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

NCT03046316 | Recruiting DMC

• 1 other identifier: CTONG1602
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lung Neoplasms

Keywords

Therapeutics; local therapy

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  month

  8 months

Secondary Outcomes (3)

• Response rate

  6 months

• Lung Cancer Symptom Scale

  12 months

• overall survival

  2 years

Study Arms (1)

local consolidative treatment

OTHER

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

Interventions

local consolidative treatment OTHER

local consolidative treatment to primary or metastases, which includes surgery, radiotherapy or interventional therapy

local consolidative treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guagndong, 510080, China

RECRUITING

Related Publications (17)

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  PMID: 38869865 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhen Wang, PhD,MD

  Guangdong General Hospital&Guangdong Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZHEN WANG, PhD,MD

CONTACT

+8683827812; hunterol@163.com

Hui-fen Huang

CONTACT

+8683827812; huifen8839@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: February 8, 2017
• Study Start: June 1, 2020
• Primary Completion: July 1, 2022
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)