A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer (NeoADAURA)

May 11, 2026 updated by: AstraZeneca

A Phase III, Randomised, Controlled, Multi-center, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer

This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
358

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Arm 1: Placebo with platinum-based chemotherapy
Placebo plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
Drug: Placebo
Oral
Drug: Cisplatin
Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles.
Drug: Carboplatin
Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles
Drug: Pemetrexed
Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 3 cycles
Experimental: Arm 2: Osimertinib with platinum-based chemotherapy
Osimertinib 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator) plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
Drug: Cisplatin
Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles.
Drug: Carboplatin
Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles
Drug: Pemetrexed
Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 3 cycles
Drug: Osimertinib
Oral
Other Names:
  • AZD9291; TAGRISSO
Experimental: Arm 3: Osimertinib monotherapy
Osimertinib 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator)
Drug: Osimertinib
Oral
Other Names:
  • AZD9291; TAGRISSO

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major Pathological Response (MPR) - IASLC Method
Time Frame: From date of randomization to an average of 12 weeks after the first dose
Defined as ≤10% viable cancer cells in the surgical specimen, as assessed per central pathology laboratory post-surgery (IASLC method). Patients will only be considered to have an MPR if they also have an R0 margin result.
From date of randomization to an average of 12 weeks after the first dose
Major Pathological Response (MPR) - Chemotherapy Method
Time Frame: From date of randomization to an average of 12 weeks after the first dose
Defined as ≤10% viable cancer cells in the surgical specimen, as assessed per central pathology laboratory post-surgery (chemotherapy method). Patients will only be considered to have an MPR if they also have an R0 margin result.
From date of randomization to an average of 12 weeks after the first dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (pCR) - IASLC Method
Time Frame: From date of randomization to an average of 12 weeks after the first dose
Defined as absence of any viable cancer cells in the dissected tumour samples, including the main tumour, lymph nodes, and margins as assessed per central pathology laboratory post-surgery using IASLC method. Patients will only be considered to have pCR if they also have an R0 margin result based on site assessment.
From date of randomization to an average of 12 weeks after the first dose
Pathological Complete Response (pCR) - Chemotherapy Method
Time Frame: From date of randomization to an average of 12 weeks after the first dose
Defined as absence of any viable cancer cells in the dissected tumour samples, including the main tumour, lymph nodes, and margins as assessed per central pathology laboratory post-surgery using chemotherapy method. Patients will only be considered to have pCR if they also have an R0 margin result based on site assessment.
From date of randomization to an average of 12 weeks after the first dose
Downstaging
Time Frame: From date of randomization to an average of 12 weeks after the first dose.
Measured using pathologic mediastinal lymph node evaluation. Pathological downstaging is defined as baseline N2 patients becoming N1/N0 or N1 to N0 at the time of surgery. Only patients with pathological staging at both baseline and surgery are included in this analysis.
From date of randomization to an average of 12 weeks after the first dose.
Concordance of EGFRm Status Between Tumor Tissue DNA and Patient-matched Plasma-derived ctDNA (Mutation Ex19Del or L858R)
Time Frame: Screening/Baseline
Comparing the baseline central cobas® EGFR Mutation Test V2 between tumor tissue DNA and matched plasma ctDNA results (excluding invalid results). Since this endpoint uses pre-randomization data, treatment arms were combined for the analysis.
Screening/Baseline
Concordance of EGFR Mutation Status Between the Local and Central Test Results From Baseline Tumor Samples (Mutation Ex19Del or L858R)
Time Frame: Screening/Baseline
Comparing the local EGFR mutation test result used for patient selection with the retrospective baseline central cobas® EGFR Mutation Test V2 results (excluding invalid results). Since this endpoint uses pre-randomization data, treatment arms were combined for the analysis.
Screening/Baseline
Change From Baseline in EORTC QLQ-C30 Primary Subscale Scores (Neoadjuvant Period)
Time Frame: Assessed at baseline, Cycle 2 Day1, Cycle 3 Day1, and Pre-surgical assessment (on D64, -1 to +21 days ).
Average change from baseline across all visits are reported. The analysis was performed using a MMRM analysis on the change from baseline in the score at each visit, including subject (random effect), treatment, visit (fixed effect & repeated measure) and treatment by visit interaction as explanatory variables, with the baseline score as a covariate along with the baseline score by assessment interaction. EORTC QLQ-C30 has 30 questions and questions are combined to produce symptom scales, individual symptom items, functional scales, and global health status (GHS)/quality of life (QoL). Each of the scale/items range from 0-100 after a linear transformation. Positive change from baseline scores on the GHS/QoL and functioning scales indicate improvement on health status/function, and negative change scores on symptom scales/items represent less symptom severity/improvement on symptom status.
Assessed at baseline, Cycle 2 Day1, Cycle 3 Day1, and Pre-surgical assessment (on D64, -1 to +21 days ).
Change From Baseline in EORTC QLQ-LC13 Primary Subscale Scores (Neoadjuvant Period)
Time Frame: Assessed at baseline, Cycle 2 Day1, Cycle 3 Day1, and Pre-surgical assessment (on D64, -1 to +21 days).

Average change from baseline across all visits are reported. The analysis was performed using a MMRM analysis on the change from baseline in the score at each visit, including subject (as a random effect), treatment, visit (as fixed effect and repeated measure) and treatment by visit interaction as explanatory variables, with the baseline score as a covariate along with the baseline score by assessment interaction. EORTC QLQ-LC13 has 13 questions and scores range from 0-100 after a linear transformation. Questions assess cough, hemoptysis, dyspnea, site specific pain, sore mouth, dysphagia, peripheral neuropathy, and alopecia and pain medication. While the QLQ-LC13 includes more scales, only the Coughing, Pain in chest, and Dyspnea subscale scores were analyzed for this endpoint.

Negative change from baseline scores indicates less symptom severity, and thus improvement on health status.
Assessed at baseline, Cycle 2 Day1, Cycle 3 Day1, and Pre-surgical assessment (on D64, -1 to +21 days).
PK Plasma Concentrations of Osimertinib
Time Frame: From the pre-dose of Cycle 2 to post-dose of Cycle 3 (each cycle is 21 days)
Summary of plasma concentrations (nM) of Osimertinib
From the pre-dose of Cycle 2 to post-dose of Cycle 3 (each cycle is 21 days)
PK Plasma Concentrations of AZ5104
Time Frame: From the pre-dose of Cycle 2 to post-dose of Cycle 3 (each cycle is 21 days)
Summary of plasma concentrations (nM) of AZ5104
From the pre-dose of Cycle 2 to post-dose of Cycle 3 (each cycle is 21 days)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cure rate
Time Frame: From the surgery until 5 years after surgery
The cure rate is defined as the percentage of people in this study who are still alive and disease free for a certain period of time after they finished the surgery. Here 5-year landmark cure rate will be calculated in the same time as OS analysis.
From the surgery until 5 years after surgery
Number of adverse events as assessed by CTCAE 5.0 and other clinical variables for safety and tolerability profile of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy prior to surgery compared with chemotherapy alone
Time Frame: From the time of enrollment to either 28-days after the last dose of last study treatment for patients who do not undergo surgery, or 90-days post-surgery
Other clinical variables include deaths, laboratory data, vital signs (pulse and BP), ECG, LVEF, ECOG performance status, and ophthalmologic assessment
From the time of enrollment to either 28-days after the last dose of last study treatment for patients who do not undergo surgery, or 90-days post-surgery
MPR using plasma-derived circulating-free tumour DNA (ctDNA)
Time Frame: From date of randomization to an average of 12 weeks after the first dose
From date of randomization to an average of 12 weeks after the first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jamie Chaft, MD, Memorial Sloan Kettering, USA
  • Principal Investigator: Masahiro Tsuboi, MD, National Cancer Center Hospital East, Japan
  • Principal Investigator: Walter Weder, MD, Thoraxchirurgie Bethanien, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D516AC00001
  • 2020-000058-89 (EudraCT Number)
  • 2022-502606-33-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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