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Durvalumab

Prior to receiving treatment participants will have samples taken from three different sources to test the microbiome bacteria to determine if it will help predict toxicity to the treatment

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Hina Khan, MD

Jun Zhang, MD, PhD

This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer participants who will receive durvalumab can predict treatment toxicity.

Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients

Using Microbiome to Predict Durvalumab Toxicity in Post-CCRT NSCLC Patients (Microdurva)

Metagenomic sequencing and taxonomic analysis

Metagenomic sequencing and Kyoto Encyclopedia of Genes and Genomes (KEGG) mapping

Rhode Island Hospital

MD, PhD

Carcinoma, Non-Small-Cell Lung

Docetaxel

Cisplatin

Immunomodulating Agents

Immunologic Factors

In keeping the same total radiation dose (60Gy), we escalate the fraction dose to find the maximum tolerable fraction dose.

1. Level 1: DT 4500cGy/15 daily fractions/300cGy in the first course，DT 1500cGy/5 daily fractions/300cGy in the second course;
2. Level 2: DT 4000cGy/10 daily fractions/400cGy in the first course， DT 2000cGy/5 daily fractions/400cGy in the second course;
3. Level 3: DT 3000cGy/6 daily fractions/500cGy in the first course， DT 3000cGy/6 daily fractions/500cGy in the second course.

RT is delivered using the IMRT technique with daily cone-beam CT image guidance. The dose limitation of organ at risk (OAR) are shown in Table 1. Patients receive a weekly infusion of docetaxel (25mg/m2) and cisplatin (25mg/m2) during RT. Consolidative immunotherapy (PD-1 or PD-L1 inhibitor) up to 1 year is administered for those without disease progression after HRT-CHT.

Split-course adaptive HRT-CHT is administered at the following three dose levels:

1. Level 1: DT 4500cGy/15 daily fractions/300cGy in the first course，DT 1500cGy/5 daily fractions/300cGy in the second course;
2. Level 2: DT 4000cGy/10 daily fractions/400cGy in the first course， DT 2000cGy/5 daily fractions/400cGy in the second course;
3. Level 3: DT 3000cGy/6 daily fractions/500cGy in the first course， DT 3000cGy/6 daily fractions/500cGy in the second course.

Hypofractionated radiotherapy

weekly infusion of docetaxel (25mg/m2) and cisplatin (25mg/m2) during RT

Concurrent chemotherapy

Consolidative immunotherapy (PD-1 or PD-L1 inhibitor) up to 1 year is administered for those without disease progression after HRT-CHT.

Consolidation immunotherapy

Hui Liu, Professor

This Phase 1 trial aimed to determine the maximum tolerated fraction dose (MTD) of hypofractionated radiotherapy (hypo-RT) combined with concurrent chemotherapy and subsequent consolidation immune checkpoint inhibitors (cICI) for patients with locally advanced non-small cell lung cancer (LA-NSCLC).

Fraction Dose Escalation of Hypo-fractionated Radiotherapy in LANSCLC

Fraction Dose Escalation of Hypofractionated Radiotherapy With Concurrent Chemotherapy and Subsequent Consolidation Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: a Phase 1 Study

The maximum tolerated fraction dose was defined as the highest DL in which \<=2 patients of the 6 treated patients experienced G3+ toxicity and \<=1 patient experienced G4+ toxicity within 12 months after RT. If a patient had multiple types of toxicities, only the highest grade of toxicity was counted.

Proportion of patients with PR and CR at 2 months after radiotherapy

Sun Yat-sen University

Professor

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Patients undergo blood sample collection throughout the study. Patients also undergo optional stool sample collection and have their medical records reviewed on study. In addition, patients provide previously-collected tissue sample, if available.

Undergo blood and optional stool/tissue sample collection

Biospecimen Collection

Electronic Health Record Review

Svetomir N. Markovic

Svetomir N Markovic

This study explores the role of T cells in monitoring disease status and response during anti-PD-1/PD-L1 treatment in patients with melanoma, lung and other cancer types. Measuring levels of specific targets such as Bim and soluble PD-L1 during therapy may help track treatment resistance and clinical outcomes. This information may also help researchers determine why some people with melanoma, lung and other cancer types respond to PD-1/PD-L1 treatment and others do not.

PRIMARY OBJECTIVES:

I. Establish the role of Bim for monitoring disease status during anti-PD-1 therapy.

II. Identify the mechanisms of resistance to anti-PD-1 blockade. III. Quantify and modulate levels of NKG7 messenger ribonucleic acid (mRNA) in CD8+ T cells.

OUTLINE: This is an observational study.

Patients undergo blood sample collection throughout the study. Patients also undergo optional stool sample collection and have their medical records reviewed on study. In addition, patients provide previously-collected tissue sample, if available.

DNA will be extracted from the blood and stool specimens

Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types

Maximizing Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types

Will be assessed by serial measurements of Bim levels in tumor-reactive CD8+ T cells from the peripheral blood of patients with advanced cancer undergoing therapy with an anti-PD-1 monoclonal antibody and correlate them with clinical outcome.

Will be assessed by reviewing blood samples to determine whether high sPD-L1 levels are associated with higher Bim levels in CD11ahigh PD-1+CD8+ T cells and decreased response to single-agent anti-PD1 blocking antibody in patients with cancer.

CD8+ T cells will be isolated from the peripheral blood of patients with advanced cancer, and messenger ribonucleic acid (mRNA) will be isolated. Qualitative and quantitative reverse transcription polymerase chain reaction (RT-PCR) assays will be performed on these samples in order to determine the levels of six different mRNA splice variants of NKG7. Results will be compared to clinical outcome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients	NCT04680377	NSCLC, Stage II... Locally Advance...		18 Years -	University of Kansas Medical Center
Fraction Dose Escalation of Hypo-fractionated Radiotherapy in LANSCLC	NCT04951063	Locally Advance...	Hypofractionate... Concurrent chem... Consolidation i...	18 Years - 75 Years	Sun Yat-sen University
Fraction Dose Escalation of Hypo-fractionated Radiotherapy in LANSCLC	NCT04951063	Locally Advance...	Hypofractionate... Concurrent chem... Consolidation i...	18 Years - 75 Years	Sun Yat-sen University
Fraction Dose Escalation of Hypo-fractionated Radiotherapy in LANSCLC	NCT04951063	Locally Advance...	Hypofractionate... Concurrent chem... Consolidation i...	18 Years - 75 Years	Sun Yat-sen University
Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types	NCT06075524	Clinical Stage ... Clinical Stage ... Locally Advance... Locally Advance... Locally Advance... Metastatic Lung... Metastatic Mali... Metastatic Mela... Stage III Lung ... Stage IV Lung C...	Biospecimen Col... Electronic Heal...	18 Years -	Mayo Clinic

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