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New combo aims to outsmart tough lung cancer

NCT ID NCT04471428

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether combining the immunotherapy atezolizumab (Tecentriq) with the targeted drug cabozantinib works better than the standard chemotherapy docetaxel for people with advanced non-small cell lung cancer that has worsened after prior treatment. The trial enrolled 366 participants across multiple centers. The main goal was to see if the combination helps people live longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atezolizumab (Tecentriq) and cabozantinib
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced lung cancer who have already tried chemotherapy and immunotherapy.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely available. The combination may not improve survival compared to standard docetaxel, and side effects from two drugs could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

366 people

The number who actually took part.

Started

Oct 2020

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

Contacts and locations

Locations

  • A.O.U Careggi

    Florence, Tuscany, 50124, Italy

  • AORN Ospedali dei Colli Ospedale Monaldi

    Naples, Campania, 80131, Italy

  • ASST Spedali Civili di Brescia

    Brescia, Lombardy, 25123, Italy

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Affinity Oncology

    Nedlands, Western Australia, 6009, Australia

  • Ajou University Medical Center

    Gyeonggi-do, 16499, South Korea

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Austin Hospital Olivia Newton John Cancer Centre

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 00151, Italy

  • Azienda Ospedaliero Universitaria di Parma

    Parma, Emilia-Romagna, 43100, Italy

  • Barts & London School of Med

    London, EC1A 7BE, United Kingdom

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 OYN, United Kingdom

  • Brüderkrankenhaus St. Josef Paderborn

    Paderborn, 33098, Germany

  • CHU Angers,Service de Pneumologie

    Angers, 49933, France

  • CHU de Grenoble

    Grenoble, 38043, France

  • CHVNG/E_Unidade 1

    Vila Nova de Gaia, 4434-502, Portugal

  • Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque

    Montpellier, 34298, France

  • Centro Hospitalar do Porto ? Hospital de Santo António

    Porto, 4099-001, Portugal

  • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

    Bydgoszcz, 85-796, Poland

  • Charleston Oncology, P .A

    Charleston, South Carolina, 29414, United States

  • Chelsea & Westminster Hospital

    London, SW10 9NH, United Kingdom

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • Clinique Ste-Elisabeth

    Namur, 5000, Belgium

  • Cliniques Universitaires St-Luc

    Brussels, 1200, Belgium

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, 15006, Spain

  • Consultants in Medical Oncology and Hematology

    Broomall, Pennsylvania, 19008, United States

  • Euromedical General Clinic of Thessaloniki

    Thessaloniki, 546 45, Greece

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • GBUZ Leningradskaya state clinical hospital

    Saint Petersburg, Sankt-Peterburg, 194291, Russia

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Henri Dunant Hospital

    Athens, 11526, Greece

  • Hopital Dupuytren

    Limoges, 87042, France

  • Hopital Tenon

    Paris, 75970, France

  • Hospital CUF Porto

    Porto, 4100-180, Portugal

  • Hospital Univ. Nuestra Señora de Valme

    Seville, 41014, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Huntsman Cancer Institute at The University of Utah

    Salt Lake City, Utah, 84112, United States

  • Hyogo Cancer Center

    Hyōgo, 673-0021, Japan

  • Hôpital Saint Joseph

    Marseille, 13285, France

  • IPO do Porto

    Porto, 4200-072, Portugal

  • IRCCS AOU San Martino - IST

    Genoa, Liguria, 16132, Italy

  • Institut Catala d Oncologia Hospital Duran i Reynals

    L'Hospitalet de LLobegat, 08908, Spain

  • Institut Jules Bordet

    Anderlecht, 1070, Belgium

  • Instituto Europeo di Oncologia

    Milan, Lombardy, 20141, Italy

  • Irccs Centro Di Riferimento Oncologico (CRO)

    Aviano, Friuli Venezia Giulia, 33081, Italy

  • KRH Klinikum Siloah-Oststadt-Heidehaus

    Hanover, 30459, Germany

  • Kaiser Permanente - San Diego

    San Diego, California, 92120, United States

  • Klinikum Koeln-Merheim

    Cologne, 51109, Germany

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Lhk Feldkirch

    Rankweil, 6830, Austria

  • Lkh Salzburg - Univ. Klinikum Salzburg

    Salzburg, 5020, Austria

  • Lkh-Univ. Klinikum Graz

    Graz, 8036, Austria

  • MEDSI Clinical Hospital on Pyatnitsky Highway

    Moscow, Moscow Oblast, 143422, Russia

  • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy

    Otwock, 05-400, Poland

  • Medizinische Universität Wien

    Vienna, 1090, Austria

  • Minnesota Oncology Hematology

    Saint Paul, Minnesota, 55102, United States

  • Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice

    Gliwice, 44-101, Poland

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg

    Blacksburg, Virginia, 24060, United States

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020, Austria

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Ospedale Provinciale Santa Maria Delle Croci

    Ravenna, Emilia-Romagna, 48100, Italy

  • Ospedale Vito Fazzi

    Lecce, Apulia, 73100, Italy

  • Policlinico Umberto I, Oncologia B

    Rome, Lazio, 00161, Italy

  • Regional Cancer Care Associates

    Bethesda, Maryland, 20817, United States

  • Regional Clinical Oncology Hospital

    Yaroslavl, Yaroslavl Oblast, 150054, Russia

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80220, United States

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4

    Bytom, 41-902, Poland

  • Samsung Changwon Hospital

    Gyeongsangnam-do, 51353, South Korea

  • Sansum Clinic

    Santa Barbara, California, 93105, United States

  • Sendai Kousei Hospital

    Miyagi, 981-0914, Japan

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605, South Korea

  • Seoul St Mary's Hospital

    Seoul, 06591, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • St. Vincent's Hospital

    Gyeonggi-do, 16247, South Korea

  • Stanford University

    Palo Alto, California, 94305, United States

  • Szpital Wojewódzki im. Miko?aja Kopernika

    Koszalin, 75-581, Poland

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • Townsville Hospital

    Townsville, Queensland, 4810, Australia

  • Ulsan University Hosiptal

    Ulsan, 44033, South Korea

  • Univ General Hosp Heraklion

    Heraklion, 711 10, Greece

  • Universitaetsklinikum Giessen und Marburg

    Marburg, 35043, Germany

  • Universitaetsklinikum Giessen und Marburg GmbH

    Giessen, 35392, Germany

  • University College London Hospital

    London, NW1 - 2PG, United Kingdom

  • Uoa Sotiria Hospital

    Athens, 115 27, Greece

  • Virginia Cancer Specialists (Fairfax) - USOR

    Fairfax, Virginia, 22031, United States

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.