Lung CancerPhase 2NEOLANCT06194448
To Evaluate the Efficacy/Safety of Osimertinib Prior to CRT and Maintenance of it With Stage III, Unresectable NSCLC With EGFR Mutations
A Phase 2 study testing Osimertinib, Cisplatin or Carboplatin; Pemetrexed or Paclitaxel and Radiation in people with Lung Cancer, run by AstraZeneca at 39 sites in 9 countries.
Trial summary
The purpose of this study is to measure efficacy and safety of osimertinib as induction therapy prior to curative intent CRT and maintenance osimertinib in 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 to 130 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Osimertinib, Cisplatin or Carboplatin; Pemetrexed or Paclitaxel and Radiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 39 sitesin 9 countries
- Study dates
- 21 Apr 2024to 7 Jul 2027
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18 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.
- Patients with histologically documented NSCLC of predominantly non-squamous, squamous, and adenosquamous pathology who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology). 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 18FDG PET plus contrast-enhanced CT in addition to or in combination with PET.
- Patient who are eligible for and - planning to undergo CCRT or SCRT treatment.
- Patients 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.
- Patients with HBV are only eligible for inclusion if they meet all the following criteria:
- Demonstrate absence of HCV co-infection or history of HCV co-infection
Show all 26Show fewer
- Demonstrate absence of HIV co-infection
- Patients with active HBV infection are eligible if they are:
- Receiving anti-viral treatment for at least 6 weeks prior to study treatment, HBV DNA is suppressed to <100 IU/mL and transaminase levels are below ULN.
- Participants with a resolved or chronic HBV infection are eligible if they are:
- Negative for HBsAg and positive for hepatitis B core antibody [anti-HBc IgG or total anti-HBc Ab]. In addition, patients should be referred to a local hepatologist and treated as per local guidelines or
- Positive for HBsAg, but for > 6 months have had transaminases levels below ULN and HBV DNA levels below <100 IU/mL or below the detectable limit of locally available test kit (i.e., are in an inactive carrier state). In addition, patients must be receiving anti-viral prophylaxis for 2-4 weeks prior to study treatment.
- Patients with HIV are only eligible for inclusion if they meet all the following criteria:
- Demonstrate absence of HBV/ HCV co-infection
- Undetectable viral RNA load for 6 months
- CD4+ count of >350 cells/μL
- No history of AIDS-defining opportunistic infection within the past 12 months
- Stable for at least 4 weeks on the same anti-HIV medications
- Availability of the EGFRm test results confirming that the tumour 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 including de novo T790M
- WHO performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline at screening and prior to first dose.
- 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.
- Male and/or female. Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and/or SoC CRT
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this CSP.
- Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics initiative research that supports the Genomic Initiative.
- Note: If a patient declines to participate in optional genetic research, there will be no penalty or loss of benefit to the patient, and he/she will not be excluded from other aspects of the study.
Who cannot join
- Any presence of small cell and mixed small-cell and non-small cell histology.
- Past medical history of ILD/pneumonitis, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis.
- 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. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator may be included after consultation with the AstraZeneca medical monitor (eg, hearing loss).
- 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 patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection (eg, patients receiving treatment for infection, including HCV, HIV, and tuberculosis) or active uncontrolled HBV 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.
Show all 34Show fewer
- 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.
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block and second-degree heart block. Patients with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted based on the investigator judgement with cardiologist consultation recommended.
- History of QT prolongation associated with other medications that required discontinuation of that medication.
- Congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death under 40 years of age in first-degree relatives or patients with any factors that increase the risk of QTc prolongation/arrhythmic events such as electrolyte abnormalities, heart failure or any concomitant medication known to prolong the QT interval and cause TdP.
- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
- Absolute neutrophil count <1.5 × 10^9/L
- Platelet count <100 × 10^9/L
- Haemoglobin <90 g/L
- Alanine transferase >2.5 times the upper limit of normal (ULN)
- Aspartate transferase >2.5 times ULN
- Total bilirubin >1.5 times ULN or >3 times ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia)
- Creatinine >1.5 times ULN concurrent with creatinine clearance <50 mL/min (measured or calculated by Cockcroft and Gault formula); confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN.
- Patients currently receiving (or 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-week prior to dosing). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.
- Prior treatment with any chemotherapy, radiation therapy, immunotherapy 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.
- Prior exposure to EGFR-TKI therapy
- 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.
- Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks (unless the safety profile is known prior to first dose of study intervention), or concurrent enrolment in another clinical study (unless the study is observational [noninterventional], or the patient is in the followup period of an interventional study).
- History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
- History of hypersensitivity to active or inactive excipients of the chemotherapy regimen of choice (pemetrexed or paclitaxel; cisplatin or carboplatin) or RT or drugs with a similar chemical structure or class to the chemotherapy.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- Previous enrolment in the present study. Rescreening of individuals who were screen failures is allowed.
- For females only: Currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
- Patients should refrain from breastfeeding from enrolment throughout the study and until 6 weeks after last dose of study intervention.
- In addition, the following are considered criteria for exclusion from the exploratory genetic research:
- Prior allogeneic bone marrow transplant.
- Non-leukocyte depleted whole blood transfusion within 120 days of genetic sample collection.
Trial locations and contacts
39 sites in 9 countries.
39 sites in 9 countries
China13 sites
Research Site
Beijing, 100021
Research Site
Changsha, 410013
Research Site
Guangzhou, 510060
Research Site
Hangzhou, 310022
Research Site
Harbin, 150081
Research Site
Hefei, 230001
Research Site
Jinan, 250117
Research Site
Nanning, 530021
Research Site
Shanghai, 200032
Research Site
Tianjin, 300060
Research Site
Wuhan, 430022
Research Site
Wuhan, 430071
Research Site
Zhengzhou, 450052
South Korea6 sites
Research Site
Cheongju-si, 28644
Research Site
Seongnam-si, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 06351
Research Site
Suwon, 16247
Thailand5 sites
Research Site
Bangkok, 10210
Research Site
Bangkok, 10330
Research Site
Chiang Rai, 57000
Research Site
Hat Yai, 90110
Research Site
Khon Kaen, 40002
Spain4 sites
Research Site
Barcelona, 08003
Research Site
Donostia / San Sebastian, 20014
Research Site
Granada, 18016
Research Site
Madrid, 28007
Israel3 sites
Research Site
Haifa, 31096
Research Site
Jerusalem, 91031
Research Site
Tel Aviv, 62748
United States2 sites
Research Site
La Jolla, California, 92093
Research Site
Palo Alto, California, 94304
Turkey (Türkiye)2 sites
Research Site
Ankara, 06010
Research Site
Yenimahalle, 06560
Vietnam2 sites
Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000
About this study
Official title: A Phase II, Open-label, Single-arm Study of Osimertinib as Induction Therapy Prior to CRT and Maintenance Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Stage III, Unresectable Non-small Cell Lung Cancer (NEOLA)
The purpose of this study is to measure efficacy and safety of osimertinib as induction therapy prior to curative intent CRT and maintenance osimertinib in adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).
Read the detailed description
The study duration will be approximately 2 years 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 to 8 weeks, followed by 6 weeks of CRT treatment and osimertinib maintenance treatment until PD or death.
The visit frequency will be every 2 weeks to 4 weeks during the induction treatment period, every 3 weeks during the CRT period (every 3 weeks for chemotherapy and daily visits for RT), and every 12 weeks during the osimertinib maintenance treatment period.
- Conditions
- Lung Cancer
- Being tested
- Osimertinib, Cisplatin or Carboplatin; Pemetrexed or Paclitaxel, Radiation
- Keywords
- EGFR +, Unresectable Non-small Cell Lung Cancer
- 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
Also called Tagrisso, AZD9291
80 mg daily (or 40 mg daily for dose reduction)
Cisplatin or Carboplatin; Pemetrexed or PaclitaxelDrug
Pemetrexed (500 mg/m2 to be administered on Day 1 of every 3-week cycle for 2 cycles) or Paclitaxel (175 mg/m2 on Day 1 of every 3-week cycle for 2 cycles) PLUS Cisplatin (75 mg/m2) or Carboplatin (AUC5) to be administered on Day 1 of every 3--week cycle for 2 cycles
RadiationDrug
Patients must have received a total dose of radiation of 60 Gy ± 10% (54 to 66 Gy) as part of the chemoradiation therapy. It is recommended but not required that patients have a:
- Mean lung dose < 20 Gy and/or V20 < 35%
- Mean oesophagus dose < 34 Gy
- Heart V50 < 25%, V30 < 50%, and V45 < 35%
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Osimertinib Induction Treatment | Experimental | Patients will receive open-label osimertinib induction treatment for 8 weeks (± 1 week window to account for patient variability and CRT scheduling), followed by CRT treatment for 6 weeks (± 1 week) and then osimertinib maintenance treatment until RECIST 1.1-defined radiological progression by investigator unless there is evidence of unacceptable toxicity or if the patient requests to stop the study treatment. Receives: Drug: Osimertinib; Drug: Cisplatin or Carboplatin; Pemetrexed or Paclitaxel; Drug: Radiation |
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 4 years)
Secondary outcomes (4)
ORR (Objective Response Rate)
ORR is defined as the proportion of patients who have a CR or PR, as determined by the investigator at local site per RECIST 1.1.
Measured: Assessed during the induction phase of the study, scans are carried out at baseline and week 8 (plus or minus visit window).
DCR (Disease Control Rate)
DCR is defined as the percentage of subjects who have a best overall response of CR or PR or SD (at 8 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 baseline and week 8 (plus or minus visit window).
OS (Overall Survival)
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 4 years)
EFS (Event-Free Survival)
EFS is defined as time from date of first dose until any of the following events: progression of disease that precludes CRT or completion of CRT, progression during or after CRT, or death due to any cause.
Measured: Assessed from first dose until a progression event or death (up to a maximum of approximately 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start21 Apr 2024
- Primary completion7 Jul 2026
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Patients will receive open-label osimertinib induction treatment for 8 weeks (± 1 week window to account for patient variability and CRT scheduling), followed by CRT treatment for 6 weeks (± 1 week) and then osimertinib maintenance treatment until RECIST 1.1-defined radiological progression by investigator unless there is evidence of unacceptable toxicity or if the patient requests to stop the study treatment.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194448
- Sponsor's protocol ID
- D516AC00003
- Other IDs
- 2023-507798-16-00, 2023
- Acronym
- NEOLA
- Status last verified
- Aug 2026
- First submitted
- 20 Dec 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual participant-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests 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
Aredo JV, Peled N, Arriola E, Wakelee H, Ahn MJ, Kwint MH, Taylor R, van der Gronde T, Nasirova F, Chen M. Osimertinib before and after chemoradiotherapy for unresectable stage III EGFR-mutated NSCLC: NEOLA Trial Protocol. Future Oncol. 2025 Dec;21(29):3731-3737. doi: 10.1080/14796694.2025.2587569. Epub 2025 Nov 14.
PubMed 41236484
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Single-arm Study of Osimertinib as Induction Therapy Prior to CRT and Maintenance Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Stage III, Unresectable Non-small Cell Lung Cancer (NEOLA)
- ClinicalTrials.gov ID
- NCT06194448
- Acronym / sponsor ID
- NEOLA / D516AC00003
- Conditions
- Lung Cancer
- Keywords
- EGFR +, Unresectable Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2024 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 8 Jan 2024 (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 CRT and maintenance osimertinib in adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).
Detailed description
The study duration will be approximately 2 years 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 to 8 weeks, followed by 6 weeks of CRT treatment and osimertinib maintenance treatment until PD or death.
The visit frequency will be every 2 weeks to 4 weeks during the induction treatment period, every 3 weeks during the CRT period (every 3 weeks for chemotherapy and 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
- Model description
- Patients will receive open-label osimertinib induction treatment for 8 weeks (± 1 week window to account for patient variability and CRT scheduling), followed by CRT treatment for 6 weeks (± 1 week) and then osimertinib maintenance treatment until RECIST 1.1-defined radiological progression by investigator unless there is evidence of unacceptable toxicity or if the patient requests to stop the study treatment.
| Arm | Type | Receives |
|---|---|---|
| Open-Label Osimertinib Induction Treatment | Experimental | Drug: Osimertinib, Drug: Cisplatin or Carboplatin; Pemetrexed or Paclitaxel, Drug: RadiationPatients will receive open-label osimertinib induction treatment for 8 weeks (± 1 week window to account for patient variability and CRT scheduling), followed by CRT treatment for 6 weeks (± 1 week) and then osimertinib maintenance treatment until RECIST 1.1-defined radiological progression by investigator unless there is evidence of unacceptable toxicity or if the patient requests to stop the study treatment. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Patients must be 18 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.
- Patients with histologically documented NSCLC of predominantly non-squamous, squamous, and adenosquamous pathology who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology). 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 18FDG PET plus contrast-enhanced CT in addition to or in combination with PET.
- Patient who are eligible for and - planning to undergo CCRT or SCRT treatment.
- Patients 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.
- Patients with HBV are only eligible for inclusion if they meet all the following criteria:
Key exclusion criteria (34 listed)
- Any presence of small cell and mixed small-cell and non-small cell histology.
- Past medical history of ILD/pneumonitis, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis.
- 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. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator may be included after consultation with the AstraZeneca medical monitor (eg, hearing loss).
- 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 patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection (eg, patients receiving treatment for infection, including HCV, HIV, and tuberculosis) or active uncontrolled HBV 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.
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 |
|---|---|---|
| OsimertinibAlso: Tagrisso, AZD929180 mg daily (or 40 mg daily for dose reduction) | Drug | Open-Label Osimertinib Induction Treatment |
| Cisplatin or Carboplatin; Pemetrexed or PaclitaxelPemetrexed (500 mg/m2 to be administered on Day 1 of every 3-week cycle for 2 cycles) or Paclitaxel (175 mg/m2 on Day 1 of every 3-week cycle for 2 cycles) PLUS Cisplatin (75 mg/m2) or Carboplatin (AUC5) to be administered on Day 1 of every 3--week cycle for 2 cycles | Drug | Open-Label Osimertinib Induction Treatment |
| RadiationPatients must have received a total dose of radiation of 60 Gy ± 10% (54 to 66 Gy) as part of the chemoradiation therapy. It is recommended but not required that patients have a: * Mean lung dose < 20 Gy and/or V20 < 35% * Mean oesophagus dose < 34 Gy * Heart V50 < 25%, V30 < 50%, and V45 < 35% | Drug | Open-Label Osimertinib Induction Treatment |
Primary outcome
PFS (Progression-Free Survival)
Time frame: Assessed from date of first dose to progression (up to a maximum of approximately 4 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.
4 secondary outcomes
ORR (Objective Response Rate)
Time frame: Assessed during the induction phase of the study, scans are carried out at baseline and week 8 (plus or minus visit window).
DCR (Disease Control Rate)
Time frame: Assessed during the induction phase of the study, scans are carried out at baseline and week 8 (plus or minus visit window).
OS (Overall Survival)
Time frame: Assessed from first dose to end of study or death (up to a maximum of approximately 4 years)
EFS (Event-Free Survival)
Time frame: Assessed from first dose until a progression event or death (up to a maximum of approximately 4 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 19 Aug 2026.
- Derived from this study: PubMed 41236484Aredo JV, Peled N, Arriola E, Wakelee H, Ahn MJ, Kwint MH, Taylor R, van der Gronde T, Nasirova F, Chen M. Osimertinib before and after chemoradiotherapy for unresectable stage III EGFR-mutated NSCLC: NEOLA Trial Protocol. Future Oncol. 2025 Dec;21(29):3731-3737. doi: 10.1080/14796694.2025.2587569. Epub 2025 Nov 14.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual participant-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests 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.
39 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osimertinib, Cisplatin or Carboplatin; Pemetrexed or Paclitaxel and Radiation in people with Lung Cancer, run by AstraZeneca at 39 sites in 9 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 26 inclusion and 34 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in China, South Korea, Thailand, Spain, Israel and 4 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.
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?
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?
PFS (Progression-Free Survival) (time frame: Assessed from date of first dose to progression (up to a maximum of approximately 4 years)). 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 NCT06194448, which also lists 1 linked publication.
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 19 Aug 2026.