, United States, 33021
      • Memorial Cancer Institute
    • Lake City, Florida, United States, 32024
      • Cancer Care of North Florida, PA
    • Pembroke Pines, Florida, United States, 33028
      • Memorial West Cancer Institute
  • Georgia
    • Athens, Georgia, United States, 30607
      • University Cancer & Blood Center, LLC
    • Savannah, Georgia, United States, 31405
      • Summit Cancer Care, PC
    • Savannah, Georgia, United States, 31404
      • Summit Cancer Care,PC
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center, Division of Hematology & Oncology
    • Chicago, Illinois, United States, 60637
      • Ships Drugs to: Emmanuel Semmes, RPh (or Ami Patel, Pharm D) University of Chicago
    • Peoria, Illinois, United States, 61615
      • Illinois CancerCare, P.C.
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
    • Wichita, Kansas, United States, 67208
      • Cancer Center of Kansas
  • Michigan
    • Brownstown, Michigan, United States, 48183
      • Josephine Ford Cancer Center-Downriver
    • Dearborn, Michigan, United States, 48126
      • Henry Ford Medical Center - Fairlane
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Novi, Michigan, United States, 48377
      • Henry Ford Medical Center - Columbus
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford Hospital and Medical Center - West Bloomfield
  • Mississippi
    • Corinth, Mississippi, United States, 38834
      • The West Clinic, PC
    • Southaven, Mississippi, United States, 38671
      • The West Clinic, PC
  • Missouri
    • Branson, Missouri, United States, 65616
      • Mercy Clinic Cancer & Hematology-Branson
    • Springfield, Missouri, United States, 65804
      • Mercy Hospital Springfield
    • Springfield, Missouri, United States, 65807
      • Mercy Clinic Cancer and Hematology - Chub O-Reilly Cancer Center
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Comprehensive Cancer Centers of Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Saint Barnabas Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Bronx, New York, United States, 10461
      • Montefiore-Einstein Center for Cancer Care
    • New York, New York, United States, 10003
      • Beth Israel Medical Center
    • New York, New York, United States, 10011
      • Beth Israel Comprehensive Cancer Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center - The New York Presbyterian Hospital
    • Stony Brook, New York, United States, 11794-9447
      • Stony Brook University Medical Center-Cancer Center
  • North Carolina
    • Hickory, North Carolina, United States, 28602
      • Carolina Oncology Specialists, PA
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Mid Dakota Clinic, PC
    • Bismarck, North Dakota, United States, 58501
      • Legacy Pharma Research
    • Bismarck, North Dakota, United States, 58501
      • St Alexius Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Hematology Oncology Associates, PA
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • The West Clinic, PC
    • Memphis, Tennessee, United States, 38104
      • The West Clinic, PC
  • Texas
    • Fort Worth, Texas, United States, 76177
      • Investigational Products Center (IPC)
    • Fort Worth, Texas, United States, 76177
      • Investigational Product Center (IPC)
  • Vermont
    • Burlington, Vermont, United States, 05401
      • 'Fletcher Allen Health Care, Inc
    • Burlington, Vermont, United States, 05405
      • Office of Clinical Trials Research, Fletcher Allen Health Care, Inc.
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
  • Washington
    • Issaquah, Washington, United States, 98029
      • Swedish Cancer Institute - Issaquah
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Advanced Non-Small Cell Lung Cancer (NSCLC).
• For Cohort I and Cohort II, advanced NSCLC patients must have received at least one prior regimen of systemic therapy which includes at least one standard chemotherapy for advanced NSCLC and who have failed (ie, progressed or intolerant due to toxicity which precludes further treatment) standard therapy for advanced or metastatic disease. To be considered intolerant to treatment, a patient must have received at least two cycles to be considered previously treated.
• For Cohort III, advanced NSCLC patients must not have received prior systemic treatment for their advanced disease and require a known EGFR (HER-1) mutation, HER-2 mutation or HER-2 amplification. Cohort III patients could have received prior adjuvant chemotherapy for Stage I-III disease or combined modality chemotherapy-radiation for Stage IIIA disease is allowed if treatment completed>12 months prior to enrollment.
• All cohorts, patients must have evidence of disease; however, measurable disease is not required to enroll.
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
• Estimated creatinine clearance ≥15 mL/min.

Exclusion Criteria:

• Prior treatment with an EGFR-targeted or HER-targeted agent (all cohorts).
• Chemotherapy, radiotherapy, biological or investigational agents within 2 weeks of baseline disease assessments (all cohorts).
• Patients with known diffuse interstitial lung disease (all cohorts).
• Investigational therapy as only treatment for advanced NSCLC without administration of an approved chemotherapy for advanced NSCLC (for Cohort I and Cohort II)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort I; Arm A: Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Doxycycline placebo orally BID for 4 weeks Arm B: Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Doxycycline 100 mg orally BID for 4 weeks	Drug: Dacomitinib; Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent; Drug: Dacomitinib; Dacomitinib 45 mg orally daily on a continuous schedule for the first 10 days in Cycle 1, followed by 4 days off treatment, followed by continuous daily dosing until disease progression, toxicity, death or withdrawal of consent; Drug: Doxycycline; Doxycycline or Doxycycline placebo BID for 4 weeks
EXPERIMENTAL: Cohort II; Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks VSL#3 probiotic 4 capsules orally daily or 1 sachet orally daily for up to 5 weeks (starting between Day minus 7 to Day minus 4 and continuing through Day 28)	Drug: Dacomitinib; Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent; Drug: Dacomitinib; Dacomitinib 45 mg orally daily on a continuous schedule for the first 10 days in Cycle 1, followed by 4 days off treatment, followed by continuous daily dosing until disease progression, toxicity, death or withdrawal of consent; Drug: Probiotic; VSL#3 probiotic 4 capsules orally daily or 1 sachet orally daily for up to 5 weeks (starting between Day minus 7 to Day minus 4 and continuing through Day 28); Drug: Alclometasone cream; Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks
EXPERIMENTAL: Cohort III; Cohort III is an interrupted dosing schedule of dacomitinib in the first cycle only	Drug: Dacomitinib; Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent; Drug: Dacomitinib; Dacomitinib 45 mg orally daily on a continuous schedule for the first 10 days in Cycle 1, followed by 4 days off treatment, followed by continuous daily dosing until disease progression, toxicity, death or withdrawal of consent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Select Dermatologic Adverse Events of Interest (SDAEI) (All Causality, All Grade) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I	SDAEI of all causality and all grades were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. 95% confidence interval (CI) calculated using exact method based on binomial distribution. After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 1 was not conducted in Cohort I Arm C.	First 8 Weeks of Treatment
Percentage of Participants With SDAEI (All Causality, Grade Greater Than or Equal to [≥] 2) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I	SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. Adverse events (AEs) were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 4.0). 95% CI calculated using exact method based on binomial distribution. After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 2 was not conducted in Cohort I Arm C.	First 8 Weeks of Treatment
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I	Patient Reported Outcomes (PROs) of Health Related Quality of Life (HRQoL) & disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses "bother". It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if greater than (>) 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant. Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit.	First 8 Weeks of Treatment
Percentage of Participants With Diarrhea AEs (All Causality, All Grade and Grade ≥2) in the First 8 Weeks of Treatment for Cohort II	Diarrhea AEs of all causality, all grade and Grade ≥2 were evaluated in participants in Cohort II. AEs were graded for severity using the NCI-CTCAE, Version 4.0. 95% CI calculated using exact method based on binomial distribution.	First 8 Weeks of Treatment
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II	Diarrhea severity was assessed using the modified-OMDQ. This questionnaire is comprised of 6 questions in total; however, only two items relate to diarrhea symptoms (item 5 and item 6). Symptoms scores were developed for both the full questionnaire and for the diarrhea-only questions for each completed survey. Mucositis questions were transformed to a score range of 0 to 10. Increasing OMDQ values are associated with greater symptom burden. Modified OMDQ completion criteria were defined as completion of all 4 questions (questions 2, 4, 5 and 6). M/T = mouth and throat.	Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up
Percentage of Participants With SDAEI (All Causality, All Grade) in the First 8 Weeks of Treatment for Cohort II	SDAEI of all causality and all grades were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. 95% CI calculated using exact method based on binomial distribution.	First 8 Weeks of Treatment
Percentage of Participants With SDAEI (All Causality, Grade ≥2) in the First 8 Weeks of Treatment for Cohort II	SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. AEs were graded for severity using the NCI-CTCAE, Version 4.0. 95% CI calculated using exact method based on binomial distribution.	First 8 Weeks of Treatment
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II	PROs of HRQoL and disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses "bother". It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if > 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant. Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit.	Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up
Mean Area Under the Plasma Concentration Time Curve From 0 to 24 Hours (AUC0-24) and From 0 to 120 Hours (AUC0-120) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III	AUC0-24 is the area under the plasma concentration-time curve (AUC) from time 0 to 24 hours post-dose. AUC0-120 is the AUC from time 0 to 120 hours post-dose. AUC was calculated by the linear trapezoidal method using a non-compartmental pharmacokinetic (PK) analysis. ng*hr/mL = nanogram hours per milliliter	Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).
Mean Maximum Observed Plasma Concentrations (Cmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III	Cmax was obtained from direct inspection of the data. ng/mL = nanograms per milliliter	Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).
Median Time of Occurrence of Cmax (Tmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III	Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.	Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Receiving Any Concomitant Drug or Non-Drug Treatment for SDAEI, Diarrhea and Mucositis for Cohort I by Treatment Arm, Cohort II, and Cohort III	Medications used concomitantly for SDAEIs, diarrhea and mucositis were evaluated for all participants who received dacomitinib on a continuous basis with a preemptive prophylactic (Cohorts I and II) or as an interrupted dosing regimen (Cohort III).	Screening to the Post-Teatment Follow-Up Visit (at least 28 days and no more than 35 days after the end of dacomitinib treatment due to progression of disease, intolerance to dacomitinib treatment, or participant withdrawal)
Mean AUC From 0 to the End of the Dosing Interval (AUC0-tau) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I	AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 24 hours. AUCtau was calculated by the linear/log trapezoidal method using a non-compartmental PK analysis.	Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
Mean Cmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I	Cmax was obtained from direct inspection of the data.	Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
Median Tmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I	Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.	Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
Mean Apparent Clearance (CL/F) for Dacomitinib on Cycle 2 Day 1 for Cohort I	CL/F was calculated as dose/AUCtau.	Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III	Ctrough was the pre-dose plasma concentration of dacomitinib at steady state obtained from direct inspection of the data. Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics.	Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.
Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III	Ctrough was the pre-dose plasma concentration of the dacomitinib metabolite PF-05199265 at steady state obtained from direct inspection of the data. Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics.	Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 26, 2011
• Primary Completion (ACTUAL): May 18, 2015
• Study Completion (ACTUAL): May 18, 2015

Study Registration Dates

• First Submitted: October 20, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (ESTIMATE): November 6, 2011

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; advanced; previously treated
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Anti-Infective Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline; Alclometasone dipropionate
• Other Study ID Numbers: A7471042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.