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Report for Clinical Trial NCT03396185

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT03396185 EGFR Gene Mutation Non Small Cell Lung Cancer Stage IIIA Non Small Cell Lung Cancer Stage IIIB
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: Icotinib

Description: 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.

Type: Drug

Icotinib


Primary Outcomes

Description: Relapse Free Survival was defined as the time from randomization to relapse of disease or death from any cause.

Measure: Relapse Free Survival of participants

Time: three years

Secondary Outcomes

Description: Overall survival was defined as the time from participants' randomization to their death due to any cause.

Measure: Overall survival of participants

Time: three years

Description: 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.

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time: three years

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 L858R

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.. 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 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 EGFR Gene Mutation Non Small Cell Lung Cancer Stage IIIA Non Small Cell Lung Cancer Stage IIIB Lung Neoplasms Carcinoma, Non-Small-Cell Lung This is a single center, single arm, open label and prospective clinical study. --- L858R ---

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.. 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 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 EGFR Gene Mutation Non Small Cell Lung Cancer Stage IIIA Non Small Cell Lung Cancer Stage IIIB Lung Neoplasms Carcinoma, Non-Small-Cell Lung This is a single center, single arm, open label and prospective clinical study. --- L858R --- --- L858R ---



HPO Nodes


HPO:
Neoplasm of the lung
Genes 61
REST GPC3 WT1 HPGD BRAF PIK3CA TP53 TRIM28 RB1 TRIP13 SLCO2A1 AKT1 CASP8 KRAS TSC1 POU6F2 EWSR1 PRKN LMNA NAB2 TERT TSC2 SLC22A18 BRCA2 PPP2R1B STAT6 STK11 MUC5B ERBB2 TSC2 MBTPS2 BAP1 TSC2 DICER1 PDGFRB PERP EGFR TSC1 DIS3L2 NOTCH3 KEAP1 DICER1 DICER1 WT1 TSC1 C11ORF95 IRF1 CYP2A6 WRN RELA WT1 PTEN SFTPC SFTPA2 ERCC6 TRPV3 TP53 H19 TRIM28 FASLG MAP3K8
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1