Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy
Verified date | February 2019 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.
Status | Completed |
Enrollment | 795 |
Est. completion date | December 27, 2017 |
Est. primary completion date | October 21, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: 1. Diagnosis of advanced stage NSCLC squamous histology. 2. Platinum-based doublet chemotherapy as 1st line treatment of Stage IIIB/IV NSCLC. 3. Eligible to receive 2nd line therapy in the opinion of the investigator. 4. Measurable disease according to RECIST 1.1. 5. Adequate Performance Status. 6. Availability of tumour tissue material for correlative studies. Archived tumour tissue is acceptable. 7. Adequate organ function. 8. Age = 18 years and above. 9. Written informed consent that is consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines. Exclusion criteria: 1. Prior treatment with Epidermal Growth Factor Receptor (EGFR) directed small molecules or antibodies. 2. Radiotherapy within 4 weeks prior to randomization. 3. Active brain metastases . 4. Any other current malignancy or malignancy diagnosed within the past three (3) years (other than basal-cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer). 5. Known pre-existing interstitial lung disease. 6. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom 7. Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug. 8. Women of child-bearing potential and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended. 9. Female patients of childbearing potential (see Section 4.2.3.3) who: 1. are nursing or 2. are pregnant or 3. are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study and/or do not agree to submit to pregnancy testing required by this protocol. 10. Active hepatitis B infection (defined as presence of Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier. 11. Known or suspected active drug or alcohol abuse in the opinion of the investigator. 12. Any contraindications for therapy with afatinib or erlotinib. 13. Known hypersensitivity to erlotinib, afatinib or the excipients of any of the trial drugs. 14. Major surgery within 4 weeks of starting study treatment. 15. Prior participation in an afatinib clinical study, even if not assigned to afatinib. 16. Use of any investigational drug within 4 weeks of randomisation (unless a longer time period is required by local regulations or by the guidelines for the investigational product). 17. Patients without Progression of their lung cancer. |
Country | Name | City | State |
---|---|---|---|
Argentina | Instituto Medico Especializado Alexander Fleming | Ciudad Autonoma de Bs As | |
Argentina | Clínica Colombo S.A. | Cordoba | |
Argentina | Instituto Oncologico de Cordoba | Cordoba | |
Argentina | Centro Oncologico de Rosario | Rosario | |
Argentina | Centro Oncologico CAIPO | San Miguel de Tucuman | |
Austria | Medical University of Innsbruck | Innsbruck | |
Austria | LKH Leoben | Leoben | |
Austria | AKH d. Stadt Linz, Pulmologie | Linz | |
Austria | SMZ Baumgartner Hoehe Otto Wagner Spital | Wien | |
Canada | Kingston General Hospital | Kingston | Ontario |
Canada | Montreal General Hospital - McGill University Health Centre | Montreal | Quebec |
Canada | Royal Victoria Hospital | Montreal | Quebec |
Canada | The Ottawa Hospital | Ottawa | Ontario |
Canada | BC Cancer Agency - Fraser Valley Centre | Surrey | British Columbia |
Chile | Centro Oncologico Antofagasta | Antofagasta | |
Chile | Instituto de Terapias Oncologicas Providencia | Providencia, Santiago | |
Chile | Centro Internacional de Estudios Clinicos - CIEC | Recoleta, Santiago De Chile | |
Chile | Orlandi Oncologia | Vitacura | |
China | Beijing Cancer Hospital | Beijing | |
China | Beijing Hospital | Beijing | |
China | First Hospital of Jilin University | Changchun | |
China | Xiangya Hospital, Central South University | Changsha | |
China | Sun Yat-Sen University Cancer Center | Guangzhou | |
China | Jiangsu Cancer Hospital | Nanjing | |
China | the 81th Hospital of PLA | Nanjing | |
China | Shanghai Chest Hospital | Shanghai | |
China | Shanghai Pulmonary Hospital | Shanghai | |
Denmark | Herlev Hospital | Herlev | |
Denmark | Næstved Sygehus | Næstved | |
Denmark | Odense Universitetshospital | Odense C | |
France | HOP d'Angers | Angers | |
France | INS Bergonié | Bordeaux | |
France | HOP Côte de Nacre | Caen | |
France | HOP de Chauny | Chauny | |
France | HOP Gabriel-Montpied | Clermont Ferrand | |
France | HOP de Creteil, Pneumo, Creteil | Creteil | |
France | HOP Le Mans | Le Mans | |
France | CTR Oscar Lambret, Cancéro, Lille | Lille | |
France | HOP Calmette | Lille | |
France | INS Paoli-Calmettes | Marseille | |
France | HOP Nord | Marseille Cedex 20 | |
France | HOP de Mulhouse, Onco, Mulhouse | Mulhouse | |
France | HOP Cochin | Paris | |
France | HOP Val de Grâce, Onco, Paris | Paris | |
France | INS Jean Godinot, Onco, Reims | Reims | |
France | HOP de Rennes, Pneumo, Rennes | Rennes | |
France | HOP Saint Quentin, Onco, Saint Quentin | Saint Quentin | |
France | HOP Civil | Strasbourg | |
France | HOP Foch | Suresnes | |
France | INS Gustave Roussy | Villejuif | |
Germany | Zentralklinik Bad Berka GmbH | Bad Berka | |
Germany | Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH | Essen | |
Germany | Klinikum Esslingen GmbH | Esslingen | |
Germany | Universitätsklinikum Frankfurt | Frankfurt am Main | |
Germany | Universitätsklinikum Freiburg | Freiburg | |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Lungenklinik Hemer | Hemer | |
Germany | Universitätsklinikum Mannheim GmbH | Mannheim | |
Germany | Universitätsklinikum Münster | Münster | |
Germany | Mathias-Spital Rheine | Rheine | |
Greece | "Hippokratio" Hospital of Athens, 2nd Internal Medicine Clin | Athens | |
Greece | General Hospital of Chest Diseases Sotiria | Athens | |
Greece | University General Hospital of Heraklion | Heraklion | |
Greece | General Hospital of Larissa | Larisa | |
Greece | University Hospital of Larisa, Oncology Clinic | Larisa | |
Greece | Metropolitan Hospital, Oncology Clinic | Neo Faliro, Athens | |
Greece | General Hospital "G. Papageorgiou" | Thessaloniki | |
Hungary | National Koranyi TBC and Pulm. Internal Med. Clinic | Budapest | |
Hungary | Semmelweis University | Budapest | |
Hungary | Institute of Chest Diseases Csongrad County,Dpt. Pulmonology | Deszk | |
Hungary | Pulmonology Institute of Veszprem County, Farkasgyepu | Farkasgyepü | |
Hungary | Aladar Petz County Teaching Hospital, Dept. Pulmonology | Györ | |
Hungary | Lung Hospital of Matra, Dept. Pulmonology | Matrahaza | |
Hungary | Josa Andras Korhaz, Nyiregyhaza | Nyiregyhaza | |
Hungary | University of Pecs, 1st internal Med. Dept., Pulmonology | Pecs | |
Hungary | Pest County Lung Hospital, Department No. 3 | Törökbalint | |
India | Vikram Hospital | Bangalore | |
India | Dr. Kamakshi Memorial Hospital | Chennai | |
India | Sri Ramachandra Medical College & Research Institute | Chennai | |
India | V S Hospital | Chennai | |
India | M.S. Patel Cancer Hospital | Karamsad | |
India | B. P .Poddar Hospital & Medical Research Ltd. | Kolkata, West Bengal | |
India | Tata Memorial Hospital | Mumbai | |
India | Ruby Hall Clinic | Pune | |
Ireland | St James's Hospital | Dublin 8 | |
Italy | P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna | Bologna | |
Italy | ASST di Cremona | Cremona | |
Italy | Spedali Riuniti di Livorno | Livorno | |
Italy | Istituto Nazionale Tumori Fondazione Pascale | Napoli | |
Italy | Istituto Oncologico Veneto IRCCS | Padova | |
Italy | Azienda Ospedaliera di Parma | Parma | |
Italy | Azienda Ospedaliera Universitaria Pisana | Pisa | |
Italy | Istituto Clinico Humanitas | Rozzano (MI) | |
Italy | Ospedale San Vincenzo | Taormina (ME) | |
Italy | Ospedale Molinette, AO Città della Salute e della | Torino | |
Italy | A. O. S. Maria della Misericordia | Udine | |
Korea, Republic of | Chungbuk National University Hospital | Cheongju | |
Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
Korea, Republic of | Gyeongsang National University Hospital | Jinju | |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | The Catholic University of Korea, Seoul St.Mary's Hospital | Seoul | |
Korea, Republic of | The Catholic University of Korea, St.Vincent's Hospital | Suwon | |
Korea, Republic of | Ulsan University Hospital | Ulsan | |
Mexico | Instituto Nacional de Cancerologia | Mexico | |
Mexico | Hospital y Clínica OCA S. A. de C. V. | Monterrey | |
Mexico | Centro Hemato-Oncologico Privado de Toluca S.A. de C.V. | Toluca | |
Netherlands | Jeroen Bosch Ziekenhuis-Hertogenbosch | 's-HERTOGENBOSCH | |
Netherlands | Rijnstate Hospital | Arnhem | |
Netherlands | Amphia Ziekenhuis | Breda | |
Netherlands | Catharina Ziekenhuis | Eindhoven | |
Netherlands | METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht | Maastricht | |
Netherlands | St. Antonius ziekenhuis, locatie Nieuwegein | Nieuwegein | |
Netherlands | Erasmus Medisch Centrum | Rotterdam | |
Portugal | CHUC - Centro Hospitalar e Universitário de Coimbra, EPE | Coimbra | |
Portugal | CHLN, EPE - Hospital de Santa Maria | Lisboa | |
Portugal | IPO Lisboa Francisco Gentil, EPE | Lisboa | |
Portugal | Centro Hospitalar São João,EPE | Porto | |
Portugal | IPO Porto Francisco Gentil, EPE | Porto | |
Portugal | Centro Hospitalar de Vila Nova de Gaia | Vila Nova de Gaia | |
Singapore | Johns Hopkins Singapore International Medical Centre | Singapore | |
Singapore | National Cancer Centre | Singapore | |
Spain | Hospital A Coruña | A Coruña | |
Spain | Hospital Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital Vall d'Hebron | Barcelona | |
Spain | Hospital Clínico San Carlos | Madrid | |
Spain | Hospital La Paz | Madrid | |
Spain | Hospital Regional Universitario de Málaga | Malaga | |
Spain | Hospital Virgen de la Victoria | Malaga | |
Spain | Hospital Clínico de Valencia | Valencia | |
Spain | Hospital Clínico Universitario Lozano Blesa | Zaragoza | |
Taiwan | Buddhist Tzu Chi General Hospital | Chiayi | |
Taiwan | Chang Gung Memorial Hospital Chiayi | Chiayi | |
Taiwan | Kaohsiung Chang Gung Memorial Hospital | Kaohsiung | |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | Taichung Veterans General Hospital | Taichung | |
Taiwan | Koo Foundation Sun Yet-Sen Cancer Center | Taipei | |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Taipe Veterans General Hospital | Taipei | |
Taiwan | Chang Gung Memorial Hospital(TaoYuan) | Taoyuan | |
Turkey | Akdeniz Universitesi Tip Fakultesi | Antalya | |
Turkey | Uludag Universitesi Tip Fakultesi, Bursa | Bursa | |
Turkey | Dicle Universitesi Tip Fakultesi | Diyarbakir | |
Turkey | Gaziantep Univ. Tip Fakultesi Tibbi Onkoloji Bilim Dali | Gaziantep | |
Turkey | Kartal Egitim Ve Arastirma Hastanesi | Istanbul | |
Turkey | Yedikule Gog. Hst. EAH | Istanbul | |
Turkey | Dr.Suat Seren EAH | Izmir | |
Turkey | Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali | Izmir | |
United Kingdom | Queen Elizabeth Hospital | Birmingham | |
United Kingdom | Royal Devon and Exeter Hospital | Exeter | |
United Kingdom | Beatson West of Scotland Cancer Centre | Glasgow | |
United Kingdom | Harrogate District Hospital | Harrogate | |
United Kingdom | Royal Free Hospital | London | |
United Kingdom | The Royal Marsden Hospital | London | |
United Kingdom | Maidstone Hospital, Kent Oncology Centre | Maidstone | |
United Kingdom | Nottingham City Hospital | Nottingham | |
United Kingdom | Scarborough Hospital | Scarborough | |
United Kingdom | The Royal Marsden Hospital | Sutton | |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | Boca Raton Reginl Hospital-Lynn Cancer Institute | Boca Raton | Florida |
United States | Montefiore Medical Center | Bronx | New York |
United States | Montefiore Medical Center | Bronx | New York |
United States | Fletcher Allen Health Care | Burlington | Vermont |
United States | Lahey Clinic | Burlington | Massachusetts |
United States | Ironwood Cancer and Research Centers | Chandler | Arizona |
United States | Blue Ridge Cancer Care | Christiansburg | Virginia |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Mid Ohio Oncology/Hematology, Inc | Columbus | Ohio |
United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
United States | Cancer Center of Cookeville Regional Medical Center | Cookeville | Tennessee |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | Oncology Hematology Associates of Norhtern Pennsylvania, PC | DuBois | Pennsylvania |
United States | Queens Medical Associates | Fresh Meadows | New York |
United States | Memorial Healthcare System | Hollywood | Florida |
United States | University of California | La Jolla | California |
United States | Cancer Care of North Florida, PA | Lake City | Florida |
United States | Commonwealth Hematology-Oncology, PC | Lawrence | Massachusetts |
United States | University of Louisville | Louisville | Kentucky |
United States | West Jefferson General Hospital and Cancer Clinic | Marrero | Louisiana |
United States | Illinois Cancer Specialists | Niles | Illinois |
United States | Virginia Oncology Associates | Norfolk | Virginia |
United States | Paris Cancer Center (PCC), Texas Oncology | Paris | Texas |
United States | Kimmel Cancer Center | Philadelphia | Pennsylvania |
United States | Temple University Cancer Center | Philadelphia | Pennsylvania |
United States | Kaiser Permanente Northwest | Portland | Oregon |
United States | Sutter Medical Group | Sacramento | California |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Cancer Therapy and Research at UTHSCSA | San Antonio | Texas |
United States | Orchard Healthcare Research Inc | Skokie | Illinois |
United States | Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | SUNY Upstate Medical University | Syracuse | New York |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
United States, Argentina, Austria, Canada, Chile, China, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Korea, Republic of, Mexico, Netherlands, Portugal, Singapore, Spain, Taiwan, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1 | Progression Free Survival (PFS) was defined as the time from randomization to disease progression (or death if the patient died before progression) by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). | |
Secondary | Overall Survival | Overall Survival is defined as the time from randomisation to death. It was a key secondary endpoint. | From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). | |
Secondary | Number of Participants With Objective Response According to RECIST 1.1 | A patient with a best overall response of Complete Responder (CR) or Partial Responder (PR) was considered to show objective response to study medication. For patients with an objective response, time to objective response was defined as the time from randomization to the first objective response; duration of objective response was defined as the time from the first objective response to progression (or death if the patient died before progression). Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). | |
Secondary | Number of Participants With Disease Control According to RECIST 1.1 | Disease control was assessed based on Independent Radiologic Review (IRR) and investigator assessment. A patient with a best overall response of CR, PR, or Stable Disease (SD) was considered to have disease control. Patients with no baseline target lesions who had no evidence of disease progression in their non-target lesions and had no new lesions were considered to have disease control. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). | |
Secondary | Tumour Shrinkage | Maximum percentage decrease from baseline in the sum of target lesion diameters following independent review. The change in the size (i.e. the sum of diameters (SOD)) of target lesions from baseline was derived. Tumour shrinkage for each patient was measured (based on Independent Radiologic Review (IRR)) as the minimum SOD of target lesions after randomisation. A negative percentage indicates decrease from baseline; positive numbers indicate an increase of tumour size. The mean maximum decrease from baseline of +5 and +9.4 reflect an average increase in tumour size. Post-baseline mean is adjusted for baseline sum of diameters and race. |
First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). | |
Secondary | Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire | Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the european organization for research and treatment of cancer (eortc) quality of life questionnaire (QLQ-C30) questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at end of treatment (EOT) and follow up prior to clinical assessment. The results displayed show number of patients with improvement in the relevant criteria. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The number of patients that were improved: Change in cough; dyspnoea and pain scores over time. | From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). | |
Secondary | Summary of Time to Deterioration in Coughing, Dyspnoea and Pain. | Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: Time to deterioration. | From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). | |
Secondary | Change in Score Over Time in Coughing,Dyspnoea and Pain | Health related quality of life (HRQoL) was measured with the following multi dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of change in score over time, adjusted for baseline score and race. Questionnaires have items relating to Cough, Dyspnoea and Pain. Overall Scores are transformed to a standardised scale of 0 to 100 with the larger value indicating a worse outcome. A change of (+/-) 10 points is considered to be relevant. The change in cough, dyspnea and pain will be assessed using a mixed effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model (presented as post baseline in data table). Post-baseline mean is adjusted for baseline and race. |
From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). |
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