Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004481-15 | EudraCT Number | ||
| MO27911 | Other Identifier | Roche |
Not provided
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| Name | Class |
|---|---|
| Spanish Lung Cancer Group | OTHER |
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Rationale:
Advanced non-small-cell lung cancer (NSCLC) patients harbouring epidermal growth factor receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival between 9 and 14 months when treated with erlotinib. However, the presence of EGFR mutations can only imperfectly predict outcome. The investigators hypothesize that progression-free survival could be influenced both by the pretreatment EGFR T790M mutation and by components of DNA repair pathways.
The investigators propose a model of treatment whereby patients with EGFR mutations (single or with T790M) can attain a benefit with longer overall PFS when treated with erlotinib plus bevacizumab. When the patients are grouped by BRCA1 mRNA levels and T790M the hypothesis is that the combination of erlotinib plus bevacizumab can improve the PFS in all subgroups.
Objectives:
Design:
This is a multinational, multi-center phase II trial of erlotinib plus bevacizumab in patients with advanced non-squamous NSCLC harbouring EGFR mutations confirmed by central re-assessment. Patients will be stratified into two subgroups, with and without EGFR T790M mutation. The stratification will be done after the inclusion of patients.
Sample size: 102 patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib plus bevacizumab | Experimental | Patients will be treated with erlotinib and bevacizumab. Bevacizumab: 15 mg/kg i.v. on day 1 of each 3-week cycle (+/- 3 days) Erlotinib: 150 mg p.o., daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Patients will be treated with erlotinib, 150 mg p.o., daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Time from the date of enrollment until an investigator-documented progression or death, whichever occurs first. Assessment of Progressive Disease (PD) is based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | From the date of enrollment until documented progression or death, whichever occurs first, assessed up to 48 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from the date of enrollment until death from any cause. | From the date of enrollment until death, assessed up to 48 months. |
| Time to Treatment Failure | Time from the date of enrollment to discontinuation of treatment for any reason including progression of disease (based on RECIST v1.1), treatment toxicity (adverse events classified according to NCI CTCAE version 4.), refusal and death. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rafael Rosell, MD | Catalan Institute of Oncology, Hospital Germans Trias i Pujol | Study Chair |
| Stahel Rolf, MD | Laboratory of Molecular Oncology, Clinic of Oncology, University Hospital Zuerich | Study Chair |
| Miquel Taron | Medical Oncology Service-ICO, Hospital Germans Trias i Pujol | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Francois Baclesse | Caen | 14000 | France | |||
| Hôpital de Marseille |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15118125 | Background | Paez JG, Janne PA, Lee JC, Tracy S, Greulich H, Gabriel S, Herman P, Kaye FJ, Lindeman N, Boggon TJ, Naoki K, Sasaki H, Fujii Y, Eck MJ, Sellers WR, Johnson BE, Meyerson M. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science. 2004 Jun 4;304(5676):1497-500. doi: 10.1126/science.1099314. Epub 2004 Apr 29. | |
| 22285168 |
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Between June 11, 2012 and Oct 28, 2014, 109 eligible patients were enrolled in 29 centers of eight European countries (Spain, Switzerland, UK, Greece, Italy, Ireland, France and Germany). All patients were included in the efficacy analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | T790M Positive | Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2013 | Jul 2, 2019 |
Not provided
Not provided
Not provided
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Not provided
| Bevacizumab | Drug | Patients will be treated with bevacizumab 15 mg/kg i.v. on day 1 of each 3-week cycle (+/- 3 days) |
|
|
| From the date of enrollment until discontinuation of treatment, assessed up to 48 months. |
| Objective Response | Objective response is defined as best overall response (CR or PR) across all assessment time-points during the period from enrollment to termination of trial treatment. Objective response, along with progressive and stable disease, will be determined using RECIST 1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial. | Assessed across all time-points from enrollment to termination of trial treatment (max 48 months). |
| Disease Control | Disease control is defined as achieving objective response (CR or PR, across all time-points from enrollment to termination of trial treatment) or stable disease for at least 6 weeks. Objective response, along with SD (disease control) and PD (no disease control), will be determined using RECIST 1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial. | Assessed across all time-points from enrollment to termination of trial treatment (max 48 months). |
| Duration of Response | Interval from the date of first documentation of objective response (CR or PR) to the date of first documented progression or relapse. Assessment of Objective response and Progressive Disease (PD) is based on the RECIST 1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial. | Assessed across all time-points from enrollment to to the date of first documented progression or relapse (max 48 months). |
| Adverse Events | Adverse events graded according to NCI CTCAE V4. | Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months). |
| Marseille |
| 13915 |
| France |
| Hospital Grosshansdorf | Großhansdorf | 22927 | Germany |
| Thoraxklinik Heidelberg GmbH | Heidelberg | 69126 | Germany |
| Lungenklinik Hemer | Hemer | 58675 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| University General Hospital of Heraklion | Heraklion | Greece |
| Papageorgias Hospital | Thessaloniki | Greece |
| St Vincent's University Hospital | Dublin | Ireland |
| St. James's Hospital | Dublin | Ireland |
| University Hospital Galway | Galway | Ireland |
| Mid-Western Regional Hospital | Limerick | Ireland |
| AMCCH | Tallaght | Ireland |
| Ospedale San Gerardo | Monza | 20900 | Italy |
| Istituto Oncologico Veneto IRCCS | Padova | 35128 | Italy |
| Casa di Cura Maddalena | Palermo | 90146 | Italy |
| Policlinico Tor Vergata Roma | Roma | 00133 | Italy |
| San Camillo Hospital | Roma | 00151 | Italy |
| Policlinico Umberto | Roma | 00161 | Italy |
| Hospital General Universitario Alicante | Alicante | 03010 | Spain |
| ICO - Hospital Universitari Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital De La Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Vall d'Hebron University Hospital | Barcelona | 08035 | Spain |
| Hospital Clínic Barcelona | Barcelona | 08036 | Spain |
| ICO - Girona | Girona | 17007 | Spain |
| ICO - Hospital Duran i Reynals | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital Clinico Universitario San Carlos | Madrid | 28040 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital General de Valencia | Valencia | 46014 | Spain |
| Hospital La Fe | Valencia | 46026 | Spain |
| University Hospital Basel | Basel | 4031 | Switzerland |
| Istituto Oncologica della Svizzera Italiana | Bellinzona | 6650 | Switzerland |
| Inselspital Bern | Bern | 3010 | Switzerland |
| Geneva University Hospital | Geneva | 1211 | Switzerland |
| Fondation du centre Pluridisciplinaire d'Oncologie (CePO) | Lausanne | 1011 | Switzerland |
| Kantonsspital Luzern | Lucerne | 6016 | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| Onkologiezentrum Berner Oberland | Thun | 3600 | Switzerland |
| Kantonsspital Winterthur | Winterthur | 8401 | Switzerland |
| University Hospital Zurich | Zurich | 8091 | Switzerland |
| Mid Essex Hospital Services NHS Trust | Chelmsford | Essex | CM1 7ET | United Kingdom |
| Queen's Hospital | Burton-on-Trent | DE13 0RB | United Kingdom |
| University Hospitals of Leicester | Leicester | LE1 5WW | United Kingdom |
| Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| Kent Oncology Centre | Maidstone | ME16 9QQ | United Kingdom |
| Christie Hospital Manchester | Manchester | M20 4BX | United Kingdom |
| Wythenshawe Hospital Manchester | Manchester | M23 9LT | United Kingdom |
| Wrexham Maelor Hospital | Wrexham | LL13 7TD | United Kingdom |
| Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre R, Bover I, Illiano A, Dansin E, de Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Munoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskyj A, Queralt C, de Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M, Paz-Ares L; Spanish Lung Cancer Group in collaboration with Groupe Francais de Pneumo-Cancerologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239-46. doi: 10.1016/S1470-2045(11)70393-X. Epub 2012 Jan 26. |
| 15728811 | Background | Kobayashi S, Boggon TJ, Dayaram T, Janne PA, Kocher O, Meyerson M, Johnson BE, Eck MJ, Tenen DG, Halmos B. EGFR mutation and resistance of non-small-cell lung cancer to gefitinib. N Engl J Med. 2005 Feb 24;352(8):786-92. doi: 10.1056/NEJMoa044238. |
| Background | Kabbinavar F, Miller VA, Johnson BE, O'Connor P, Soh C-H, ATLAS Investigators. Overall survival in ATLAS, a Phase IIIb trial comparing bevacizumab therapy +/- erlotinib after completion of chemotherapy with bevacizumab for first-line treatment of locally advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC). J Clin Oncol 2010; 28 (May suppl; abstr 7526). |
| 28408243 | Derived | Rosell R, Dafni U, Felip E, Curioni-Fontecedro A, Gautschi O, Peters S, Massuti B, Palmero R, Aix SP, Carcereny E, Fruh M, Pless M, Popat S, Kotsakis A, Cuffe S, Bidoli P, Favaretto A, Froesch P, Reguart N, Puente J, Coate L, Barlesi F, Rauch D, Thomas M, Camps C, Gomez-Codina J, Majem M, Porta R, Shah R, Hanrahan E, Kammler R, Ruepp B, Rabaglio M, Kassapian M, Karachaliou N, Tam R, Shames DS, Molina-Vila MA, Stahel RA; BELIEF collaborative group. Erlotinib and bevacizumab in patients with advanced non-small-cell lung cancer and activating EGFR mutations (BELIEF): an international, multicentre, single-arm, phase 2 trial. Lancet Respir Med. 2017 May;5(5):435-444. doi: 10.1016/S2213-2600(17)30129-7. Epub 2017 Apr 10. |
| T790M Negative |
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | T790M Positive | Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle). |
| BG001 | T790M Negative | Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Smoking status | Count of Participants | Participants |
| ||||||||||||||||
| Histological diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| ECOG performance status | ECOG Performance status scaling: PS 0:Fully active, able to carry on all pre-disease performance without restriction PS 1:Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work PS 2:Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours PS 3:Capable of only limited self-care, confined to bed or chair more than 50% of waking hours PS 4:Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair | Count of Participants | Participants |
| |||||||||||||||
| Brain metastasis | Count of Participants | Participants |
| ||||||||||||||||
| Type of EGFR mutation | Count of Participants | Participants |
| ||||||||||||||||
| BRCA1 mRNA expression | Count of Participants | Participants |
| ||||||||||||||||
| AEG1 mRNA expression | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival | Time from the date of enrollment until an investigator-documented progression or death, whichever occurs first. Assessment of Progressive Disease (PD) is based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Posted | Median | 95% Confidence Interval | months | From the date of enrollment until documented progression or death, whichever occurs first, assessed up to 48 months. |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | Time from the date of enrollment until death from any cause. | Posted | Median | 95% Confidence Interval | months | From the date of enrollment until death, assessed up to 48 months. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure | Time from the date of enrollment to discontinuation of treatment for any reason including progression of disease (based on RECIST v1.1), treatment toxicity (adverse events classified according to NCI CTCAE version 4.), refusal and death. | Posted | Median | 95% Confidence Interval | months | From the date of enrollment until discontinuation of treatment, assessed up to 48 months. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Objective Response | Objective response is defined as best overall response (CR or PR) across all assessment time-points during the period from enrollment to termination of trial treatment. Objective response, along with progressive and stable disease, will be determined using RECIST 1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial. | Patients with only 1 tumor assessment are classified as "Non-Evaluable", because they cannot be accounted for the Objective Response rate. | Posted | Count of Participants | Participants | Assessed across all time-points from enrollment to termination of trial treatment (max 48 months). |
| |||||||||||||||||||||||||||||||
| Secondary | Disease Control | Disease control is defined as achieving objective response (CR or PR, across all time-points from enrollment to termination of trial treatment) or stable disease for at least 6 weeks. Objective response, along with SD (disease control) and PD (no disease control), will be determined using RECIST 1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial. | Posted | Count of Participants | Participants | Assessed across all time-points from enrollment to termination of trial treatment (max 48 months). |
| ||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Interval from the date of first documentation of objective response (CR or PR) to the date of first documented progression or relapse. Assessment of Objective response and Progressive Disease (PD) is based on the RECIST 1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial. | Posted | Median | 95% Confidence Interval | months | Assessed across all time-points from enrollment to to the date of first documented progression or relapse (max 48 months). |
| |||||||||||||||||||||||||||||||
| Secondary | Adverse Events | Adverse events graded according to NCI CTCAE V4. | Three patients never started treatment (2 lost to follow-up, one from each arm and 1 withdrawal from T790M negative arm). | Posted | Count of Participants | Participants | Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months). |
|
|
Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up).
Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T790M Positive | Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle). | 1 | 36 | 12 | 36 | 36 | 36 |
| EG001 | T790M Negative | Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle). | 0 | 70 | 19 | 70 | 69 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboembolic event | Vascular disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Colonic perforation | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Lung infection | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Nervous system disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Anal hemorrhage | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Bone infection | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Fever | General disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Hepatobiliary disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Hypotension | Vascular disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Seizure | Nervous system disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Sepsis | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Serum amylase increased | Investigations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Fatigue | General disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Alanine aminotransferase increase | Investigations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Aspartate aminotransferase increase | Investigations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Pain | General disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Skin and subcutaneous tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Headache | Nervous system disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Paronychia | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Eye disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Metabolism and nutrition disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Depression | Psychiatric disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Edema limbs | General disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Fever | General disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Nail infection | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Anal hemorrhage | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Dry eye | Eye disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Oral hemorrhage | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Flu like symptoms | General disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | General disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Lung infection | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Nervous system disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Creatinine increased | Investigations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Hematoma | Vascular disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Renal and urinary disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Aphonia | Nervous system disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Other | Blood and lymphatic system disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Rhinitis infective | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Lip infection | Infections and infestations | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Nail discoloration | Skin and subcutaneous tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | NCI CTCAE Version 4. | Systematic Assessment |
| |
| Watering eyes | Eye disorders | NCI CTCAE Version 4. | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heidi Roschitzki-Voser | European Thoracic Oncology Platform (ETOP) | +41 31 511 94 18 | belief@etop-eu.org |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2015 | Jun 26, 2019 | SAP_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
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Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle). |
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