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Active, not recruitingNCT07718139Updated Jul 21, 2026

Demographics, Clinical Characteristics and Outcomes in Resected Non-Small Cell Lung Cancer Patients Receiving Immunotherapy in Europe and Canada

An observational study in Non-Small Cell Lung Cancer, sponsored by Bristol-Myers Squibb. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • Non-Small Cell Lung Cancer
  • NSCLC
  • neoadjuvant immunotherapy
  • perioperative immunotherapy
  • nivolumab;
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 300 is above the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of another primary malignancy (excluding non-melanoma skin cancer) within 5 years prior to NSCLC diagnosis or at any time after diagnosis
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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).

    Biological: nivolumab · Biological: pembrolizumab · Biological: durvalumab

Interventions

  • Biologicalnivolumab

    As per product label

  • Biologicalpembrolizumab

    As per product label

  • Biologicaldurvalumab

    As per product label

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 14 months

  2. 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.

    Time frame: Up to 14 months

  3. 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.

    Time frame: Up to 90 days

  4. 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).

    Time frame: Up to 14 months

  5. Number of participants by surgical resection type

    Surgical resection type will be categorized as lobectomy, bilobectomy, segmentectomy, wedge resection, pneumonectomy, or sleeve resection.

    Time frame: Day 1

  6. Number of participants by surgical approach

    Surgical approach will be categorized as open thoracotomy, video-assisted thoracoscopic surgery (VATS), or robotic-assisted surgery.

    Time frame: Day 1

  7. 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.

    Time frame: Up to 90 days

Secondary outcomes

  1. Overall survival from surgical resection

    Overall survival (OS) is defined as the time from surgical resection to death from any cause.

    Time frame: Up to 46 months

  2. 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.

    Time frame: Up to 46 months

  3. Number of participants initiating adjuvant immunotherapy after surgery

    Adjuvant immunotherapy includes pembrolizumab, durvalumab, or nivolumab.

    Time frame: Up to 14 months

  4. Time (days) from surgery to initiation of adjuvant immunotherapy

    Time frame: Up to 14 months

  5. 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.

    Time frame: Up to 46 months

  6. Length of hospital stay (days) following surgical resection

    Time frame: Up to 90 days

  7. Number of participants with immune-mediated adverse events (AEs) during neoadjuvant immunotherapy

    Time frame: Up to 22 months

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Study locations

1 site
  • IQVIA
    London, United Kingdom
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References and documents

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07718139
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Jul 21, 2026
Start date
Feb 28, 2026
Primary completion
Sep 30, 2026 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Jul 21, 2026

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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