Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-16 @ 3:28 PM
Study NCT ID:
NCT05167851
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-12-22
First Post:
2021-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Efficacy of First-line Lazertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant Non-small Cell Lung Cancer
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
A Multicentre Two-arm, Phase II Trial Assessing the Safety and Efficacy of First-line Lazertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant Non-small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is based on the observations that disease progression under EGFR(Epidermal Growth Factor Receptor) targeting TKI(Tyrosine Kinase Inhibitor) most frequently occurs at the original sites of metastatic disease and that the majority of patients shows disease progression in a limited number of metastatic lesions, a situation defined as oligoprogression.
All studies reported a significantly and clinically relevant improved OS(Overall Survival) or PFS(Period Free Survival) for adding locally ablative therapy to standard of care systemic therapy. However, these studies included only very few NSCLC(non small cell lunc cancer) patients with activating driver mutations and the benefit of adding upfront local radiotherapy might be smaller or larger in this NSCLC(non small cell lunc cancer) patient population with activating driver mutations and treatment with TKIs(Tyrosine Kinase Inhibitor) smaller because of the higher systemic efficacy of TKIs(Tyrosine Kinase Inhibitor) compared to chemotherapy or larger because the benefit of local treatment might become most obvious if potential microscopic disease is successfully controlled by TKI(Tyrosine Kinase Inhibitor)s .Consequently, there is a clinical need to evaluate locally ablative therapy in oligometastatic EGFR (Epidermal Growth Factor Receptor) -mutant NSCLC(non small cell lunc cancer) patients and simultaneously a strong rational that this population might benefit in particular from a combined modality treatment: the benefit of locally ablative therapy is expected to be largest in situations of effective systemic therapies to control locally untreated microscopic disease which is true for EGFR (Epidermal Growth Factor Receptor) targeting.
The investigator therefore propose a prospective two-arm phase II study, which aims to evaluate safety and efficacy of lazertinib combined with early locally ablative radiotherapy of all cancer sites in patients with synchronous oligometastatic (primary tumour and maximum 5 metastases) EGFR (Epidermal Growth Factor Receptor) -mutant (exon 19 deletion or exon 21 L858R) NSCLC. Eradication of all macroscopic cancer sites at the time of primary diagnosis by combined modality treatment is expected to decrease the risk of resistance development with only microscopic disease potentially remaining. This will result in an improvement of PFS(Period Free Survival) and OS(Overall Survival) without added high-grade toxicity.
All studies reported a significantly and clinically relevant improved OS(Overall Survival) or PFS(Period Free Survival) for adding locally ablative therapy to standard of care systemic therapy. However, these studies included only very few NSCLC(non small cell lunc cancer) patients with activating driver mutations and the benefit of adding upfront local radiotherapy might be smaller or larger in this NSCLC(non small cell lunc cancer) patient population with activating driver mutations and treatment with TKIs(Tyrosine Kinase Inhibitor) smaller because of the higher systemic efficacy of TKIs(Tyrosine Kinase Inhibitor) compared to chemotherapy or larger because the benefit of local treatment might become most obvious if potential microscopic disease is successfully controlled by TKI(Tyrosine Kinase Inhibitor)s .Consequently, there is a clinical need to evaluate locally ablative therapy in oligometastatic EGFR (Epidermal Growth Factor Receptor) -mutant NSCLC(non small cell lunc cancer) patients and simultaneously a strong rational that this population might benefit in particular from a combined modality treatment: the benefit of locally ablative therapy is expected to be largest in situations of effective systemic therapies to control locally untreated microscopic disease which is true for EGFR (Epidermal Growth Factor Receptor) targeting.
The investigator therefore propose a prospective two-arm phase II study, which aims to evaluate safety and efficacy of lazertinib combined with early locally ablative radiotherapy of all cancer sites in patients with synchronous oligometastatic (primary tumour and maximum 5 metastases) EGFR (Epidermal Growth Factor Receptor) -mutant (exon 19 deletion or exon 21 L858R) NSCLC. Eradication of all macroscopic cancer sites at the time of primary diagnosis by combined modality treatment is expected to decrease the risk of resistance development with only microscopic disease potentially remaining. This will result in an improvement of PFS(Period Free Survival) and OS(Overall Survival) without added high-grade toxicity.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: