Targeted Treatment With Intercalated Radiotherapy in EGFR-mutant IIIA/IIIB NSCLC

NCT03074864 | Unknown Phase 2 FDA Drug

• 1 other identifier: TREND
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the efficacy and safety of intercalated combination of erlotinib and radiotherapy for patients with EGFR-mutant, unresectable, locally advanced NSCLC, and to explore a new treatment strategy for this subset. After Induction by erlotinib, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance.

Conditions

Non-small Cell Lung Cancer; Epidermal Growth Factor Receptor

Keywords

Activating mutations,lung cancer,radiotherapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  assessed by the RECIST 1.1 criteria

  Tumor response will be evaluated through study completion, an average of 6 weeks.

Secondary Outcomes (4)

• 1 year survival rate

  Pts after maintenance phase will receive long-term follow-up including CT scan every 12 weeks for up to 10 years.

• 3 year survival rate

  Pts after maintenance phase will receive long-term follow-up including CT scan every 12 weeks for up to 10 years.

• Progression free survival（PFS）

  Occurrence of local or regional progression, distant metastases, or death from any cause from the time of treatment to the occurrence of one of the failure events, whichever occurs first, assessed up to 10 years.

• Overall survival

  Time from treatment to death from any cause, assessed up to 10 years.

Other Outcomes (1)

• Quality of Life (QOL)

  Questionnaire of QOL will be recorded for up to 24 weeks.

Study Arms (1)

EGFR-mutant IIIA/IIIB NSCLC

EXPERIMENTAL

Erlotinib Hydrochloride 150mg daily intercalated with radiotherapy

Drug: Erlotinib Hydrochloride

Interventions

Erlotinib Hydrochloride DRUG

Subjects receive erlotinib tablet 150mg orally once daily, after 12 weeks of induction phase, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance phase. At the end of maintenance, the subjects enter into the follow-up period.

Also known as: Cp-358,774, OSI-774, Tarceva

EGFR-mutant IIIA/IIIB NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged ≥18 years.
• ECOG performance status 0-2.
• Pathologically diagnosed of non-small cell lung cancer, and staged as unresectable IIIA/IIIB according the TNM staging system (2009).
• EGFR activating mutations in exon 18, 19 or 21were detected in tumor tissue or plasma.
• Measurable disease must be characterized according to RECIST 1.1 criteria.
• Life expectancy ≥12 weeks.
• Adequate pulmonary function: FEV1.0 \>50% of the normal predicted value, or DLCO \>40% of the normal predicted value.
• Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3.0 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
• Adequate renal function: serum creatinine ≤ 1. 5 x ULN, and creatinine clearance ≥ 45 ml/min.
• Adequate hematological function: Absolute neutrophil count (ANC) ≥1.0 x 109/L, and Platelet count ≥75 x 109/L, and Hemoglobin ≥8 g/dL.
• Female subjects should not be pregnant or breast-feeding.
• Written informed consent provided.
• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

You may not qualify if:

• Histologically mixed with small-cell lung cancer.
• Mutations in EGFR exon 20 are detected.
• Exposure to prior chest irradiation before the enrollment.
• Patients with prior chemotherapy or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
• History of another malignancy in the last 5 years with the exception of the following: Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted; Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
• Existence of interstitial lung disease.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hua-Jun CHEN, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: EGFR-TKI intercalted with radiotherapy

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 9, 2017
• Study Start: February 27, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2020
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

CN (1)