ADVANCED / RECURRENT NON-SMALL CELL LUNG CANCER
Conditions
Interventions
None listed
Sponsors
Bristol-Myers Squibb K.K. Ono Pharmaceutical CO.,LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For entry into this study, the following criteria MUST be met at the time of informed consent: 1. Patients aged over 20 years 2. Histologically confirmed advanced or recurrent NSCLC 3. Patients who have received or scheduled to administrate nivolumab plus ipilimumab with or without chemotherapy as first-line treatment from the date of approval of nivolumab plus ipilimumab with or without chemotherapy to December 31, 2021. a) Pemetrexed plus cisplatin or carboplatin for patients with non-squamous histology and paclitaxel plus carboplatin for patients with squamous histology are only acceptable combinations of chemotherapy. 4. Patients who have signed written informed consent form with their own free will after they have been given an adequate explanation and a fully understanding of this study a) Patients who have difficulty in writing may be registered in this study by writing on their behalf by a person equivalent to a legally acceptable representative, with the patient's oral consent. b) In patients for whom it is difficult to obtain informed consent, the patient's legally acceptable representative may be registered if informed consent is obtained after explanation to the legally acceptable representative. c) If it is difficult to obtain informed consent from the patient or legally acceptable representative for various reasons other than a) and b), registration is allowed by opt-out.
Exclusion criteria
Exclusion criteria: For entry into the study, the following criteria MUST NOT be met at the time of informed consent: 1. In patients with non-squamous histology, patients who are confirmed to be positive for EGFR gene mutation or ALK fusion gene for which EGFR tyrosine kinase inhibitor or ALK tyrosine kinase inhibitor is indicated. 2. Patients who had antineoplastic treatment as first-line treatment of advanced or recurrent NSCLC prior to initiation of nivolumab plus ipilimumab with or without chemotherapy. However, patients who correspond to a) or b) below will be included in this study. a) Prior perioperative chemotherapy or Stage III chemoradiotherapy or durvalumab combination chemoradiotherapy. b) Patients who are received or have received bisphosphonates or denosumab for bone metastasis 3. Patients who initiated treatment with nivolumab plus ipilimumab and added chemotherapy from the second course onwards. 4. Patients who received investigational anti-tumor drug in clinical trial after being diagnosed with NSCLC 5. Other patients who are judged by the investigators to be inappropriate for enrollment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Actual treatment -Descriptions of administration (duration of treatment, rates of patients with second-line treatment, etc.) -Effectiveness (overall survival, time to next treatment, treatment-free survival, and treatment continuation rate) -Safety (incidence of CTCAE v 5.0 Grade 3 or higher immune-related adverse events and incidence of treatment-related adverse events leading to treatment discontinuation) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effectiveness in patients evaluated for response in accordance with RECIST v 1.1 (progression-free survival, objective response rate, disease control rate, and duration of response) 2. Effectiveness and safety by patient background 3. Effectiveness and safety of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors 4. Time to onset of immune-related adverse events to be collected, treatment for these events and time to symptom improvement, and impact on effectiveness 5. Descriptions of administration (duration of treatment, reasons for treatment discontinuation, etc.), effectiveness (response rate) and safety (treatment related death) of second-line treatment 6. Effectiveness in patients who discontinued treatment due to treatment-related adverse events within 90 days 7. Descriptions of administration (duration of treatment, reasons for treatment discontinuation, etc.), effectiveness (response rate and overall survival) and safety (treatment related death) of second-line treatment in patients with disease progression within 90 days | — |
Countries
Japan
Contacts
Public Contacthayato konishi
Mebix, Inc Research Promotion Headquarters
Outcome results
None listed