Icotinib as Neoadjuvant and Adjuvant Therapy in EGFR-mutant Stage IIIB or Oligometastasis Non-small Cell Lung Cancer

NCT03349203 | Unknown Phase 2

• 1 other identifier: BD-IC-IV81
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the pulmonary and metastases lesions objective response rate after Icotinib preoperative therapy in EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery.

Conditions

EGF-R Positive Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate as assessed by RECIST1.1

  Objective Response Rate was defined as the percentage of participants whose tumor lesions disappear completely or diameters reduced by at least 30% as assessed by RECIST1.1.

  eight weeks

Secondary Outcomes (4)

• Disease Control Rate as assessed by RECIST1.1

  five years after surgery

• Time to Tumor Progression as assessed by RECIST1.1

  five years after surgery

• Overall survival of participants

  five years after surgery

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  five years after surgery

Study Arms (1)

Icotinib

EXPERIMENTAL

Patients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks before surgery and 2 years as adjuvant therapy after surgery or till progressive disease or unaccepted toxicity.

Drug: Icotinib

Interventions

Icotinib DRUG

Patients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day by mouth for 8 weeks as neoadjuvant therapy before surgery and 2 years as adjuvant therapy or till progressive disease or unaccepted toxicity.

Also known as: Conmana

Icotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histology or cytology confirmed Non-small Cell Lung Cancer; EGFR mutation (EGFR 19del and/or 21L858R) detected by tumor tissue biopsy of primary lesion or metastatic lesion or plasma ctDNA
• No previous anti-tumor treatment such as surgery, chemotherapy, radiotherapy or biological therapy
• Stage IIIB or IV Oligometastasis Non-small Cell Lung Cancer. (a) stage IV Oligometastasis: the metastasis organ mainly include: 1. adrenal metastasis which can be potentially resected by surgery or radically treated by SRS radiotherapy; 2. brain metastasis which can be potentially resected by surgery or radically treated by SRS radiotherapy. At the same time, the primary lesion of the lung can be completely removed, which should be T1-2, N0-1 or T3, N0. (b) stage IIIB (T1-3, N3): it is limited to patients who are unsuitable or refuse to accept pulmonary primary lesion radiotherapy. It only include subclavian lymph node or anterior scalenus lymph node metastasis (mediastinal lymph node metastasis is excluded by PET-CT). The metastasis lesion should be single or less than 3, its diameter is no more than 3 cm and can be potentially resected.
• Sufficient tumor histological specimens (non-cytology) for molecular marker analysis
• At least one lesion with measurable diameter and its longest diameter is large than 10 mm by CT measurement

You may not qualify if:

• Previous systemic anti-tumor treatment of Non-small Cell Lung Cancer, including cytotoxic drug therapy, targeted drug therapy (tyrosine kinase inhibitors or monoclonal antibodies) and experimental treatment, etc
• Previous local radiotherapy of Non-small Cell Lung Cancer
• Be allergic to any component of Icotinib tablet (Conmana)
• Other cancers within five years prior to the treatment of this study. Except for cervical carcinoma, basal cell carcinoma and bladder epithelial neoplasm (including Ta and Tis)
• Any instable systemic disease, including: active infection, high blood pressure out of control, unstable angina, onset of angina pectoris within the past 3 months, congestive heart failure, myocardial infarction, severe arrhythmia, liver, kidney or metabolic disease
• Previous interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy or any active intersexual lung disease with clinical evidence
• Idiopathic pulmonary fibrosis detected by CT scan at baseline;
• Not fully controlled eye inflammation or infections, or any condition that may lead to the above eye diseases
• Human immunodeficiency virus infection
• Patients undergoing major surgery or severe trauma within 2 months prior to the first use of the experimental drug
• Patients with Small Cell Lung Cancer
• Pregnant or lactating women
• Neurological or psychiatric disorders history, including epilepsy or dementia
• Other situations not appropriate to enter the group considering by the investigators

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Science

Beijing, China

RECRUITING

MeSH Terms

Interventions

icotinib

Study Officials

• Shugeng Gao

  Cancer Hospital Chinese Academy of Medical Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shugeng Gao, MD

CONTACT

13801185056; gaoshugeng@vip.sina.com

Feiyue Feng

CONTACT

13693532206; feiyuefeng_cn@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 21, 2017
• Study Start: October 1, 2018
• Primary Completion: February 1, 2022
• Study Completion: December 30, 2023
• Last Updated: July 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)