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NCT Number: NCT07718139

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IQVIA

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Nivolumab

Biological

As per product label

Pembrolizumab

Biological

As per product label

Durvalumab

Biological

As per product label

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. Overall survival from surgical resection

    Time frame: Up to 46 months

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

  2. Event-free survival from surgical resection

    Time frame: Up to 46 months

    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.

  3. Number of participants initiating adjuvant immunotherapy after surgery

    Time frame: Up to 14 months

    Adjuvant immunotherapy includes pembrolizumab, durvalumab, or nivolumab.

  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

    Time frame: Up to 46 months

    Post-surgical therapies received during follow-up will be summarized and include adjuvant immunotherapy, adjuvant chemotherapy, radiotherapy, targeted therapy, and advanced or metastatic treatments.

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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