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
1 other identifier
interventional
366
14 countries
87
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2020
Typical duration for phase_3
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2020
CompletedFirst Posted
Study publicly available on registry
July 15, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2022
CompletedResults Posted
Study results publicly available
December 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2025
CompletedDecember 22, 2025
December 1, 2025
2 years
July 7, 2020
September 26, 2023
December 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
Progression-Free Survival (PFS) as Determined by Investigator
Up to approximately 24 months
Confirmed Objective Response Rate (ORR) as Determined by Investigator
Up to approximately 24 months
Duration of Response (DOR) as Determined by Investigator
Up to approximately 24 months
Time to Confirmed Deterioration (TTCD) in Patient-reported Physical Functioning (PF)
Up to approximately 24 months
TTCD in Patient-reported Global Health Status (GHS)
Up to approximately 24 months
- +8 more secondary outcomes
Study Arms (2)
Atezolizumab + Cabozantinib
EXPERIMENTALParticipants received atezolizumab on Day 1 of each 21-day cycle and cabozantinib orally once daily on Days 1-21 of each cycle.
Docetaxel
ACTIVE COMPARATORParticipants received docetaxel on Day 1 of each 21-day cycle.
Interventions
Cabozantinib will be administered orally, once daily at a dose of 40 mg on Days 1-21 of each cycle.
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
Docetaxel will be administered by IV infusion at a starting dose of 75mg/m2 on Day 1 of each 21-day cycle.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +31 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Exelixiscollaborator
Study Sites (92)
Stanford University
Palo Alto, California, 94305, United States
Kaiser Permanente - San Diego
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
Related Publications (2)
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.
PMID: 38552197DERIVEDXing 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.
PMID: 34409776DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2020
First Posted
July 15, 2020
Study Start
October 1, 2020
Primary Completion
September 28, 2022
Study Completion
January 17, 2025
Last Updated
December 22, 2025
Results First Posted
December 20, 2023
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
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).