Clinical trial · Interventional
Local Therapy in Advanced NSCLC With Non-progressive Disease (PD) After First Line Therapy
Local Consolidative Therapy (LCT) in Patients With Advanced Stage Non-small Cell Lung Cancer Who do Not Progress After Front Line Systemic Therapy
NCT03046316CI-TRIAL-00046119LOCALunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| local consolidative treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- local consolidative treatment
- description
- 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.
- interventionNames
- Other: local consolidative treatment
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 8 months
- description
- month
Secondary outcomes (3)
- measure
- Response rate
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (17)
- BACKGROUNDBarlesi F, Scherpereel A, Rittmeyer A, Pazzola A, Ferrer Tur N, Kim JH, Ahn MJ, Aerts JG, Gorbunova V, Vikstrom A, Wong EK, Perez-Moreno P, Mitchell L, Groen HJ. Randomized phase III trial of maintenance bevacizumab with or without pemetrexed after first-line induction with bevacizumab, cisplatin, and pemetrexed in advanced nonsquamous non-small-cell lung cancer: AVAPERL (MO22089). J Clin Oncol. 2013 Aug 20;31(24):3004-11. doi: 10.1200/JCO.2012.42.3749. Epub 2013 Jul 8. PMID 23835708
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7. PMID 26742998
- BACKGROUNDHellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995 Jan;13(1):8-10. doi: 10.1200/JCO.1995.13.1.8. No abstract available. PMID 7799047
- BACKGROUNDSuzuki H, Yoshino I. Approach for oligometastasis in non-small cell lung cancer. Gen Thorac Cardiovasc Surg. 2016 Apr;64(4):192-6. doi: 10.1007/s11748-016-0630-7. Epub 2016 Feb 19. PMID 26895202
- BACKGROUNDShimada Y, Saji H, Kakihana M, Kajiwara N, Ohira T, Ikeda N. Survival outcomes for oligometastasis in resected non-small cell lung cancer. Asian Cardiovasc Thorac Ann. 2015 Oct;23(8):937-44. doi: 10.1177/0218492315596463. Epub 2015 Jul 22. PMID 26207006
- BACKGROUNDPan H, Simpson DR, Mell LK, Mundt AJ, Lawson JD. A survey of stereotactic body radiotherapy use in the United States. Cancer. 2011 Oct 1;117(19):4566-72. doi: 10.1002/cncr.26067. Epub 2011 Mar 15. PMID 21412761
- BACKGROUNDRusthoven KE, Kavanagh BD, Cardenes H, Stieber VW, Burri SH, Feigenberg SJ, Chidel MA, Pugh TJ, Franklin W, Kane M, Gaspar LE, Schefter TE. Multi-institutional phase I/II trial of stereotactic body radiation therapy for liver metastases. J Clin Oncol. 2009 Apr 1;27(10):1572-8. doi: 10.1200/JCO.2008.19.6329. Epub 2009 Mar 2.