Non Small Cell Lung Cancer NSCLCNCT07169708
A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL)
An observational study of Non Small Cell Lung Cancer NSCLC, run by Ono Pharmaceutical Co., Ltd. at 9 sites in Taiwan.
Trial summary
The goal of this observational study is to learn about the effectiveness of Nivolumab in combination with chemotherapy as Neoadjuvant therapy for patients with non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer NSCLC
- How many people
- 100 participants
- Where
- 9 sitesTaiwan
- Study dates
- 20 Mar 2026to 30 Jun 2026
- Phase
- Observational
- 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
Study population: The cohort patients will be selected from the assigned medical centers.
Who may be able to join
- Aged 18 years and older
- Patients who are diagnosed with pathologically confirmed, non-metastatic, resectable NSCLC
- Patients who have received at least one cycle of neoadjuvant nivolumab combined with chemotherapy since the approval of the regimen in February 2023, and who have at least one imaging assessment of EFS and surgical status recorded. For patients who underwent surgery, at least one pathological report is required.
- Patients who have been followed up for at least 12 months (from first dose of neoadjuvant therapy to last medical record date at study site), exceptional case as follows:
- Patients who expired within 12 months of follow-up
- Patients who experience disease progression or recurrence but continue to follow-up
- Participants with histologically confirmed Stage II-III NSCLC (per the 8th International Association for the Study of Lung Cancer) who are considered resectable.
Who cannot join
- Patients with distant metastasis (M1 disease according to the eighth edition of the American Joint Committee on Cancer [AJCC] cancer staging manual) prior to neoadjuvant therapy
- Patients with N3 disease per AJCC 8th edition
- Patients with known EGFR mutations or ALK translocation
- Patients who have received any prior systemic therapy for NSCLC
- Patients with a history of previous cancers or other concurrent malignancies within 10 years before the first dose of nivolumab
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Penny Medical Affairs Specialist, Clinical Pharmacology contact
9 sites in 1 country
Taiwan9 sites, 9 recruiting
- Recruiting
Chang Gung Memorial Hospital Kaohsiung Branch
Kaohsiung City
Yu-Fen Study Coordinator, +886-7-7317123 ext. #2639
Chin-Chou Wang, Medicine
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Wan-Ming Study Coordinator
Jen-Yu Hung, Medicine
- Recruiting
Kaohsiung Veterns General Hospital
Kaohsiung City
Shuen-Dury Yu
En-Kuei Tang, Medicine
- Recruiting
China Medical University Hospital
Taichung
Mei-Hui Study Coordinator, +886-4-2206-5866
Te-Chun Hsia, Medicine
- Recruiting
Taichung Veterans General Hospital
Taichung
Shu-Jen Study Coordinator
Yen-Hsiang Huang, Medicine
- Recruiting
Mackay Memorial Hospital Taipei Branch
Taipei
Rainie Study Coordinator, +886-2-25433535
Jian Su, Medicine
- Recruiting
National Taiwan University Hospital
Taipei
Jo-Yu Study Coordinator, +886-2-23123456 ext. #62910
Jin-Yuan Shih, Medicine
- Recruiting
Taipei Veteran General Hospital
Taipei
Ping-Ju Study Coordinator, +886-2-2871-2121 ext. #82872
Chien-Sheng Huang, Medicine
- Recruiting
Chang Gung Memorial Hospital Linkou Branch
Taoyuan
Wen Study Coordinator
Cheng-Ta Yang, Medicine
About this study
Official title: A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan
The goal of this observational study is to learn about the effectiveness of Nivolumab in combination with chemotherapy as Neoadjuvant therapy for patients with non-small cell lung cancer (NSCLC). The main question it aims to answer is:
Does patient with NSCLC in treatment of Nivolumab combined with chemotherapy demonstrate better pCR and PFS ? Is it safe for patient with NSCLC in treatment of Nivolumab combined with chemotherapy ?
The data for those participants already receiving nivolumab in combination with chemotherapy as part of their regular medical care for NSCLC will be collected within the designated collection period.
Read the detailed description
Rationale :
In Taiwan, lung cancer is the most common cancer and has the highest mortality rate among the top 10 cancers, accounting for 19.4% of all cancer-related deaths in 2022. Additionally, 94.3% of lung cancer cases were diagnosed as NSCLC (n = 16,420). Based on clinical staging (per AJCC 8th edition), 2.26% of NSCLC cases were classified as stage 0, 35.75% as stage I, 3.79% as stage II, 8.80% as stage III, 41.01% as stage IV, and 8.39% had an unknown stage.25 The US Food and Drug Administration (FDA) approved nivolumab in combination with platinum-doublet chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC in March 2022 and Taiwan subsequently approved this indication in February 2023. However, the real-world effectiveness of this treatment and the NSCLC patient profile, particularly in the Taiwanese population, remains unclear, as does the patient profile for adjuvant therapy following neoadjuvant chemo-immunotherapy (chemo-IO). Therefore, this study aims to address these gaps and consolidate nivolumab's role in resectable NSCLC by bridging the data gap with real-world evidence.
- Conditions
- Non Small Cell Lung Cancer NSCLC
- Keywords
- NeoReal, NSCLC, Nivolumab, Opdivo, Neoadjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resectable NSCLC Patients | Receive Nivolumab in Combination with Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) rate
Pathological complete response (pCR) is defined as the absence of viable tumor residue at the primary site. The pCR rate is defined as number of enrolled patients with absence of viable tumor residue in resected lung tissue, divided by the total number of enrolled patients who at least receive in the first dose of nivolumab. If non-pCR, the number of lymph node metastases will be documented if available.
Measured: At least 12 months retrospectively
Event-free survival (EFS)
Event-free survival (EFS) is defined as the time from the first dose of neoadjuvant treatment to the date when any of the following events is first confirmed:
- Any disease progression precluding surgery
- Progression for patients without surgery
- Progression or recurrence after surgery
- Death due to any cause
If a patient does not experience any events and remains alive, the observation is expected to extend to the longest period allowed by the IRB.
Measured: At least 12 months retrospectively
Incidences of AE and SAE
An adverse event (AE) is defined as any untoward medical occurrence in a patient administered nivolumab and which does not necessarily have a causal relationship with this treatment.
Serious adverse event (SAE) is any untoward medical occurrence at any dose that results in any of the following outcomes
- Death
- A life-threatening event,
- Inpatient hospitalization or prolongation of existing hospitalization,
- A persistent or significant disability/incapacity,
- A congenital anomaly/birth defect,
- Development of a serious undesired medical event requiring intervention to prevent permanent impairment or damage (devices).
Measured: At least 12 months retrospectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start20 Mar 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer NSCLCStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169708
- Sponsor's protocol ID
- R1132-NIV-24
- Status last verified
- Apr 2026
- First submitted
- 28 Aug 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan
- ClinicalTrials.gov ID
- NCT07169708
- Acronym / sponsor ID
- R1132-NIV-24
- Conditions
- Non Small Cell Lung Cancer NSCLC
- Keywords
- NeoReal, NSCLC, Nivolumab, Opdivo, Neoadjuvant therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Sep 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 goal of this observational study is to learn about the effectiveness of Nivolumab in combination with chemotherapy as Neoadjuvant therapy for patients with non-small cell lung cancer (NSCLC). The main question it aims to answer is:
Does patient with NSCLC in treatment of Nivolumab combined with chemotherapy demonstrate better pCR and PFS ? Is it safe for patient with NSCLC in treatment of Nivolumab combined with chemotherapy ?
The data for those participants already receiving nivolumab in combination with chemotherapy as part of their regular medical care for NSCLC will be collected within the designated collection period.
Detailed description
Rationale :
In Taiwan, lung cancer is the most common cancer and has the highest mortality rate among the top 10 cancers, accounting for 19.4% of all cancer-related deaths in 2022. Additionally, 94.3% of lung cancer cases were diagnosed as NSCLC (n = 16,420). Based on clinical staging (per AJCC 8th edition), 2.26% of NSCLC cases were classified as stage 0, 35.75% as stage I, 3.79% as stage II, 8.80% as stage III, 41.01% as stage IV, and 8.39% had an unknown stage.25 The US Food and Drug Administration (FDA) approved nivolumab in combination with platinum-doublet chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC in March 2022 and Taiwan subsequently approved this indication in February 2023. However, the real-world effectiveness of this treatment and the NSCLC patient profile, particularly in the Taiwanese population, remains unclear, as does the patient profile for adjuvant therapy following neoadjuvant chemo-immunotherapy (chemo-IO). Therefore, this study aims to address these gaps and consolidate nivolumab's role in resectable NSCLC by bridging the data gap with real-world evidence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resectable NSCLC Patients | – | –Receive Nivolumab in Combination with Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort patients will be selected from the assigned medical centers.
Key inclusion criteria (7 listed)
- Aged 18 years and older
- Patients who are diagnosed with pathologically confirmed, non-metastatic, resectable NSCLC
- Patients who have received at least one cycle of neoadjuvant nivolumab combined with chemotherapy since the approval of the regimen in February 2023, and who have at least one imaging assessment of EFS and surgical status recorded. For patients who underwent surgery, at least one pathological report is required.
- Patients who have been followed up for at least 12 months (from first dose of neoadjuvant therapy to last medical record date at study site), exceptional case as follows:
- Participants with histologically confirmed Stage II-III NSCLC (per the 8th International Association for the Study of Lung Cancer) who are considered resectable.
Key exclusion criteria (5 listed)
- Patients with distant metastasis (M1 disease according to the eighth edition of the American Joint Committee on Cancer [AJCC] cancer staging manual) prior to neoadjuvant therapy
- Patients with N3 disease per AJCC 8th edition
- Patients with known EGFR mutations or ALK translocation
- Patients who have received any prior systemic therapy for NSCLC
- Patients with a history of previous cancers or other concurrent malignancies within 10 years before the first dose of nivolumab
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
Pathological Complete Response (pCR) rate
Time frame: At least 12 months retrospectively
Pathological complete response (pCR) is defined as the absence of viable tumor residue at the primary site. The pCR rate is defined as number of enrolled patients with absence of viable tumor residue in resected lung tissue, divided by the total number of enrolled patients who at least receive in the first dose of nivolumab. If non-pCR, the number of lymph node metastases will be documented if available.
Event-free survival (EFS)
Time frame: At least 12 months retrospectively
Event-free survival (EFS) is defined as the time from the first dose of neoadjuvant treatment to the date when any of the following events is first confirmed: * Any disease progression precluding surgery * Progression for patients without surgery * Progression or recurrence after surgery * Death due to any cause If a patient does not experience any events and remains alive, the observation is expected to extend to the longest period allowed by the IRB.
Incidences of AE and SAE
Time frame: At least 12 months retrospectively
An adverse event (AE) is defined as any untoward medical occurrence in a patient administered nivolumab and which does not necessarily have a causal relationship with this treatment. Serious adverse event (SAE) is any untoward medical occurrence at any dose that results in any of the following outcomes * Death * A life-threatening event, * Inpatient hospitalization or prolongation of existing hospitalization, * A persistent or significant disability/incapacity, * A congenital anomaly/birth defect, * Development of a serious undesired medical event requiring intervention to prevent permanent impairment or damage (devices).
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 20 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Penny Medical Affairs Specialist, Clinical Pharmacology contact
9 sites in 1 country: 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 NSCLC, run by Ono Pharmaceutical Co., Ltd. at 9 sites in Taiwan.
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 7 inclusion and 5 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Taiwan. 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?
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 Penny Medical Affairs Specialist, Clinical Pharmacology (886-2-8786-9750, penny.tsai@ono-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) rate (time frame: At least 12 months retrospectively). The study lists 3 primary outcomes in all. 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 20 May 2026.