Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

Titre officiel

Maintenance Systemic Therapy Versus Local Consolidative Therapy (LCT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial

Sommaire:

Cet essai de phase II/III avec répartition aléatoire porte sur l’efficacité de la chimiothérapie d’entretien avec ou sans radiothérapie stéréotaxique corporelle pour le traitement des patients atteints d’un cancer du poumon non à petites cellules de stade IV. Les médicaments utilisés en chimiothérapie d’entretien, comme le docétaxel, le pemetrexed disodique et la gemcitabine, agissent de différentes manières pour stopper la croissance des cellules tumorales, soit en tuant les cellules soit en les empêchant de se diviser ou de se propager. La radiothérapie stéréotaxique corporelle est une radiothérapie spécialisée qui dirige des rayons X à dose moins élevée directement sur la tumeur pendant plusieurs jours et pourrait causer moins de dommages aux tissus normaux. L’administration d’une chimiothérapie d’entretien et d’une radiothérapie stéréotaxique corporelle en concomitance pourrait s’avérer plus efficace que la chimiothérapie d’entretien seule pour le traitement des patients atteints d’un cancer du poumon non à petites cellules de stade IV.

Description de l'essai

Primary Outcome:

  • Phase II - Progression-Free Survival (PFS)
  • Phase III - Overall Survival (OS)
Secondary Outcome:
  • Time to In-Field Failure
  • Incidence of adverse events graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5
  • Duration of Maintenance Chemotherapy Usage
  • Time to Development of New Lesions
PRIMARY OBJECTIVES:
Phase II To evaluate the impact of adding local consolidative therapy (LCT) to maintenance systemic therapy versus maintenance systemic therapy alone on progression-free survival for patients with metastatic non-small cell lung cancer (NSCLC) with no evidence of progression and limited metastatic sites after first-line systemic therapy. Phase III To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on overall survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic therapy. SECONDARY OBJECTIVES:
I. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on in-field local failure. II. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on the time to development of new lesions. III. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on toxicity. IV. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on duration of maintenance systemic therapy usage. V. To evaluate the effect of adding LCT to systemic therapy in limited stage IV NSCLC on Quality of Life (QOL) VI. To collect biospecimens and evaluate the correlation between clinical outcomes and circulating tumour DNA (ctDNA). OUTLINE:

Patients are randomized into 1 of 2 arms. ARM 1 (CHEMOTHERAPY ALONE): ): Patients may receive docetaxel intravenously (IV) over 60 minutes on Day 1, erlotinib hydrochloride orally (PO) once daily (QD), or gemcitabine IV over 30 minutes on Days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on Day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM 2 (SBRT AND CHEMOTHERAPY): Patients undergo LCT over 2-4 weeks. If LCT cannot be used to treat primary disease sites, patients also undergo intensity-modulated radiation therapy (IMRT) or 3-dimensional conformal radiation therapy (3DCRT) over 3-5 weeks. Within 2 weeks after completion of radiation therapy, patients receive chemotherapy as in Arm 1. Patients may possibly undergo surgery. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, then annually thereafter.

Voir cet essai sur ClinicalTrials.gov

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