Local Therapy in Advanced NSCLC With Non-progressive Disease (PD) After First Line Therapy (LOCAL)

July 21, 2020 updated by: Yi-Long Wu, Guangdong Association of Clinical Trials

Local Consolidative Therapy (LCT) in Patients With Advanced Stage Non-small Cell Lung Cancer Who do Not Progress After Front Line Systemic Therapy

This is a prospective single arme real-world study clinical study, which aims to investigate the overall benefit and safety of consolidative therapy in advanced NSCLC (stage III/IV) patients , who do not progress after front line systemic therapy (chemotherapy, target therapy or immunological checkpoint inhibitors).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It is required that pathological diagnosis and genetic profile including epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) and ROS proto-oncogene 1 (ROS1) be established prior to enrollment. Standard front line systemic should be given according to clinical practice. Molecular targeting drugs for patients with driving mutations should be acquired legally. Patients without driving mutations should undergo standard first line chemotherapy and or immunological checkpoint inhibitors. One cycle is three weeks and response evaluation is done every two cycles. CR, PR and SD should be confirmed after four cycles of therapy.

Patients, who achieve non-PD after four cycles of treatment, with distant metastasis involving no more than five total metastatic lesions, will be screened and enrolled.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: ZHEN WANG, PhD,MD
  • Phone Number: 50811 +8683827812
  • Email: hunterol@163.com

Study Contact Backup

Study Locations

  • China
    • Guagndong
      • Guangzhou, Guagndong, China, 510080
        • Recruiting
        • Guangdong General Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, age >= 18 years, with life expectancy of at least 12 weeks.
  • Patients with histologically documented metastatic (stage IV) non-small cell lung cancer.
  • Subjected to driving genes examination including EGFR, ALK and ROS1.
  • Achieve complete response (CR)/partial response (PR)/stable disease (SD) after front line systemic treatment (chemotherapy, targeted therapy or immunological checkpoint inhibitors).
  • Total metastatic lesions is limited to five.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of <= 2.
  • Patients must have measurable disease according to the RECIST (version 1.1) criteria.

  • Adequate organ function as defined by the following criteria:

    • Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 upper limit of normal (ULN) in the absence of liver metastases or up to 5 ULN in case of liver metastases. Total bilirubin <= 1.5 ULN.
    • Bone marrow function: Granulocyte count >= 1,500/mm3 and platelet count ≥100,000/mm3 and hemoglobin >= 80g/dl.
    • Renal function: serum creatinine <= 1.5 ULN or creatinine clearance >= 60 ml/min. (based on modified Cockcroft-Gault formula).
    • Adequate coagulating function.
  • For all females of childbearing potential a negative serum/urine pregnancy test must be obtained within 48 hours before enrollment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Males must agree to use effective contraception during the study period and for at least 12 weeks after completion of the study treatment.
  • Written (signed) informed Consent to participate in the study.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Stage I-III a NSCLC completing radical treatment , then undergoing systemic anti-cancer treatment after recurrence.
  • Patients with PFS no more than 3 months. to first line theray.
  • Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
  • Prior palliative surgery or other local therapy specifically directed against advanced lung cancer.
  • Contraindication for localized treatment including surgery, radiotherapy or interventional therapy judged by physicians.
  • Patients with any unstable systemic disease (including active infections, significant cardiovascular disease, any significant hepatic, renal or metabolic disease).
  • Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
  • Nursing or lactating women.
  • Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
  • Patients who has mental disorder or other disease that contribute to no compliance.
  • Unwilling to write informed consent to participate in the study.
  • Patients who is unwilling to accept the follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: local consolidative treatment
Patients will be referred to multiple disciplinary treatment discussion for the decision of local consolidative treatment to primary or metastatic lesions including surgery, radiotherapy or interventional therapy.
Other: local consolidative treatment
local consolidative treatment to primary or metastases, which includes surgery, radiotherapy or interventional therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 8 months
month
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 6 months
percentage(%)
6 months
Lung Cancer Symptom Scale
Time Frame: 12 months
quality of life
12 months
overall survival
Time Frame: 2 years
month
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Association of Clinical Trials

Investigators

  • Principal Investigator: Zhen Wang, PhD,MD, Guangdong General Hospital&Guangdong Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2026

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

February 5, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTONG1602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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