Lung CancerPhase 2NSCLCNCT07295821
Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study
A Phase 2 study testing Osimertinib in people with Lung Cancer, run by AstraZeneca at 20 sites in China.
Trial summary
The purpose of this study is to measure efficacy and safety of osimertinib as induction therapy prior to curative intent RT and maintenance osimertinib in chemotherapy ineligible or refusal adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Osimertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 20 sitesChina
- Study dates
- 1 Apr 2026to 30 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent form.
- Participants with histologically documented NSCLC of predominantly nonsquamous, squamous, and adenosquamous pathology who present with locally advanced, unresectable (Stage III, according to Version 8 of the IASLC Staging Manual in Thoracic Oncology) disease. It is recommended but not required that except for overt cT4 disease, nodal status N2, or N3 should have been proven by biopsy, via endobronchial ultrasound, mediastinoscopy, thoracoscopy, or in absence of biopsy, should have been confirmed with whole body contrast-enhanced CT.
- Participants who had recurred from Stage I/II/III after complete surgery or had gross incomplete resections can be included if they didn't receive treatment with any chemotherapy, radiation therapy, immunotherapy, targeted therapy, or investigational agents.
- Participants with availability of the EGFRm test results confirming that the tumor harbors 1 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 including de novo T790M
- WHO performance status of 0, 1 or 2 with no deterioration over the previous 2 weeks prior to baseline at screening and prior to first dose.
- Participants who are eligible for and planning to undergo RT treatment per physician assessment.
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- Participant refusal or ineligible for chemotherapy per physician assessment.
- Minimum life expectancy of > 12 weeks at Day 1.
- At least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
- Capable of giving signed informed consent as described which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Who cannot join
- Any presence of small cell and mixed small-cell and non-small cell histology.
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the participant to participate in the trial or which would jeopardize compliance with the protocol, or active infection.
- 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.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease. Patients who have received RT with overlapping fields (eg, cured breast cancer) should be excluded.
- Patient meets any of the following cardiac criteria: Mean resting QTc > 470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value.
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- Inadequate bone marrow reserve or organ function.
- Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy. Prior treatment with any chemotherapy, radiation therapy, immunotherapy, targeted therapy, or investigational agents for locally advanced, unresectable Stage III NSCLC. Prior surgical resection (ie, Stage I, II, or III) with no systemic treatment with residual disease or a recurrence is permitted.
- 11 Prior exposure to EGFR-TKI therapy. 12 Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.
- 13 Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks.
- 14 History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
- 15 History of hypersensitivity to active or inactive excipients of RT. 16 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- 17 Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- 18 Previous enrolment in the present study. Rescreening of individuals who were screen failures is allowed.
- 19 For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
- 20 Patients should refrain from breastfeeding from enrolment throughout the study and until 6 weeks after last dose of study intervention.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
20 sites in 1 country
China20 sites, 20 recruiting
- Not yet recruiting
Research Site
Beijing, 100021
- Not yet recruiting
Research Site
Beijing, 100730
- Not yet recruiting
Research Site
Changchun, 130021
- Not yet recruiting
Research Site
Changsha, 410013
- Not yet recruiting
Research Site
Chengdu, 610041
- Not yet recruiting
Research Site
Foshan, 528000
- Not yet recruiting
Research Site
Fuzhou, 350011
- Not yet recruiting
Research Site
Guangzhou, 510060
- Recruiting
Research Site
Guangzhou, 510100
- Not yet recruiting
Research Site
Harbin, 150081
- Not yet recruiting
Research Site
Hefei, 230031
- Not yet recruiting
Research Site
Jinan, 250021
- Not yet recruiting
Research Site
Kunming, 650118
- Not yet recruiting
Research Site
Nanchang, 330006
- Not yet recruiting
Research Site
Qingdao, 110016
- Not yet recruiting
Research Site
Shanghai, 200120
- Not yet recruiting
Research Site
Shanghai, 200433
- Not yet recruiting
Research Site
Taiyuan, 030000
- Recruiting
Research Site
Wenzhou, 325000
- Not yet recruiting
Research Site
Xuzhou, 221000
About this study
Official title: Phase II, Single-arm Multicenter Study of Osimertinib Induction Before Radiotherapy and Maintenance in Chemo-ineligible or Refusing Patients With Stage III, Unresectable NSCLC and EGFR Mutation-positive Tumors
The purpose of this study is to measure efficacy and safety of osimertinib as induction therapy prior to curative intent RT and maintenance osimertinib in chemotherapy ineligible or refusal adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).
Read the detailed description
Study details include:
- The study duration will be approximately 13 months for recruitment and 2 years of follow up from the last patient's initiation into the study.
- The induction treatment with osimertinib will be up to12 weeks, followed by 6 weeks of RT treatment and osimertinib maintenance treatment until disease progression or death.
- The visit frequency will be once after 12 weeks during the induction treatment period, every 3 weeks during the RT period (daily visits for RT), and every 12 weeks during the osimertinib maintenance treatment period.
- Conditions
- Lung Cancer
- Being tested
- Osimertinib
- Keywords
- NSCLC
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
80 mg Osimertinib QD
| Study group | Role | What they receive |
|---|---|---|
| Osimertinib as Induction Therapy Prior to Radiotherapy and Maintenance | Experimental | 80 mg Osimertinib QD Receives: Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS (Progression-Free Survival)
PFS is defined as the time from date of first dose until progression per RECIST 1.1 as assessed by the investigator at the local site, or death due to any cause.
Measured: Assessed from date of first dose to progression (up to a maximum of approximately 2 years)
Secondary outcomes (2)
Disease Control Rate (DCR)
DCR is defined as the percentage of subjects who have a best overall response of CR or PR or SD (at 12 weeks) as determined by the investigator at the local site per RECIST 1.1.
Measured: Assessed during the induction phase of the study, scans are carried out at week 12 (plus or minus visit window).
Overall Survival (OS)
OS is defined as time from date of first dose until the date of death due to any cause.
Measured: Assessed from first dose to end of study or death (up to a maximum of approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Apr 2026
- Primary completion30 May 2029 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295821
- Sponsor's protocol ID
- D5167L00001
- Acronym
- NSCLC
- Status last verified
- Apr 2026
- First submitted
- 24 Nov 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trails via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrails.pharmacm.com/ST/Submission/Disclosure. Indicates that AZ accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Single-arm Multicenter Study of Osimertinib Induction Before Radiotherapy and Maintenance in Chemo-ineligible or Refusing Patients With Stage III, Unresectable NSCLC and EGFR Mutation-positive Tumors
- ClinicalTrials.gov ID
- NCT07295821
- Acronym / sponsor ID
- NSCLC / D5167L00001
- Conditions
- Lung Cancer
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 May 2029 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 22 Dec 2025 (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.
The purpose of this study is to measure efficacy and safety of osimertinib as induction therapy prior to curative intent RT and maintenance osimertinib in chemotherapy ineligible or refusal adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).
Detailed description
Study details include:
- The study duration will be approximately 13 months for recruitment and 2 years of follow up from the last patient's initiation into the study.
- The induction treatment with osimertinib will be up to12 weeks, followed by 6 weeks of RT treatment and osimertinib maintenance treatment until disease progression or death.
- The visit frequency will be once after 12 weeks during the induction treatment period, every 3 weeks during the RT period (daily visits for RT), and every 12 weeks during the osimertinib maintenance treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osimertinib as Induction Therapy Prior to Radiotherapy and Maintenance | Experimental | Drug: Osimertinib80 mg Osimertinib QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent form.
- Participants with histologically documented NSCLC of predominantly nonsquamous, squamous, and adenosquamous pathology who present with locally advanced, unresectable (Stage III, according to Version 8 of the IASLC Staging Manual in Thoracic Oncology) disease. It is recommended but not required that except for overt cT4 disease, nodal status N2, or N3 should have been proven by biopsy, via endobronchial ultrasound, mediastinoscopy, thoracoscopy, or in absence of biopsy, should have been confirmed with whole body contrast-enhanced CT.
- Participants who had recurred from Stage I/II/III after complete surgery or had gross incomplete resections can be included if they didn't receive treatment with any chemotherapy, radiation therapy, immunotherapy, targeted therapy, or investigational agents.
- Participants with availability of the EGFRm test results confirming that the tumor harbors 1 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 including de novo T790M
- WHO performance status of 0, 1 or 2 with no deterioration over the previous 2 weeks prior to baseline at screening and prior to first dose.
Key exclusion criteria (16 listed)
- Any presence of small cell and mixed small-cell and non-small cell histology.
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the participant to participate in the trial or which would jeopardize compliance with the protocol, or active infection.
- 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.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease. Patients who have received RT with overlapping fields (eg, cured breast cancer) should be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osimertinib80 mg Osimertinib QD | Drug | Osimertinib as Induction Therapy Prior to Radiotherapy and Maintenance |
Primary outcome
PFS (Progression-Free Survival)
Time frame: Assessed from date of first dose to progression (up to a maximum of approximately 2 years)
PFS is defined as the time from date of first dose until progression per RECIST 1.1 as assessed by the investigator at the local site, or death due to any cause.
2 secondary outcomes
Disease Control Rate (DCR)
Time frame: Assessed during the induction phase of the study, scans are carried out at week 12 (plus or minus visit window).
Overall Survival (OS)
Time frame: Assessed from first dose to end of study or death (up to a maximum of approximately 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trails via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrails.pharmacm.com/ST/Submission/Disclosure. Indicates that AZ 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.
AstraZeneca Clinical Study Information Center contact
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osimertinib in people with Lung Cancer, run by AstraZeneca at 20 sites in China.
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 10 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (Progression-Free Survival) (time frame: Assessed from date of first dose to progression (up to a maximum of approximately 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2026.