Lung Cancer
Conditions
Keywords
Extensive Disease-Small Cell Lung Cancer
Brief summary
This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.
Interventions
Amrubicin Hydrochloride combined with cisplatin
DRUGEtoposide-Cisplatin combined chemotherapy
combined chemotherapy
Sponsors
Sumitomo Pharma (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically/cytologically proven small cell lung cancer * Extensive disease * No prior chemotherapy regimen * Age 18 years or older * ECOG performance status of 0-1
Exclusion criteria
* Brain metastasis requiring treatment * Treatment (Surgical or radiotherapy)of primary tumor * Interstitial pneumonia or pulmonary fibrosis * Abnormal cardiac function or myocardial infraction within 6 months before study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | 1.5 years after last subject enrolled |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | 1.5 years after last subject enrolled | — |
| Objective Response Rate | participants were followed for the duration of the study, an average of 12 weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Other
| Measure | Time frame |
|---|---|
| Overall Survival at 6 and 12 Months | 6 and 12 months. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Amrubicin, Anticancer, Injection | 149 |
| Etoposide, Anticancer, Injection | 150 |
| Total | 299 |
Baseline characteristics
| Characteristic | Amrubicin, Anticancer, Injection | Etoposide, Anticancer, Injection | Total |
|---|---|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 10.03 | 57.45 years STANDARD_DEVIATION 9.78 | 56.78 years STANDARD_DEVIATION 9.92 |
| Region of Enrollment China | 149 participants | 150 participants | 299 participants |
| Sex: Female, Male Female | 35 Participants | 37 Participants | 72 Participants |
| Sex: Female, Male Male | 114 Participants | 113 Participants | 227 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 149 / 149 | 148 / 150 |
| serious Total, serious adverse events | 21 / 149 | 8 / 150 |
Outcome results
Primary
Overall Survival
Time frame: 1.5 years after last subject enrolled
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Amrubicin Combined With Cisplatin Group | Overall Survival | 11.79 month |
| Etoposide Combined With Cisplatin Group | Overall Survival | 10.28 month |
Secondary
Objective Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: participants were followed for the duration of the study, an average of 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amrubicin Combined With Cisplatin Group | Objective Response Rate | 69.80 percentage of participants |
| Etoposide Combined With Cisplatin Group | Objective Response Rate | 57.33 percentage of participants |
Secondary
Progression-Free Survival
Time frame: 1.5 years after last subject enrolled
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Amrubicin Combined With Cisplatin Group | Progression-Free Survival | 6.83 month |
| Etoposide Combined With Cisplatin Group | Progression-Free Survival | 5.72 month |
Other Pre-specified
Overall Survival at 6 and 12 Months
Time frame: 6 and 12 months.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Amrubicin Combined With Cisplatin Group | Overall Survival at 6 and 12 Months | 6-month | 89.26 percentage of patients |
| Amrubicin Combined With Cisplatin Group | Overall Survival at 6 and 12 Months | 12-month | 48.59 percentage of patients |
| Etoposide Combined With Cisplatin Group | Overall Survival at 6 and 12 Months | 6-month | 86.00 percentage of patients |
| Etoposide Combined With Cisplatin Group | Overall Survival at 6 and 12 Months | 12-month | 41.93 percentage of patients |