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Lung cancer trial halted: did adding an Anti-Inflammatory drug help?

NCT ID NCT03631199

Disease control Sponsor: Novartis Pharmaceuticals 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 phase 3 study tested whether adding canakinumab (an anti-inflammatory drug) to standard immunotherapy (pembrolizumab) and chemotherapy could help people with advanced non-small cell lung cancer live longer. The trial enrolled 673 participants but was terminated early, so the full results are not available. The approach aimed to reduce inflammation that might help tumors grow, but the early stop raises questions about safety or lack of benefit.

What this could mean

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

Active substance
canakinumab (an anti-inflammatory drug) plus pembrolizumab (an immunotherapy) and chemotherapy
What this could lead to
If successful, this combination could improve survival for people with advanced lung cancer by boosting the immune system's ability to fight tumors.
What could go wrong
The trial was terminated early, so results are limited. Adding canakinumab may increase side effects without clear benefit, and the study's early stop means we may never know if it truly works.

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

673 people

The number who actually took part.

Started

Dec 2018

Finished

Jan 2026

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 to 100 years

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.

Key inclusion criteria: * Histologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting * Known PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required. * Eastern Cooperative oncology group (ECOG) performance status of 0 or 1. * At least 1 measurable lesion by RECIST 1.1 Key exclusion criteria: * Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways). * Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1β inhibitor). * Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations (identified in exons 19, 20, or 21), and/or ALK rearrangement by locally approved laboratory testing. * Previously untreated or symptomatic central nervous system (CNS) metastases or lepto-meningeal disease. * Subject with suspected or proven immune-compromised state or infections. * Subject has prior to starting study drug: received live vaccination ≤3 months, had major surgery ≤4 weeks prior to starting study drug, has thoracic radiotherapy: lung fields ≤ 4 weeks, other anatomic sites ≤ 2 weeks, palliative radiotherapy for bone lesions ≤ 2 weeks.

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Conditions

The condition(s) this trial relates to.

Neoplasm Metastasis 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

  • AdventHealth

    Orlando, Florida, 32804, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Novartis Investigative Site

    Caba, Buenos Aires, C1426ANZ, Argentina

  • Novartis Investigative Site

    Caba, C1431FWO, Argentina

  • Novartis Investigative Site

    Westmead, New South Wales, 2145, Australia

  • Novartis Investigative Site

    Wooloongabba, Queensland, 4102, Australia

  • Novartis Investigative Site

    Melbourne, Victoria, 3000, Australia

  • Novartis Investigative Site

    Murdoch, Western Australia, 6150, Australia

  • Novartis Investigative Site

    Linz, Upper Austria, 4020, Austria

  • Novartis Investigative Site

    Salzburg, 5020, Austria

  • Novartis Investigative Site

    Barretos, São Paulo, 14784 400, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01246 000, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04014-002, Brazil

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1Z2, Canada

  • Novartis Investigative Site

    Brampton, Ontario, L6R 3J7, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9, Canada

  • Novartis Investigative Site

    Temuco, Araucania, 4810469, Chile

  • Novartis Investigative Site

    Santiago, 8420383, Chile

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150081, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430030, China

  • Novartis Investigative Site

    Changsha, Hunan, 410013, China

  • Novartis Investigative Site

    Changchun, Jilin, 130012, China

  • Novartis Investigative Site

    Xi’an, Shanxi, 710038, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310022, China

  • Novartis Investigative Site

    Beijing, 100036, China

  • Novartis Investigative Site

    Valledupar, Cesar Department, 200001, Colombia

  • Novartis Investigative Site

    Ostrava, Vitkovice, 703 84, Czechia

  • Novartis Investigative Site

    Brno, 625 00, Czechia

  • Novartis Investigative Site

    Brno, 656 53, Czechia

  • Novartis Investigative Site

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    Herning, 7400, Denmark

  • Novartis Investigative Site

    Oulu, FIN-90220, Finland

  • Novartis Investigative Site

    Marseille, Bouches Du Rhone, 13915, France

  • Novartis Investigative Site

    Lyon, 69373, France

  • Novartis Investigative Site

    Montpellier, 34070, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Paris, 75231, France

  • Novartis Investigative Site

    Munich, Bavaria, 81377, Germany

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075, Germany

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 51109, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04347, Germany

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120, Germany

  • Novartis Investigative Site

    Berlin, 13125, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Georgsmarienhütte, 49124, Germany

  • Novartis Investigative Site

    Gerlingen, 70839, Germany

  • Novartis Investigative Site

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    Athens, GR, 115 27, Greece

  • Novartis Investigative Site

    Athens, 185 47, Greece

  • Novartis Investigative Site

    Kowloon, 999077, Hong Kong

  • Novartis Investigative Site

    Veszprém, 8200, Hungary

  • Novartis Investigative Site

    Reykjavik, 101, Iceland

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500034, India

  • Novartis Investigative Site

    Gurgaon, Haryana, 122 001, India

  • Novartis Investigative Site

    Pune, Maharashtra, 411013, India

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302017, India

  • Novartis Investigative Site

    Hyderabad, Telangana, 500082, India

  • Novartis Investigative Site

    Kolkata, West Bengal, 700160, India

  • Novartis Investigative Site

    Avellino, AV, 83100, Italy

  • Novartis Investigative Site

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    Milan, MI, 20132, Italy

  • Novartis Investigative Site

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Modena, MO, 41124, Italy

  • Novartis Investigative Site

    Padova, PD, 35128, Italy

  • Novartis Investigative Site

    Perugia, PG, 06129, Italy

  • Novartis Investigative Site

    Parma, PR, 43126, Italy

  • Novartis Investigative Site

    Orbassano, TO, 10043, Italy

  • Novartis Investigative Site

    Milan, 20141, Italy

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4648681, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648, Japan

  • Novartis Investigative Site

    Himeji, Hyōgo, 670-8520, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 241-8515, Japan

  • Novartis Investigative Site

    Sakai, Osaka, 591-8555, Japan

  • Novartis Investigative Site

    Sunto Gun, Shizuoka, 4118777, Japan

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 1040045, Japan

  • Novartis Investigative Site

    Ube, Yamaguchi, 755-0241, Japan

  • Novartis Investigative Site

    Osaka, 5458586, Japan

  • Novartis Investigative Site

    Beirut, 1100 2070, Lebanon

  • Novartis Investigative Site

    Saida, 652, Lebanon

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

  • Novartis Investigative Site

    Kuantan, Pahang, 25100, Malaysia

  • Novartis Investigative Site

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    Groningen, 9713 GZ, Netherlands

  • Novartis Investigative Site

    Groningen, 9728 NZ, Netherlands

  • Novartis Investigative Site

    Drammen, 3004, Norway

  • Novartis Investigative Site

    City of Taguig, National Capital Region, 1634, Philippines

  • Novartis Investigative Site

    Makati City, 1229, Philippines

  • Novartis Investigative Site

    Quezon, 1102, Philippines

  • Novartis Investigative Site

    San Juan City, 1502, Philippines

  • Novartis Investigative Site

    Gliwice, 44 101, Poland

  • Novartis Investigative Site

    Poznan, 60 569, Poland

  • Novartis Investigative Site

    Tomaszw Mazowiecki, 97-200, Poland

  • Novartis Investigative Site

    Lisbon, 1769 001, Portugal

  • Novartis Investigative Site

    Porto, 4200-072, Portugal

  • Novartis Investigative Site

    Cluj-Napoca, Cluj, 400015, Romania

  • Novartis Investigative Site

    Craiova, Dolj, 200347, Romania

  • Novartis Investigative Site

    Arkhangelsk, 163045, Russia

  • Novartis Investigative Site

    Omsk, 644013, Russia

  • Novartis Investigative Site

    Saint Petersburg, 192148, Russia

  • Novartis Investigative Site

    Saint Petersburg, 196603, Russia

  • Novartis Investigative Site

    Saint Petersburg, 197022, Russia

  • Novartis Investigative Site

    Singapore, 119228, Singapore

  • Novartis Investigative Site

    Singapore, 168583, Singapore

  • Novartis Investigative Site

    Singapore, S308433, Singapore

  • Novartis Investigative Site

    Bratislava, 83310, Slovakia

  • Novartis Investigative Site

    Kosice-Saca, 958 01, Slovakia

  • Novartis Investigative Site

    Gyeonggi-do, Korea, 10408, South Korea

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Granada, Andalusia, 18014, Spain

  • Novartis Investigative Site

    Badalona, Barcelona, 08916, Spain

  • Novartis Investigative Site

    Donostia / San Sebastian, Gipuzkoa, 20014, Spain

  • Novartis Investigative Site

    Las Palmas de Gran C, Las Palmas, 35016, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28040, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Madrid, 28046, Spain

  • Novartis Investigative Site

    Málaga, 29010, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Zaragoza, 50009, Spain

  • Novartis Investigative Site

    Stockholm, 171 76, Sweden

  • Novartis Investigative Site

    Basel, 4031, Switzerland

  • Novartis Investigative Site

    Kaohsiung City, 83301, Taiwan

  • Novartis Investigative Site

    Tainan, 704, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taipei, 11217, Taiwan

  • Novartis Investigative Site

    Taoyuan, 333, Taiwan

  • Novartis Investigative Site

    Songkhla, Hat Yai, 90110, Thailand

  • Novartis Investigative Site

    Khon Kaen, THA, 40002, Thailand

  • Novartis Investigative Site

    Bangkok, 10330, Thailand

  • Novartis Investigative Site

    Bangkok, 10400, Thailand

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Istanbul, Bagcilar, 34214, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Bilkent Cankaya, 06800, Turkey (Türkiye)

  • Novartis Investigative Site

    Edirne, Merkez, 22030, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

  • Novartis Investigative Site

    High Heaton, Newcastle Upon Tyne, NE7 7DN, United Kingdom

  • Novartis Investigative Site

    London, NW3 2QG, United Kingdom

  • Novartis Investigative Site

    Manchester, M20 2BX, United Kingdom

  • Novartis Investigative Site

    Plymouth, PL6 8DH, United Kingdom

  • Novartis Investigative Site

    Hanoi, 100000, Vietnam

  • Pacific Shores Medical Group

    Long Beach, California, 90813, United States

  • USC Kenneth Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

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