Non-small cell lung cancer NSCLC, Non-Squamous cell carcinoma, Squamous cell carcinoma, Adenocarcinoma
Conditions
Interventions
Patients enrolled will receive the following treatment as specified by histology and prior therapy.
Non-squamous (Non-Sq) / previously treated with pemetrexed
Carboplatin (AUC=5, day 1) + nab-paclitax
Antineoplastic Agents
Platinum compounds
Sponsors
Ninomiya Kiichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A definitive diagnosis of non-small cell lung cancer has been made by histology or cytology. 2) Patients must have received the following treatment regimens as initial therapy for at least 3 months (90 days) since the last administration. Non-squamous non-small cell lung cancer Cisplatin/carboplatin + pemetrexed + pembrolizumab Carboplatin + paclitaxel + bevacizumab + atezolizumab Carboplatin + nab-paclitaxel + atezolizumab Cisplatin/carboplatin + pemetrexed + atezolizumab Cisplatin/carboplatin + pemetrexed + nivolumab + ipilimumab Cisplatin/carboplatin + pemetrexed + durvalumab + tremelimumab Carboplatin + nab-paclitaxel + durvalumab + tremelimumab Carboplatin + paclitaxel + bevacizumab + nivolumab Squamous cell non-small cell lung cancer Carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab Carboplatin + paclitaxel + nivolumab + ipilimumab Carboplatin + nab-paclitaxel + durvalumab + tremelimumab Cisplatin/carboplatin + gemcitabine + durvalumab + tremelimumab 3) Patients with driver gene mutations (EGFR/ALK/ROS1/BRAF/RET/MET/KRASG12C/HER2/NTRK) have undergone targeted therapy and exacerbation as described in the guidelines for lung cancer treatment. 4) Age at the time of consent is 18 years or older. 5) Performance Status (ECOG) 0-1 6) Has measurable disease. 7) Latest laboratory values within 14 days prior to enrollment (same day of the week 2 weeks prior to enrollment is acceptable) meet all of the following criteria 1. White blood cell count > 3,000 /mm3 and neutrophil count > 1,500 /mm3 2. Hemoglobin 100,000 /mm3 4. AST (GOT) 92% or PaO2 > 60 Torr at room air 8) The purpose and details of the study have been explained to the patient, and written consent has been obtained from the patient.
Exclusion criteria
Exclusion criteria: 1) Patients with a history of allergy to platinum (cisplatin or carboplatin). 2) Patients with active interstitial pneumonia evident on chest X-ray. 3) Patients with serious cardiac or cerebrovascular disease, active peptic ulcer, fever over 38 degrees Celsius or serious infection, poorly controlled diabetes mellitus, or severe psychiatric or hearing disease. 4) Patients with symptomatic brain metastases. (Patients whose disease has been stabilized by local therapy or other means may be enrolled.) 5) Patients who have been disease-free for 3 years or less and have overlapping cancers that are considered to have a more clearly defined prognosis than lung cancer. 6) Patients with thoracoabdominal or pericardial effusions requiring repeated drainage (may be enrolled if the effusion becomes controllable). 7) Pregnant/lactating women or women who may or intend to become pregnant or men with such partners. 8) Patients requiring urgent radiotherapy. 9) Other patients deemed inappropriate by the physician in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall survival 2) Objective Response Rate 3) Toxicity (CTCAE ver 5.0) | — |
Contacts
Public ContactKiichiro Ninomiya
Okayama University Hospital
Outcome results
None listed