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

NCT07718139 | Active Not Recruiting FDA Drug

• 1 other identifier: CA209-1620
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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).

  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.

  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.

  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.

  Up to 90 days

Secondary Outcomes (7)

• Overall survival from surgical resection

  Up to 46 months

• Event-free survival from surgical resection

  Up to 46 months

• Number of participants initiating adjuvant immunotherapy after surgery

  Up to 14 months

• Time (days) from surgery to initiation of adjuvant immunotherapy

  Up to 14 months

• Number of participants receiving post-surgical systemic and local therapies

  Up to 46 months

Study Arms (2)

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

nivolumab BIOLOGICAL

As per product label

Neoadjuvant Phase Only; Perioperative Immunotherapy

pembrolizumab BIOLOGICAL

As per product label

Neoadjuvant Phase Only; Perioperative Immunotherapy

durvalumab BIOLOGICAL

As per product label

Neoadjuvant Phase Only; Perioperative Immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosed with non-small-cell lung cancer (NSCLC) stage IIA to IIIB
• Participants aged ≥18 years at time of NSCLC diagnosis
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

IQVIA

London, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; pembrolizumab; durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 21, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)