Local therapy for advanced lung cancer patients with stable disease after initial treatment

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

This study is testing if a new local treatment can help people with advanced lung cancer who are stable after their first treatment feel better and live longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangdong Association of Clinical Trials (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guagndong)
• Trial ID: NCT03046316 on ClinicalTrials.gov

What this trial studies

This prospective single-arm clinical study investigates the safety and overall benefit of consolidative local therapy in patients with advanced non-small cell lung cancer (NSCLC) who have not progressed after first-line systemic therapy. Eligible patients must have a confirmed diagnosis and genetic profiling, and they should have achieved a complete response, partial response, or stable disease after initial treatment. The study will evaluate the effectiveness of local consolidative treatment in patients with limited metastatic lesions, with response assessments conducted every two cycles. The aim is to determine if this approach can improve outcomes for patients with advanced NSCLC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stage IV NSCLC who have achieved stable disease after first-line systemic therapy and have limited metastatic lesions.

Not a fit: Patients with progressive disease after initial treatment or those with more than five metastatic lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes and prolong survival for patients with advanced NSCLC who have stable disease after initial therapy.

How similar studies have performed: Other studies have shown promising results with similar local therapy approaches in advanced NSCLC, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guagndong

• Guangdong General Hospital — Guangzhou, Guagndong, China (Recruiting)

Study contacts

• Principal investigator: Zhen Wang, PhD,MD — Guangdong General Hospital&Guangdong Academy of Medical Sciences
• Study coordinator: ZHEN WANG, PhD,MD

Conditions Lung Neoplasms; Therapeutics; local therapy