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Local Consolidation Therapy

PROCEDURE5 trials

Sponsors

M.D. Anderson Cancer Center

Conditions

ALK Gene RearrangementAdvanced Lung CarcinomaLung AdenocarcinomaLung Non-Small Cell CarcinomaOligoProgressive Metastatic DiseaseOligometastatic Malignant Solid NeoplasmRecurrent Lung Non-Small Cell CarcinomaStage III Lung Cancer AJCC v8

Phase 1

Local Consolidative Therapy and Brigatinib in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer
Active, not recruitingNCT03707938
M.D. Anderson Cancer CenterAdvanced Lung Carcinoma, ALK Gene Rearrangement, Lung Non-Small Cell Carcinoma +4
Start: 2018-12-18End: 2026-01-28Updated: 2025-11-03

Phase 2

Systemic Therapy With or Without Local Consolidative Therapy in Treating Patients With Oligometastatic Solid Tumor
Active, not recruitingNCT03599765
M.D. Anderson Cancer CenterOligometastatic Malignant Solid Neoplasm
Start: 2018-07-31End: 2029-12-31Updated: 2026-06-12
Local Consolidative Therapy and Durvalumab for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy
RecruitingNCT04892953
M.D. Anderson Cancer CenterStage IIIA Lung Cancer AJCC v8, Stage IIIA Lung Non-Small Cell Cancer AJCC v7, Stage IIIB Lung Cancer AJCC v8 +4
Start: 2021-07-07End: 2029-09-30Target: 51Updated: 2026-09-03
A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP)
RecruitingNCT06367972
M.D. Anderson Cancer CenterOligoProgressive Metastatic Disease
Start: 2024-06-06End: 2030-10-10Target: 400Updated: 2026-06-11

Phase 3

Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
Active, not recruitingNCT03391869
M.D. Anderson Cancer CenterLung Adenocarcinoma, Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Start: 2017-12-29End: 2027-03-31Updated: 2026-09-18

Related Papers

Abstract 1138: Clinical grade circulating tumor DNA methylation predicts outcome to brigatinib plus local consolidative therapy in patients with ALK rearranged NSCLC - Liquid biopsy correlates from the BRIGHTSTAR trial
Cancer Research2026-04-03
World-wide oligometastatic prostate cancer (omPC) meta-analysis leveraging individual patient data (IPD) from randomized trials (WOLVERINE): An analysis from the X-MET collaboration.
Journal of Clinical Oncology2025-02-1016 citations
Metastasis-directed therapy (MDT) plus androgen deprivation therapy (ADT) for oligometastatic prostate cancer (omPC): Primary results of the EXTEND continuous ADT (cADT) basket plus combined analysis with the updated intermittent ADT (iADT) basket and immune correlatives.
Journal of Clinical Oncology2025-02-102 citations
Longitudinal Tracking of <i>ALK</i>-Rearranged NSCLC From Plasma Using Circulating Tumor RNA and Circulating Tumor DNA.
2025-01-066 citations
High peripheral T cell diversity is associated with lower risk of toxicity and superior response to dual immune checkpoint inhibitor therapy in patients with metastatic NSCLC
Journal for ImmunoTherapy of Cancer2024-12-019 citations
Adding Metastasis-Directed Therapy to Standard-of-Care Systemic Therapy for Oligometastatic Breast Cancer (EXTEND): A Multicenter, Randomized Phase 2 Trial.
2024-10-306 citations
Addition of Metastasis-Directed Therapy to Systemic Therapy for Oligometastatic Pancreatic Ductal Adenocarcinoma (EXTEND): A Multicenter, Randomized Phase II Trial
Journal of Clinical Oncology2024-08-0543 citations
Addition of metastasis-directed therapy to standard-of-care systemic therapy for oligometastatic pancreatic ductal adenocarcinoma (EXTEND): Results of a multicenter, randomized phase II trial.
Journal of Clinical Oncology2024-01-2014 citations
Distinct patterns of auto-reactive antibodies associated with organ-specific immune-related adverse events
Frontiers in Immunology2023-12-125 citations
Longitudinal tracking of <i>ALK</i>-positive lung cancer from plasma using circulating-tumor RNA and circulating-tumor DNA in the BRIGHTSTAR clinical trial.
Journal of Clinical Oncology2023-06-011 citations
Addition of Metastasis-Directed Therapy to Intermittent Hormone Therapy for Oligometastatic Prostate Cancer
JAMA Oncology2023-04-06164 citations
Definitive Local Consolidative Therapy for Oligometastatic Solid Tumors: Results From the Lead-in Phase of the Randomized Basket Trial EXTEND.
2022-06-0916 citations
Auto-reactive antibodies as predictive markers for immune checkpoint–induced pneumonitis.
Journal of Clinical Oncology2022-06-0123 citations
Clinical outcome and potential benefits of post-progression immunotherapy for patients with metastatic NSCLC with primary resistance to ipilumumab and nivolumab in the LONESTAR phase III study.
Journal of Clinical Oncology2022-06-014 citations
BRIGHTSTAR: A pilot trial of local consolidative therapy (LCT) with brigatinib in tyrosine kinase inhibitor (TKI)-naïve ALK-rearranged advanced NSCLC.
Journal of Clinical Oncology2020-05-2014 citations