"Real world treatment practice, effectiveness, and safety of nivolumab combination with chemotherapy as a neoadjuvant therapy for resectable NSCLC patients in Japan, an observational study"

JRCT ID: jRCT1031240063

Registered date:07/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Resectable Non-Small Cell Lung Cancer
• Date of first enrollment: 01/07/2024
• Target sample size: 200
• Study type: Observational

Outcome(s)

Primary Outcome

- Real world treatment practice
Patients characteristics
Treatment status
Cancellation rate of surgery in patients treated with nivolumab combined with chemotherapy as a neoadjuvant therapy
- Safety
Treatment-related adverse events from the start of nivolumab combined with chemotherapy as a neoadjuvant therapy to within 100 days after the last dose; TRAE incidence
Immune-mediated adverse events from the start of nivolumab combined with chemotherapy as a neoadjuvant therapy to within 100 days after the last dose; IMAE incidence
- Effectiveness
Pathological complete response rate (pCR rate).
Event-free survival (EFS)
Overall Survival (OS)

Secondary Outcome

<Regarding nivolumab combined with chemotherapy as a neoadjuvant therapy>
- Treatment pattern
Treatment status in patients where surgery was cancelled
Treatment status in patients where surgery was postponed
Treatment status in patients with recurrence
Aggregation of the above treatment status items by patient characteristics
- Safety
Incidence of adverse events within 100 days after the last dose of nivolumab combined with chemotherapy as a neoadjuvant therapy
Incidence of adverse events leading to cancellation of surgery
Incidence of adverse events leading to delay of surgery
Aggregation of the above safety items by patient characteristics
Other aggregations required for safety evaluation
- Effectiveness
Time to distant metastasis or death (TTDM)
Overall response rate (ORR)
Pathological evaluation in the primary lesion
Aggregation of the above efficacy items by patient characteristics
Other aggregations required for efficacy evaluation
<Regarding surgery>
Surgical details
Operative procedure
Completeness of resection
Incidence of surgery-related adverse events within 90 days of surgery
<Regarding postoperative adjuvant therapy>
- Treatment pattern of postoperative adjuvant therapy
Treatment status
Aggregation of the above treatment status by patient characteristics
<Regarding the subsequent therapies>
- Treatment pattern of the subsequent therapies
Treatment status
Aggregation of the above treatment status items by patient characteristics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients aged 18 years or older
2) Patients diagnosed with resectable non-small cell lung cancer
3) Patients who started or were planned to started nivolumab combined with chemotherapy as a neoadjuvant therapy * between April 1, 2023, and September 30, 2024.
*Acceptable concomitant chemotherapy are cisplatin (or carboplatin) plus gemcitabine and carboplatin plus paclitaxel for squamous cell carcinoma, and cisplatin (or carboplatin) plus pemetrexed and carboplatin plus paclitaxel for non-squamous cell carcinoma.
4) (For those patients who were visiting the participating medical institutions) Patients who provided written consent with their own free will and full understanding, after receiving sufficient explanation regarding enrollment in the study,
(For those who have been transferred to another hospital) Patients who provided written or verbal consent with their own free will and full understanding, after receiving sufficient explanation regarding enrollment in this study. In cases where consent was obtained verbally, the verbal consent will be recorded in the medical records. Subsequently, for cases were written consent is obtainable, written consent will be obtained.
In addition, the following conditions are acceptable:
a) In the case of patients difficulty in writing, enrollment for this study is permitted through the use of a scribe by an individual equivalent to a legally authorized representative, based on the patient's verbal consent.
b) For patients who are unable to provide consent themselves or who have died, enrollment through a legally authorized representative is permitted when written consent is obtained after explanation to the representative.

Exclude criteria

1) Patients with a positive EGFR mutation or ALK fusion gene confirmed prior to initiation of nivolumab combination with chemotherapy as a neoadjuvant therapy
2) Patients who have participated in a trial for antitumor effects in NSCLC and who have received a therapeutic agent
3) Patients who have received antitumor medication within 3 months before the initiation of nivolumab combined chemotherapy as a neoadjuvant therapy (however, those are receiving hormonal therapy are allowed for enrollment)
4) Patients with a complication of treatment-related adverse events of hematologic toxicity due to treatment with antitumor agents that had occurred more than 3 months before initiation of nivolumab combined with chemotherapy as a neoadjuvant therapy
5) Patients who started nivolumab combined with chemotherapy as a neoadjuvant therapy outside the participating medical institutions and were transferred to the participating medical institutions
6) Patients who are considered inappropriate for enrollment in the study, which was judged by the principal investigator or investigations at participating medical institutions

Related Information

• Primary Sponsor: Matsumoto Hiroki
• Secondary Sponsor: Park Jihyun,Bristol Myers Squibb Co. Ltd.