Advanced/ recurrent Non-small cell lung cancer with Interstitial lung disease Non-small cell lung cancer, Interstitial lung disease
Conditions
Interventions
Carboplatin (AUC 6 mg/mL/min, day1)+ nab-paclitaxel (100 mg/m2, day1, 8, 15), every 28 days for 4 to 6 cycles.
Chemotherapy, Carboplatin, nab-paclitaxel
Sponsors
Suzuki Takuji
Thoracic Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: First registration 1) Histologically or cytologically proven non-small cell lung cancer (NSCLC). 2) Unresectable stage 3/4 or recurrent. 3) Chronic fibrotic Interstitial lung disease. HRCT revealed (1) reticular shadow with basal and peripheral predominance suggestive of UIP pattern, or (2) peribronchovascular shadow suggestive of NSIP pattern. 4) CBDCA+nab-PTX is scheduled or administered as first line chemotherapy. 5) Before second line chemotherapy. (Dose not include ICI.) 6) Age>=18 years. 7) Written informed consent. Second registration 1) Completed 4-6 cycles of first line chemotherapy. (CBDCA+nab-PTX) 2) Best Overall Response of first line chemotherapy was CR, PR or SD. (Confirmation is not required.) 3) Developed signs of disease progression with a time interval >= 90 days between relapse and the last administration of CBDCA as first line chemotherapy. 4) With measurable or evaluable lesions according to RECIST Version1.1. 5) ECOG Performance Status ==1,500 / mm3 - Platelet count: >=100,000 / mm3 - AST: ==90% - %FVC: >=50%, %DLco: >=36% (performed within 90 days prior to registration is acceptable) 7) Expected survival of at least 12 weeks. 8) Written informed consent.
Exclusion criteria
Exclusion criteria: First registration 1) Developed signs of disease progression with a time interval 10mg of prednisolone equivalent up to 14 days before registration. 8) Treatment history with thoracic radiotherapy. 9) Symptomatic brain metastasis or spinal cord metastases. - If brain metastases are present, the patient is eligible if asymptomatic or if more than 15 days have passed since local treatment and corticosteroids are less than 10 mg/day of prednisolone equivalent. 10) Uncontrollable Pleural/pericardial effusions, or ascites. - Patients with pleural/pericardial effusions, or ascites that do not require continuous drainage or are clinically stable after drainage are eligible. (The period must have passed for 7 days after the drainage has ended. 11) Active multiple primary neoplasms diagnosed within 3 years. - Duplication of carcinoma in situ (intraepithelial carcinoma) that is cured by local treatment is not included in active multiple primary neoplasms. 12) Active hepatitis B, hepatitis C, or HIV infection. - If the patient is positive for HBs antigen or HBV-DNA, he/she is excluded. - If the patient is positive for HBs antibody or HBc antibody, HBV DNA level is measured and the virus level is negative, the patient is eligible. - If the patient is positive for HCV antibody, he/she is excluded. 13) Serious complications such as thromboembolism, peptic ulcer, cerebral ischemic attack, congestive heart failure, unstable angina pectoris, uncontrolled arrhythmia or myocardial infarction within 6 months. 14) Hypersensitivity to any of the ingredients or additives of CBDCA or nab-PTX. 15) Pregnant women, lactating women, and women with a positive pregnancy test. Men and women who are pregnant, lactating women, and women who have had a positive pregnancy test or who do not intend to use contraception. 16) Active infection. 17) Other conditions not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 months Progression-free survival without acute exacerbation of interstitial lung disease rate (3m PFS without AE-ILD rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Objective Response Rate (ORR) - Disease Control Ratio (DCR) - Overall Survival (OS) - Progression-free survival (PFS) - Progression-free survival without acute exacerbation of interstitial lung disease (PFS without AE-ILD) - Safety - The incidence and severity of treatment-related pneumonitis - The incidence and severity of acute exacerbation of interstitial lung disease | — |
Contacts
Public ContactTaku Itoh
Chiba University Hospital
Outcome results
None listed