PF-00299804 in Stage IIIB or Stage IV Non-Small Cell Lung Cancer Not Responding to Standard Therapy for Advanced or Metastatic Cancer

A Double Blind Placebo Controlled Randomized Trial of PF-804 in Patients With Incurable Stage IIIB/IV Non-Small Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease

RATIONALE: PF-00299804 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether PF-00299804 is more effective than a placebo in treating patients with advanced non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying PF-00299804 to see how well it works compared with a placebo in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to standard therapy for advanced or metastatic cancer.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: PF-00299804; Drug: Placebo

Detailed Description

OBJECTIVES:

Primary

• To compare overall survival in patients with incurable stage III or IV non-small cell lung cancer receiving PF-00299804 versus placebo after failure of standard therapy for advanced metastatic disease.

Secondary

• To compare overall survival in KRAS-WT patients between the two arms.
• To compare overall survival in EGFR-mutant patients between the two arms.
• To compare progression-free survival between arms.
• To compare objective response rates between arms.
• To estimate time to response and response duration in these patients.
• To evaluate the nature, severity, and frequency of toxicities between arms.
• To compare quality of life between arms.
• To determine the incremental cost-effectiveness and cost-utility ratios for PF-00299804.
• To correlate the expression of tumor and blood markers (at diagnosis) with outcomes and response.

OUTLINE: This is a multicenter study. Patients are stratified according to center, performance status (0 or 1 vs 2 or 3), tobacco use (never vs past or present), best response to prior EGFR tyrosine kinase inhibitor (progressive disease vs other), weight loss (< 5% vs ≥ 5% or unknown), and ethnicity (East Asian vs other). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Blood, serum, plasma, and tissue samples are collected and examined for biomarkers and gene mutations, and may be banked for future studies.

Patients complete quality-of-life questionnaires EORTC QLQ-C30 and other questionnaires at baseline and then periodically during and after completion of study treatment.

Cost effectiveness and cost utility of PF-00299804 is assessed via the Health Utilities Index (EQ-5D) and the Resource Utilization Assessment periodically.

After completion of study treatment, patients are followed at 4 weeks and then every 12 weeks thereafter.

• Study Type: Interventional
• Enrollment (Actual): 720
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina
    • Damic-Fundacion Rusculleda
  • San Miguel de Tucuman, Argentina, T4000IAK
    • Centro Medico San Roque
  • B1878dvb Bs. As.
    • Buenos Aires, B1878dvb Bs. As., Argentina
      • CER - Instituto Medico
  • Provincia De Buenos Aires
    • Berazategui, Provincia De Buenos Aires, Argentina, 01884
      • COIBA Centro de Oncologia e Investigacion
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Kogarah, New South Wales, Australia, 2217
      • St. George Hospital, Cancer Care Centre
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Hospital
    • St. Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital
    • Nambour, Queensland, Australia, 4560
      • Nambour General Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
    • Footscray, Victoria, Australia, 3011
      • Western Hospital
    • Frankston, Victoria, Australia, 3199
      • Frankston Hospital - Peninsula Oncology Centre
    • Geelong, Victoria, Australia, 3220
      • Geelong Hospital
    • Heidelberg, Victoria, Australia, 3084
      • Austin Hospital
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• Brazil
  • Belo Horizonte, Brazil, 30150-270
    • Oxion Hospital Dia Oncologia LTDA - Oxion
  • Centro, Brazil, 98700-000
  • Salvador, Brazil, 40170-110
    • Nucleo de Oncologia da Bahia
  • Sao Paulo, Brazil, 01224-010
    • GRAM - Grupo de Assistencia Medica
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90840-440
      • Centro de Oncologia e Radioterapia (COR) Mae de Deus
  • SP
    • Barretos, SP, Brazil, 14784-400
      • Fundacao Pio XII - Hospital de Cancer de Barretos
    • Porto Alegre, SP, Brazil, 17210-120
      • Centro de Pesquisa Clinica do Hospital
  • Sao Paulo
    • Brasilia, Sao Paulo, Brazil, 01321-001
      • ESHO - Empresa de Servicos Hospitalares Ltda.
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Abbotsford, British Columbia, Canada, V2S 0C2
      • BCCA - Abbotsford Centre
    • Surrey, British Columbia, Canada, V3V 1Z2
      • BCCA - Fraser Valley Cancer Centre
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BCCA - Vancouver Cancer Centre
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Atlantic Health Sciences Corporation
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Dr. H. Bliss Murphy Cancer Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • QEII Health Sciences Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre at Hamilton Health Sciences
    • Kingston, Ontario, Canada, K7L 5P9
      • Cancer Centre of Southeastern Ontario at Kingston
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Program
    • Oshawa, Ontario, Canada, L1G 2B9
      • Lakeridge Health Oshawa
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Health Research Institute - General Division
    • Sault Ste. Marie, Ontario, Canada, P6B 0A8
      • Algoma District Cancer Program
    • St. Catharines, Ontario, Canada, L2S 0A9
      • Niagara Health System
    • Sudbury, Ontario, Canada, P3E 5J1
      • Health Sciences North
    • Toronto, Ontario, Canada, M5G 2M9
      • Univ. Health Network-Princess Margaret Hospital
    • Windsor, Ontario, Canada, N8W 2X3
      • Windsor Regional Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • CHUM - Hopital Notre-Dame
    • Montreal, Quebec, Canada, H2W 1S6
      • McGill University - Dept. Oncology
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre
• Italy
  • Benevento, Italy, 82100
    • U.O. di Oncologia Medica Azienda Ospedaliera G Rummo
  • Fano, Italy, 61032
    • Ospedale Santa Croce
  • Genova, Italy, 16149
    • U.O. di Oncologia Ospedale Villa Scassi
  • Meldola, Italy, 47014
    • Intstituto Scientifico Romangnolo
  • Messina, Italy, 98125
    • U.O.C. Terapie Integrate in Oncologia,
  • Messina, Italy, 98158
    • U.O.C. Oncologia Medica,
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Mirano, Italy, 30035
    • U.O.C. di Oncologia U.L.S.S. 13
  • Napoli, Italy, 80131
    • Dott. Fortunato Ciardiello,Cattedra Oncologia Medica
  • Napoli, Italy, 80131
    • Unita Sperimentazioni Cliniche Istituto per lo
  • Padova, Italy, 35128
    • UOC Oncologia Medica II Instituto Oncologio Veneto
  • Palermo, Italy
    • La Maddalena, Dipartimento Oncologico
  • Piacenza, Italy, 29100
    • Azienda USL di Piacenza, Ospedale Gugliemimo Salieto
  • Rome, Italy, 00152
    • Azienda Ospedaliera S. Camillo-Forlanin
  • Rome, Italy, 00161
    • Policlinico Umberto I, Universita Sapienza
  • San Giovanni Rotondo, Italy, 71013
    • Ospedale Casa Sollievo della Sofferenza
  • Sondalo, Italy, 23039
    • Ospedale E. Morelli-Sondalo
  • PN
    • Aviano, PN, Italy, 33081
      • Centro di Riferimento Oncologico - CRO
  • VA
    • Saronno, VA, Italy, 21047
      • A.O. Busto Arsizio - P.O. Saronno
• Korea, Republic of
  • GyeongGi-Do, Korea, Republic of, 443-721
    • Ajou University Hospital
  • Jeongnam, Korea, Republic of, 519-763
    • Chonnan National University Hwasun Hospital
  • Seoul, Korea, Republic of, 120-752
    • Yonsei University College of Medicine
  • Seoul, Korea, Republic of, 134-791
    • Seoul Veterans Hospital
  • Seoul, Korea, Republic of, 137-701
    • The Catholic University of Korea,
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
• Peru
  • Lima, Peru, 18
    • Hospital Central de la Fuerza Aerea Del Peru
  • Lima, Peru
    • Hospital Nacional Luis N. Saenz
  • Lima, Peru
    • Instituto de Oncologia y Radioterapia de
• Philippines
  • Cebu City, Philippines, 6000
    • Perpetual Succour Hospital
  • Makati City, Philippines, 1229
    • Makati Medical Center
  • Manila, Philippines, 1000
    • Phillippine General Hospital
• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Tainan, Taiwan, 736
    • Chi-Mei Foundation Hospital
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn University
  • Bangkok, Thailand, 10400
    • Ramathibodi hospital
  • Bangkok, Thailand, 10700
    • Siriraj Hospital, Oncology Unit
  • Chiangmai, Thailand, 50200
    • Maharaj Nakorn Chiangmai Hospital
• United States
  • California
    • Arcadia, California, United States, 91007
      • Shapiro, Stafford and Yee
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Clintell, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Eligibility Criteria

• Histologically confirmed diagnosis of non-small cell carcinoma of the lung. Patients must have an adequate histopathology or cytology specimen must consent to release of all specimens for this protocol, and the centre/pathologist must have agreed to submission of the specimens.
• Patients must have evidence of disease, but measurable disease is not mandatory. To be considered evaluable for complete or partial response assessment, patients must have at least one measurable lesion as follows:

X-ray ≥ 20 mm Spiral CT scan or physical exam ≥ 10 mm (lymph nodes must be ≥ 15 mm in the short axis); Measurable lesions must be outside a previous radiotherapy field if they are the sole site of disease, unless disease progression has been documented.

• Male or female, 18 years of age or older.
• ECOG performance status of 0, 1, 2 or 3. Patients with performance status of 3 are eligible providing that the investigator attests that the patient has a reasonable life expectancy (≥ 6 weeks).
• Adequate renal and hepatic functions as defined by the following required laboratory values obtained within 14 days prior to randomization. If anemic, patients should be asymptomatic and should not be decompensated.

Creatinine <1.5 upper limit of normal Total bilirubin < 1.5 upper limit of normal ALT (SGPT) < 2.5 times the upper limit of normal. Note: If clearly attributable to liver metastasis, ALT (SGPT) values < 5 times the upper limit of normal are permitted.

- Previous Therapy Failure of a treatment regimen is defined as the inability to continue a regimen for any reason including, but not limited to, progressive disease, toxicity, or patient request. Up to a maximum of three lines of chemotherapy for advanced/metastatic disease (defined below) and at least one of erlotinib or gefitinib for advanced/ metastatic disease (defined below) should have failed.

Exchange of one chemotherapy agent for another within a combination chemotherapy regimen is not considered a new regimen in the following circumstances

• carboplatin is substituted for cisplatin due to nephrotoxicity
• one agent in the combination regimen is changed due to hypersensitivity occurring in the first cycle.

Chemotherapy for Advanced/Metastatic Disease:

Patients must have recovered from any reversible toxic effects and at least 21 days must have elapsed from the last dose and prior to randomization (14 days from the last dose for chemotherapy regimens administered on a weekly schedule). Further palliative cytotoxic chemotherapy must not be planned.

Patients < 70 years:

• Must have received 1 and up to a maximum of 3prior chemotherapy regimens (at least one of the three must have been a combination regimen and at least one must have contained platinum).

Patients ≥ 70 years (generally accepted as being at the time of the administration of the first regimen of chemotherapy for advanced disease):

• Must have received 1 and up to a maximum of 3 prior chemotherapy regimens for their disease. These may have been single agent chemotherapy regimens and a platinum agent is not required in keeping with current standards of practice.

Adjuvant Chemotherapy: Patients may ALSO have had prior adjuvant therapy for completely resected disease, providing completed at least 12 months prior to randomization. Adjuvant regimens < 12 months prior to randomization and combined chemotherapy/radiation regimens for irresectable locally advanced stage III disease (irrespective of timing), are considered to be for advanced/metastatic disease and constitute one of the 3 permissible regimens. Patients must have recovered from any reversible treatment related toxicities prior to randomization.

EGFR Inhibitor Therapy: Patients may only be enrolled after failure of prior gefitinib or erlotinib for advanced or metastatic disease. Patients who have received adjuvant gefitinib or erlotinib for completely resected NSCLC and who have recurred < 12 months after discontinuing erlotinib or gefitinib are eligible. Patients who received gefitinib or erlotinib for neoadjuvant therapy only are not eligible. EGFR inhibitor therapy must have been discontinued at least 21 days prior to randomization. Patients who discontinued prior gefitinib or erlotinib therapy for severe or life threatening organ toxicity are not eligible. Patients may also have received other EGFR active agents (such as reversible oral agents or monoclonal antibodies or vaccines) in addition to erlotinib or gefitinib but may not have received ANY prior irreversible EGFR inhibitor such as BIBW2992, HKI-272 (neratinib).

Maintenance Therapy: The same chemotherapy or agent/s continued for longer than 4-6 cycles for the purposes of 'maintenance' is considered one regimen; if another chemotherapy agent is given with 'maintenance' intent, it is considered a second regimen providing that 'failure' is documented. Patients who received erlotinib or gefitinib with 'maintenance' intent after completion of 1st line chemotherapy are eligible providing that 'failure' is documented.

Radiation: Patients may have had prior radiation therapy provided that a minimum of 14 days has elapsed between the end of radiotherapy and randomization onto the study. (Exceptions may be made however, for low dose, non-myelosuppressive radiotherapy. Patients must have recovered from any acute toxic effects from radiation prior to randomization.

Previous Surgery: Previous surgery is permitted provided that wound healing has occurred and at least 14 days have elapsed (major surgery).

• Patient able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires. The baseline assessment must already have been completed. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.
• Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
• Patients must be accessible for treatment and follow-up. All randomized patients must be followed and treated at participating centres. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
• In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient randomization.

Ineligibility Criteria

Patients who fulfill any of the following criteria are not eligible for admission to the study:

• Patients receiving concurrent treatment with other experimental drugs or anti-cancer therapy.
• Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF > 50%.
• Patients with untreated brain or meningeal metastases are not eligible (CT scans are not required to rule this out unless there is a clinical suspicion of CNS disease). Patients with treated CNS disease who have radiologic or clinical evidence of stable brain metastases, with no evidence of cavitation or hemorrhage in the brain lesion, are eligible providing that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to randomization).

• Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol, including

  • Severe dry eye syndrome
  • Keratoconjunctivitis sicca
  • Sjogren's syndrome
  • Severe exposure keratopathy
  • Disorders that might increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, neutrophilic keratitis)
  • Uncontrolled inflammatory gastrointestinal diseases (Crohn's, ulcerative colitis etc.)
  • Prior pneumonitis/ILD secondary to EGFR inhibitors
• Mean QTc with Bazetts correction > 470msec in screening ECG or history of familial long QT syndrome.
• Drugs that are highly dependent on CYP2D6 for metabolism are prohibited, since PF-804 is a potent CYP2D6 inhibitor in in vitro assays. These inhibitors or inducers are prohibited from 7 days prior to the first dose until the end of treatment with PF-804. These include: S-metoprolol, propafenone, timolol, amitriptyline, clomipramine, desipramine, imipramine, paroxetine, haloperidol, risperidone, thioridazine, codeine, flecainide, mexilletine, tamoxifen, venlafaxine. Lidocaine may be used with clinical monitoring (including telemetry). Opiates such as morphine, oxycodone, dihydrocodeine, hydrocodone, and tramadol can be used as substitutes to replace codeine. Use of these opiates should be monitored for altered analgesia during treatment with PF-804 as they may be partly metabolized by CYP2D6. If PF-804 is administered with drugs which are P-glycoprotein (P-gp) substrates and have a narrow therapeutic index, monitoring for exaggerated effect and/or toxicities is recommended.
• Pregnancy or inadequate contraception. Women must be post-menopausal, surgically sterile, or use two reliable forms of contraception. Women of child-bearing potential must have a pregnancy test taken and proven negative within 7 days prior to randomization. Men must be surgically sterile or use a barrier method of contraception.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PF-00299804; Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.	Drug: PF-00299804; PF-804 45 mg PO, daily
Placebo Comparator: Placebo; Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.	Drug: Placebo; Placebo 45 mg PO, daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Median and 95% confidence intervals	42 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival in KRAS-WT Patients	Median and 95% confidence intervals of Overall survival in KRAS-WT patients	42 Months
Overall Survival in EGFR-mutant Patients	Overall survival by EGFR-mutantion subgroups	42 Months
Progression-free Survival	progression were evaluated using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee	42 Months
Objective Response Rate	Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported.Objective response rate is the sum of CR + PR divided by the total number of patients in each group.	42 months
Number of Participants With Toxicity as Measured by NCI CTCAE Version 4.0	Number of participants with Toxicities by treatment received according to NCI CTCAE version 4.0	42 Months

Collaborators and Investigators

• Sponsor: NCIC Clinical Trials Group
• Collaborators: Pfizer
• Investigators: Study Chair: Penny Bradbury, MD, NCIC Clinical Trials Group; Study Chair: Michael Millward, MD, Sir Charles Gairdner Hospital - Nedlands; Study Chair: Peter Ellis, MD, Margaret and Charles Juravinski Cancer Centre

Publications and helpful links

General Publications

• Ellis PM, Shepherd FA, Millward M, Perrone F, Seymour L, Liu G, Sun S, Cho BC, Morabito A, Leighl NB, Stockler MR, Lee CW, Wierzbicki R, Cohen V, Blais N, Sangha RS, Favaretto AG, Kang JH, Tsao MS, Wilson CF, Goldberg Z, Ding K, Goss GD, Bradbury PA; NCIC CTG; Australasian Lung Cancer Trials Group; NCI Naples Clinical Trials Unit. Dacomitinib compared with placebo in pretreated patients with advanced or metastatic non-small-cell lung cancer (NCIC CTG BR.26): a double-blind, randomised, phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1379-88. doi: 10.1016/S1470-2045(14)70472-3. Epub 2014 Oct 15.
• Martin P, Shiau CJ, Pasic M, Tsao M, Kamel-Reid S, Lin S, Tudor R, Cheng S, Higgins B, Burkes R, Ng M, Arif S, Ellis PM, Hubay S, Kuruvilla S, Laurie SA, Li J, Hwang D, Lau A, Shepherd FA, Le LW, Leighl NB. Clinical impact of mutation fraction in epidermal growth factor receptor mutation positive NSCLC patients. Br J Cancer. 2016 Mar 15;114(6):616-22. doi: 10.1038/bjc.2016.22. Epub 2016 Feb 18.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2009
• Primary Completion (Actual): January 15, 2014
• Study Completion (Actual): November 27, 2015

Study Registration Dates

• First Submitted: October 21, 2009
• First Submitted That Met QC Criteria: October 21, 2009
• First Posted (Estimated): October 22, 2009

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
• 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
• Other Study ID Numbers: BR26; CAN-NCIC-BR26 (Other Identifier: PDQ); PFIZER-CAN-NCIC-BR26 (Other Identifier: Pfizer); CDR0000657246 (Other Identifier: PDQ)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No