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Lung cancer patients may soon get immunotherapy as a quick shot instead of a long IV drip

NCT ID NCT03735121

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a subcutaneous (under-the-skin) injection of the immunotherapy drug atezolizumab works as well as the standard intravenous (IV) infusion in people with advanced non-small cell lung cancer who had already tried platinum-based chemotherapy. The trial enrolled 438 participants and had two parts: first to find the right dose for the shot, then to confirm that the shot delivers similar drug levels in the blood. If successful, this could make treatment much more convenient.

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 rHuPH20 (ENHANZE)
What this could lead to
If successful, this could offer a more convenient, faster way to receive atezolizumab as a shot under the skin instead of a lengthy IV infusion.
What could go wrong
This is a Phase 3 trial, but it primarily checks whether the subcutaneous version reaches similar drug levels in the blood. It may not show better cancer control or survival, and there could be injection-site reactions.

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

438 people

The number who actually took part.

Started

Dec 2018

Finished

Nov 2024

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 documented locally advanced or metastatic NSCLC * Prior platinum-containing regimen or disease recurrence ≤ 6 months since prior platinum-based adjuvant/neoadjuvant regimen. * Measurable disease as defined by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy ≥12 weeks * Adequate hematologic and end-organ function Additional Inclusion Criteria (Part 2 Only) • Availability of tissue and known epidermal growth factor receptor (EGFR) status Exclusion Criteria: * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Uncontrolled or symptomatic hypercalcemia * Pregnancy or breastfeeding * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis * Severe infection ≤ 4 weeks * Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to study treatment * Significant cardiovascular disease * Prior allogeneic stem cell or solid organ transplantation * Treatment with a live, attenuated vaccine ≤ 4 weeks * Treatment with systemic immunostimulatory agents ≤ 4 weeks or 5 half-lives of the drug * Treatment with systemic immunosuppressive medication ≤ 2 weeks Additional Exclusion Criteria (Part 2 Only) • Tested tumor programmed death-ligand-1 (PD-L1) expression status with an intention to treat the patient if positive

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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.

Non-small cell lung cancer

Contacts and locations

Locations

  • APHM

    Marseille, 13385, France

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asst Papa Giovanni XXIII

    Bergamo, Lombardy, 24128, Italy

  • Auckland City Hospital, Cancer and Blood Research

    Auckland, 1023, New Zealand

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • Bradford Hill Centro de Investigaciones Clinicas

    Recoleta, 8420383, Chile

  • Centro Medico Monte Carmelo

    Arequipa, 04001, Peru

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE, Argentina

  • Centrum Terapii Wspolczesnej

    Lodz, 93-319, Poland

  • Chelyabinsk Regional Clinical Oncology Dispensary

    Chelyabinsk, Moscow Oblast, 454087, Russia

  • Christchurch Clinical Studies Trust Ltd

    Christchurch, New Zealand

  • Chulalongkorn Hospital

    Bangkok, 10330, Thailand

  • Clinica CIMCA

    San José, 10103, Costa Rica

  • Clinica Internacional, Sede San Borja

    Lima, Lima 41, Peru

  • Clínica San Gabriel

    Lima, 15088, Peru

  • Communal Non profit Enterprise Regional Center of Oncology

    Kharkiv, Kharkiv Governorate, 61070, Ukraine

  • Consultorio Dr. Miguel Angel Escudero

    Salta, 4400, Argentina

  • Cuidados oncologicos

    Querétaro City, Querétaro, 76000, Mexico

  • Ege Uni Medical Faculty Hospital

    Izmir, 35100, Turkey (Türkiye)

  • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

    Moscow, Moscow Oblast, 115478, Russia

  • Faculty of Med. Siriraj Hosp.

    Bangkok, 10700, Thailand

  • Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod

    Nizhny Novgorod, Niznij Novgorod, 603081, Russia

  • Fundación CENIT para la Investigación en Neurociencias

    Buenos Aires, C1125ABD, Argentina

  • General Hospital "G.Papanikolaou"

    Asvestochóri, 570 10, Greece

  • Groote Schuur Hospital ( Uni of Capetown )

    Cape Town, 7506, South Africa

  • Grupo Angeles

    Guatemala City, 01015, Guatemala

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100, Mexico

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Hospital El Pilar

    Guatemala City, 01015, Guatemala

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • ICIMED Instituto de Investigación en Ciencias Médicas

    San José, 10108, Costa Rica

  • INCA 1- Instituto Nacional de Câncer X

    Rio de Janeiro, 20231-050, Brazil

  • INTEGRA Cancer Institute

    Guatemala City, 01010, Guatemala

  • IRCCS Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089, Italy

  • Ico Rene Gauducheau

    Saint-Herblain, 44805, France

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • Ivano-Frankivsk Regional Oncology Center

    Ivano-Frankivsk, 76018, Ukraine

  • James Lind Centro de Investigación Del Cáncer

    Temuco, 4800827, Chile

  • Jilin Cancer Hospital

    Changchun, 132013, China

  • Jinan Central Hospital

    Jinan, 250013, China

  • MEDSI Clinical Hospital on Pyatnitsky Highway

    Moscow, Moscow Oblast, 143422, Russia

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200, Thailand

  • Matrai Gyogyintezet

    Mátraháza, 3233, Hungary

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, 05-400, Poland

  • Medipol University Medical Faculty

    Istanbul, 34214, Turkey (Türkiye)

  • Mordovia State University

    Saransk, Respublika Mordoviya, 430032, Russia

  • Multidisciplinary clinic Reaviz

    Samara, 443011, Russia

  • Municipal Institution City Clinical Hospital #4 of Dnipro City Council

    Dnipropetrovsk, Katerynoslav Governorate, 49102, Ukraine

  • Murmansk Regional Clinical Hospital named after P.A. Bayandin

    Murmansk, 183047, Russia

  • Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie

    Warsaw, 02-781, Poland

  • Oncocentro Apys

    Viña del Mar, 2520598, Chile

  • Oncomedica

    Guatemala City, 01010, Guatemala

  • Oncosalud Sac

    Lima, 41, Peru

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Prapokklao Hospital

    Chanthaburi, 22000, Thailand

  • Prince of Songkla University

    Hat Yai, 90110, Thailand

  • RCI Sumy Regional Clinical Oncological Dispensary

    Sumy, 40005, Ukraine

  • Rajavithi Hospital

    Bangkok, 10400, Thailand

  • Református Pulmonológiai Centrum

    Törökbálint, 2045, Hungary

  • Regionalny Szpital Specjalistyczny im. W. Bieganskiego

    Grudzi?dz, 86-300, Poland

  • Riga East Clinical University Hospital Latvian Oncology Centre

    Riga, LV-1079, Latvia

  • SBIH Kaluga Region Clinical Oncology Dispensary

    Kaluga, 248007, Russia

  • Samsung Medical Centre

    Seoul, 135-170, South Korea

  • Sandton Oncology Medical Group

    Sandton, 2196, South Africa

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou, 310016, China

  • Sotiria Hospital

    Athens, 104 31, Greece

  • Tauranga Hospital, Clinical Trials Unit

    Tauranga, 3112, New Zealand

  • Udonthani Cancer Hospital, Udonthani

    Muang,Udonthani, 41330, Thailand

  • Vajira Hospital

    Bangkok, 10300, Thailand

  • Waikato Hospital - Cancer and Blood Research Trials Unit

    Hamilton, 3204, New Zealand

  • West China Hospital - Sichuan University

    Chengdu, 610047, China

  • Wilgers Oncology Centre

    Pretoria, 0001, South Africa

More trials for these conditions

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