Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Durvalumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Durvalumab 1500mg, IV, Q3W, 2 cycles Albumin paclitaxel 260 mg/m2 +

Carboplatin AUC5, IV, Q3W, 2 cycles Chemoradiotherapy(CRT):

Cohort 1: 2 Gy in 5 Fraction

Cohort 2: 2 Gy in 10 Fraction

Cohort 3: 2 Gy in 15 Fraction

Day1 and 22 nanoparticle albumin-bound paclitaxel 260 mg/m2 and carboplatin AUC 5

nanoparticle albumin bound paclitaxel

10 Gy in 5 fractions, 20 Gy in 10 fractions, 30 Gy in 15 fractions respectively in our three groups from Day1

low dose radiation therapy

Juan Li, Doctor

Introduction: Although PACIFIC regimen definitive concurrent chemoradiotherapy (CRT) followed by Durvalumab consolidation therapy is considered the standard of care for most of stage III NSCLC patients, neoadjuvant immunotherapy combined with chemotherapy followed by surgery has shown the trend to be considered for some potentially resectable patients. The rationales for neoadjuvant treatment are tumor regression effect before surgery, early eradication of micrometastasis. Recently the investigators also find some clinical trials exploring the adding of 45 Gy in 25 fractions radiation to the combination of chemotherapy and immunotherapy neoadjuvant therapy and the investigators could see the safety is the most concern, especially the pneumonitis incidence. Low dose radiation could help control the toxicity induced by radiation and has synergic effect with immunotherapy. The aim of this phase Ib study is to assess the safety and feasibility of the combination of the concurrent low dose radiation, chemotherapy and Durvalumab neoadjuvant therapy, to explore which radiation dose is the best among our three-dose designs and evaluate if the combining neoadjuvant therapy could further improve MPR in the meantime no severe toxicities especially the grade 3-4 pneumonitis would happen.

Method: 9 eligible patients with histologically confirmed NSCLC (potentially resectable clinical stage III according to the American Joint Committee on Cancer 8th staging system) are enrolled. Patients receive Chemo (Day1 and 22 nanoparticle albumin-bound paclitaxel 260 mg/m2 and carboplatin AUC 5 ) and durvalumab (Day 1 and 22, 1500mg) and radiotherapy of 10 Gy in 5 fractions, 20 Gy in 10 fractions, 30 Gy in 15 fractions respectively in our three groups from Day1, followed by surgery. After surgery, patients are suggested to be treated with durvalumab for one year (every 4weeks, 1500 mg). The primary endpoints are safety and tolerability. The secondary endpoints are objective response rate (ORR), event-free survival EFS), overall survival (OS), pathologic complete response (pCR), and major pathologic response(MPR) in the primary tumor. biomarker analysis of PD-L1 using cancer tissue and LIPI, ctDNA using blood sample will be conducted pre-and post- neoadjuvant and post-surgery.

Neoadjuvant LDRT Combined With Durvalumab in Potentially Resectable Stage III NSCLC

A Phase Ib Trial on the Safety and Feasibility of Neoadjuvant Low Dose Radiation, Chemotherapy and Durvalumab for Potentially Resectable Stage III Non-small Cell Lung Cancer (NSCLC)

Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit. AEs and SAEs will be examined with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03.

Objective Response Rate determined by Response Evaluation Criteria in Solid Tumors

Juan LI, MD

director of a department of medical oncology

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Recurrence

Lymphoma, Mantle-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Mantle Cell Lymphoma

Patients undergo ultra low dose radiation for 1-2 days before chemotherapy free-targeted therapy. Patients may receive a second, longer course of radiation if the lesion treated does not respond.

Low Dose Radiation Therapy

Bouthaina S Dabaja

Bouthaina S. Dabaja

This phase II trial studies how well ultra low dose radiation works before or after chemotherapy-free targeted therapy in treating patients with mantle cell lymphoma that has come back or does not respond to treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Ultra low dose radiation is generally associated with a lower risk of side effects which may allow patients to be able to receive low-dose radiation therapy more often than high-dose radiation therapy. This trial may help doctors learn if giving ultra low dose radiation helps control mantle cell lymphoma and improves response to chemotherapy free targeted therapy.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of adding ultra low dose radiation (ULDR) to chemotherapy free-targeted therapy (CTFTT) in contributing to a durable overall response in treated locations by estimating overall response rate (ORR) at 3 months.

SECONDARY OBJECTIVES:

I. To evaluate if ULDR can improve progression-free survival and overall survival.

II. To evaluate the prognostic factors associated with inferior progression-free survival, including patient related and previous treatment related and if radiation can overcome these prognostic factors.

III. To evaluate if radiation helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.

OUTLINE:

Patients undergo ultra low dose radiation for 1-2 days before chemotherapy free-targeted therapy. Patients may receive a second, longer course of radiation if the lesion treated does not respond.

After completion of study treatment, patients are followed up every 6 months for up to 5 years.

Ultra Low Dose Radiation Delivered Before or After Chemotherapy-Free Targeted Therapy in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

Phase II Trial to Assess the Efficacy of Ultra Low Radiation Dose Delivered Prior or After Chemotherapy Free Targeted Therapy for the Treatment of Relapsed/Refractory Mantle Cell Lymphoma

ORR will be based on the tumors residing within the radiated field using the sum of the longest tumoral axes treated. Responses are defined as follows: i) complete response (CR): \> 75% reduction in the sum of the longest tumoral axes treated within a radiation field; ii) partial response (PR): 50 to 75% reduction; and stable disease (SD): a reduction \< 50%. Progressive disease will be defined as any relative increase in the sum of the longest tumoral axes within the radiated field. ORR will be assessed by positron emission tomography (PET)/computed tomography (CT) at 3-months after the conclusion of ultra low dose radiation (ULDR). The Lugano Classification will be used to assess tumor response. Will estimate ORR at 3 months by providing an exact 95% confidence interval for the evaluable study population.

Will be estimated at select time points of interest using the Kaplan-Meier method for all patients enrolled in the study. The origination point for time will begin at the inception of ULDR. Cox proportional hazards regression will be used to evaluate potential prognostic factors.

Logistic regression will be utilized to assess the effect of patient characteristics such as ATM mutational status, on the Overall Response Rate(ORR ).

Logistic regression will be utilized to assess the effect of patient characteristics such PET/CT metabolic parameters, on the Overall Response Rate (ORR).

Will be used to summarize patient characteristics such as transitions to other investigational drugs at select time points in a patient's follow-up domain. These summaries will indicate if ULDR helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.

Will be used to summarize patient characteristics such as disease bulk at select time points in a patient's follow-up domain. These summaries will indicate if ULDR helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.

Will be used to summarize patient characteristics such as symptoms at select time points in a patient's follow-up domain. These summaries will indicate if ULDR helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.

Will be used to summarize patient characteristics such as performance status at select time points in a patient's follow-up domain. These summaries will indicate if ULDR helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant LDRT Combined With Durvalumab in Potentially Resectable Stage III NSCLC	NCT05157542	Stage III Non-s...	Durvalumab nanoparticle al... low dose radiat...	18 Years - 75 Years	Sichuan Cancer Hospital and Research Institute
Ultra Low Dose Radiation Delivered Before or After Chemotherapy-Free Targeted Therapy in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma	NCT04054167	Recurrent Mantl... Refractory Mant...	Low Dose Radiat...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for low dose radiation therapy