Icotinib and Arsenic Trioxide in Treating Non-small-cell Lung Cancer Patients With Resistance to EGFR-TKI

Betta Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Icotinib; Drug: Arsenic trioxide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02066870

BD-IC-IV55

Details and patient eligibility

About

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.

Enrollment: 9 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

Icotinib and arsenic trioxide

Experimental group

Description:

Icotinib is administered 125 mg three times per day, until disease progression or untolerated toxicity. 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.

Treatment:

Drug: Arsenic trioxide

Drug: Icotinib