Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03153358
Other study ID # EK2017001
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received May 7, 2017
Last updated May 13, 2017
Start date June 2, 2017
Est. completion date May 2, 2019

Study information

Verified date May 2017
Source Sichuan Cancer Hospital and Research Institute
Contact juan li, doctor
Phone +8613880276636
Email dr.lijuan@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Many patients with oncogene-driven non-small-cell lung cancer (NSCLC) treated with tyrosine kinase inhibitors experience limited sites of disease progression. For multiple metastases in patients with advanced NSCLC, increased local treatment may benefit to prolong patient survival. This study investigated the benefits of icotinib limited systemic disease progression and continuation of Stereotactic Body Radiation Therapy,in patients with metastatic EGFR-mutant NSCLC.


Description:

Lung cancer is the leading cause of cancer morbidity and mortality worldwide. The majority of lung cancer is nonsquamous NSCLC. EGFR tyrosine kinase inhibitors (EGFR-TKI) is a effective first-line treatment for EGFR mutations non-squamous NSCLC treatment.Icotinib is the first EGFR-TKI,and have been proved efficiently in the treatment of lung cancer, and SBRT become a main therapy for the primary lesion,Accordingly, we have come to a scientific hypothesis that icotinib combination with SBRT might be a better treatment strategy for stageIV non-squamous NSCLC patients with EGFR mutation. It can improve the PFS of stage ⅢB/Ⅳ non-squamous NSCLC patients with EGFR mutation . The primary endpoint is disease-free time to progression (PFS). The secondary study endpoint is objective response rate (ORR), disease control rate (DCR),overall survival(OS) safety and quality of life (QOL). Through this study lay the foundation for further exploration of the non-squamous NSCLC first-line treatment in patients with EGFR mutation strategy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date May 2, 2019
Est. primary completion date November 2, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Histologic documentation of primary lung carcinoma, non-squamous histology with EGFR mutation.

- Stage disease according to the 7th Edition of the American Joint Committee on Cancer staging system

- Not received radiotherapy, chemotherapy or other biological treatment

- Measureable disease

- Life expectancy of>=12 months

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

- Absolute neutrophil count (ANC)>=2,500/mm^3

- Hemoglobin>=9.0 g/dL

- Total bilirubin<=1.5 x upper limit of normal(ULN)

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase [AST]) and serum glutamic pyruvic transaminase (SGPT) (alanine transferase [ALT])<=2.5 x ULN in patients without liver or bone metastases; <5 x ULN in patients with liver or bone metastases

- Cockcroft-Gault calculated creatinine clearance of>=45 ml/min or creatinine<=1.5 x ULN

- Prothrombin time (PT)<=1.5 x ULN

- Partial thromboplastin time (PTT)<=ULN

- Negative pregnancy test done<=7 days prior to randomization, for women of childbearing potential only

- Provide informed written consent

- Willing to return to Sichuan cancer hospital for follow-up

- Willing to provide tissue and blood samples for correlative research purposes

Exclusion Criteria:

- Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component

- Known allergic to EGFR TKI any ingredients

- Prior chemotherapy or treatment for metastatic non-small cell lung cancer

- Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive, per MD discretion

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

- Other active malignancy<=3 years prior to randomization;

- Ongoing or active infection, symptomatic congestive heart failure , cardiac arrhythmia, psychiatric illness/social situations, or any other medical condition that would limit compliance with study requirements

- History of bleeding diathesis or coagulopathy

- Inadequately controlled hypertension (systolic blood pressure of>150 mmHg or diastolic pressure>100 mmHg on anti-hypertensive medications)

- Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury <=28 days or core biopsy <=7 days prior to randomization

- Pregnancy or breast-feeding women

- Other situation which researchers think that doesn't fit into the group

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Icotinib
icotinib 125 milligram three times a day
Radiation:
SBRT
given radiation for the primary lesion

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sichuan Cancer Hospital and Research Institute

Outcome

Type Measure Description Time frame Safety issue
Primary progression free survival the time to disease to progression according the RESCIT four weeks
Secondary object responsible rate the proportion the patients have receives the complete remission and partial remission four weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03668496 - A Study of SHR-1210 in Combination With Carboplatin + Paclitaxel in Subjects With Squamous NSCLC Phase 3
Active, not recruiting NCT03322072 - Calypso Guided High Precision Stereotactic Ablative Radiosurgery for Lung TUmours Using Real-Time Tumour Tracking & Respiratory Gating N/A
Recruiting NCT05497973 - Psychosocial eHealth in Advanced Lung Cancer N/A
Recruiting NCT06076005 - Lung Cancer ID (Identity) Study
Recruiting NCT05860296 - Testing Experimental Anti-cancer Drug SLC-391 With an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers Phase 1/Phase 2
Recruiting NCT05311709 - Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities Phase 2
Completed NCT04825912 - Resilience Measurement in Older Adults With Late-Stage Lung Cancer N/A
Completed NCT03529851 - Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients N/A
Completed NCT03558165 - Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay
Completed NCT03076164 - A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib Phase 1/Phase 2
Recruiting NCT04595734 - Liver Toxicity in Lung Cancer Patients Treated With Immune-checkpoint Inhibitors.
Recruiting NCT04519983 - Efficacy of SRT as Salvage Therapy in Patients With Brain Oligo-progression of EGFR-mutant Non-small Cell Lung Cancer After Failure of the Third-generation EGFR-TKIs Phase 2
Not yet recruiting NCT05701384 - Lazertinib 160mg in EGFR T790M NSCLC Phase 2
Withdrawn NCT03409341 - Personalizing Immune Checkpoint Inhibitor Therapy
Active, not recruiting NCT03728361 - Nivolumab and Temozolomide in Treating Patients With Recurrent or Refractory Small-Cell Lung Cancer or Advanced Neuroendocrine Cancer Phase 2
Not yet recruiting NCT06024941 - Re-induction of a Systemic Immune Response in Metastatic or Locally Recurrent Lung Cancer Phase 2
Recruiting NCT04669223 - Comparing Different Sizes of Small-bore Chest Drains in Malignant Pleural Effusion N/A
Recruiting NCT05996263 - Prognostic Value of Combined Approach Based on KEAP1/NFE2L2 Mutations and Pre-therapeutic FDG-PET/CT Radiomic Analysis in Advanced Non-small-cell Lung Cancer PDL1 ≥ 50% Treated With Pembrolizumab (PEMBROMIC)
Completed NCT04057196 - Self-System Therapy for Older Adults With Lung Cancer N/A
Recruiting NCT06000358 - The Effect of Combined Cryotherapy and Immunotherapy on Systemic T Cell Changes and Clinical Outcomes in Metastatic Non-small Cell Lung Cancer N/A