First-line Icotinib With Concurrent Radiotherapy for NSCLC With EGFR Mutation
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ClinicalTrials.gov Identifier: NCT02883543 |
Recruitment Status : Unknown
Verified August 2016 by Zhen-zhou Yang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Recruitment status was: Active, not recruiting
First Posted : August 30, 2016
Last Update Posted : August 30, 2016
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Condition or disease | Intervention/treatment | Phase |
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Non-small Cell Lung Cancer | Drug: icotinib Drug: Chemotherapy Radiation: Radiotherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 330 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase III Study of Icotinib With Concurrent Radiotherapy as First-line Treatment for Unresectable/Oligometastasis NSCLC With EGFR Activating Mutation: a Prospective, Multicentre, Open-label, Randomised Study |
Study Start Date : | June 2016 |
Estimated Primary Completion Date : | June 2018 |
Estimated Study Completion Date : | June 2019 |

Arm | Intervention/treatment |
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Experimental: icotinib plus radiotherapy
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy.
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Drug: icotinib
Icotinib is orally administered three times per day. Radiation: Radiotherapy 5Gy/75.00Gy, 10f/2w for peripheral lung cancer, and 2.4Gy/59.52Gy, 20f/4w for central lung cancer. |
Active Comparator: icotinib
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib monotherapy.
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Drug: icotinib
Icotinib is orally administered three times per day. |
Active Comparator: chemotherapy plus radiotherapy
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive chemotherapy plus concurrent radiotherapy.
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Drug: Chemotherapy
Chemotherapy is given by intravenous administration. Three regimens are available in this study. Regimen 1: etoposide 75mg/m2 d1-5 + cisplatin 75 mg/m2 day1/ day1-2. Regimen 2: docetaxel 75mg/m2 d1 + cisplatin 75 mg/m2 day1/ day1-2. Regimen 3: pemetrexed 500mg/m2 d1 + cisplatin 75 mg/m2 day1/ day1-2 Radiation: Radiotherapy 5Gy/75.00Gy, 10f/2w for peripheral lung cancer, and 2.4Gy/59.52Gy, 20f/4w for central lung cancer. |
- Progression-free survival [ Time Frame: 2 years ]
- Incidence of radiation injure of the lungs [ Time Frame: 2 years ]Measured according to NCI CTCAE v4.0
- Overall survival [ Time Frame: 5 years ]
- Tumor response after icotinib induction [ Time Frame: 8 weeks ]
- Quality of life [ Time Frame: 2 years ]Measured by FACT-L

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aged 18 to 75 years
- Pathologically documented NSCLC
- Unresectable stage III or oligometastasis (less than three metastasis lesions, brain metastasis is not permitted) stage IV confirmed by CT and/or MRI
- Positive EGFR mutation confirmed by ARMS
- At least 3-month life expectancy
- KPS ≥ 70
- Adequate hematological values: hemoglobin ≥ 100 g/L, absolute neutrophils count ≥ 1.5 x 109/L, platelets count ≥ 100 x 109/L
- Adequate hepatic function: bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 1.5 x ULN
- Written informed consent before patient registration and any protocol-related procedures
Exclusion Criteria:
- Previous radiotherapy
- Received other investigational systemic drugs within 4 weeks prior to study entry
- Severe or uncontrolled systemic disease
- Active autoimmune disease, or a documented history of autoimmune/acquired immune disease, or a history of organ transplant
- Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator
- Any other serious underlying medical (e.g. active uncontrolled infection, active gastric ulcer, uncontrolled seizures), psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883543
Study Chair: | Zhenzhou Yang, MD | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University |
Responsible Party: | Zhen-zhou Yang, Director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University |
ClinicalTrials.gov Identifier: | NCT02883543 |
Other Study ID Numbers: |
RILI2016 |
First Posted: | August 30, 2016 Key Record Dates |
Last Update Posted: | August 30, 2016 |
Last Verified: | August 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |