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| Name | Class |
|---|---|
| Exelixis | INDUSTRY |
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This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab given in combination with cabozantinib compared with docetaxel monotherapy in patients with metastatic NSCLC, with no sensitizing EGFR mutation or ALK translocation, who have progressed following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab + Cabozantinib | Experimental | Participants received atezolizumab on Day 1 of each 21-day cycle and cabozantinib orally once daily on Days 1-21 of each cycle. |
|
| Docetaxel | Active Comparator | Participants received docetaxel on Day 1 of each 21-day cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabozantinib | Drug | Cabozantinib will be administered orally, once daily at a dose of 40 mg on Days 1-21 of each cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. Participants alive at the time of the analysis were censored at the date when they were last known to be alive as documented by the investigator. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley. | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) as Determined by Investigator | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1), or death from any cause (whichever occurred first). PD was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters of the target lesions recorded since the treatment started, including screening, or the appearance of one or more new lesions. In addition, the sum of diameters also demonstrated an absolute increase of ≥ 5 millimeters (mm). Participants who were alive and did not experience PD at the time of analysis, were censored on the date of last tumor assessment. Participants with no post-baseline tumor assessment were censored at the date of randomization. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States | ||
| Kaiser Permanente - San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38552197 | Derived | Neal J, Pavlakis N, Kim SW, Goto Y, Lim SM, Mountzios G, Fountzilas E, Mochalova A, Christoph DC, Bearz A, Quantin X, Palmero R, Antic V, Chun E, Edubilli TR, Lin YC, Huseni M, Ballinger M, Graupner V, Curran D, Vervaet P, Newsom-Davis T. CONTACT-01: A Randomized Phase III Trial of Atezolizumab + Cabozantinib Versus Docetaxel for Metastatic Non-Small Cell Lung Cancer After a Checkpoint Inhibitor and Chemotherapy. J Clin Oncol. 2024 Jul 10;42(20):2393-2403. doi: 10.1200/JCO.23.02166. Epub 2024 Mar 29. | |
| 34409776 |
| Label | URL |
|---|---|
| Related Info | View source |
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Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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Participants were randomized in a 1:1 ratio to receive either docetaxel monotherapy or atezolizumab & cabozantinib combination therapy. A total of 14 participants did not receive any study treatment and were therefore excluded from the safety analysis.
A total of 366 participants with metastatic non-small cell lung cancer (NSCLC) previously treated with anti-programmed death ligand 1/programmed cell death protein 1 (PD-L1/PD-1) antibody and platinum-containing chemotherapy took part in the study at 97 investigative sites across 15 countries from 01 October 2020 to 17 January 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel Monotherapy | Participants received docetaxel, 75 milligrams per square meter (mg/m^2), intravenously (IV) on Day 1 of each 21-day cycle until unacceptable toxicity or disease progression (PD) or loss of clinical benefit as determined by the investigator. |
| FG001 | Atezolizumab + Cabozantinib |
| 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 | Mar 22, 2023 | Sep 26, 2023 |
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| Atezolizumab | Drug | Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle. |
|
|
| Docetaxel | Drug | Docetaxel will be administered by IV infusion at a starting dose of 75mg/m2 on Day 1 of each 21-day cycle. |
|
| Up to approximately 24 months |
| Confirmed Objective Response Rate (ORR) as Determined by Investigator | Confirmed ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to RECIST v1.1. CR= disappearance of all target lesions. In addition, any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR= at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. 95% CIs for rates were constructed using the Clopper-Pearson method. Percentages have been rounded off. | Up to approximately 24 months |
| Duration of Response (DOR) as Determined by Investigator | DOR for participants with confirmed ORR=time from first documented objective response to PD, as determined by investigator per RECIST v1.1, or death from any cause (whichever occurred first). PD=≥ 20% increase in sum of longest diameters of target lesions, taking as reference smallest sum of longest diameters of target lesions recorded since treatment started, including screening, or appearance of new lesions. In addition, sum of diameters also demonstrated an absolute increase of ≥ 5 mm. Confirmed ORR=percentage of participants with a CR or PR on two consecutive occasions ≥4 weeks apart, as determined by investigator per RECIST v1.1. CR= disappearance of all target lesions. PR=≥ 30% decrease in sum of diameters of all target lesions. Participants who had not progressed and who did not die at the time of analysis were censored at the time of last tumor assessment date. Kaplan-Meier method was used to estimate median. 95% CI for median was computed using Brookmeyer and Crowley method. | Up to approximately 24 months |
| Time to Confirmed Deterioration (TTCD) in Patient-reported Physical Functioning (PF) | TTCD analyses was performed for patient-reported PF (items 1 to 5) of European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30). The PF was measured on 4-point scale (1='Not at all' to 4='Very much'). TTCD for PF was defined as time from date of randomization to first confirmed clinically meaningful decrease from baseline in PF score held for at least 2 consecutive assessments or initial clinically meaningful decrease from baseline followed by death from any cause within 21 days or until next tumor assessment, whichever occurs first. A score change of ≥ of 10-point on EORTC QLQ-C30 PF scale was determined as being clinically meaningful. Scores were averaged, transformed to 0-100 scale; where higher score represented high/healthy level of functioning. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley. | Up to approximately 24 months |
| TTCD in Patient-reported Global Health Status (GHS) | TTCD analyses was performed for GHS and quality of life (QoL) (items 29 and 30) of EORTC QLQ-C30. GHS/ QoL items were scored on a 7-point scale that ranges from "very poor" to "excellent." TTCD for GHS/QoL was defined as the time from the date of randomization to the first confirmed clinically meaningful decrease from baseline in GHS/QoL score held for at least two consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 21 days or until the next tumor assessment, whichever occurs first. A score change of ≥ 10-point on the EORTC QLQ-C30 GHS/QoL scale was determined as being clinically meaningful. Scores were averaged, transformed to 0-100 scale; where higher score for GHS/QoL= better health-related QoL. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley. | Up to approximately 24 months |
| PFS Rates Assessed by Investigator | PFS rates were defined as the percentage of participants alive and without PD as assessed by the investigator according to RECIST v1.1 at 6 months and 1 year after randomization. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints, including baseline. In addition, the sum of diameters also demonstrated an absolute increase of ≥ 5 mm. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley. Percentages have been rounded off. | 6 months and 1 year |
| OS Rates | OS rates were defined as the percentage of participants who were alive at 1 and 2 years. Participants alive at the time of the analysis were censored at the date when they were last known to be alive as documented by the investigator. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley. Percentages have been rounded off. | 1 and 2 years |
| Percentage of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any of the following: unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; any new disease or exacerbation of an existing disease; recurrence of an intermittent medical condition not present at baseline; any deterioration in a laboratory value or other clinical test; AEs related to a protocol-mandated intervention. AEs were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v5.0). Percentages have been rounded off. | Up to approximately 41.4 months |
| Minimum Serum Concentration (Cmin) of Atezolizumab | Predose on Day 1 of Cycles 1, 2, 3, 4, 8, 12 and 16 (Cycle= 21 days) |
| Maximum Serum Concentration (Cmax) of Atezolizumab | 30 minutes (min) postdose on Day 1 of Cycle 1 (Cycle= 21 days) |
| Minimum Plasma Concentration (Cmin) of Cabozantinib | Predose on Day 1 of Cycles 1, 2, 3, 4, and 5 (Cycle= 21 days) |
| Maximum Plasma Concentration (Cmax) of Cabozantinib | Predose on Day 1 of Cycles 1, 2, 3, 4, and 5 (Cycle= 21 days) |
| Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response). The total number of participants who developed ADAs to atezolizumab was determined by summing the ADA-positive participants across all timepoints. | Pre-dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 and post-treatment follow-up (≤ 30 days after final dose) (Cycle= 21 days) |
| San Diego |
| California |
| 92120 |
| United States |
| Sansum Clinic | Santa Barbara | California | 93105 | United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80220 | United States |
| Regional Cancer Care Associates | Bethesda | Maryland | 20817 | United States |
| Minnesota Oncology Hematology | Saint Paul | Minnesota | 55102 | United States |
| Consultants in Medical Oncology and Hematology | Broomall | Pennsylvania | 19008 | United States |
| Charleston Oncology, P .A | Charleston | South Carolina | 29414 | United States |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Huntsman Cancer Institute at The University of Utah | Salt Lake City | Utah | 84112 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg | Blacksburg | Virginia | 24060 | United States |
| Virginia Cancer Specialists (Fairfax) - USOR | Fairfax | Virginia | 22031 | United States |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Townsville Hospital | Townsville | Queensland | 4810 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Austin Hospital Olivia Newton John Cancer Centre | Heidelberg | Victoria | 3084 | Australia |
| Affinity Oncology | Nedlands | Western Australia | 6009 | Australia |
| Lkh-Univ. Klinikum Graz | Graz | 8036 | Austria |
| Ordensklinikum Linz Elisabethinen | Linz | 4020 | Austria |
| Lhk Feldkirch | Rankweil | 6830 | Austria |
| Lkh Salzburg - Univ. Klinikum Salzburg | Salzburg | 5020 | Austria |
| Medizinische Universität Wien | Vienna | 1090 | Austria |
| Institut Jules Bordet | Anderlecht | 1070 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| Clinique Ste-Elisabeth | Namur | 5000 | Belgium |
| CHU Angers,Service de Pneumologie | Angers | 49933 | France |
| CHU de Grenoble | Grenoble | 38043 | France |
| Hopital Dupuytren | Limoges | 87042 | France |
| Hôpital Saint Joseph | Marseille | 13285 | France |
| Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque | Montpellier | 34298 | France |
| Hopital Tenon | Paris | 75970 | France |
| Zentralklinik Bad Berka GmbH | Bad Berka | 99437 | Germany |
| Klinikum Koeln-Merheim | Cologne | 51109 | Germany |
| Universitaetsklinikum Giessen und Marburg GmbH | Giessen | 35392 | Germany |
| KRH Klinikum Siloah-Oststadt-Heidehaus | Hanover | 30459 | Germany |
| Universitaetsklinikum Giessen und Marburg | Marburg | 35043 | Germany |
| Brüderkrankenhaus St. Josef Paderborn | Paderborn | 33098 | Germany |
| Uoa Sotiria Hospital | Athens | 115 27 | Greece |
| Henri Dunant Hospital | Athens | 11526 | Greece |
| Univ General Hosp Heraklion | Heraklion | 711 10 | Greece |
| Euromedical General Clinic of Thessaloniki | Thessaloniki | 546 45 | Greece |
| Ospedale Vito Fazzi | Lecce | Apulia | 73100 | Italy |
| AORN Ospedali dei Colli Ospedale Monaldi | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | Emilia-Romagna | 43100 | Italy |
| Ospedale Provinciale Santa Maria Delle Croci | Ravenna | Emilia-Romagna | 48100 | Italy |
| Irccs Centro Di Riferimento Oncologico (CRO) | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Rome | Lazio | 00151 | Italy |
| Policlinico Umberto I, Oncologia B | Rome | Lazio | 00161 | Italy |
| IRCCS AOU San Martino - IST | Genoa | Liguria | 16132 | Italy |
| ASST Spedali Civili di Brescia | Brescia | Lombardy | 25123 | Italy |
| Instituto Europeo di Oncologia | Milan | Lombardy | 20141 | Italy |
| A.O.U Careggi | Florence | Tuscany | 50124 | Italy |
| Hyogo Cancer Center | Hyōgo | 673-0021 | Japan |
| Sendai Kousei Hospital | Miyagi | 981-0914 | Japan |
| Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| Centrum Onkologii im. Prof. Franciszka ?ukaszczyka | Bydgoszcz | 85-796 | Poland |
| SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4 | Bytom | 41-902 | Poland |
| Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice | Gliwice | 44-101 | Poland |
| Szpital Wojewódzki im. Miko?aja Kopernika | Koszalin | 75-581 | Poland |
| Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy | Otwock | 05-400 | Poland |
| Centro Hospitalar do Porto ? Hospital de Santo António | Porto | 4099-001 | Portugal |
| Hospital CUF Porto | Porto | 4100-180 | Portugal |
| IPO do Porto | Porto | 4200-072 | Portugal |
| CHVNG/E_Unidade 1 | Vila Nova de Gaia | 4434-502 | Portugal |
| MEDSI Clinical Hospital on Pyatnitsky Highway | Moscow | Moscow Oblast | 143422 | Russia |
| GBUZ Leningradskaya state clinical hospital | Saint Petersburg | Sankt-Peterburg | 194291 | Russia |
| S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Regional Clinical Oncology Hospital | Yaroslavl | Yaroslavl Oblast | 150054 | Russia |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| St. Vincent's Hospital | Gyeonggi-do | 16247 | South Korea |
| Ajou University Medical Center | Gyeonggi-do | 16499 | South Korea |
| Samsung Changwon Hospital | Gyeongsangnam-do | 51353 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13605 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| Ulsan University Hosiptal | Ulsan | 44033 | South Korea |
| Complejo Hospitalario Universitario A Coruña (CHUAC) | A Coruña | 15006 | Spain |
| Institut Catala d Oncologia Hospital Duran i Reynals | L'Hospitalet de LLobegat | 08908 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Univ. Nuestra Señora de Valme | Seville | 41014 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 OYN | United Kingdom |
| Barts & London School of Med | London | EC1A 7BE | United Kingdom |
| University College London Hospital | London | NW1 - 2PG | United Kingdom |
| Chelsea & Westminster Hospital | London | SW10 9NH | United Kingdom |
| Derived |
| Xing P, Wang M, Zhao J, Zhong W, Chi Y, Xu Z, Li J. Study protocol: A single-arm, multicenter, phase II trial of camrelizumab plus apatinib for advanced nonsquamous NSCLC previously treated with first-line immunotherapy. Thorac Cancer. 2021 Oct;12(20):2825-2828. doi: 10.1111/1759-7714.14113. Epub 2021 Aug 18. |
Participants received atezolizumab, 1200 milligrams (mg), IV, on Day 1 of each 21-day cycle along with cabozantinib, 40 mg, orally, given once a day (QD) on Days 1-21 of each cycle until unacceptable toxicity, PD, or loss of clinical benefit as determined by the investigator. |
| Safety-evaluable Population | Safety-evaluable population included all randomized participants who had received any amount of study drug, with participants grouped according to the actual treatment received. |
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| COMPLETED |
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| NOT COMPLETED |
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The Intent-to-treat (ITT) population included all randomized participants, whether or not the participant received the assigned treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel Monotherapy | Participants received docetaxel, 75 mg/m^2, IV on Day 1 of each 21-day cycle until unacceptable toxicity or PD or loss of clinical benefit as determined by the investigator. |
| BG001 | Atezolizumab + Cabozantinib | Participants received atezolizumab, 1200 mg, IV, on Day 1 of each 21-day cycle along with cabozantinib, 40 mg, orally, given QD on Days 1-21 of each cycle until unacceptable toxicity, PD, or loss of clinical benefit as determined by the investigator. |
| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. Participants alive at the time of the analysis were censored at the date when they were last known to be alive as documented by the investigator. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley. | The ITT population included all randomized participants, whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 24 months |
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| Secondary | Progression-Free Survival (PFS) as Determined by Investigator | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1), or death from any cause (whichever occurred first). PD was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters of the target lesions recorded since the treatment started, including screening, or the appearance of one or more new lesions. In addition, the sum of diameters also demonstrated an absolute increase of ≥ 5 millimeters (mm). Participants who were alive and did not experience PD at the time of analysis, were censored on the date of last tumor assessment. Participants with no post-baseline tumor assessment were censored at the date of randomization. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley. | The ITT population included all randomized participants, whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 24 months |
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| Secondary | Confirmed Objective Response Rate (ORR) as Determined by Investigator | Confirmed ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to RECIST v1.1. CR= disappearance of all target lesions. In addition, any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR= at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. 95% CIs for rates were constructed using the Clopper-Pearson method. Percentages have been rounded off. | The ITT population included all randomized participants, whether or not the participant received the assigned treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 24 months |
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| Secondary | Duration of Response (DOR) as Determined by Investigator | DOR for participants with confirmed ORR=time from first documented objective response to PD, as determined by investigator per RECIST v1.1, or death from any cause (whichever occurred first). PD=≥ 20% increase in sum of longest diameters of target lesions, taking as reference smallest sum of longest diameters of target lesions recorded since treatment started, including screening, or appearance of new lesions. In addition, sum of diameters also demonstrated an absolute increase of ≥ 5 mm. Confirmed ORR=percentage of participants with a CR or PR on two consecutive occasions ≥4 weeks apart, as determined by investigator per RECIST v1.1. CR= disappearance of all target lesions. PR=≥ 30% decrease in sum of diameters of all target lesions. Participants who had not progressed and who did not die at the time of analysis were censored at the time of last tumor assessment date. Kaplan-Meier method was used to estimate median. 95% CI for median was computed using Brookmeyer and Crowley method. | Participants in the ITT population who had a confirmed objective response (CR or PR) as determined by the investigator per RECIST v1.1 were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Up to approximately 24 months |
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| Secondary | Time to Confirmed Deterioration (TTCD) in Patient-reported Physical Functioning (PF) | TTCD analyses was performed for patient-reported PF (items 1 to 5) of European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30). The PF was measured on 4-point scale (1='Not at all' to 4='Very much'). TTCD for PF was defined as time from date of randomization to first confirmed clinically meaningful decrease from baseline in PF score held for at least 2 consecutive assessments or initial clinically meaningful decrease from baseline followed by death from any cause within 21 days or until next tumor assessment, whichever occurs first. A score change of ≥ of 10-point on EORTC QLQ-C30 PF scale was determined as being clinically meaningful. Scores were averaged, transformed to 0-100 scale; where higher score represented high/healthy level of functioning. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley. | The ITT population included all randomized participants, whether or not the participant received the assigned treatment. Participants without a confirmed deterioration at the time of analysis were censored at the last time they were known to have not deteriorated. | Posted | Median | 95% Confidence Interval | months | Up to approximately 24 months |
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| Secondary | TTCD in Patient-reported Global Health Status (GHS) | TTCD analyses was performed for GHS and quality of life (QoL) (items 29 and 30) of EORTC QLQ-C30. GHS/ QoL items were scored on a 7-point scale that ranges from "very poor" to "excellent." TTCD for GHS/QoL was defined as the time from the date of randomization to the first confirmed clinically meaningful decrease from baseline in GHS/QoL score held for at least two consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 21 days or until the next tumor assessment, whichever occurs first. A score change of ≥ 10-point on the EORTC QLQ-C30 GHS/QoL scale was determined as being clinically meaningful. Scores were averaged, transformed to 0-100 scale; where higher score for GHS/QoL= better health-related QoL. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley. | Participants without a confirmed deterioration at the time of analysis were censored at the last time they were known to have not deteriorated. The ITT population included all randomized participants, whether or not the participant received the assigned treatment. Only responders were analysed in this endpoint. | Posted | Median | 95% Confidence Interval | months | Up to approximately 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS Rates Assessed by Investigator | PFS rates were defined as the percentage of participants alive and without PD as assessed by the investigator according to RECIST v1.1 at 6 months and 1 year after randomization. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints, including baseline. In addition, the sum of diameters also demonstrated an absolute increase of ≥ 5 mm. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley. Percentages have been rounded off. | The ITT population included all randomized participants, whether or not the participant received the assigned treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months and 1 year |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OS Rates | OS rates were defined as the percentage of participants who were alive at 1 and 2 years. Participants alive at the time of the analysis were censored at the date when they were last known to be alive as documented by the investigator. Kaplan-Meier method was used to estimate the median. 95% CI for median was computed using the method of Brookmeyer and Crowley. Percentages have been rounded off. | The ITT population is defined as all randomized participants, whether or not the participant received the assigned treatment. Participants alive at the time of the analysis were censored at the date when they were last known to be alive as documented by the investigator. At the time of the analysis, there were no participants with 24 months or more of survival follow-up, therefore, survival rate at the 2-year timepoint was not estimable. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 and 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any of the following: unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; any new disease or exacerbation of an existing disease; recurrence of an intermittent medical condition not present at baseline; any deterioration in a laboratory value or other clinical test; AEs related to a protocol-mandated intervention. AEs were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v5.0). Percentages have been rounded off. | Safety-evaluable population included all randomized participants who had received any amount of study drug, with participants grouped according to the actual treatment received. | Posted | Number | percentage of participants | Up to approximately 41.4 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minimum Serum Concentration (Cmin) of Atezolizumab | Pharmacokinetic (PK)-evaluable population for atezolizumab included all participants who had received any dose of atezolizumab and who had evaluable PK samples. Number analyzed is the number of participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter (μg/ml) | Predose on Day 1 of Cycles 1, 2, 3, 4, 8, 12 and 16 (Cycle= 21 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Serum Concentration (Cmax) of Atezolizumab | PK-evaluable population included all participants who had received any dose of atezolizumab and who had evaluable PK samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | 30 minutes (min) postdose on Day 1 of Cycle 1 (Cycle= 21 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minimum Plasma Concentration (Cmin) of Cabozantinib | PK-evaluable population included all participants who had received any dose of cabozantinib and who had evaluable PK samples. Number analyzed is the number of participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Predose on Day 1 of Cycles 1, 2, 3, 4, and 5 (Cycle= 21 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) of Cabozantinib | Cmax was not collected for this outcome measure because PK of cabozantinib was well characterized through the cabozantinib development for mono- therapy. An established population PK model for cabozantinib is available for the PK data from NCT04471428 (study GO41892). The PK data collected in the current study is sufficient for the population PK model to characterize the exposure of cabozantinib in this study. | Posted | Predose on Day 1 of Cycles 1, 2, 3, 4, and 5 (Cycle= 21 days) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response). The total number of participants who developed ADAs to atezolizumab was determined by summing the ADA-positive participants across all timepoints. | Safety-evaluable population included all randomized participants who had received any amount of study drug, with participants grouped according to the actual treatment received. Overall number analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Pre-dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 and post-treatment follow-up (≤ 30 days after final dose) (Cycle= 21 days) |
|
|
All-cause mortality: Up to 44.6 months SAE and other AEs: Up to 41.4 months
Safety-evaluable population which included all randomized participants who had received any amount of study drug. A total of 14 participants did not receive any study treatment and were therefore excluded from the safety analysis. All-cause mortality reported for deaths that occurred during study based on ITT population.
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 | Docetaxel Monotherapy | Participants received docetaxel, 75 mg/m^2, IV on Day 1 of each 21-day cycle until unacceptable toxicity or PD or loss of clinical benefit as determined by the investigator. | 131 | 180 | 58 | 167 | 148 | 167 |
| EG001 | Atezolizumab + Cabozantinib | Participants received atezolizumab, 1200 mg, IV, on Day 1 of each 21-day cycle along with cabozantinib, 40 mg, orally, given QD on Days 1-21 of each cycle until unacceptable toxicity, PD, or loss of clinical benefit as determined by the investigator. | 147 | 186 | 76 | 185 | 173 | 185 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pneumopericardium | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Anorectal disorder | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Infusion related hypersensitivity reaction | Immune system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Bacterial colitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Mycobacterium avium complex infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Bladder disorder | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Bronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Pneumonia necrotising | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2022 | Sep 26, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C558660 | cabozantinib |
| C000594389 | atezolizumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Not Stated |
|
| Unknown |
|
Unstratified Analysis
| Log Rank |
| 0.4709 |
| Hazard Ratio (HR) |
| 0.907 |
| 2-Sided |
| 95 |
| 0.696 |
| 1.182 |
Hazard ratio was estimated by Cox regression model. |
| Superiority |
Participants received atezolizumab, 1200 mg, IV, on Day 1 of each 21-day cycle along with cabozantinib, 40 mg, orally, given QD on Days 1-21 of each cycle until unacceptable toxicity, PD, or loss of clinical benefit as determined by the investigator.
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants received atezolizumab, 1200 mg, IV, on Day 1 of each 21-day cycle along with cabozantinib, 40 mg, orally, given QD on Days 1-21 of each cycle until unacceptable toxicity, PD, or loss of clinical benefit as determined by the investigator. |
|
|
| Atezolizumab + Cabozantinib |
Participants received atezolizumab, 1200 mg, IV, on Day 1 of each 21-day cycle along with cabozantinib, 40 mg, orally, given QD on Days 1-21 of each cycle until unacceptable toxicity, PD, or loss of clinical benefit as determined by the investigator. |
|
|
|
| Atezolizumab + Cabozantinib |
Participants received atezolizumab, 1200 mg, IV, on Day 1 of each 21-day cycle along with cabozantinib, 40 mg, orally, given QD on Days 1-21 of each cycle until unacceptable toxicity, PD, or loss of clinical benefit as determined by the investigator. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|