Icotinib as Consolidation Therapy After Chemoradiotherapy in EGFR-Mutant Stage IIIA-IIIB Non-small Cell Lung Cancer

Phase 2

• Conditions: Non Small Cell Lung Cancer Stage IIIA; Non Small Cell Lung Cancer Stage IIIB; EGFR Gene Mutation
• Interventions: Drug: Icotinib

• Registration Number: NCT03396185
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2017-12-28
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-10
• Study Start: 2018-05-09
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18
• Primary Completion: 2022-02-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Icotinib	Icotinib	Patients with EGFR-mutant stage IIIA-IIIB and unresectable lung adenocarcinoma will receive Icotinib with a dose of 125 mg three times per day orally till progressive disease or unaccepted toxicity as consolidation therapy after synchronous or sequential chemoradiotherapy.

Primary Outcome Measures

Name	Time	Method
Relapse Free Survival of participants	three years	Relapse Free Survival was defined as the time from randomization to relapse of disease or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Overall survival of participants	three years	Overall survival was defined as the time from participants' randomization to their death due to any cause.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	three years	The number of participants with treatment-related adverse events as assessed by CTCAE v4.0 would be recorded and calculated after them participating into the study and taking the experimental drug.

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Science; 🇨🇳 Beijing, China