- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00818441
Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
19. Dezember 2018 aktualisiert von: Pfizer
A PHASE 2, OPEN-LABEL TRIAL OF DACOMITINIB (PF-00299804) IN SELECTED PATIENTS WITH ADVANCED ADENOCARCINOMA OF THE LUNG
This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
119
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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New Territories, Hongkong
- Department of Clinical Oncology, Tuen Mun Hospital
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Shatin, NT, Hongkong
- Prince of Wales Hospital
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NEW Territories
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Tuen Mun, NEW Territories, Hongkong
- Department of Clinical Oncology, Tuen Mun Hospital
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Tuen Mun, NEW Territories, Hongkong
- Department of Clinical Oncology, Tuen Mun Hospital
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Aichi, Japan, 464-8681
- Aichi cancer center central hospital Thoracic Oncology
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Tokyo
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Koto-Ku, Tokyo, Japan, 135-8550
- The Cancer Institute Hospital of JFCR
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Seoul, Korea, Republik von, 110-744
- Seoul National University Hospital
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Seoul, Korea, Republik von, 120-752
- Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
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Seoul, Korea, Republik von, 135-710
- SamsungMedicalCenter, Sungkyunkwan Univ School of Medicine
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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California
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Orange, California, Vereinigte Staaten, 92868-3298
- University of California, Irvine
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Orange, California, Vereinigte Staaten, 92868
- Chao Family Comprehensive Cancer Center UC Irvine Medical Center
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Pleasant Hill, California, Vereinigte Staaten, 94523
- Bay Area Cancer Research Group, LLC
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Salinas, California, Vereinigte Staaten, 93901
- Pacific Cancer Care
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San Francisco, California, Vereinigte Staaten, 94110
- San Francisco General Hospital
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045
- University of Colorado Hospital
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Aurora, Colorado, Vereinigte Staaten, 80045
- University of Colorado Clinical Trials Office (CTO)
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Florida
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Fort Myers, Florida, Vereinigte Staaten, 33919
- Florida Cancer Specialists
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Maryland
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Bethesda, Maryland, Vereinigte Staaten, 20892
- National Institutes of Health National Cancer Institute
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Vereinigte Staaten, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Brigham & Women's Hospital
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Boston, Massachusetts, Vereinigte Staaten, 02210
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Vereinigte Staaten, 02210
- Dana-Farber Cancer lnstitute
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Missouri
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Springfield, Missouri, Vereinigte Staaten, 65804
- St. John's Hospital,
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New York
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New York, New York, Vereinigte Staaten, 10022
- Memorial Sloan-Kettering Cancer Center
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Stony Brook, New York, Vereinigte Staaten, 11794-9446
- Stony Brook University Medical Center - Cancer Center
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27514
- Investigational Drug Service, Pharmacy Department, UNC Hospitals
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Chapel Hill, North Carolina, Vereinigte Staaten, 27599-7600
- UNC Hospitals, The University of North Carolina at Chapel Hill
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Chapel Hill, North Carolina, Vereinigte Staaten, 27599-2008
- Division of Hemotology/Oncology
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Durham, North Carolina, Vereinigte Staaten, 27710
- Morris Cancer Center
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North Dakota
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Bismarck, North Dakota, Vereinigte Staaten, 58501
- Legacy Pharma Research
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Bismarck, North Dakota, Vereinigte Staaten, 58501
- Mid Dakota Clinic, P.C
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Tennessee
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Chattanooga, Tennessee, Vereinigte Staaten, 37404
- Chattanooga Oncology & Hematology Associates, P.C.
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Nashville, Tennessee, Vereinigte Staaten, 37203 (Administration)
- Sarah Cannon Research Institute
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Nashville, Tennessee, Vereinigte Staaten, 37203(Pharmacy)
- Sarah Cannon Research Institute
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Virginia
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Richmond, Virginia, Vereinigte Staaten, 23230
- Virginia Cancer Institute
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Washington
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Seattle, Washington, Vereinigte Staaten, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, Vereinigte Staaten, 98195
- University of Washington Medical Center
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Advanced adenocarcinoma of lung, measurable disease
- Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
- patients with known EGFR activating mutation regardless of smoking status
- ECOG(Eastern Cooperative Oncology Group) 0-1.
Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy
Exclusion Criteria:
- Active brain metastases
- Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
- known EGFR wild type NSCLC
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Cohort A
Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
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Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose).
In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.
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Experimental: Cohort B
Dacomitinib in patients with HER2 mutated or amplified NSCLC
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Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose).
In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Progression-Free Survival (PFS) at Month 4: Cohort A
Zeitfenster: Baseline up to Month 4
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PFS at Month 4 was defined as percentage of participants who were alive and event free (event defined as progressive disease [PD] or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment.
Documentation of progression was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria.
PD = greater than or equal to (>=) 20 percent (%) increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.
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Baseline up to Month 4
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Progression-Free Survival (PFS) at Month 4: Cohort B
Zeitfenster: Baseline up to Month 4
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PFS at Month 4 was defined as percentage of patients who were alive and event free (event defined as PD or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment.
Documentation of progression was based on RECIST v1.0 criteria.
PD: >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.
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Baseline up to Month 4
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Progression-Free Survival (PFS)
Zeitfenster: Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
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PFS was defined as the time in months from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first.
PFS was calculated as (first event date [if not reached, censored date as the last known event-free date] minus first dosing date plus 1) divided by 30.44.
PD: >= 20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions.
Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria.
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Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
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Best Overall Response (BOR)
Zeitfenster: Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
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BOR: best response recorded from treatment start until disease progression/recurrence based on RECIST v1.0.
Complete Response (CR): disappearance of all lesions.
Partial Response (PR): >=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum of longest diameters, associated to non-progressive disease response for non target lesions.
PD: >=20% increase in sum of longest diameters of target lesions taking as reference smallest sum of longest diameters since treatment start, or appearance of >=1 new lesion, or unequivocal progression in non-target lesions.
Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start.
CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after the initial objective documentation of the response.
SD must have met the SD criteria at least once after start of treatment in a minimum interval of 6 weeks.
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Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
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Duration of Response (DR)
Zeitfenster: Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
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Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first.
Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause [if not reached, censored date] minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44.
DR was calculated for a subgroup of participants with a confirmed objective tumor response.
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Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.
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Overall Survival (OS)
Zeitfenster: Randomization until death or last date known to be alive.
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Time in months from the start of study treatment to date of death due to any cause.
OS was calculated as (the death date or last alive date minus the date of first dose of study medication plus 1) divided by 30.44.
Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
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Randomization until death or last date known to be alive.
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European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score
Zeitfenster: Baseline (Cycle [C]1 Day 1), up to C75
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EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties).
Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent').
For GHS, functional scales, symptom scales and single items, scores were averaged, transformed to 0-100 scale; higher score=better level of functioning/health or greater degree of symptoms.
Improvement was defined as a mean increase from baseline of ≥10 for GHS and functional scales or a mean decrease from baseline of ≤10 for symptom scales.
Worsened was defined as a mean decrease from baseline of ≤10 for GHS and functional scales or a mean increase from baseline of ≥10 for symptom scales.
Stable was a mean change from baseline of <10.
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Baseline (Cycle [C]1 Day 1), up to C75
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European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score
Zeitfenster: Baseline (C1D1) up to C75
|
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week.
The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain ).
Response range: (1) not at all to (4) very much.
Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms.
Results are reported for coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, and other pain.
Improvement was defined as a mean decrease from baseline of ≤10.
Worsened was defined as a mean increase from baseline of ≥10.
Stable was a mean change from baseline of <10.
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Baseline (C1D1) up to C75
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Trough Plasma Concentrations (Ctrough) of Dacomitinib
Zeitfenster: Predose on C1D14, C2D1, C3D1, C4D1
|
Results for Ctrough were summarized as per the dose received during given cycle: no dose (treatment interruption at any cycle due to treatment-related toxicity), dacomitinib 15 mg (dacomitinib 15 mg at any cycle due to treatment-related toxicity at higher doses), 30 mg (dacomitinib 30 mg at any cycle as starting dose or dose reduction due to treatment-related toxicity at higher doses), 45 mg (dacomitinib 45 mg at any cycle as starting dose or dose escalation due to satisfactory toleration of dacomitinib 30 mg treatment).
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Predose on C1D14, C2D1, C3D1, C4D1
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Kris MG, Camidge DR, Giaccone G, Hida T, Li BT, O'Connell J, Taylor I, Zhang H, Arcila ME, Goldberg Z, Janne PA. Targeting HER2 aberrations as actionable drivers in lung cancers: phase II trial of the pan-HER tyrosine kinase inhibitor dacomitinib in patients with HER2-mutant or amplified tumors. Ann Oncol. 2015 Jul;26(7):1421-7. doi: 10.1093/annonc/mdv186. Epub 2015 Apr 21.
- Janne PA, Ou SI, Kim DW, Oxnard GR, Martins R, Kris MG, Dunphy F, Nishio M, O'Connell J, Paweletz C, Taylor I, Zhang H, Goldberg Z, Mok T. Dacomitinib as first-line treatment in patients with clinically or molecularly selected advanced non-small-cell lung cancer: a multicentre, open-label, phase 2 trial. Lancet Oncol. 2014 Dec;15(13):1433-1441. doi: 10.1016/S1470-2045(14)70461-9. Epub 2014 Nov 5.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
11. März 2009
Primärer Abschluss (Tatsächlich)
27. April 2012
Studienabschluss (Tatsächlich)
30. April 2015
Studienanmeldedaten
Zuerst eingereicht
5. Januar 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. Januar 2009
Zuerst gepostet (Schätzen)
7. Januar 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Januar 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
19. Dezember 2018
Zuletzt verifiziert
1. Dezember 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- A7471017
- 2011-002794-39 (EudraCT-Nummer)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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.
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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