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

STATUS

Recruiting
End date

Jul 1, 2026
participants needed

60
sponsor

Guangdong Association of Clinical Trials

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Updated on 25 January 2021

See if I qualify

platelet count

cancer

total bilirubin

measurable disease

lung cancer

metastasis

liver metastasis

ROS1

EGFR

granulocyte count

lung carcinoma

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).

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.

Details

Condition	Pulmonary Disease, Lung Disease, Lung Neoplasm, Lung Cancer, Lung Cancer, Lung Disease, lung tumor
Treatment	local consolidative treatment
Clinical Study Identifier	NCT03046316
Sponsor	Guangdong Association of Clinical Trials
Last Modified on	25 January 2021

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Eligibility		Yes	No	Not Sure
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

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