Back to results

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

Primary Purpose

Non-small Cell Lung Cancer, Epidermal Growth Factor Receptor

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Erlotinib Hydrochloride

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Activating mutations,lung cancer,radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Guangdong General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EGFR-mutant IIIA/IIIB NSCLC

Arm Description

Erlotinib Hydrochloride 150mg daily intercalated with radiotherapy

Outcomes

Primary Outcome Measures

Objective response rate

assessed by the RECIST 1.1 criteria

Secondary Outcome Measures

1 year survival rate

To evaluate the 1 year survival rate of the new strategy.

3 year survival rate

To evaluate the 3 year survival rate of the new strategy.

Progression free survival（PFS）

The product limit estimator developed by Kaplan and Meier will be used.

Overall survival

The product limit estimator developed by Kaplan and Meier will be used. Their 95% confidence intervals will be estimated.

Full Information

NCT ID

NCT03074864

First Posted

February 27, 2017

Last Updated

March 5, 2017

Sponsor

Guangdong Provincial People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03074864

Brief Title

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

Acronym

TREND

Official Title

Intercalated Combination of Erlotinib and Radiotherapy for Patients With EGFR-mutant, Unresectable, Locally Advanced Non-small-cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 27, 2017 (Actual)

Primary Completion Date

June 30, 2019 (Anticipated)

Study Completion Date

June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangdong Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Chemoradiation therapy is the standard treatment for unresectable, locally advanced NSCLC, but its efficacy reaches a platform, and treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitors (TKIs) produce a dramatic response in patients carrying EGFR activating mutations in the metastatic setting. Multiple prospective trials show that EGFR-TKIs have a better tolerability when compared with chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer, Epidermal Growth Factor Receptor

Keywords

Activating mutations,lung cancer,radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Model Description

EGFR-TKI intercalted with radiotherapy

Masking

None (Open Label)

Allocation

N/A

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EGFR-mutant IIIA/IIIB NSCLC

Arm Type

Experimental

Arm Description

Erlotinib Hydrochloride 150mg daily intercalated with radiotherapy

Intervention Type

Drug

Intervention Name(s)

Erlotinib Hydrochloride

Other Intervention Name(s)

Cp-358,774, OSI-774, Tarceva

Intervention Description

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.

Primary Outcome Measure Information:

Title

Objective response rate

Description

assessed by the RECIST 1.1 criteria

Time Frame

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

Secondary Outcome Measure Information:

Title

1 year survival rate

Description

To evaluate the 1 year survival rate of the new strategy.

Time Frame

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

Title

3 year survival rate

Description

To evaluate the 3 year survival rate of the new strategy.

Time Frame

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

Title

Progression free survival（PFS）

Description

The product limit estimator developed by Kaplan and Meier will be used.

Time Frame

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.

Title

Overall survival

Description

The product limit estimator developed by Kaplan and Meier will be used. Their 95% confidence intervals will be estimated.

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Quality of Life (QOL)

Description

To evaluate the Quality of Life (QOL) of subjects during treatment.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hua-Jun CHEN, MD

Organizational Affiliation

Guangdong Provincial People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangdong General Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs