Non-Small Cell Lung CancerNCT07718139
Demographics, Clinical Characteristics and Outcomes in Resected Non-Small Cell Lung Cancer Patients Receiving Immunotherapy in Europe and Canada
An observational study of Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 1 site in United Kingdom.
Trial summary
This study uses existing medical records to better understand how immunotherapy is used in people in Europe and Canada with non-small cell lung cancer (NSCLC) who undergo surgery. It looks at participant characteristics, treatments received before and after surgery, and outcomes such as survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- nivolumab, pembrolizumab and durvalumab
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2026to 31 Mar 2027
- 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: Adults diagnosed with non-metastatic stage IIA-IIIB non-small cell lung cancer (NSCLC) receiving neoadjuvant or perioperative immunotherapy in routine clinical practice across Europe and Canada.
Who may be able to join
- Diagnosed with non-small-cell lung cancer (NSCLC) stage IIA to IIIB
- Participants aged ≥18 years at time of NSCLC diagnosis
- Initiated and received neoadjuvant nivolumab or neoadjuvant phase of perioperative immunotherapy during the patient inclusion period
- Documented record of curative surgical resection following receipt of neoadjuvant nivolumab or neoadjuvant phase of perioperative immunotherapy
- NSCLC is assessed as resectable by a clinician, surgeon, or multidisciplinary team.
Who cannot join
- Diagnosis of another primary malignancy (excluding non-melanoma skin cancer) within 5 years prior to NSCLC diagnosis or at any time after diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Demographics, Clinical Characteristics and Outcomes in Resected Non-Small Cell Lung Cancer Patients Receiving Immunotherapy in Europe and Canada
This study uses existing medical records to better understand how immunotherapy is used in people in Europe and Canada with non-small cell lung cancer (NSCLC) who undergo surgery. It looks at participant characteristics, treatments received before and after surgery, and outcomes such as survival.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- nivolumab, pembrolizumab, durvalumab
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, neoadjuvant immunotherapy, perioperative immunotherapy, nivolumab;
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumabBiological
As per product label
pembrolizumabBiological
As per product label
durvalumabBiological
As per product label
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Phase Only | Participants with resected non-small-cell lung cancer (NSCLC) stage IIA-IIIB who received neoadjuvant immunotherapy prior to surgery but did not initiate adjuvant immunotherapy post-surgery. Receives: Biological: nivolumab; Biological: pembrolizumab; Biological: durvalumab | |
| Perioperative Immunotherapy | Participants with resected non-small-cell lung cancer (NSCLC) stage IIA-IIIB who received immunotherapy before surgery and continued the same immunotherapy after surgery (adjuvant phase). Receives: Biological: nivolumab; Biological: pembrolizumab; Biological: durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with pathological complete response after neoadjuvant immunotherapy and surgical resection.
Pathological complete response (pCR) is defined as 0% residual viable tumor cells in the primary tumor and all sampled regional lymph nodes following neoadjuvant immunotherapy and surgical resection.
Measured: Up to 14 months
Number of participants with major pathological response after neoadjuvant immunotherapy and surgical resection.
Major pathological response (MPR) is defined as ≤10% residual viable tumor cells in the primary tumor and all sampled regional lymph nodes following neoadjuvant immunotherapy and surgical resection.
Measured: Up to 14 months
Number of participants with post-operative complications following surgical resection
Post-operative complications include infection, pneumonia, respiratory failure requiring assisted ventilation or intubation, immune-related pneumonitis, myocardial infarction, atrial fibrillation, cardiac failure, unplanned intensive care unit admission, stroke, acute renal failure, bronchopleural fistula, empyema, re-operation, prolonged hospitalization, prolonged air leak greater than 5 days, in-hospital death, 30-day death, and 90-day death.
Measured: Up to 90 days
Number of participants by surgical resection margin status
Surgical resection margin status following surgery will be categorized as R0 (no residual tumor), R1 (microscopic residual tumor), or R2 (macroscopic residual tumor).
Measured: Up to 14 months
Number of participants by surgical resection type
Surgical resection type will be categorized as lobectomy, bilobectomy, segmentectomy, wedge resection, pneumonectomy, or sleeve resection.
Measured: Day 1
Number of participants by surgical approach
Surgical approach will be categorized as open thoracotomy, video-assisted thoracoscopic surgery (VATS), or robotic-assisted surgery.
Measured: Day 1
Number of participants with all-cause mortality within 90 days after surgery
All-cause mortality occurring during hospitalization or within 90 days after surgical resection will be summarized.
Measured: Up to 90 days
Secondary outcomes (7)
Overall survival from surgical resection
Overall survival (OS) is defined as the time from surgical resection to death from any cause.
Measured: Up to 46 months
Event-free survival from surgical resection
Event-free survival (EFS) is defined as the time from surgical resection to the first occurrence of disease recurrence or progression after surgery, or death from any cause.
Measured: Up to 46 months
Number of participants initiating adjuvant immunotherapy after surgery
Adjuvant immunotherapy includes pembrolizumab, durvalumab, or nivolumab.
Measured: Up to 14 months
Time (days) from surgery to initiation of adjuvant immunotherapy
Measured: Up to 14 months
Number of participants receiving post-surgical systemic and local therapies
Post-surgical therapies received during follow-up will be summarized and include adjuvant immunotherapy, adjuvant chemotherapy, radiotherapy, targeted therapy, and advanced or metastatic treatments.
Measured: Up to 46 months
Length of hospital stay (days) following surgical resection
Measured: Up to 90 days
Number of participants with immune-mediated adverse events (AEs) during neoadjuvant immunotherapy
Measured: Up to 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start28 Feb 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Mar 2027 (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 CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718139
- Sponsor's protocol ID
- CA209-1620
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Demographics, Clinical Characteristics and Outcomes in Resected Non-Small Cell Lung Cancer Patients Receiving Immunotherapy in Europe and Canada
- ClinicalTrials.gov ID
- NCT07718139
- Acronym / sponsor ID
- CA209-1620
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, neoadjuvant immunotherapy, perioperative immunotherapy, nivolumab;
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Jul 2026 (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 study uses existing medical records to better understand how immunotherapy is used in people in Europe and Canada with non-small cell lung cancer (NSCLC) who undergo surgery. It looks at participant characteristics, treatments received before and after surgery, and outcomes such as survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Phase Only | – | Biological: nivolumab, Biological: pembrolizumab, Biological: durvalumabParticipants with resected non-small-cell lung cancer (NSCLC) stage IIA-IIIB who received neoadjuvant immunotherapy prior to surgery but did not initiate adjuvant immunotherapy post-surgery. |
| Perioperative Immunotherapy | – | Biological: nivolumab, Biological: pembrolizumab, Biological: durvalumabParticipants with resected non-small-cell lung cancer (NSCLC) stage IIA-IIIB who received immunotherapy before surgery and continued the same immunotherapy after surgery (adjuvant phase). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with non-metastatic stage IIA-IIIB non-small cell lung cancer (NSCLC) receiving neoadjuvant or perioperative immunotherapy in routine clinical practice across Europe and Canada.
Key inclusion criteria (5 listed)
- Diagnosed with non-small-cell lung cancer (NSCLC) stage IIA to IIIB
- Participants aged ≥18 years at time of NSCLC diagnosis
- Initiated and received neoadjuvant nivolumab or neoadjuvant phase of perioperative immunotherapy during the patient inclusion period
- Documented record of curative surgical resection following receipt of neoadjuvant nivolumab or neoadjuvant phase of perioperative immunotherapy
- NSCLC is assessed as resectable by a clinician, surgeon, or multidisciplinary team.
Key exclusion criteria (1 listed)
- Diagnosis of another primary malignancy (excluding non-melanoma skin cancer) within 5 years prior to NSCLC diagnosis or at any time after diagnosis
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 |
|---|---|---|
| nivolumabAs per product label | Biological | Neoadjuvant Phase Only, Perioperative Immunotherapy |
| pembrolizumabAs per product label | Biological | Neoadjuvant Phase Only, Perioperative Immunotherapy |
| durvalumabAs per product label | Biological | Neoadjuvant Phase Only, Perioperative Immunotherapy |
Primary outcome
Number of participants with pathological complete response after neoadjuvant immunotherapy and surgical resection.
Time frame: Up to 14 months
Pathological complete response (pCR) is defined as 0% residual viable tumor cells in the primary tumor and all sampled regional lymph nodes following neoadjuvant immunotherapy and surgical resection.
Number of participants with major pathological response after neoadjuvant immunotherapy and surgical resection.
Time frame: Up to 14 months
Major pathological response (MPR) is defined as ≤10% residual viable tumor cells in the primary tumor and all sampled regional lymph nodes following neoadjuvant immunotherapy and surgical resection.
Number of participants with post-operative complications following surgical resection
Time frame: Up to 90 days
Post-operative complications include infection, pneumonia, respiratory failure requiring assisted ventilation or intubation, immune-related pneumonitis, myocardial infarction, atrial fibrillation, cardiac failure, unplanned intensive care unit admission, stroke, acute renal failure, bronchopleural fistula, empyema, re-operation, prolonged hospitalization, prolonged air leak greater than 5 days, in-hospital death, 30-day death, and 90-day death.
Number of participants by surgical resection margin status
Time frame: Up to 14 months
Surgical resection margin status following surgery will be categorized as R0 (no residual tumor), R1 (microscopic residual tumor), or R2 (macroscopic residual tumor).
Number of participants by surgical resection type
Time frame: Day 1
Surgical resection type will be categorized as lobectomy, bilobectomy, segmentectomy, wedge resection, pneumonectomy, or sleeve resection.
Number of participants by surgical approach
Time frame: Day 1
Surgical approach will be categorized as open thoracotomy, video-assisted thoracoscopic surgery (VATS), or robotic-assisted surgery.
Number of participants with all-cause mortality within 90 days after surgery
Time frame: Up to 90 days
All-cause mortality occurring during hospitalization or within 90 days after surgical resection will be summarized.
7 secondary outcomes
Overall survival from surgical resection
Time frame: Up to 46 months
Event-free survival from surgical resection
Time frame: Up to 46 months
Number of participants initiating adjuvant immunotherapy after surgery
Time frame: Up to 14 months
Time (days) from surgery to initiation of adjuvant immunotherapy
Time frame: Up to 14 months
Number of participants receiving post-surgical systemic and local therapies
Time frame: Up to 46 months
Length of hospital stay (days) following surgical resection
Time frame: Up to 90 days
Number of participants with immune-mediated adverse events (AEs) during neoadjuvant immunotherapy
Time frame: Up to 22 months
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 21 Jul 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site 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, run by Bristol-Myers Squibb at 1 site in United Kingdom.
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 1 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
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?
Number of participants with pathological complete response after neoadjuvant immunotherapy and surgical resection. (time frame: Up to 14 months). The study lists 7 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 21 Jul 2026.