New drug combo before surgery shows promise for lung cancer patients

NCT ID NCT04351555

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Sep 10, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether giving the targeted drug osimertinib (Tagrisso) before surgery, alone or with chemotherapy, works better than standard chemotherapy alone for people with a specific type of lung cancer (EGFR-mutant, non-small cell). About 358 patients with stage II to IIIB disease will receive treatment before their tumor is removed. The main goal is to see if the tumor shrinks enough to leave few or no cancer cells behind.

What this could mean

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

Active substance: Osimertinib (Tagrisso) with or without chemotherapy (cisplatin, carboplatin, pemetrexed)
What this could lead to: If successful, this could offer a more effective pre-surgery treatment for EGFR-mutant lung cancer, potentially improving survival and reducing recurrence.
What could go wrong: This is still a phase 3 trial, so results are not yet proven. Osimertinib can cause side effects like rash, diarrhea, and lung inflammation, and adding chemotherapy increases toxicity.

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

358 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Jun 2029

An estimate. End dates often move.

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.

Inclusion Criteria: * Male or female, at least 18 years of age. For patients aged \<20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative * Histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II - IIIB N2) disease (according to Version 8 of the IASLC Cancer Staging Manual \[IASLC Staging Manual in Thoracic Oncology 2016\]). * Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialised in oncologic procedures). * Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing * A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (eg., T790M, G719X, Exon20 insertions, S7681 and L861Q). Exclusion Criteria: * Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. * History of another primary malignancy (including any known or suspected synchronous primary lung cancer), except for the following: Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of investigational product (IP) and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease; Adequately treated carcinoma in situ without evidence of disease; Any synchronous Stage IA primary lung cancer that is ≤2 cm and planned to be resected during surgery for the Stage II to IIIB N2 lung tumour. * Patients who have pre-operative radiotherapy treatment as part of their care plan * Mixed small cell and NSCLC histology * Stages I, IIIB N3, IIIC, IVA, and IVB NSCLC * T4 tumours infiltrating the great vessels, the carina, the trachea, the oesophagus, the heart, and/or the vertebral body; and/or any bulky N2 disease. * Patients who are candidates to undergo only segmentectomies or wedge resections * Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug * Prior treatment with EGFR-TKI therapy * Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP) 3A4 (at least 3 weeks prior)

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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

Research Site

Duarte, California, 91010, United States
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Irvine, California, 92618, United States
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San Francisco, California, 94143, United States
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Santa Monica, California, 90404, United States
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Santa Rosa, California, 95403, United States
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Boston, Massachusetts, 02215, United States
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Lebanon, New Hampshire, 03756, United States
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Commack, New York, 11725, United States
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New York, New York, 10032, United States
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Houston, Texas, 77030, United States
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Fairfax, Virginia, 22031, United States
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Seattle, Washington, 98104, United States
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Graz, 8036, Austria
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Vienna, 1210, Austria
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Barretos, 14784-400, Brazil
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Fortaleza, 60135-040, Brazil
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Jaú, 17204310, Brazil
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Porto Alegre, 90035-000, Brazil
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Porto Alegre, 90610-000, Brazil
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Recife, 52010-075, Brazil
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Rio de Janeiro, 22271-110, Brazil
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Santa Maria, 97015-450, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01327-001, Brazil
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São Paulo, 04038-034, Brazil
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São Paulo, 04501-000, Brazil
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Panagyurishte, 4500, Bulgaria
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Pleven, 5804, Bulgaria
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Sofia, 1113, Bulgaria
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Toronto, Ontario, M5G 2N2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Las Condes, 7560908, Chile
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Santiago, 7500713, Chile
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Santiago, 7500921, Chile
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Beijing, 100142, China
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Beijing, 100191, China
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Beijing, CN-100730, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chongqing, 400037, China
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Guangzhou, 510062, China
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Guangzhou, 510095, China
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Guangzhou, 510120, China
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Guangzhou, 510515, China
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Hangzhou, 310009, China
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Hangzhou, 310022, China
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Kunming, 650118, China
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Nanchang, 330006, China
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Nantong, 226001, China
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Shandong, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shanghai, 200433, China
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Suzhou, 215006, China
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Ürümqi, 830000, China
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Wanzhou, 404000, China
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Wenzhou, CN-325000, China
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Xiamen, 361004, China
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Yangzhou, 225001, China
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Avignon, 84902, France
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Bordeaux, 33000, France
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Berlin, 12351, Germany
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Bielefeld, 33611, Germany
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Cologne, 51109, Germany
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Esslingen a.N., 73730, Germany
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Freiburg im Breisgau, 79106, Germany
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Gauting, 82131, Germany
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Georgsmarienhütte, 49124, Germany
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Halle, 06120, Germany
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Oldenburg, 26121, Germany
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Würzburg, 97067, Germany
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Mumbai, 400012, India
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Namakkal, 637001, India
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New Delhi, 110029, India
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Varanasi, 221005, India
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Haifa, 3109601, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 95847, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 5265601, Israel
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Tel Aviv, 62748, Israel
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Bari, 70124, Italy
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Florence, 50134, Italy
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Monza, 20900, Italy
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Orbassano, 10043, Italy
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Padova, 35128, Italy
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Rozzano, 20089, Italy
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Varese, 21100, Italy
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Akashi-shi, 673-8558, Japan
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Bunkyō City, 113-8431, Japan
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Chiba, 260-8677, Japan
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Hiroshima, 734-8551, Japan
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Kashiwa, 227-8577, Japan
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Kōtoku, 135-8550, Japan
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Kyoto, 606-8507, Japan
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Niigata, 951-8566, Japan
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Osaka, 541-8567, Japan
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Sakai, 590-0197, Japan
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Sakaishi, 591-8555, Japan
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Sendai, 981-0914, Japan
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Shinjuku-ku, 160-0023, Japan
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Sunto-gun, 411-8777, Japan
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Yokohama, 241-8515, Japan
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Aguascalientes, 20230, Mexico
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D.F, 14050, Mexico
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Mexico City, '14080, Mexico
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La Libertad, 13013, Peru
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Lima, 0051, Peru
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Lima, 15036, Peru
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Lima, L41, Peru
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Lima, LIMA 34, Peru
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Olsztyn, 10-357, Poland
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Kazan', 420029, Russia
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Krasnoyarsk, 660133, Russia
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Moscow, 105229, Russia
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Nizhny Novgorod, 603081, Russia
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Obninsk, 249036, Russia
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Perm, 614990, Russia
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Saint Petersburg, 191036, Russia
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Saint Petersburg, 197758, Russia
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Daegu, 41404, South Korea
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Hwasun-gun, 58128, South Korea
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Incheon, 21431, South Korea
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Seoul, 02447, South Korea
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Seoul, 08308, South Korea
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Seoul, 42601, South Korea
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Yangsan, 50612, South Korea
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Barcelona, 08035, Spain
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Madrid, 28040, Spain
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Majadahonda, 28222, Spain
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Málaga, 29010, Spain
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Winterthur, 8401, Switzerland
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Zurich, CH-8091, Switzerland
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Taichung, 40201, Taiwan
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Taichung, 40447, Taiwan
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Tainan, 73657, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 110, Taiwan
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Taipei, 112, Taiwan
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Taipei, 235, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Chiang Mai, 50200, Thailand
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Khon Kaen, 40002, Thailand
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Pathum Thani, 12120, Thailand
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Phisanulok, 65000, Thailand
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Ankara, 06010, Turkey (Türkiye)
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Ankara, 06800, Turkey (Türkiye)
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Ankara, 6500, Turkey (Türkiye)
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Istanbul, 34010, Turkey (Türkiye)
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Istanbul, 34214, Turkey (Türkiye)
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Malatya, 44280, Turkey (Türkiye)
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Birmingham, B9 5SS, United Kingdom
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Liverpool, L7 8YA, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam

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