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
Updated on 25 January 2021
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 IdentifierNCT03046316
SponsorGuangdong Association of Clinical Trials
Last Modified on25 January 2021

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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