A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA) (LAURA)

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, International Study of Osimertinib as Maintenance Therapy in Patients With Locally Advanced, Unresectable EGFR Mutation-positive Non-Small Cell Lung Cancer (Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy (LAURA).

A global study to assess the efficacy and safety of osimertinib following chemoradiation in patients with stage III unresectable Epidermal Growth Factor Receptor Mutation Positive non-small cell lung cancer

Study Overview

• Status: Active, not recruiting
• Conditions: Non Small Cell Lung Cancer (Stage III)
• Intervention / Treatment: Drug: Osimertinib 80mg/40mg; Drug: Placebo Osimertinib 80mg/40mg

Detailed Description

This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of osimertinib following chemoradiation in patients with stage III unresectable EGFR mutation-positive NSCLC, including the most common EGFR sensitising mutations (Ex19Del and L858R), either alone or in combination with other EGFR mutations. Chemoradiation may have been given either given concurrently or sequentially. Patients whose disease has not progressed following chemoradiation will be randomised within 6 weeks of completion of chemoradiation to receive osimertinib or placebo in a 2:1 ratio, and treatment will be continued until disease progression, unacceptable toxicity or other discontinuation criteria are met. After progression, patients can be unblinded and may receive open-label osimertinib. After the final OS analysis, the study blind will be broken and patients still receiving open-label osimertinib will be supplied with open-label osimertinib by AstraZeneca for as long as their treating physician considers they are deriving clinical benefit.

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autónoma de Bs. As., Argentina, C1199ABB
    • Research Site
  • Ciudad Autónoma de Bs. As., Argentina, 1426
    • Research Site
  • Mar del Plata, Argentina, 7600
    • Research Site
  • Rosario, Argentina, 2000
    • Research Site
  • San Salvador de Jujuy, Argentina, 4600
    • Research Site
• Brazil
  • Barretos, Brazil, 14784-400
    • Research Site
  • Curitiba, Brazil, 81520-060
    • Research Site
  • Florianópolis, Brazil, 88034-000
    • Research Site
  • Fortaleza, Brazil, 60336-045
    • Research Site
  • Porto Alegre, Brazil, 90610-000
    • Research Site
  • Porto Alegre, Brazil, 90160-093
    • Research Site
  • Ribeirão Preto, Brazil, 14021-636
    • Research Site
  • São Paulo, Brazil, 01246-000
    • Research Site
  • São Paulo, Brazil, 01221-0100
    • Research Site
• China
  • Beijing, China, 100021
    • Research Site
  • Beijing, China, 100730
    • Research Site
  • Changchun, China, 130000
    • Research Site
  • Changsha, China, 410013
    • Research Site
  • Chengdu, China, 610041
    • Research Site
  • Guangzhou, China, 510100
    • Research Site
  • Hangzhou, China, 310006
    • Research Site
  • Hangzhou, China, 310022
    • Research Site
  • Hangzhou, China, 310003
    • Research Site
  • Jinan, China, 250117
    • Research Site
  • Linhai, China, 317000
    • Research Site
  • Shanghai, China, 200032
    • Research Site
  • Shanghai, China, 200030
    • Research Site
  • Wuhan, China, 430022
    • Research Site
  • Wuhan, China, 430030
    • Research Site
  • Ürümqi, China, 830099
    • Research Site
• Hungary
  • Budapest, Hungary, 1083
    • Research Site
  • Budapest, Hungary, 1121
    • Research Site
  • Gyöngyös - Mátraháza, Hungary, 3200
    • Research Site
  • Pécs, Hungary, 7623
    • Research Site
• India
  • Bangalore, India, 560068
    • Research Site
  • Gurgaon, India, 122001
    • Research Site
  • Hubli, India, 580025
    • Research Site
  • Karamsad, India, 388325
    • Research Site
  • Kolkata, India, 700160
    • Research Site
  • Nashik, India, 422002
    • Research Site
  • New Delhi, India, 110063
    • Research Site
  • New Delhi, India, 110085
    • Research Site
  • New Delhi, India, 11029
    • Research Site
• Japan
  • Hiroshima, Japan, 734-8551
    • Research Site
  • Kanazawa, Japan, 920-8641
    • Research Site
  • Kashiwa, Japan, 227-8577
    • Research Site
  • Nagoya, Japan, 460-0001
    • Research Site
  • Niigata, Japan, 951-8566
    • Research Site
  • Osaka, Japan, 541-8567
    • Research Site
  • Sakaishi, Japan, 591-8555
    • Research Site
  • Sapporo, Japan, 003-0804
    • Research Site
  • Sayama, Japan, 589-8511
    • 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
• Malaysia
  • George Town, Malaysia, 10450
    • Research Site
  • Kuala Lumpur, Malaysia, 59100
    • Research Site
  • Kuala Selangor, Malaysia, 46050
    • Research Site
• Mexico
  • Mérida, Mexico, 97134
    • Research Site
• Peru
  • Lima, Peru, LIMA 34
    • Research Site
  • Lima, Peru, LIMA 41
    • Research Site
  • Lima, Peru, LIMA 31
    • Research Site
  • Lima, Peru, Lima 32
    • Research Site
  • San Isidro, Peru, 27
    • Research Site
• Russia
  • Kazan', Russia, 420029
    • Research Site
  • Kostroma, Russia, 156005
    • Research Site
  • Moscow, Russia, 121205
    • Research Site
  • Novisibirsk, Russia, 630082
    • Research Site
  • Obninsk, Russia, 249036
    • Research Site
  • Saint Petersburg, Russia, 197758
    • Research Site
  • Saint Petersburg, Russia, 197022
    • Research Site
  • Ufa, Russia, 450054
    • Research Site
• South Korea
  • Cheongju-si, South Korea, 28644
    • Research Site
  • Incheon, South Korea, 21565
    • Research Site
  • Seongnam-si, South Korea, 13620
    • Research Site
  • Seoul, South Korea, 05505
    • Research Site
  • Seoul, South Korea, 06351
    • Research Site
• Spain
  • Barcelona, Spain, 08003
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • San Sebastián, Spain, 20014
    • Research Site
  • Seville, Spain, 41009
    • Research Site
  • Valencia, Spain, 46009
    • Research Site
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Research Site
  • Taichung, Taiwan, 40705
    • Research Site
  • Taichung, Taiwan, 40447
    • Research Site
  • Taichung, Taiwan, 402
    • Research Site
  • Tainan, Taiwan, 70403
    • Research Site
  • Taipei, Taiwan, 10002
    • Research Site
  • Taipei, Taiwan, 11217
    • Research Site
  • Taoyuan, Taiwan, 00333
    • Research Site
• Thailand
  • Bangkok, Thailand, 10300
    • Research Site
  • Bangkok, Thailand, 10330
    • Research Site
  • Bangkok, Thailand, 10400
    • Research Site
  • Bangkok, Thailand, 10700
    • Research Site
  • Hat Yai, Thailand, 90110
    • Research Site
  • Khon Kaen, Thailand, 40002
    • Research Site
  • Lampang, Thailand, 52000
    • Research Site
  • Mueang, Thailand, 50200
    • Research Site
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01120
    • Research Site
  • Adapazarı, Turkey (Türkiye), 54290
    • Research Site
  • Ankara, Turkey (Türkiye), 06280
    • Research Site
  • Ankara, Turkey (Türkiye), 6200
    • Research Site
  • Ankara, Turkey (Türkiye)
    • Research Site
  • Istanbul, Turkey (Türkiye), 34030
    • Research Site
  • Istanbul, Turkey (Türkiye), 34854
    • Research Site
  • Izmir, Turkey (Türkiye), 35620
    • Research Site
• United States
  • California
    • Duarte, California, United States, 91010
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Research Site
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Research Site
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Research Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Research Site
• Vietnam
  • Hanoi, Vietnam, 100000
    • Research Site
  • Ho Chi Minh City, Vietnam, 700000
    • Research Site
  • Ho Chi Minh City, Vietnam, 70000
    • Research Site
  • Hà Nội, Vietnam, 100000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Male or female aged at least 18 years.
2. Patients with histologically documented NSCLC of predominantly non-squamous Pathology who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer [IASLC] Staging Manual in Thoracic Oncology).
3. The tumor harbours one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations, assessed by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test in a CLIA certified (USA sites) or an accredited local laboratory (sites outside of the USA) or by central testing (cobas® v2 only).
4. Patients must have received either concurrent chemoradiation or sequential chemoradiation including at least 2 cycles of platinum based chemotherapy and a total dose of radiation of 60 Gy ±10% (54 to 66 Gy).
5. Chemoradiation must be completed ≤6 weeks prior to randomization.
6. Patients must not have had disease progression during or following definitive platinum-based, chemoradiation therapy.
7. World Health Organization (WHO) performance status of 0 or 1.
8. Life expectancy >12 weeks at Day 1.
9. Female patients who are not abstinent (in line with the preferred and usual lifestyle choice) must be using adequate contraceptive measures, must not be breast feeding, and must have a negative pregnancy test prior to first dose of study drug; or female patients must have an evidence of non-childbearing potential.

Exclusion Criteria

1. Mixed small cell and non-small cell lung cancer histology
2. History of interstitial lung disease (ILD) prior to chemoradiation
3. Symptomatic pneumonitis following chemoradiation
4. Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) > Grade 2 from the prior chemoradiation therapy

5. Any of the following cardiac criteria:

   • Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs
   • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG
   • Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes
6. Inadequate bone marrow reserve or organ function
7. History of other malignancies, except: adequately treated non-melanoma skin cancer or lentigo maligna , curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for > 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
8. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
9. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
10. Prior treatment with any prior chemotherapy, radiation therapy, immunotherapy or investigational agents for NSCLC outside of that received in the definitive setting for Stage III disease (chemotherapy and radiotherapy in SCRT and CCRT regimens is allowed for treatment of Stage III disease).
11. Prior treatment with EGFR-TKI therapy
12. Major surgery as defined by the investigator within 4 weeks of the first dose of study drug.
13. Patients currently receiving (unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior to receiving the first dose of study drug).
14. Contraindication to MRI, including but not limited to, claustrophobia, pace makers, metal implants, intracranial surgical clips and metal foreign bodies

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osimertinib; Osimertinib (80mg or 40mg orally, once daily), in accordance with the randomization schedule.	Drug: Osimertinib 80mg/40mg; The initial dose of Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Placebo Comparator: Placebo Osimertinib; Matching placebo for Osimertinib (80mg or 40mg orally, once daily), in accordance with the randomization schedule	Drug: Placebo Osimertinib 80mg/40mg; The initial dose of Placebo Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR)	Time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression, based on BICR assessment according to RECIST v1.1	Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Progression-free Survival (PFS) Events in Patients With EGFR Ex19del or L858R Mutation	Number of PFS events (PFS is time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression, based on BICR assessment according to RECIST v1.1)	Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
Number of Participants With Progression-free Survival (PFS) Events in Patients With EGFR Mutations Ex19del or L858R Detectable in Plasma-derived ctDNA	Number of PFS events (PFS is time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression, based on blinded independent central review (BICR) assessment according to RECIST v1.1)	Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
Central Nervous System (CNS) Progression-free Survival (PFS) by Blinded Independent Central Review (BICR)	Time from randomisation until the date of CNS disease progression or death (by any cause in the absence of CNS progression) regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression, based on CNS BICR assessment according to RECIST v1.1	Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
Overall Survival (Count)	Number of patients with Overall Survival (OS), the time from the date of randomisation until date of death by any cause	Date of randomisation to date of death by any cause. Assessed up to a maximum of approximately 63 months
Overall Survival (Duration)	Time from the date of randomisation until death by any cause	Date of randomisation to date of death by any cause. Assessed up to a maximum of approximately 63 months
Objective Response Rate by Blinded Independent Central Review (BICR)	Percentage of evaluable patients with at least one BICR assessed visit response of complete response (CR) or partial response (PR). CR defined as disappearance of all target lesions (TL) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm. PR defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline sum of diameters). Responses include both confirmed and unconfirmed BICR responses	Every 8 weeks for first 48 weeks, then every 12 weeks until radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
Duration of Response, Unconfirmed by Blinded Independent Central Review (BICR)	Date of PFS event - date of first unconfirmed response + 1 day (and expressed in months) for unconfirmed responses only	Every 8 weeks for first 48 weeks, then every 12 weeks until radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
Disease Control Rate by Blinded Independent Central Review (BICR)	Percentage of patients who have a best overall response of complete response (CR), partial response (PR) or stable disease (SD) as assessed by BICR	Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
Tumour Shrinkage by Blinded Independent Central Review (BICR)	Depth of response (or tumour shrinkage or change in tumour size) was assessed using BICR responses in target lesions. The best change in tumour size is the largest decrease from baseline or the smallest increase from baseline in the absence of a reduction	Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
Proportion With Tumour Shrinkage by Blinded Independent Central Review (BICR)	Proportion with depth of response (or tumour shrinkage or change in tumour size)	Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
Time to Death or Distant Metastases by Blinded Independent Central Review (BICR)	Time from the date of randomisation until the first date of distant metastases or date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is detected on a scan that is anywhere other than lung or regional lymph node according to RECIST v1.1 or proven by biopsy	Time from randomisation to the date of distant metastases or death. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
Time to Study Treatment Discontinuation	Time from randomisation to the earlier of the date of study treatment discontinuation (regardless of the reason for study treatment discontinuation) or death (i.e. date of study treatment discontinuation/death or censoring - date of randomisation + 1 day, expressed in months)	Time from randomisation to the earlier of the date of study treatment discontinuation or death. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
Time to First Subsequent Treatment	Time from the date of randomisation to the earlier of the date of anti-cancer therapy start date following study drug discontinuation or death	Time from randomisation to the start of first subsequent anti-cancer therapy or death. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
Time to Second Subsequent Treatment	Time from the date of randomisation to the earlier of the second subsequent anti-cancer therapy start date following study drug discontinuation or death	Time from randomisation to the start of second subsequent anti-cancer therapy or death. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
Second Progression-free Survival (PFS2)	Time from randomisation to the earliest progression event following first objective disease progression, subsequent to the first subsequent therapy, or death.	Every 8 weeks for first 48 weeks, then every 12 weeks. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Suresh S Ramalingam, MD, Emory University School of Medicine, Atlanta, U.S.; Principal Investigator: Shun Lu, MD, Shanghai Chest Hospital, Shanghai, China

Publications and helpful links

General Publications

• Lu S, Casarini I, Kato T, Cobo M, Ozguroglu M, Hodge R, van der Gronde T, Saggese M, Ramalingam SS. Osimertinib Maintenance After Definitive Chemoradiation in Patients With Unresectable EGFR Mutation Positive Stage III Non-small-cell Lung Cancer: LAURA Trial in Progress. Clin Lung Cancer. 2021 Jul;22(4):371-375. doi: 10.1016/j.cllc.2020.11.004. Epub 2021 Jan 6.
• Murat-Onana ML, Ramalingam SS, Janne PA, Gray JE, Ahn MJ, John T, Yatabe Y, Huang X, Rukazenkov Y, Javey M, Brown H, Li-Sucholeiki X. EGFR mutation testing across the osimertinib clinical program. Lung Cancer. 2025 Jun;204:108549. doi: 10.1016/j.lungcan.2025.108549. Epub 2025 Apr 18.
• Lu S, Kato T, Dong X, Ahn MJ, Quang LV, Soparattanapaisarn N, Inoue T, Wang CL, Huang M, Yang JC, Cobo M, Ozguroglu M, Casarini I, Khiem DV, Sriuranpong V, Cronemberger E, Takahashi T, Runglodvatana Y, Chen M, Huang X, Grainger E, Ghiorghiu D, van der Gronde T, Ramalingam SS; LAURA Trial Investigators. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. N Engl J Med. 2024 Aug 15;391(7):585-597. doi: 10.1056/NEJMoa2402614. Epub 2024 Jun 2.
• Tu CY, Hsia TC, Lin YC, Liang JA, Li CC, Chien CR. Efficacy of Definitive Radiotherapy for Patients with Clinical Stage IIIB or IIIC Lung Adenocarcinoma and Epidermal Growth Factor Receptor (EGFR) Mutations Treated Using First- or Second-Generation EGFR Tyrosine Kinase Inhibitors. Can Respir J. 2024 Mar 5;2024:8889536. doi: 10.1155/2024/8889536. eCollection 2024.
• Lu S, Kato T, Dong X, Ahn MJ, Quang LV, Soparattanapaisarn N, Inoue T, Wang CL, Huang M, Yang JC, Cobo M, Ozguroglu M, Casarini I, Sriuranpong V, Cronemberger E, Takahashi T, Runglodvatana Y, Chen M, Huang X, Grainger E, Ghiorghiu D, van der Gronde T, Ramalingam SS. A plain language review of results from the LAURA study: osimertinib after chemoradiotherapy for patients with EGFR-mutated non-small cell lung cancer that cannot be removed by surgery. Future Oncol. 2026 May;22(11):1247-1262. doi: 10.1080/14796694.2026.2652543. Epub 2026 Apr 27.
• Arriola E, Casarini I, Ozguroglu M, Huang M, Takahashi T, Lai X, Goto K, Maneenil K, Lee KH, Cobo M, Valdiviezo N, Evans A, Bolanos A, Huang X, Lai R, Ramalingam SS. Patient-reported outcomes from the LAURA study: osimertinib in patients with unresectable stage III EGFR-mutated non-small cell lung cancer after definitive chemoradiotherapy. Eur J Cancer. 2026 Apr 12;240:116744. doi: 10.1016/j.ejca.2026.116744. Online ahead of print.

Helpful Links

• D5160C00048_CSP_redacted
• D5160C00048_SAP_redacted
• D5160C00048_CSR synopsis_redacted

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): January 5, 2024
• Study Completion (Estimated): October 29, 2027

Study Registration Dates

• First Submitted: April 20, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Phase III; EGFR; Osimertinib; Unresectable NSCLC; chemoradiation therapy; Non Small Cell Lung Cancer (Stage III)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Tyrosine Kinase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; osimertinib
• Other Study ID Numbers: D5160C00048; 2018-001061-16 (EudraCT Number); 2022-500860-36-00 (Registry Identifier: CTIS)

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
• product manufactured in and exported from the U.S.: No