Study of Atezolizumab in Combination With Cabozantinib Versus Docetaxel in Patients With Metastatic Non-Small Cell Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy (CONTACT-01)

A Phase III, Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Atezolizumab Given in Combination With Cabozantinib Versus Docetaxel Monotherapy in Patients With Metastatic Non-Small Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Cabozantinib; Drug: Atezolizumab; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Actual): 366
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
  • Queensland
    • Townsville, Queensland, Australia, 4810
      • Townsville Hospital
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Hospital Olivia Newton John Cancer Centre
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Affinity Oncology
• Austria
  • Graz, Austria, 8036
    • LKH-Univ. Klinikum Graz
  • Linz, Austria, 4020
    • Ordensklinikum Linz Elisabethinen
  • Rankweil, Austria, 6830
    • Lhk Feldkirch
  • Salzburg, Austria, 5020
    • Lkh Salzburg - Univ. Klinikum Salzburg
  • Vienna, Austria, 1090
    • Medizinische Universität Wien
• Belgium
  • Anderlecht, Belgium, 1070
    • Institut Jules Bordet
  • Brussels, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Namur, Belgium, 5000
    • Clinique Ste-Elisabeth
• France
  • Angers, France, 49933
    • CHU Angers,Service de Pneumologie
  • Grenoble, France, 38043
    • CHU de Grenoble
  • Limoges, France, 87042
    • Hopital Dupuytren
  • Marseille, France, 13285
    • Hôpital Saint Joseph
  • Montpellier, France, 34298
    • Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque
  • Paris, France, 75970
    • Hopital Tenon
• Germany
  • Bad Berka, Germany, 99437
    • Zentralklinik Bad Berka GmbH
  • Cologne, Germany, 51109
    • Klinikum Koeln-Merheim
  • Giessen, Germany, 35392
    • Universitaetsklinikum Giessen und Marburg GmbH
  • Hanover, Germany, 30459
    • KRH Klinikum Siloah-Oststadt-Heidehaus
  • Marburg, Germany, 35043
    • Universitaetsklinikum Giessen und Marburg
  • Paderborn, Germany, 33098
    • Brüderkrankenhaus St. Josef Paderborn
• Greece
  • Athens, Greece, 115 27
    • Uoa Sotiria Hospital
  • Athens, Greece, 11526
    • Henri Dunant Hospital
  • Heraklion, Greece, 711 10
    • Univ General Hosp Heraklion
  • Thessaloniki, Greece, 546 45
    • Euromedical General Clinic of Thessaloniki
• Italy
  • Apulia
    • Lecce, Apulia, Italy, 73100
      • Ospedale Vito Fazzi
  • Campania
    • Napoli, Campania, Italy, 80131
      • AORN Ospedali dei Colli Ospedale Monaldi
  • Emilia-Romagna
    • Parma, Emilia-Romagna, Italy, 43100
      • Azienda Ospedaliero Universitaria di Parma
    • Ravenna, Emilia-Romagna, Italy, 48100
      • Ospedale Provinciale Santa Maria Delle Croci
  • Friuli Venezia Giulia
    • Aviano, Friuli Venezia Giulia, Italy, 33081
      • Irccs Centro Di Riferimento Oncologico (CRO)
  • Lazio
    • Rome, Lazio, Italy, 00151
      • Azienda Ospedaliera San Camillo Forlanini
    • Rome, Lazio, Italy, 00161
      • Policlinico Umberto I, Oncologia B
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • IRCCS AOU San Martino - IST
  • Lombardy
    • Brescia, Lombardy, Italy, 25123
      • ASST Spedali Civili di Brescia
    • Milan, Lombardy, Italy, 20141
      • Instituto Europeo di Oncologia
  • Tuscany
    • Florence, Tuscany, Italy, 50124
      • A.O.U Careggi
• Japan
  • Hyōgo, Japan, 673-0021
    • Hyogo Cancer Center
  • Miyagi, Japan, 981-0914
    • Sendai Kousei Hospital
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR
• Poland
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
  • Bytom, Poland, 41-902
    • SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4
  • Gliwice, Poland, 44-101
    • Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice
  • Koszalin, Poland, 75-581
    • Szpital Wojewódzki im. Miko?aja Kopernika
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
• Portugal
  • Porto, Portugal, 4100-180
    • Hospital CUF Porto
  • Porto, Portugal, 4200-072
    • IPO do Porto
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto ? Hospital de Santo António
  • Vila Nova de Gaia, Portugal, 4434-502
    • CHVNG/E_Unidade 1
• Russia
  • Moscow Oblast
    • Moscow, Moscow Oblast, Russia, 143422
      • MEDSI Clinical Hospital on Pyatnitsky Highway
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 197758
      • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
    • Saint Petersburg, Sankt-Peterburg, Russia, 194291
      • GBUZ Leningradskaya state clinical hospital
  • Yaroslavl Oblast
    • Yaroslavl, Yaroslavl Oblast, Russia, 150054
      • Regional Clinical Oncology Hospital
• South Korea
  • Cheongju-si, South Korea, 28644
    • Chungbuk National University Hospital
  • Goyang-si, South Korea, 10408
    • National Cancer Center
  • Gyeonggi-do, South Korea, 16247
    • St. Vincent's Hospital
  • Gyeonggi-do, South Korea, 16499
    • Ajou University Medical Center
  • Gyeongsangnam-do, South Korea, 51353
    • Samsung Changwon Hospital
  • Incheon, South Korea, 21565
    • Gachon University Gil Medical Center
  • Seongnam-si, South Korea, 13605
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
  • Seoul, South Korea, 06591
    • Seoul St Mary's Hospital
  • Ulsan, South Korea, 44033
    • Ulsan University Hosiptal
• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña (CHUAC)
  • L'Hospitalet de LLobegat, Spain, 08908
    • Institut Catala d Oncologia Hospital Duran i Reynals
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Seville, Spain, 41014
    • Hospital Univ. Nuestra Señora de Valme
  • Valencia, Spain, 46026
    • Hospital Universitari i Politècnic La Fe
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital
  • Glasgow, United Kingdom, G12 OYN
    • Beatson West of Scotland Cancer Centre
  • London, United Kingdom, SW10 9NH
    • Chelsea & Westminster Hospital
  • London, United Kingdom, NW1 - 2PG
    • University College London Hospital
  • London, United Kingdom, EC1A 7BE
    • Barts & London School of Med
• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University
    • San Diego, California, United States, 92120
      • Kaiser Permanente - San Diego
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic
  • Colorado
    • Denver, Colorado, United States, 80220
      • Rocky Mountain Cancer Centers
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Regional Cancer Care Associates
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • Minnesota Oncology Hematology
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • Consultants in Medical Oncology and Hematology
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Oncology, P .A
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute at the University of Utah
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists (Fairfax) - USOR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic NSCLC
• Documented radiographic disease progression during or following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially for metastatic NSCLC
• Measurable disease per RECIST v1.1 outside CNS as assessed by investigator
• Known PD-L1 status or availability of tumor tissue for central PD-L1 testing
• ECOG Performance Status score of 0 or 1
• Recovery to baseline or Grade <=1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable on supportive therapy in the opinion of the investigator
• Adequate hematologic and end-organ function
• Negative HIV test at screening
• Negative hepatitis B surface antigen (HBsAg) test at screening
• Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
• Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs,
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.

Exclusion Criteria:

• Prior therapy with the following agents for NSCLC: Cabozantinib, Docetaxel, Combination of an anti-PD-L1/PD-1 antibody concurrently with a vascular endothelial growth factor (VEGF)R targeting tyrosine kinase inhibitor (TKI)
• Treatment with investigational therapy within 28 days prior to initiation of study treatment
• Documentation of known sensitizing mutation in the EGFR gene or ALK fusion oncogene
• Patients with known ROS1 rearrangements, BRAF V600E mutations, or other actionable oncogenes with approved therapies if available
• Symptomatic, untreated, or actively progressing CNS metastases
• History of leptomeningeal disease
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (more frequently than once monthly)
• Severe hepatic impairment
• Uncontrolled or symptomatic hypercalcemia
• Any other active malignancy at the time of initiation of study treatment or diagnosis of another malignancy within 3 years prior to initiation of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, incidental prostate cancer, or carcinoma in situ of the prostate, cervix, or breast
• Stroke, transient ischemic attack, myocardial infarction or other symptomatic ischemic events within 6 months of initiation of study treatment
• Significant vascular disease within 6 months of initiation of study treatment
• Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
• Active tuberculosis
• Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion on the investigator, could impact patient safety
• Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
• Current treatment with anti-viral therapy for HBV
• Major surgical procedure, other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
• Pregnant or lactating females, or intention of becoming pregnant during the treatment with atezolizumab in combination with cabozantinib in the experimental arm or during the treatment with docetaxel in the control arm, or within 5 months after the final dose of atezolizumab and/or 4 months after the final dose of cabozantinib, whichever is later.
• Ongoing Grade >= 2 sensory or motor neuropathy
• Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, granulomatosis with polyangiitis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions: Patients with a history of autoimmune-mediated hypothyroidism who are on thyroid replacement hormone are eligible for the study. Patients with controlled Type 1 diabetes mellitus are eligible for the study. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided all of following conditions are met: Rash must cover < 10% of body surface area.
• Pharmacologically uncompensated, symptomatic hypothyroidism
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• Prior allogeneic stem cell or solid organ transplantation
• Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
• Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
• Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions: Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication are eligible for the study after Medical Monitor confirmation has been obtained. Patients who received mineralocorticoids, inhaled or low-dose systemic corticosteroids for COPD or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
• History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
• Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
• Known allergy or hypersensitivity to any component of the cabozantinib formulation
• History of severe hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80
• Concomitant anticoagulation with coumarin agents, direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors
• History of risk factors for torsades de pointes
• Corrected QT interval corrected through use of Fridericia's formula (QTcF) > 480 ms per ECG within 14 days before initiation of study treatment
• Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic BP > 90 mm Hg despite optimal antihypertensive treatment
• Tumors invading the GI-tract, active peptic ulcer disease, acute pancreatitis, acute obstruction of the pancreatic or biliary duct, appendicitis, cholangitis, cholecystitis, diverticulitis, gastric outlet obstruction, or inflammatory bowel disease
• Abdominal fistula, bowel obstruction, GI perforation, or intra-abdominal abscess within 6 months before initiation of study treatment
• Known cavitating pulmonary lesion(s) or known endobronchial disease manifestation
• Lesions invading major pulmonary blood vessels
• Clinically significant hematuria, hematemesis, hemoptysis of > 0.5 teaspoon (2.5 mL) of red blood, coagulopathy, or other history of significant bleeding within 3 months before initiation of study treatment
• Serious non-healing wound/ulcer/bone fracture
• Malabsorption syndrome
• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption are also excluded.
• Requirement for hemodialysis or peritoneal dialysis
• Inability to swallow tablets

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atezolizumab + Cabozantinib; Participants received atezolizumab on Day 1 of each 21-day cycle and cabozantinib orally once daily on Days 1-21 of each cycle.	Drug: Cabozantinib; Cabozantinib will be administered orally, once daily at a dose of 40 mg on Days 1-21 of each cycle.; Drug: Atezolizumab; Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.; Other Names: Tecentriq
Active Comparator: Docetaxel; Participants received docetaxel on Day 1 of each 21-day cycle.	Drug: Docetaxel; Docetaxel will be administered by IV infusion at a starting dose of 75mg/m2 on Day 1 of each 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Exelixis
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): September 28, 2022
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; atezolizumab; cabozantinib
• Other Study ID Numbers: GO41892

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No