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

Phase 1

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Icotinib; Drug: Arsenic trioxide

• Registration Number: NCT02066870
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-17
• Study First Submitted QC: 2014-02-17
• Study First Posted: 2014-02-20
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-13
• Primary Completion: 2015-09
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Icotinib and arsenic trioxide	Icotinib	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.
Icotinib and arsenic trioxide	Arsenic trioxide	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Serious and Non-Serious Adverse Events	Up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Up to 4 months
Time to death	Up to 24 months

Trial Locations

Locations (1)

Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; 🇨🇳 Beijing, China