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

EGFR Gene Mutation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03396185
• Other study ID #: CH-L-069
• Status: Recruiting
• Phase: Phase 2
• Start date: May 9, 2018
• Est. completion date: February 1, 2023

Study information

• Verified date: January 2018
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: Junling Li, MD
• Phone: 13801178891
• Email: drlijunling[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR Gene Mutation
• Lung Neoplasms
• Non Small Cell Lung Cancer Stage IIIA
• Non Small Cell Lung Cancer Stage IIIB

Intervention

Drug:
• Icotinib
Patients who have 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.

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Science	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse Free Survival of participants	Relapse Free Survival was defined as the time from randomization to relapse of disease or death from any cause.	three years
Secondary	Overall survival of participants	Overall survival was defined as the time from participants' randomization to their death due to any cause.	three years
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	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.	three years