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: Active, not recruiting
• 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; Oncology
  • 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; Klinische Abteilung für Onkologie
  • Linz, Austria, 4020
    • Ordensklinikum Linz Elisabethinen
  • Rankweil, Austria, 6830
    • Lhk Feldkirch; Interne Medizin Abt.
  • Salzburg, Austria, 5020
    • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
  • Wien, Austria, 1090
    • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
• Belgium
  • Anderlecht, Belgium, 1070
    • Institut Jules Bordet
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Gent, Belgium, 9000
    • UZ Gent
  • Namur, Belgium, 5000
    • Clinique Ste-Elisabeth
• France
  • Amiens, France, 80090
    • Clinique de l'Europe
  • Angers, France, 49933
    • CHU Angers,Service de Pneumologie
  • Grenoble, France, 38043
    • CHU de Grenoble
  • Limoges, France, 87042
    • Hopital Dupuytren; Pneumologie
  • Marseille, France, 13285
    • Hôpital Saint Joseph; Oncologie Medicale
  • Montpellier, France, 34298
    • Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie
  • Mulhouse, France, 68070
    • Centre Hospitalier de Mulhouse - Hopital Emile Muller
  • Paris, France, 75970
    • Hopital Tenon;Pneumologie
• Germany
  • Bad Berka, Germany, 99437
    • Zentralklinik Bad Berka GmbH; Pneumologie
  • Essen, Germany, 45136
    • KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie
  • Gießen, Germany, 35392
    • Universitaetsklinikum Giessen und Marburg GmbH; Medizinische Klinik IV und V
  • Hannover, Germany, 30459
    • KRH Klinikum Siloah-Oststadt-Heidehaus
  • Köln, Germany, 51109
    • Klinikum Koeln-Merheim; Lungenklinik
  • Marburg, Germany, 35043
    • Universitaetsklinikum Giessen und Marburg
  • Paderborn, Germany, 33098
    • Brüderkrankenhaus St. Josef Paderborn
• Greece
  • Athens, Greece, 115 22
    • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
  • Athens, Greece, 115 27
    • Uoa Sotiria Hospital; Oncology
  • Athens, Greece, 115 26
    • Henri Dunant Hospital; Oncology Dept.
  • Heraklion, Greece, 711 10
    • Univ General Hosp Heraklion; Medical Oncology
  • Thessaloniki, Greece, 546 45
    • Euromedical General Clinic of Thessaloniki; Oncology Department
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
    • Parma, Emilia-Romagna, Italy, 43126
      • Azienda Ospedaliero Universitaria di Parma
    • Ravenna, Emilia-Romagna, Italy, 48100
      • Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
  • Friuli-Venezia Giulia
    • Aviano, Friuli-Venezia Giulia, Italy, 33081
      • Irccs Centro Di Riferimento Oncologico (CRO)
  • Lazio
    • Roma, Lazio, Italy, 151
      • Azienda Ospedaliera San Camillo Forlanini
    • Roma, Lazio, Italy, 00161
      • Policlinico Umberto I, Oncologia B
  • Liguria
    • Genova, Liguria, Italy, 16132
      • IRCCS AOU San Martino - IST
  • Lombardia
    • Brescia, Lombardia, Italy, 25123
      • ASST Spedali Civili di Brescia
    • Milano, Lombardia, Italy, 20141
      • Instituto Europeo di Oncologia
    • Rozzano (MI), Lombardia, Italy, 20089
      • Istituto Clinico Humanitas
  • Puglia
    • Lecce, Puglia, Italy, 73100
      • Ospedale Vito Fazzi
  • Toscana
    • Florence, Toscana, Italy, 50124
      • A.O.U Careggi
• Japan
  • Hyogo, 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
• Korea, Republic of
  • Cheongju si, Korea, Republic of, 28644
    • Chungbuk National University Hospital
  • Goyang-si, Korea, Republic of, 10408
    • National Cancer Center
  • Gyeonggi-do, Korea, Republic of, 16247
    • St. Vincent's Hospital
  • Gyeonggi-do, Korea, Republic of, 16499
    • Ajou University Medical Center
  • Gyeongsangnam-do, Korea, Republic of, 51353
    • Samsung Changwon Hospital
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Seongnam-si, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06591
    • Seoul St Mary's Hospital
  • Ulsan, Korea, Republic of, 44033
    • Ulsan University Hosiptal
• Poland
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii
  • Bytom, Poland, 41-902
    • SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej
  • Gliwice, Poland, 44-101
    • Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.
  • Koszalin, Poland, 75-581
    • Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
• Portugal
  • Lisboa, Portugal, 1796-001
    • Hospital Pulido Valente; Servico de Pneumologia
  • Porto, Portugal, 4200-072
    • IPO do Porto; Servico de Oncologia Medica
  • Porto, Portugal, 4100-180
    • Hospital CUF Porto; Servico Pneumologia
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
  • Vila Nova de Gaia, Portugal, 4434-502
    • CHVNG/E_Unidade 1; Servico de Pneumologia
• Russian Federation
  • Jaroslavl
    • Yaroslavl, Jaroslavl, Russian Federation, 150054
      • Regional Clinical Oncology Hospital
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 143422
      • MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
  • Sankt Petersburg
    • Saint-Petersburg, Sankt Petersburg, Russian Federation, 197758
      • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
    • St. Petersburg, Sankt Petersburg, Russian Federation, 194291
      • GBUZ Leningradskaya state clinical hospital
• Spain
  • Barcelona, Spain, 08908
    • Institut Catala d Oncologia Hospital Duran i Reynals
  • Barcelona, Spain, 08035
    • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz; Servicio de Oncologia
  • Sevilla, Spain, 41014
    • Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe; Oncologia
  • Valencia, Spain, 46015
    • Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
  • LA Coruña
    • A Coruña, LA Coruña, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital
  • Glasgow, United Kingdom, G12 0YN
    • Beatson West of Scotland Cancer Centre
  • Huddersfield, United Kingdom, HD3 3EA
    • Huddersfield Royal Infirmary; The Learning Centre
  • London, United Kingdom, N7 9NH
    • University College London Hospital
  • London, United Kingdom, SW10 9TH
    • Chelsea & Westminster Hospital
  • London, United Kingdom, NW3 2QS
    • Royal Free Hospital
  • London, United Kingdom, EC1A 7BE
    • Barts & London School of Med; Medical Oncology
• 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
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Center
  • 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
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists (Fairfax) - USOR
    • Roanoke, Virginia, United States, 24014
      • Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg

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 disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurred first). Progressive disease (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. Participants who were alive and did not experience disease progression 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.	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. PR: at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.	Up to approximately 24 months
Duration of Response (DOR) as Determined by Investigator	DOR for participants with confirmed ORR was defined as time from first occurrence of documented objective response to disease progression (PD), as determined by investigator according to RECIST v1.1, or death from any cause (whichever occurred first). PD was defined as at least 20% increase in sum of longest diameters of target lesions, taking as reference the smallest sum of longest diameters of target lesions recorded since treatment started, including screening, or appearance of one or more new lesions. Confirmed ORR was defined as percentage of participants with a CR or PR on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1. 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 method of Brookmeyer and Crowley.	Up to approximately 24 months
Time to Confirmed Deterioration in Patient-Reported Physical Functioning (PF)	Time to confirmed deterioration (TTCD) analyses was performed for patient-reported physical functioning (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 is measured on 4-point scale (1='Not at all' to 4='Very much'). TTCD for PF is 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
Time to Confirmed Deterioration in Patient-Reported Global Health Status (GHS)	Time to confirmed deterioration (TTCD) analyses was performed for global health status (GHS) and quality of life (QoL) (items 29 and 30) of EORTC QLQ-C30. GHS/ QoL items are scored on a 7-point scale that ranges from "very poor" to "excellent." TTCD for GHS/QoL is defined as the time from the date of randomization to the first confirmed clinically meaningful decrease from baseline in GHS/QoLscore 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 progression as assessed by the investigator according to RECIST v1.1. Progressive disease (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.	6 months and 1 year
OS Rates	Overall Survival (OS) rate is defined as the percentage of participants who were alive at 1 year 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.	1 and 2 years
Percentage of Participants With Adverse Events	An adverse event is any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, regardless of causal attribution. AEs were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v5.0)	From signing the informed consent form up to the study completion date: 28 February 2024 (i.e., approximately 41 months)
Minimum Serum Concentration (Cmin) of Atezolizumab		Predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (each cycle is 21 days)
Maximum Serum Concentration (Cmax) of Atezolizumab		Postdose on Day 1 of Cycle 1 (each cycle is 21 days)
Minimum Plasma Concentration (Cmin) of Cabozantinib		Predose on Day 1 of Cycles 1, 2, 3, 4, and 5 (each cycle is 21 days)
Maximum Plasma Concentration (Cmax) of Cabozantinib		Predose on Day 1 of Cycles 1, 2, 3, 4, and 5 (each cycle is 21 days)
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab		Predose on Day 1 of Cycles 1,2,3,4,8,12 and 16 (each cycle is 21 days) and at post-treatment follow-up visit (≤ 30 days after final dose)

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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): September 28, 2022
• Study Completion (Estimated): April 30, 2024

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 (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Docetaxel; Atezolizumab
• 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