Non-small Cell Lung CancerEARLY-EGFRNCT04742192
Non-interventional, Prospective Study to Determine Prevalence of EGFR Mutations in Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 33 sites in 15 countries.
Trial summary
This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC up to 6 weeks prior to enrolment into the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 601 participants
- Where
- 33 sitesin 15 countries
- Study dates
- 4 Mar 2021to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who have stage IA to IIIB NSCLC with non-squamous histology and who have undergone surgical resection of tumour up to 6 weeks prior to enrolment
Who may be able to join
- Adult male or female patients ≥18 years old or 'adults' according to age of majority as defined by the local regulations
- Patient or next of kin/legal representative is willing and able to provide informed consent according to the local regulations, where applicable
- Patients with stage IA to IIIB (on the basis of pathologic criteria) NSCLC with adenocarcinoma, or mixed histology with an adenocarcinoma component who have undergone surgical resection of the tumour during the preceding 6 weeks
- Availability of FFPE tissue specimen suitable for EGFRm testing (either the primary diagnostic sample or the surgically resected tumour specimen)
- Availability of medical records at the participating site detailing the initial diagnosis, staging, and surgical management of NSCLC
Who cannot join
- Patients who fulfil any of the following exclusion criteria will not be eligible for the study:
- Histology of the tumour is considered not to be of primary lung in origin
- Histology is pure squamous cell carcinoma, pure small cell carcinoma, or large cell carcinoma origin lacking any immunohistochemistry evidence of adenocarcinoma differentiation -
Trial locations and contacts
33 sites in 15 countries.
33 sites in 15 countries
Philippines6 sites
Research Site
Cebu City
Research Site
City of Taguig, Philippines
Research Site
Iliolo City, Philippines
Research Site
Makati
Research Site
Manila
Research Site
Quezon City
India4 sites
Research Site
Kashmīr
Research Site
Kolkata
Research Site
Mumbai
Research Site
New Delhi
Mexico3 sites
Research Site
Guadalajara, 64700
Research Site
Mexico City, Mexico City, 6720
Research Site
Monterrey, 44260
Argentina2 sites
Research Site
Buenos Aires, 1415
Research Site
Rosario - Santa Fe, Argentina, S2002RE
Colombia2 sites
Research Site
Bogotá, 110111
Research Site
Montería -Cordoba, Colombia, 230002
Vietnam2 sites
Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 70000
About this study
Official title: A Multicountry, Multicentre, Non-interventional, Prospective Study to Determine the Prevalence of EGFR Mutations in Patients With Early-stage, Surgically Resected, Non-squamous, Non-small Cell Lung Cancer
This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC up to 6 weeks prior to enrolment into the study.
The main objective of this study is to determine the prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB) non-squamous NSCLC as there are limited data on its prevalence in this patient population.
Read the detailed description
This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC up to 6 weeks prior to enrolment into the study. Eligible patients should have availability of formalin-fixed paraffin-embedded (FFPE) specimen(s) to be primarily tested for EGFRm at validated local laboratories or a central laboratory. The informed consent will be obtained from the patients during their routine clinical care visit before data are collected from the medical records. The data on socio-demographics, tumour staging, histology, surgical management, and neoadjuvant therapies will be collected from available medical records at the treating facility by the investigator. If PD-L1 testing is conducted as part of routine clinical care, the available results will be recorded. Patients will be followed prospectively and follow-up will be considered as complete once EGFRm status of the patient's tumour sample is known and any planned adjuvant therapy has been recorded.
- Conditions
- Non-small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall proportion of patients with EGFRm
Prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC followed by Proportion of EGFRm by the following subgroup:
- Histology (adenocarcinoma, bronchiole-alveolar, large cell carcinoma, mixed, other, unknown)
Measured: 3 month
Proportion of EGFRm in Pathologic Stage
Prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC followed by Proportion of EGFRm by the following subgroup:
- Pathologic stage (IA, IB, IIA, IIB, IIIA, IIIB with lymph node metastasis status [N0, N1, and N2])b
Measured: 3 Month
Secondary outcomes (2)
Proportion of patients with the EGFRm types
Proportion of patients with the following EGFRm types:
- Exon19 deletions
- Exon21 L858R
- Exon20 T790M
- Others (compound mutationsb, uncommon mutations [including G719X, L861Q, S768I, and 20 insertions])
Measured: 3 Month
Proportion of patients who were prescribed modalities
Proportion of patients who were prescribed these modalities:
- Only surgical resection
- Surgical resection and radiotherapy
- Surgical resection and systemic therapy (neoadjuvant and/or adjuvant)
- Surgical resection, radiotherapy and systemic therapy (neoadjuvant and/or adjuvant)
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start4 Mar 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742192
- Sponsor's protocol ID
- D5161R00028
- Acronym
- EARLY-EGFR
- Status last verified
- Aug 2023
- First submitted
- 25 Jan 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Batra U, Prabhash K, Noronha V, Deshpande R, Khurana S, Bhat GM, Mistry R, Agarwala V, Rajpurohit S, Poladia B, Sharma M, Banday SZ. Prevalence of EGFR Mutations in Patients With Resected Stage I to III Nonsquamous Non-Small Cell Lung Cancer: Results of India Cohort. JCO Glob Oncol. 2025 Jan;11:e2400353. doi: 10.1200/GO-24-00353. Epub 2025 Jan 7.
PubMed 39772802Soo RA, Reungwetwattana T, Perroud HA, Batra U, Kilickap S, Tejado Gallegos LF, Donner N, Alsayed M, Huggenberger R, Van Tu D. Prevalence of EGFR Mutations in Patients With Resected Stages I to III NSCLC: Results From the EARLY-EGFR Study. J Thorac Oncol. 2024 Oct;19(10):1449-1459. doi: 10.1016/j.jtho.2024.06.008. Epub 2024 Jun 14.
PubMed 38880172
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicountry, Multicentre, Non-interventional, Prospective Study to Determine the Prevalence of EGFR Mutations in Patients With Early-stage, Surgically Resected, Non-squamous, Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04742192
- Acronym / sponsor ID
- EARLY-EGFR / D5161R00028
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC up to 6 weeks prior to enrolment into the study.
The main objective of this study is to determine the prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB) non-squamous NSCLC as there are limited data on its prevalence in this patient population.
Detailed description
This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC up to 6 weeks prior to enrolment into the study. Eligible patients should have availability of formalin-fixed paraffin-embedded (FFPE) specimen(s) to be primarily tested for EGFRm at validated local laboratories or a central laboratory. The informed consent will be obtained from the patients during their routine clinical care visit before data are collected from the medical records. The data on socio-demographics, tumour staging, histology, surgical management, and neoadjuvant therapies will be collected from available medical records at the treating facility by the investigator. If PD-L1 testing is conducted as part of routine clinical care, the available results will be recorded. Patients will be followed prospectively and follow-up will be considered as complete once EGFRm status of the patient's tumour sample is known and any planned adjuvant therapy has been recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have stage IA to IIIB NSCLC with non-squamous histology and who have undergone surgical resection of tumour up to 6 weeks prior to enrolment
Key inclusion criteria (5 listed)
- Adult male or female patients ≥18 years old or 'adults' according to age of majority as defined by the local regulations
- Patient or next of kin/legal representative is willing and able to provide informed consent according to the local regulations, where applicable
- Patients with stage IA to IIIB (on the basis of pathologic criteria) NSCLC with adenocarcinoma, or mixed histology with an adenocarcinoma component who have undergone surgical resection of the tumour during the preceding 6 weeks
- Availability of FFPE tissue specimen suitable for EGFRm testing (either the primary diagnostic sample or the surgically resected tumour specimen)
- Availability of medical records at the participating site detailing the initial diagnosis, staging, and surgical management of NSCLC
Key exclusion criteria (3 listed)
- Patients who fulfil any of the following exclusion criteria will not be eligible for the study:
- Histology of the tumour is considered not to be of primary lung in origin
- Histology is pure squamous cell carcinoma, pure small cell carcinoma, or large cell carcinoma origin lacking any immunohistochemistry evidence of adenocarcinoma differentiation -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall proportion of patients with EGFRm
Time frame: 3 month
Prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC followed by Proportion of EGFRm by the following subgroup: o Histology (adenocarcinoma, bronchiole-alveolar, large cell carcinoma, mixed, other, unknown)
Proportion of EGFRm in Pathologic Stage
Time frame: 3 Month
Prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC followed by Proportion of EGFRm by the following subgroup: o Pathologic stage (IA, IB, IIA, IIB, IIIA, IIIB with lymph node metastasis status [N0, N1, and N2])b
2 secondary outcomes
Proportion of patients with the EGFRm types
Time frame: 3 Month
Proportion of patients who were prescribed modalities
Time frame: 3 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 39772802Batra U, Prabhash K, Noronha V, Deshpande R, Khurana S, Bhat GM, Mistry R, Agarwala V, Rajpurohit S, Poladia B, Sharma M, Banday SZ. Prevalence of EGFR Mutations in Patients With Resected Stage I to III Nonsquamous Non-Small Cell Lung Cancer: Results of India Cohort. JCO Glob Oncol. 2025 Jan;11:e2400353. doi: 10.1200/GO-24-00353. Epub 2025 Jan 7.
- Derived from this study: PubMed 38880172Soo RA, Reungwetwattana T, Perroud HA, Batra U, Kilickap S, Tejado Gallegos LF, Donner N, Alsayed M, Huggenberger R, Van Tu D. Prevalence of EGFR Mutations in Patients With Resected Stages I to III NSCLC: Results From the EARLY-EGFR Study. J Thorac Oncol. 2024 Oct;19(10):1449-1459. doi: 10.1016/j.jtho.2024.06.008. Epub 2024 Jun 14.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 33 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Philippines, India, Egypt, Mexico, Argentina and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall proportion of patients with EGFRm (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04742192, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.