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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002180-25 | EudraCT Number | ||
| MO40388 | Other Identifier | F.Hoffman-La Roche Ltd |
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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The aim of this clinical trial is to assess the effect of treatment with a monoclonal antibody called atezolizumab in patients diagnosed with a type of lung cancer called malignant pleural mesothelioma. The efficacy (whether the treatment works), safety and tolerability (side effects of treatment) of atezolizumab plus bevacizumab in combination with standard chemotherapy versus bevacizumab in combination with standard chemotherapy will be investigated.
Malignant pleural mesothelioma (MPM) is a rare and aggressive cancer arising from the mesothelial surface of the pleura. In Europe, the incidence is about 20 per million and is almost always caused by asbestos exposure, with a usual lag time of 30 years between exposure and presentation. Patients diagnosed with advanced MPM have limited treatment options, representing a strict unmet need. Despite decades of clinical research, cytotoxic chemotherapy remains one of the few therapeutic options that has been proven to improve survival in advanced MPM in a randomised controlled trial.
The combination of cisplatin and pemetrexed has become standard first-line therapy worldwide for patients who are not suitable for aggressive surgery or in whom chemotherapy is recommended as part of a multimodality regimen. Carboplatin is often substituted for cisplatin, due to simpler and shorter administration and assumption of a more favourable toxicity profile based on experience in other diseases. Patients with MPM have limited treatment options, representing a strict unmet need.
An antibody is a common type of protein usually made in the body in response to a foreign substance. Antibodies attack foreign substances and protect against infection. The two monoclonal antibodies (atezolizumab and bevacizumab) used in this trial are laboratory-produced antibodies. Atezolizumab is engineered to attach to immune cells to stimulate their activity against cancer cells.
Atezolizumab and bevacizumab are both approved by the European Medicines Agency for the treatment of lung and other cancers. The addition of atezolizumab to bevacizumab plus standard chemotherapy for the treatment of MPM is being investigated in this trial.
All participants will receive 4-6 cycles of standard chemotherapy consisting of carboplatin AUC 5 (area under the plasma concentration versus time curve) plus pemetrexed 500mg/m^2 given intravenously, on day 1 of every 3 week cycle for about 12 to 18 weeks.
Participants will be randomly assigned to one of two treatment groups:
Treatment 1
OR
Treatment 2
Participants will continue to receive treatment until disease progression, or until treatment is stopped at the request of the participant or treating doctor, or the participant withdraws consent.
A total of 400 participants from approximately 45 centres in Europe are expected to be included in this trial which will take approximately 6 years to be completed after the first participant is enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab plus chemotherapy | Active Comparator | Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m^2 intravenously on day 1 every 3 weeks |
|
| Atezolizumab plus bevacizumab plus chemotherapy | Experimental | Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m^2 intravenously on day 1 every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Carboplatin belongs to the group of medicines known as alkylating agents. Carboplatin interferes with the growth of cancer cells, which eventually are destroyed. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival is defined as the time from the date of randomisation until death from any cause. Data for patients who are not reported as having died at the date of analysis will be censored at the date when they were last known to be alive. Data for patients without post-baseline information will be censored at the date of randomization (plus 1 day). | From randomization until death from any cause, up to 52 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) According to the mRECIST v1.1 | PFS is defined as the time from the date of randomisation until documented progression (according to the mRECIST v1.1) or death, if progression is not documented. Censoring (for participants without a PFS/death event) will occur at the date of last tumour assessment. Patients without a post-baseline tumour assessment will be censored at the date of randomization (plus 1 day). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enriqueta Felip, MD-PhD | Vall d'Hebron University Hospital | Study Chair |
| Sanjay Popat, PhD, MBBS | Royal Marsden NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Leuven | Leuven | Belgium | ||||
| CHU Liege |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12860938 | Background | Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. doi: 10.1200/JCO.2003.11.136. | |
| 26719230 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezolizumab Plus Bevacizumab Plus Chemotherapy | Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m^2 intravenously on day 1 every 3 weeks |
| FG001 | Bevacizumab Plus Chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jan 18, 2021 | Feb 11, 2026 |
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|
| Pemetrexed | Drug | Pemetrexed is a type of drug known as an anti metabolite. It stops cells making and repairing DNA so they can't grow and multiply. |
|
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| Bevacizumab | Drug | Bevacizumab is an angiogenesis inhibitor. It works by targeting a protein called vascular endothelial growth factor (VEGF) that helps cancers form new blood vessels. By stopping this process, bevacizumab 'suffocates' the blood supply to the cancer, shrinking it and stopping it from growing. |
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| Atezolizumab | Drug | Atezolizumab is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain protein in cancer cells. This helps the immune system to fight against the cancer cells, and helps to slow tumor growth. |
|
|
| From randomization until documented progression (PD) according to mRECIST v1.1 or death from any cause (whichever occurred first), up to 52 months. |
| Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined as the percentage of patients that achieve a best overall response [complete response (CR) or partial response (PR)] evaluated according to the mRECIST v1.1 across all post-randomization time-points until the end of protocol treatment. Confirmation of response will not be required. | From randomization to termination of trial treatment, up to 52 months. |
| Disease Control (DC) at 24 Weeks | Disease Control (DC) is defined as complete or partial response, or disease stabilisation at 24 weeks (+/- 10 days). Patients with no available scan at this time period, but with scan performed before 24 weeks - 10 days and scan performed after 24 weeks + 10 days showing disease control, will be considered as disease control. | From randomization to 24 weeks; participants assessed for treatment response status at 24 weeks. |
| Time to Treatment Failure (TTF) | Time to Treatment Failure (TTF) is defined as the time from the date of randomisation to discontinuation of protocol treatment for any reason (including progression of disease, death, discontinuation of at least one of the drugs consisting the treatment combination due to any reason, such as toxicity or refusal). Censoring will occur at the last follow-up date. | From randomization until discontinuation of protocol treatment for any reason, up to 52 months. |
| Duration of Response (DoR) | Duration of Response (DoR) is defined as the interval from the date of first documentation of objective response (complete response or partial response, according to the mRECIST v1.1) to the date of first documented progression/relapse or death. | From documentation of objective response until the date of first documented progression/relapse or death, up to 52 months. |
| Quality of Life (QoL) | QoL is assessed by the Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso) an 8-item questionnaire including five symptoms associated with mesothelioma (i.e., appetite loss, fatigue, cough, dyspnoea, and pain) and three items addressing symptomatic distress, normal activity, and global QoL. All items are measured by visual analogue scales (VAS) using 100-mm lines to assess the intensity of each item based on patient responses within the time frame of the past day. Each item is assigned an individual score corresponding to the length of the line representing intensity as marked by the patient on a 0-100 scale, with 0 as the best rating (i.e., no symptom distress, no interference with activity level, or best possible health-related quality of life) and 100-mm as the worst rating. The primary QoL endpoint is the change in the LCSS total score (average of all 8 items) from baseline to 12 weeks after treatment start. | From randomization until 12 weeks after treatment start, up to 52 months. |
| Adverse Events | Adverse events, according to CTCAE v5.0. | From randomization to 90 days after the last dose of protocol treatment, up to 52 months. |
| Liège |
| Belgium |
| Unicancer - Institut Bergonie | Bordeaux | France |
| Caen- CHU | Caen | France |
| Le Mans - CHG | Le Mans | France |
| Lyon - Centre Léon Bérard | Lyon | France |
| Hospital Nord | Marseille | France |
| Curie Cancer Center Paris | Paris | France |
| Toulouse - CHU | Toulouse | France |
| Tours - CHU | Tours | France |
| SS Antonio e Biagio e Cesare Arrigo Hospital | Alessandria | Italy |
| IRCCS Instituto Tumori Giovanni Paolo II | Bari | Italy |
| Fondazione IRCCS Istituto Nazionale die Tumori | Milan | Italy |
| Instituto Europeo di Oncologia (IEO) | Milan | Italy |
| AULSS2 Marca Trevigiana Treviso | Treviso | Italy |
| University Hospital of Turin | Turin | Italy |
| Alicante University Hospital ISABIAL | Alicante | Spain |
| ICO Hospitalet | Barcelona | Spain |
| Vall Hebron University Hospital/Vall Hebron Institue Oncology | Barcelona | Spain |
| Puerta de Hierro Hospital | Majadahonda | Spain |
| Hospital Parc Tauli Sabadell | Sabadell | Spain |
| Virgen del Rocio | Seville | Spain |
| Complexo Hospitalario Universitario de Vigo | Vigo | Spain |
| Kantonsspital Aarau | Aarau | Switzerland |
| Istituto Oncologica della Svizzera Italiana | Bellinzona | Switzerland |
| Ferdinando Cerciello | Bern | Switzerland |
| Kantonsspital Graubünden | Chur | Switzerland |
| CHUV | Lausanne | Switzerland |
| Luzerner Kantonsspital | Lucerne | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | Switzerland |
| Kantonsspital Winterthur | Winterthur | Switzerland |
| UniversitätSpital Zürich | Zurich | Switzerland |
| Addenbrooke's Hospital | Cambridge | United Kingdom |
| Clatterbridge Cancer Centre | Liverpool | United Kingdom |
| Guy's and St Thomas' Hospital | London | United Kingdom |
| Royal Marsden Hospital (Fulham Road) | London | United Kingdom |
| Royal Marsden Hospital (Sutton) | London | United Kingdom |
| Kent Oncology Centre | Maidstone | United Kingdom |
| Wythenshawe Hospital | Manchester | United Kingdom |
| Plymouth Hospitals NHS Trust | Plymouth | United Kingdom |
| Weston Park Hospital | Sheffield | United Kingdom |
| Royal Cornwall Hospital | Truro | United Kingdom |
| Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Riviere F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-1414. doi: 10.1016/S0140-6736(15)01238-6. Epub 2015 Dec 21. |
| 23860535 | Background | Ceresoli GL, Zucali PA, Mencoboni M, Botta M, Grossi F, Cortinovis D, Zilembo N, Ripa C, Tiseo M, Favaretto AG, Soto-Parra H, De Vincenzo F, Bruzzone A, Lorenzi E, Gianoncelli L, Ercoli B, Giordano L, Santoro A. Phase II study of pemetrexed and carboplatin plus bevacizumab as first-line therapy in malignant pleural mesothelioma. Br J Cancer. 2013 Aug 6;109(3):552-8. doi: 10.1038/bjc.2013.368. Epub 2013 Jul 16. |
| 26205340 | Background | Melero I, Berman DM, Aznar MA, Korman AJ, Perez Gracia JL, Haanen J. Evolving synergistic combinations of targeted immunotherapies to combat cancer. Nat Rev Cancer. 2015 Aug;15(8):457-72. doi: 10.1038/nrc3973. |
| 26826488 | Background | Soto-Ortiz L, Finley SD. A cancer treatment based on synergy between anti-angiogenic and immune cell therapies. J Theor Biol. 2016 Apr 7;394:197-211. doi: 10.1016/j.jtbi.2016.01.026. Epub 2016 Jan 27. |
| 27571927 | Background | Wallin JJ, Bendell JC, Funke R, Sznol M, Korski K, Jones S, Hernandez G, Mier J, He X, Hodi FS, Denker M, Leveque V, Canamero M, Babitski G, Koeppen H, Ziai J, Sharma N, Gaire F, Chen DS, Waterkamp D, Hegde PS, McDermott DF. Atezolizumab in combination with bevacizumab enhances antigen-specific T-cell migration in metastatic renal cell carcinoma. Nat Commun. 2016 Aug 30;7:12624. doi: 10.1038/ncomms12624. |
| 17534390 | Background | Tsiouris A, Walesby RK. Malignant pleural mesothelioma: current concepts in treatment. Nat Clin Pract Oncol. 2007 Jun;4(6):344-52. doi: 10.1038/ncponc0839. |
| 18227828 | Background | Fennell DA, Gaudino G, O'Byrne KJ, Mutti L, van Meerbeeck J. Advances in the systemic therapy of malignant pleural mesothelioma. Nat Clin Pract Oncol. 2008 Mar;5(3):136-47. doi: 10.1038/ncponc1039. |
| 23977545 | Background | Nowak AK. Chemotherapy for malignant pleural mesothelioma: a review of current management and a look to the future. Ann Cardiothorac Surg. 2012 Nov;1(4):508-15. doi: 10.3978/j.issn.2225-319X.2012.10.05. No abstract available. |
| 29753121 | Background | Armato SG 3rd, Nowak AK. Revised Modified Response Evaluation Criteria in Solid Tumors for Assessment of Response in Malignant Pleural Mesothelioma (Version 1.1). J Thorac Oncol. 2018 Jul;13(7):1012-1021. doi: 10.1016/j.jtho.2018.04.034. Epub 2018 May 9. |
| 33358660 | Derived | Uprety D. CheckMate 743: A Glimmer of Hope for Malignant Pleural Mesothelioma. Clin Lung Cancer. 2021 Mar;22(2):71-73. doi: 10.1016/j.cllc.2020.11.009. Epub 2020 Dec 2. No abstract available. |
Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m^2 intravenously on day 1 every 3 weeks |
| Received at least one dose of trial treatment |
|
| On treatment | Patients who were on treatment at database cut-off for final efficacy analysis: September 01, 2023 |
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| Treatment failures | Atezolizumab plus bevacizumab plus chemotherapy: 109 progressions, 62 toxicities, 9 deaths, 7 investigator decisions, 1 patient decision, 2 other; Bevacizumab plus chemotherapy: 141 progressions, 35 toxicities, 9 deaths, 1 investigator decision, 2 patient decisions, 8 other |
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| Never started treatment |
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| COMPLETED | Patients who were on follow-up at database cut-off for final efficacy analysis: September 01, 2023 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Atezolizumab Plus Bevacizumab Plus Chemotherapy | Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m^2 intravenously on day 1 every 3 weeks |
| BG001 | Bevacizumab Plus Chemotherapy | Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m^2 intravenously on day 1 every 3 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Smoking status | Current smoker: Still smokes cigarettes, Former smoker: Smoked at least 100 cigarettes in the past during the whole life, Never smoker: Smoked 0-99 cigarettes during the whole life. | Count of Participants | Participants |
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| ECOG Performance Status | 0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. | Count of Participants | Participants |
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| Stage | Stage is based on the 8th TNM classification for Malignant Pleural Mesothelioma (American Joint Committee on Cancer) and is categorized here as "IV" (advanced stage) vs "Other" including the following stage categories: I (IA or IB), II, III (IIIA or IIIB). | Count of Participants | Participants |
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| Histology | Count of Participants | Participants |
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| Asbestos exposure | Count of Participants | Participants |
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| PD-L1 TPS% | Count of Participants | Participants |
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| EORTC prognostic score | EORTC PROGNOSTIC SCORE: Curran et al. Journal of Clinical Oncology. 1998 Jan; Vol16:145-152 | Count of Participants | Participants |
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| Mesothelioma risk score (MRS) | Mesothelioma risk score (MRS): Banna et al. Lung Cancer. 2022 Jul; 169:77-83 The risk factors are baseline systemic immune-inflammatory index (good: < 1,250 vs poor: ≥ 1,250) and baseline haemoglobin (good: ≥ LLN vs poor: < LLN) (LLN = 135 for males, LLN = 120 for females)) | Count of Participants | Participants |
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| Medical history | Count of Participants | Participants |
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| 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 | Overall Survival (OS) | Overall survival is defined as the time from the date of randomisation until death from any cause. Data for patients who are not reported as having died at the date of analysis will be censored at the date when they were last known to be alive. Data for patients without post-baseline information will be censored at the date of randomization (plus 1 day). | Efficacy population (Intention-To-Treat cohort of all randomised patients) | Posted | Median | 95% Confidence Interval | months | From randomization until death from any cause, up to 52 months. |
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| Secondary | Progression-free Survival (PFS) According to the mRECIST v1.1 | PFS is defined as the time from the date of randomisation until documented progression (according to the mRECIST v1.1) or death, if progression is not documented. Censoring (for participants without a PFS/death event) will occur at the date of last tumour assessment. Patients without a post-baseline tumour assessment will be censored at the date of randomization (plus 1 day). | Efficacy population (Intention-To-Treat cohort of all randomised patients) | Posted | Median | 95% Confidence Interval | months | From randomization until documented progression (PD) according to mRECIST v1.1 or death from any cause (whichever occurred first), up to 52 months. |
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| Secondary | Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined as the percentage of patients that achieve a best overall response [complete response (CR) or partial response (PR)] evaluated according to the mRECIST v1.1 across all post-randomization time-points until the end of protocol treatment. Confirmation of response will not be required. | Efficacy population (Intention-To-Treat cohort of all randomised patients) | Posted | Count of Participants | Participants | From randomization to termination of trial treatment, up to 52 months. |
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| Secondary | Disease Control (DC) at 24 Weeks | Disease Control (DC) is defined as complete or partial response, or disease stabilisation at 24 weeks (+/- 10 days). Patients with no available scan at this time period, but with scan performed before 24 weeks - 10 days and scan performed after 24 weeks + 10 days showing disease control, will be considered as disease control. | Efficacy population (Intention-To-Treat cohort of all randomised patients) | Posted | Count of Participants | Participants | From randomization to 24 weeks; participants assessed for treatment response status at 24 weeks. |
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| Secondary | Time to Treatment Failure (TTF) | Time to Treatment Failure (TTF) is defined as the time from the date of randomisation to discontinuation of protocol treatment for any reason (including progression of disease, death, discontinuation of at least one of the drugs consisting the treatment combination due to any reason, such as toxicity or refusal). Censoring will occur at the last follow-up date. | Efficacy population (Intention-To-Treat cohort of all randomised patients) | Posted | Median | 95% Confidence Interval | months | From randomization until discontinuation of protocol treatment for any reason, up to 52 months. |
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| Secondary | Duration of Response (DoR) | Duration of Response (DoR) is defined as the interval from the date of first documentation of objective response (complete response or partial response, according to the mRECIST v1.1) to the date of first documented progression/relapse or death. | Patients with objective response | Posted | Median | 95% Confidence Interval | months | From documentation of objective response until the date of first documented progression/relapse or death, up to 52 months. |
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| Secondary | Quality of Life (QoL) | QoL is assessed by the Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso) an 8-item questionnaire including five symptoms associated with mesothelioma (i.e., appetite loss, fatigue, cough, dyspnoea, and pain) and three items addressing symptomatic distress, normal activity, and global QoL. All items are measured by visual analogue scales (VAS) using 100-mm lines to assess the intensity of each item based on patient responses within the time frame of the past day. Each item is assigned an individual score corresponding to the length of the line representing intensity as marked by the patient on a 0-100 scale, with 0 as the best rating (i.e., no symptom distress, no interference with activity level, or best possible health-related quality of life) and 100-mm as the worst rating. The primary QoL endpoint is the change in the LCSS total score (average of all 8 items) from baseline to 12 weeks after treatment start. | QoL cohort: all randomized patients who had baseline assessment and at least one on-treatment post-baseline score for any LCSS-Meso item | Posted | Mean | 95% Confidence Interval | units on a scale | From randomization until 12 weeks after treatment start, up to 52 months. |
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| Secondary | Adverse Events | Adverse events, according to CTCAE v5.0. | Safety population, patients who received at least 1 dose of treatment: 198 in ABC/200 in BC. But, one patient assigned in the BC arm received ABC. For the safety analysis, the patient is evaluated according to the treatment received irrespective of the allocated treatment at randomization (safety population: 199 in each arm). Of note, in the next section, all-cause mortality was assessed for all randomized, while serious adverse events/adverse events were assessed for the safety population. | Posted | Count of Participants | Participants | From randomization to 90 days after the last dose of protocol treatment, up to 52 months. |
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Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
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 | Atezolizumab Plus Bevacizumab Plus Chemotherapy | Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m^2 intravenously on day 1 every 3 weeks | 145 | 200 | 92 | 199 | 197 | 199 |
| EG001 | Bevacizumab Plus Chemotherapy | Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m^2 intravenously on day 1 every 3 weeks | 150 | 200 | 67 | 199 | 197 | 199 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Immune thrombo-cytopenic purpura | Blood and lymphatic system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Asystole | Cardiac disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (v5.0) | Systematic Assessment |
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| Chest pain - cardiac | Cardiac disorders | CTCAE (v5.0) | Systematic Assessment |
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| Heart failure | Cardiac disorders | CTCAE (v5.0) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | CTCAE (v5.0) | Systematic Assessment |
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| Myocarditis | Cardiac disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Colonic perforation | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Gastric hemorrhage | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Typhlitis | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Flu like symptoms | General disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| General clinical conditions worsening | General disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| General status alteration | General disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Generalized edema | General disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Lumbar spine joint range of motion decreased | General disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Autoimmune disorder | Immune system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| COVID-19 infection | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Fungemia | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Infection (unknown source) | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Pleural infection | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Port-a-cath infection | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (v5.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE (v5.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (v5.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (v5.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (v5.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (v5.0) | Systematic Assessment |
| |
| Chronic myeloid leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (v5.0) | Systematic Assessment |
| |
| Prostate adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (v5.0) | Systematic Assessment |
| |
| Small cell neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (v5.0) | Systematic Assessment |
| |
| Urinary bladder nodule (left trigone region) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (v5.0) | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Renal biopsy | Renal and urinary disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Renal toxicity | Renal and urinary disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease (COPD) | Respiratory, thoracic and mediastinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Organized pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Bullous dermatitis | Skin and subcutaneous tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Elective surgery popliteal aneurysm | Surgical and medical procedures | CTCAE (v5.0) | Systematic Assessment |
| |
| Arterial thromboembolism | Vascular disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Peripheral ischemia | Vascular disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Superficial thrombophlebitis | Vascular disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (v5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (v5.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (v5.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (v5.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (v5.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (v5.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Watering eyes | Eye disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| COVID-19 infection | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| GGT increased | Investigations | CTCAE (v5.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Serum amylase increased | Investigations | CTCAE (v5.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (v5.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (v5.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | CTCAE (v5.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE (v5.0) | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (v5.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (v5.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heidi Roschitzki, PhD | ETOP IBCSG Partners Foundation | +41 31 511 94 00 | heidi.roschitzki@etop.ibcsg.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2022 | Feb 11, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| D000068258 | Bevacizumab |
| C000594389 | atezolizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Black |
|
| Former smoker |
|
| Never smoked |
|
| 1 |
|
| Unknown/Missing |
|
| Other |
|
| Non pure epithelioid |
|
| Possible |
|
| No |
|
| Unknown/Missing |
|
| 1-49 |
|
| ≥50 |
|
| Unknown/Missing |
|
| Poor prognosis |
|
| 1-Intermediate |
|
| 2-Poor |
|
| No |
|
The HR for atezolizumab plus bevacizumab plus chemotherapy versus bevacizumab plus chemotherapy is provided. |
| Superiority |
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
| Participants |
|
|
|
Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m^2 intravenously on day 1 every 3 weeks |
|
|
| Counts |
|---|
| Participants |
|
|