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NCT Number: NCT06169956

An Observational Study to Evaluate Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy in Non-Metastatic Non-Small Cell Lung Cancer Participants in Germany

The purpose of this observational study is to collect and evaluate real-world data to assess the effectiveness of neoadjuvant nivolumab when given in combination with platinum-based chemotherapy in participants with early-stage, resectable non-small cell lung cancer (NSCLC) in Germany

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Key information

Conditions

Resectable Non-small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikverbund Allgaeu

Kempten (Allgäu), Bavaria, 87439, Germany

Location status: Recruiting

Location contact

Christian Schumann, Site 0001

CONTACT

+8315302382

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 years or older
  • Diagnosis of non-metastatic non-small cell lung cancer with tumor Programmed death-ligand 1 (PD-L1) expression level of 1% or more (tumor proportion score (TPS); according to label approved in the European Union)
  • Decision to initiate a neoadjuvant treatment with nivolumab plus platinum-based chemotherapy for treatment of non-small cell lung cancer according to current Summary of product characteristics and independent of the study
  • Willing to complete patient-reported outcome questionnaires and sufficient understanding of the German language
  • Signed written informed consent
  • Other criteria according to current Summary of product characteristics

Exclusion criteria

  • Current primary diagnosis of cancer other than non-small cell lung cancer that requires systemic or other treatment
  • Other contraindications according to current Summary of product characteristics

Treatment and study plan

Neoadjuvant nivolumab in combination with platinum-based chemotherapy

Drug

Neoadjuvant treatment of resectable non-small cell lung cancer with nivolumab in combination with chemotherapy according to current summary of product characteristics

Primary outcomes

  1. Event-free survival

    Time frame: Up to 5 years

Secondary outcomes

  1. Pathologic complete response (pCR) rate

    Time frame: Up to 5 years

  2. Rate of major pathologic response (MPR)

    Time frame: Up to 5 years

  3. Rate of partial pathologic response (pPR)

    Time frame: Up to 5 years

  4. Rate of pathologic non-responder

    Time frame: Up to 5 years

  5. Rate of tumor response

    Time frame: Up to 5 years

    Classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)

  6. Participant age

    Time frame: Baseline

  7. Participant sex

    Time frame: Baseline

  8. Participant insurance status

    Time frame: Baseline

  9. Participant employment status

    Time frame: Baseline

  10. Participant height in cm

    Time frame: Baseline

  11. Participant weight in kg

    Time frame: Baseline

  12. Eastern Cooperative Oncology Group Performance Status (ECOG-PS)

    Time frame: Baseline and up to 5 years

    ECOG-PS score of 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS score of 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS score of 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours. ECOG-PS score of 3 = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours. ECOG-PS score of 4 = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. ECOG-PS score of 5 = Dead

  13. Participant medical history

    Time frame: Baseline

  14. Participant history of smoking

    Time frame: Baseline

  15. Participant concomitant treatments

    Time frame: Baseline and during neoadjuvant nivolumab plus platinum-based chemotherapy, up to 5 years

  16. Participant subsequent treatments

    Time frame: Up to 5 years

  17. Date of initial diagnosis of NSCLC

    Time frame: Baseline

  18. Primary tumor assessed by histology subtype

    Time frame: Baseline

  19. Tumor stage assessed by tumor node metastasis (TNM; stage IB-IIIA)

    Time frame: Baseline

  20. Location of primary tumor

    Time frame: Baseline

  21. Date of local relapse

    Time frame: Baseline to end of study, up to 5 years

  22. Location of metastases

    Time frame: Baseline to end of study, up to 5 years

  23. Date of metastatic diagnosis

    Time frame: Baseline to end of study, up to 5 years

  24. Tumor size assessed by medical imaging using x-rays, computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, bone scintigraphy, positron emission tomography-computed tomography (PET- CT)

    Time frame: Up to 5 years

  25. Tumor location assessed by medical imaging using x-rays, computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, bone scintigraphy, positron emission tomography-computed tomography (PET- CT)

    Time frame: Up to 5 years

  26. Number of participants with abnormal hematology results

    Time frame: Up to 5 years

  27. Number of participants with abnormal clinical chemistry results

    Time frame: Up to 5 years

  28. Number of participants with abnormal biomarker results

    Time frame: Baseline to end of study, up to 5 years

  29. Type of surgery

    Time frame: Up to 5 years

  30. Completeness of resection assessed by residual tumor classification

    Time frame: Up to 5 years

    R0: no residual tumor, R1: microscopic residual tumor, R2: macroscopic residual tumor, Rx: unknown

  31. Number of participants with tumor resection

    Time frame: Up to 5 years

  32. Extend of resection (R0/R1/R2)

    Time frame: Up to 5 years

  33. Number of lymph nodes resected

    Time frame: Up to 5 years

  34. Surgical approach

    Time frame: Up to 5 years

    Thoracotomy, minimal invasive (video-assisted thoracoscopic surgery [VATS], robotic-assisted thoracic surgery [RATS]), minimal invasive to thoracotomy (conversion)

  35. Length of hospital stay following surgery

    Time frame: From surgery to discharge from hospital, assessed up to 5 years

  36. Incidence of adverse events

    Time frame: Up to 5 years

  37. Severity of adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0

    Time frame: Up to 5 years

  38. Patient-reported health-related Quality of Life assessed by using the validated European Quality of Life 5 Dimension 3 Level (EQ-5D-3L) questionnaire

    Time frame: Up to 5 years

    EQ-5D-3L summary index: 1 represents perfect health, 0 represents death, negative values represent health states considered worse than death

  39. Time to next treatment

    Time frame: Up to 5 years

    Time between end of primary treatment (neoadjuvant treatment + surgery + if needed by physician's assessment adjuvant therapy) to start of next treatment)

  40. Dosing of nivolumab

    Time frame: Up to 5 years

  41. Treatment regimens

    Time frame: Up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy for Non-Metastatic NSCLC: A German, Nationwide, Prospective, Observational, Multicenter Study in Patients Scheduled to Receive 3 Cycles Nivolumab in Combination With Platinum-Based Chemotherapy for Non-Metastatic (Stage and PD-L1 Expression According to Label) Non-Small Cell Lung Cancer

Acronym: NENI

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Dec 14, 2023
Registry last updated
Apr 18, 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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