Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-02-27 @ 8:28 AM
Study NCT ID:
NCT02191059
Status:
UNKNOWN
Last Update Posted:
2014-07-31
First Post:
2014-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel to Treat Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531470', 'term': 'icotinib'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-30', 'studyFirstSubmitDate': '2014-07-13', 'studyFirstSubmitQcDate': '2014-07-13', 'lastUpdatePostDateStruct': {'date': '2014-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate(ORR)', 'timeFrame': '10-12 months'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival(PFS)', 'timeFrame': '10-12 months'}, {'measure': 'Overall Survival(OS)', 'timeFrame': '10-12momths'}, {'measure': 'Health Related Quality of Life(HRQoL)', 'timeFrame': '10-12months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non Small Cell Lung Cancer', 'Wild Type EGFR', 'Icotinib', 'Second-line Treatment'], 'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': '1. There is as yet no optimal treatment regimen for patients with epidermal growth factor receptor (EGFR) gene wild type non-small-cell lung cancer (NSCLC) .\n2. Icotinib is a new type of small molecule EGFR TKI, developed and patented by Zhejiang BetaPharma Co., Ltd.(Hangzhou, Zhejiang, China, Patent No. WO2003082830). It has the similar anti-tumor activity with gefitinib, erlotinib. Pre-clinical studies showed icotinib could significantly inhibit the EGFR tyrosine kinase activity. Notably, anti-tumor activities were observed in patients with advanced NSCLC.\n3. In this study, we will evaluate the efficiency of intermittent high dose of Icotinib in combination with Docetaxel as second-line treatment for NSCLC patients with wild type EGFR. The overall response rate(ORR),progression free survival(PFS) ,overall survival(OS) and health related quality of life(HRQoL) will be monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically or cytologically confirmed stage IIIB/IV NSCLC patients progressing after first-line chemotherapy;\n* Patients must have stopped prior platinum-based therapy at least four weeks prior to enroll and fully recovered from chemotherapy-induced toxicity;\n* Age: 18-70 years old;\n* Patients with wild-type EGFR;\n* With a histologically or cytologically confirmed measurable disease (longest diameters \\>=10mm with Spiral computed tomography (CT)and \\>=20mm with conventional CT) according to Response Evaluation Criteria in Solid Tumors (RECIST Criteria);\n* Patients must have Eastern Cooperative Oncology Group(ECOG)Performance Status of 0-2;\n* Must have an expected survival time of at least 12 weeks;\n* Patients should have adequate bone marrow function defined as an absolute peripheral neutrophil count (ANC) of ≥1.5 ´ 109/L, platelet count of ≥ 75´ 109/L; Hemoglobin(Hb) ≥ 9g/dL;\n* adequate hepatic function: bilirubin ≤2x the upper limit of normal, glutamic-oxaloacetic transaminase(AST )and glutamate pyruvate transaminase(ALT)≤2x the upper limit of normal (≤5x the upper limit of normal if evidence of liver metastases);\n* adequate renal function: bilirubin serum creatinine ≤1.5 x the upper limit of normal;\n* No malabsorption or other gastrointestinal disorders affecting drug absorption;\n* Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to study entry.Male patients must use at least one reliable form of contraception during treatment and within 3 months after treatment;\n* Patients have provided a signed Informed Consent Form.\n\nExclusion Criteria:\n\n* Experience of Anti-EGFR Monoclonal Antibody or small molecular compounds therapy such as gefitinib, cetuximab, erlotinib or trastuzumab;\n* Concomitant use with phenytoin, carbamazepine, rifampicin, phenobarbital or St. John's Wort;\n* Allergic to icotinib or any of the excipients of this product.\n* Prior chemotherapy with any paclitaxel agents;\n* Central nervous system (CNS) metastases without radiotherapy and/or surgery;\n* Evidence of clinically active Interstitial lung diseases;\n* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases;\n* Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non melanoma skin cancer or cervical carcinoma in situ);\n* Psychiatric illness that would prevent the patient from giving informed consent;\n* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study;\n* Patient is concurrently using other approved or investigational antineoplastic agent;\n* Pregnant or lactating women;\n* Positive epidermal growth factor receptor mutation."}, 'identificationModule': {'nctId': 'NCT02191059', 'briefTitle': 'Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel to Treat Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shandong Cancer Hospital and Institute'}, 'officialTitle': 'Single Arm, Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel as Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR:', 'orgStudyIdInfo': {'id': 'Icotinib'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermittent High Dose of Icotinib', 'description': 'Intermittent High Dose of Icotinib in Combination With Docetaxel:\n\nIcotinib 625mg tablet b ymouth three times per day for day1-2, Docetaxel 75mg/m2 injection intravenous drip for day 3, 3 weeks as 1 cycle', 'interventionNames': ['Drug: Icotinib', 'Drug: Docetaxel']}], 'interventions': [{'name': 'Icotinib', 'type': 'DRUG', 'armGroupLabels': ['Intermittent High Dose of Icotinib']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere, Docecad'], 'armGroupLabels': ['Intermittent High Dose of Icotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Zhehai Wang, MD', 'role': 'CONTACT', 'email': 'wzhai8778@sina.com', 'phone': '0086-531-67626331'}, {'name': 'Zhehai Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shandong Cancer Hospital and Institute', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Zhehai Wang, MD', 'role': 'CONTACT', 'email': 'wzhai8778@sina.com', 'phone': '0086-531-67626331'}], 'overallOfficials': [{'name': 'Zhehai Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Cancer Hospital and Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Cancer Hospital and Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President', 'investigatorFullName': 'Zhehai Wang', 'investigatorAffiliation': 'Shandong Cancer Hospital and Institute'}}}}