Back to results

TKI Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant NSCLC

Primary Purpose

Non-Small Cell Lung Cancer Metastatic

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Local radiation therapy

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer Metastatic focused on measuring Non small cell lung cancer, Oligo-metastasis, EGFR activating mutation, Radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18 and ≤75;
ECOG performance status 0-1;
Patients must provide study specific informed consent prior to study entry;
Pathologically or cytologically diagnosed as NSCLC;
EGFR activating mutation to TKI approved by histology, cytology or circulation tumor DNA;
Stage IV NSCLC with ≤ 3 metastatic lesions (AJCC, 8th ed.) confirmed by meticulous radiographic examination. Brain MRI and 18F PET/CT is strongly recommended unless there is a contraindication;
Patients have received≥3 months of TKI therapy and do not received disease progression;
HB ≥ 10.0 g/dL;
Absolute number of neutrophil granulocyte ≥ 1.5 × 109/L;
Absolute number of PLT ≥ 100 × 109/L;
Total bilirubin ≤ 1.5 folds of the maximum extent;
ALT and AST ≤ 2.0 folds of the maximum extent;
Cr ≤ 1.25 folds of the maximum extent and Ccr ≥ 60mLl/min.

Exclusion Criteria:

Patients have received thoracic radiotherapy before;
Malignant pleural effusion, pericardial effusion or peritoneal effusion;
Patients have severe pulmonary comorbidity, such as ILD, COPD or other active pulmonary disease;
Any unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, CHF (NYHA ≥ II), MI within 6 months of enrollment, severe arrhythmia requiring medication，hepatic, nephric or metabolic disease;
HIV infection；
Pregnancy or lactation women;
ECOG status ≥2；
Mixed SCLC component;
Other factors that is considered ineligible.

Sites / Locations

Cancer Hospital/Institute, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Local therapy

Arm Description

Consolidation local radiotherapy

Outcomes

Primary Outcome Measures

Progression free survival

Duration between the first date of TKI administration and disease progression or last follow-up

Secondary Outcome Measures

Overall response

Post-RT response compared with the baseline status at the first data of TKI administration

Overall survival

Duration between the first date of TKI administration and any cause of death or last follow up

Time to progression of initial lesions

Duration between the first date of TKI administration and the progression of the initial lesions or last follow up

Time to appearance of new metastatic lesions

Duration between the first date of TKI administration and the occurrence of new lesions or last follow up

Treatment related toxicity

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

EORTC Quality of life

Quality of life evaluation using EORTC questionnaires

Full Information

NCT ID

NCT03916913

First Posted

April 13, 2019

Last Updated

April 16, 2019

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03916913

Brief Title

TKI Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant NSCLC

Official Title

Tyrosine Kinase Inhibitor Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant Non-small Cell Lung Cancer: A Phase II Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

January 1, 2022 (Anticipated)

Study Completion Date

January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.

Detailed Description

Tyrosine kinase inhibitor (TKI) has been widely accepted as the first-line therapy for stage IV NSCLC with active mutation of EGFR. Olio-metastasis is a disease status between localized and extended status of disease, namely with the limited number of lesions, which is generally defined as ≤ 5. A couple of phase II studies have shown that consolidation local management was able to prolong the local-regional tumor control and might further improve overall survival (OS) for oligo-metastatic NSCLC who have gained disease control from systemic therapy. However, there is lack of data regarding whether local radiotherapy (RT) could improve progression free survival (PFS) and OS for NSCLC with active EGFR mutation who have benefited from TKI. In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.

6. Conditions and Keywords

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

Non-Small Cell Lung Cancer Metastatic

Keywords

Non small cell lung cancer, Oligo-metastasis, EGFR activating mutation, Radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Local therapy

Arm Type

Experimental

Arm Description

Consolidation local radiotherapy

Intervention Type

Radiation

Intervention Name(s)

Local radiation therapy

Intervention Description

Local radiotherapy on all sites of disease including primary and metastatic lesions

Primary Outcome Measure Information:

Title

Progression free survival

Description

Duration between the first date of TKI administration and disease progression or last follow-up

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Overall response

Description

Post-RT response compared with the baseline status at the first data of TKI administration

Time Frame

1 month after RT

Title

Overall survival

Description

Duration between the first date of TKI administration and any cause of death or last follow up

Time Frame

2 year

Title

Time to progression of initial lesions

Description

Duration between the first date of TKI administration and the progression of the initial lesions or last follow up

Time Frame

1 year

Title

Time to appearance of new metastatic lesions

Description

Duration between the first date of TKI administration and the occurrence of new lesions or last follow up

Time Frame

1 year

Title

Treatment related toxicity

Description

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Time Frame

1 year

Title

EORTC Quality of life

Description

Quality of life evaluation using EORTC questionnaires

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 and ≤75; ECOG performance status 0-1; Patients must provide study specific informed consent prior to study entry; Pathologically or cytologically diagnosed as NSCLC; EGFR activating mutation to TKI approved by histology, cytology or circulation tumor DNA; Stage IV NSCLC with ≤ 3 metastatic lesions (AJCC, 8th ed.) confirmed by meticulous radiographic examination. Brain MRI and 18F PET/CT is strongly recommended unless there is a contraindication; Patients have received≥3 months of TKI therapy and do not received disease progression; HB ≥ 10.0 g/dL; Absolute number of neutrophil granulocyte ≥ 1.5 × 109/L; Absolute number of PLT ≥ 100 × 109/L; Total bilirubin ≤ 1.5 folds of the maximum extent; ALT and AST ≤ 2.0 folds of the maximum extent; Cr ≤ 1.25 folds of the maximum extent and Ccr ≥ 60mLl/min. Exclusion Criteria: Patients have received thoracic radiotherapy before; Malignant pleural effusion, pericardial effusion or peritoneal effusion; Patients have severe pulmonary comorbidity, such as ILD, COPD or other active pulmonary disease; Any unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, CHF (NYHA ≥ II), MI within 6 months of enrollment, severe arrhythmia requiring medication，hepatic, nephric or metabolic disease; HIV infection； Pregnancy or lactation women; ECOG status ≥2； Mixed SCLC component; Other factors that is considered ineligible.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jingbo Wang, MD

Phone

+861087788056

wangjingbo303@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaotong Lu, MD

Phone

+861087788503

lxt0115@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jingbo Wang, MD

Organizational Affiliation

Cancer Hospital, CAMS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Hospital/Institute, Chinese Academy of Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jingbo Wang, Dr.

Phone

8610-87788503

wangjingbo303@yahoo.com

First Name & Middle Initial & Last Name & Degree

Luhua Wang, Dr.

Phone

8610-87788799

wlhwq@yahoo.com

First Name & Middle Initial & Last Name & Degree

Jingbo Wang, Dr.

First Name & Middle Initial & Last Name & Degree

Luhua Wang, Dr.

First Name & Middle Initial & Last Name & Degree

Zhouguang Hui, Dr.

First Name & Middle Initial & Last Name & Degree

JianYang Wang, Dr.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

TKI Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant NSCLC

We'll reach out to this number within 24 hrs