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Completed

NCT Number: NCT06735781

Clinical Outcomes of Patients With Resectable Non-Small Cell Lung Cancer Receiving Neoadjuvant Nivolumab Plus Chemotherapy in France

The purpose of this study is to evaluate real-world effectiveness of neoadjuvant nivolumab plus chemotherapy in France.

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) 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

Centre François Baclesse, Caen, France

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Who can participate

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

Inclusion criteria

  • Having a diagnosis of resectable non-small cell lung cancer (NSCLC)
  • Being 18 years or above at the time of their NSCLC diagnosis
  • Having initiated a neoadjuvant treatment with nivolumab and chemotherapy outside a clinical trial
  • Being indexed in the site database
  • Being followed at the site for at least 5 months, except for patients with a record of death

Exclusion criteria

  • Having any primary tumor other than NSCLC on or before the date of NSCLC diagnosis that required a treatment ending less than 12-months before the nivolumab plus chemotherapy neoadjuvant treatment

Treatment and study plan

Nivolumab

Drug

As prescribed by the treating clinician

Primary outcomes

  1. Rate of pathological complete response on date of surgery

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Secondary outcomes

  1. Study population baseline demographics

    Time frame: Baseline

  2. Study population baseline clinical characteristics

    Time frame: Baseline

  3. Surgery rate

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  4. Time from diagnosis to start of neoadjuvant treatment

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  5. Average dose of nivolumab infusions

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  6. Frequency of nivolumab infusions

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  7. Duration of nivolumab treatment

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  8. Type of chemotherapy received in combination with nivolumab treatment as neoadjuvant treatment

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  9. Infusion setting (hospital or at home)

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  10. Survival status

    Time frame: at 3, 6, 9, 12, 18, and 24 months (or until loss of follow-up, death, or end of study observation period (31 months))

  11. Subsequent treatments received after nivolumab treatment

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  12. Disease progression/relapse status

    Time frame: At 3, 6, 9, 12, 18, and 24 months (or until loss of follow-up, death, or end of study observation period (31 months))

  13. Rate of major pathological response

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  14. Adverse events

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  15. Time to surgery from initial diagnosis

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  16. Time to surgery from the first dose of neoadjuvant therapy

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  17. Time to surgery from the last dose of neoadjuvant therapy

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  18. Surgery type

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  19. Duration of surgery

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  20. Extent of surgical resection

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  21. Rate of lymph node resection

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  22. Type of surgery complications

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  23. Length of hospital stay

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

  24. Reasons for not having surgery as indicated by the multi-disciplinary tumor board

    Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Short-term Clinical Outcomes of Patients With Resectable Non-Small Cell Lung Cancer Receiving Nivolumab Plus Chemotherapy as Neoadjuvant Therapy in France

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

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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