Clinical trial NCT03396185: Icotinib as Consolidation Therapy After Chemoradiotherapy in EGFR-Mutant Stage IIIA-IIIB Non-small Cell Lung Cancer
Official title: Icotinib as Consolidation Therapy After Synchronous or Sequential Chemoradiotherapy in Stage IIIA-IIIB Non-small Cell Lung Cancer With EGFR Sensitive Mutation: A Single Center, Single Arm, Open Label and Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: EGFR Gene Mutation
Non Small Cell Lung Cancer Stage IIIA
Non Small Cell Lung Cancer Stage IIIB
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the relapse free survival of patients who have EGFR-mutant stage IIIA-IIIB Non-small Cell Lung Cancer and receive Icotinib as consolidation therapy after synchronous or sequential chemoradiotherapy.

Detailed description: This is a single center, single arm, open label and prospective clinical study. Patients who have EGFR-mutant stage IIIA-IIIB and unresectable lung adenocarcinoma will receive Icotinib as consolidation therapy after synchronous or sequential chemoradiotherapy. The primary objective of this study is relapse free survival. The secondary objectives are overall survival, the frequency of adverse events and patients' quality of life.

Eligibility criteria: Inclusion Criteria:

* Unresectable stage IIIA-IIIB Non-small Cell Lung Cancer, histology or cytology confirmed lung adenocarcinoma, pathological specimens with EGFR 19 del and/or 21 L858R gene mutation detected by amplification refractory mutation system method
* Before receiving synchronous or sequential chemoradiotherapy, no metastasis detected by head MRI, bone scan, chest enhanced CT scan and the abdominal (including dual adrenal) enhanced CT scan
* Only received synchronous or sequential chemoradiotherapy as anti-tumor treatment; after that, chest enhanced CT showed no progressive disease (including Complete Response, Partial Response and Stable Disease )
* Platinum-based chemotherapy regimen, including: vinorelbine, docetaxel, paclitaxel, pemetrexed, etoposide, etc and combination of platinum (including but not limited to cisplatin and carboplatin)
* 3DCRT or IMRT radiotherapy technology with a dose of 95% PTV 60-66gy, 2Gy once daily, 5 times weekly, up to 30-33 times
* ECOG score 0-1
* Able to enter the group within 4-12 weeks after the completion of synchronous or sequential chemoradiotherapy
* Expected survival more than 12 weeks

Exclusion Criteria:

* Other malignant tumors within five years, except for completely cured cervical carcinoma, basal or squamous cell carcinoma
* In addition to synchronous or sequential chemoradiotherapy, ever received other systemic anti-tumor treatment, including chemotherapy or targeted therapy
* Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease
* Upper vena cava syndrome at baseline
* Idiopathic pulmonary fibrosis detected by CT at baseline
* Definite neurological or psychiatric disorders, including epilepsy or dementia
* Pregnant or lactating women

Primary outcomes:
measure: Relapse Free Survival of participants
timeFrame: three years
Secondary outcomes:
measure: Overall survival of participants
timeFrame: three years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: three years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Science
Study officials:
References: