Non-small Cell Lung Cancer
Conditions
Keywords
Icotinib, Arsenic Trioxide, Resistance, Non-small cell lung cancer
Brief summary
The NSCLC patients who experienced good clinical responses to an EGFR-TKI will inevitably develop acquired resistance. A great deal of research are focusing on this issue. Arsenic trioxide showed efficacy and safety in acute promyelocytic leukemia, multiple myeloma and other solid tumors. Moreover, preclinical studies showed arsenic trioxide can reduce the resistance of tumor cells to chemotherapy and TKIs.
Interventions
DRUGIcotinib
Icotinib is administered orally 125 mg three times per day, until disease progression or untolerated toxicity.
DRUGArsenic trioxide
Arsenic trioxide is administered by intravenous injection with an initial dose of 4mg/m2 per day for day 1 to day 14 every 21 days. Three dose levels, 4mg/m2, 6mg/m2 and 8mg/m2 will be evaluated according to predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 2 patients developed a DLT. There was no further dose escalation when this dose was achieved.
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed stage IIIB/IV lung cancer with EGFR mutation * Progressed after platinum-based chemotherapy * The last anti-tumor therapy before entering this study must be gefitinib, erlotinib or icotinib, and the duration for tumor response must be no less than 4 months, or the duration for stable disease must be no less than 6 months * With a measurable disease with conventional CT) according to RECIST Criteria * WHO performance status(PS)\<= 2 * N\>=1.5×109/L, Plt\>=1.0×109/L,Hb\>=9g/dL; AST&ALT should \<2.5ULN(without liver metastasis) or \<5ULN(with liver metastasis).TBIL\<=1.5ULN. * Signed and dated informed consent before the start of specific protocol procedures.
Exclusion criteria
* Allergic to icotinib or arsenic trioxide. * Patients with metastatic brain tumors with symptoms. * Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Serious and Non-Serious Adverse Events | Up to 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | Up to 4 months |
| Time to death | Up to 24 months |
Countries
China
Contacts
Primary ContactYuankai Shi, MD
Outcome results
None listed