Icotinib for Completed Resected IB NSCLC With EGFR Mutation

Learn more about:
Related Clinical Trial
A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care Docetaxel With Either Cetuximab or Bortezomib as First-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Icotinib for Completed Resected IB NSCLC With EGFR Mutation Circulating Tumor DNA in Patients at High Risk for Lung Cancer Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery Combination Chemotherapy, Radiation Therapy, and Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers Radiation Therapy, Chemotherapy, and Soy Isoflavones in Treating Patients With Stage IIIA-IIIB Non-Small Cell Lung Cancer Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer S0536: Cetuximab, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Inoperable Stage III Non-Small Cell Lung Cancer Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer Combination Chemotherapy and Radiation Therapy With or Without Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC Image-Guided Hypofractionated Radiation Therapy With Stereotactic Body Radiation Therapy Boost and Combination Chemotherapy in Treating Patients With Stage II-III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery Bevacizumab, Paclitaxel, Carboplatin, and Radiation Therapy to the Chest in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery QUILT-3.017: Study of NEO-201 in Solid Tumors Photodynamic Therapy in Treating Patients With Lung Cancer Vaccine Treatment for Advanced Non-Small Cell Lung Cancer S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib Single Agent Chemotherapy +/- Nivolumab in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC The Tracking Molecular Evolution for NSCLC (T-MENC) Study Phase 1a/1b Study of TPST-1495 Alone and With Pembrolizumab in Subjects With Solid Tumors An Integrated Approach to Treating Recurrent Thoracic Carcinomas Resistant to Tyrosine Kinase Inhibitors Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC) P2 of RMT in Combo w Durvalumab or Durva + Chemo in Untreated Adenocarcinoma NSCLC Feasibility and Safety of Nintedanib in Combination With Nivolumab in Pretreated Patients With Advanced or Metastatic NSCLC of Adenocarcinoma Histology Targeted Stem Cells Expressing TRAIL as a Therapy for Lung Cancer Combination Nab-paclitaxel (N-P) and Nintedanib or N-P and Placebo in Relapsed NSCLC Adenocarcinoma Prospective Radiological Study of HRCT to Predict Pathological Noninvasiveness in NSCLC To Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer Hsp90 Inhibitor AUY922 and Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer Impact of Concomitant Genetic Alterations in EGFR Mutated Adenocarcinoma by NGS Analysis: A Multicenter Study Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001) Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the Lung Lung Cancer Mutation Consortium Protocol The Detection of EGFR Mutations in Liquid Based Cytology Samples NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma A Safety and Efficacy Study of Farletuzumab in Subjects With Adenocarcinoma of the Lung Study of Vintafolide (MK-8109, EC145) in Participants With Progressive Adenocarcinoma of the Lung (MK-8109-008, EC-FV-03) Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR Telomere Biology in Early Adenocarcinoma of the Lung

Brief Title

Icotinib for Completed Resected IB NSCLC With EGFR Mutation

Official Title

A Randomized, Phase II Trial of Icotinib Versus Observation as Adjuvant Treatment in Stage IB Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutation

Brief Summary

      This phase II trial studies how well icotinib works in treating patients with completely
      resected stage IB NSCLC harboring EGFR mutation.
    

Detailed Description

      Adjuvant chemotherapy have shown little evidence of survival benefit in patients with stages
      IB non-small cell lung cancer (NSCLC) after complete resection. Epidermal growth factor
      receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with EGFR
      mutant non-small cell lung cancer (NSCLC). Icotinib is a novel EGFR-TKI developed by a group
      of Chinese scientists and clinician. In the phase III ICOGEN trial, icotinib had
      non-inferiority efficacy to gefitinib with better safety. This study is studying icotinib to
      see how well it works in treating patients with fully resected stage IB NSCLC harboring EGFR
      mutation.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall survival

Secondary Outcome

 Disease-free survival

Condition

Lung Neoplasms

Intervention

Icotinib

Study Arms / Comparison Groups

 Intervention group
Description:  Icotinib 125 mg three times daily (375 mg per day) orally for 12 months.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

128

Start Date

January 2015

Completion Date

January 2020

Primary Completion Date

January 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Written informed consent provided.

          -  Males or females, Aged 18-75 years.

          -  Able to comply with the required protocol and follow-up procedures, and able to
             receive oral medications.

          -  Had completely resected pathological confirmed stage IIA-IIIA NSCLC.

          -  EGFR activating mutation in exon 19 or 21.

          -  Patient who can start the investigational therapy within 3-6 weeks after the complete
             resection.

          -  ECOG performance status of 0-1.

          -  Had a life expectancy of 12 weeks or more.

          -  Adequate hematological function, adequate liver function and renal function.

          -  Female patients, except those who are postmenopausal or surgically sterilized, must
             have a negative pre-study serum or urine pregnancy test.

        Exclusion Criteria:

          -  Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g.
             erlotinib, gefitinib, cetuximab, trastuzumab).

          -  Inability to comply with protocol or study procedures.

          -  Had a history another malignancy in the last 5 years with the exception of cured basal
             cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured
             epithelial carcinoma of the bladder.

          -  Any evidence confirmed tumor recurrence before investigational therapy.

          -  Known severe hypersensitivity to icotinib or any of the excipients of this product.

          -  Evidence of clinically active interstitial lung disease.

          -  Eye inflammation not fully controlled or conditions predisposing the subject to this.

          -  Any unstable systemic disease (including active infection, uncontrolled hypertension,
             unstable angina, congestive heart failure, myocardial infarction within the previous 6
             months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic
             disease).

          -  Known human immunodeficiency virus (HIV) infection.

          -  Pregnancy or breast-feeding women.

          -  Ingredients mixed with small cell lung cancer patients.

          -  History of neurologic or psychiatric disorders.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Si-Yu Wang, MD, +86 20 87343314, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02264210

Organization ID

GASTO1003

Secondary IDs

wsy004

Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University


Study Sponsor

Si-Yu Wang, MD, Principal Investigator, Guangdong Province Association Study of Thoracic Oncology


Verification Date

October 2017