Neoplasms

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Adenocarcinoma

Neoplastic Cells, Circulating

Adenocarcinoma of Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasm Metastasis

Neoplastic Processes

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Pemetrexed

Cisplatin

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

IA lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted.

IA lung adenocarcinoma cases with high abundant CTCs prior to operation will only undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.

IA lung adenocarcinoma cases with low abundant CTCs prior to operation will only undergo segmentectomy. Postoperative CTC monitoring will be conducted.

IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted.

IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.

IB lung adenocarcinoma cases with low abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.

lobectomy

segmentecomy

chemotherapy（pemetrexed+CISPLATIN）

Lymphadenectomy or lymph node dissection is the surgical removal of one or more groups of lymph nodes. It is almost always performed as part of the surgical management of cancer. In a regional lymph node dissection, some of the lymph nodes in the tumor area are removed; in a radical lymph node dissection, most or all of the lymph nodes in the tumor area are removed.

Lymphadenectomy

CanPatrol TM was used to detect CTCs, which is a newly established technology to detect CTCs, containing the following steps: (1) To remove erythrocytes by red blood cell lysis and deplete CD45+ leukocytes in 10ml blood sample using a magnetic bead separation method; (2) To enrich CTCs by 8-μm-diameter-pore calibrated membrane filters; and (3) To identify and characterize CTCs by using RNA-in situ hybridization (ISH), based on the branched DNA (bDNA) signal amplification technology, to detect EMT markers, e.g., cytokeratins(CK) 8, 18 and 19, epithelial cell adhesion molecule (EpCAM), vimentin and twist. The details of classification of CTCs by using CanPatrol TM was depicted in the recently published protocol. Finally, the CTCs were clustered into three subtypes, as per the EMT markers, i.e., epithelial (E-) CTCs, mesenchymal (M-) CTCs and epithelial- mesenchymal (E\&M-) CTCs.

CanPatrolTM to detect CTCs

Bo Deng

In 2015-2016, 224,390 cases were newly diagnosed with lung cancer in USA. Of all the cases, 83% are non-small cell lung cancer (NSCLC). Currently, the 5-year survival rate of NSCLC patients is 21%, and more than 25% of early stage NSCLC patients, who have undergone surgical treatment, will have a relapse or progression.

Circulating tumor cells (CTCs), which shed from the primary tumor into the vasculature or lymphatics, can be regarded as a new prognostic factors of metastatic process. Thus far, CTCs-detection technologies can be divided into epithelial cell adhesion molecule (EpCAM)-based detection methods, e.g., the widely used CellSearch® and Adnatest®,and EpCAM-independent detection methods, e.g., ISET® and ScreenCell®. Herein, the investigators used a newly established approach, i.e., CanPatrolTM to detect CTCs in early stage lung Adenocarcinoma cases.

The investigator aim to explore whether CTCs detection prior to surgery can be contributive to the early diagnosis, or may help to predict the prognosis and guide the treatment strategy of early stage lung Adenocarcinoma.

Application of Detecting Circulating Tumor Cells in the Accurate Treatment of Early Stage Lung Adenocarcinoma

Application of Detecting Circulating Tumor Cells in the Accurate Diagnosis and Treatment of Early Stage Lung Adenocarcinoma

Third Military Medical University

Principal Investigator

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Neoplasm, Residual

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Durvalumab

Antineoplastic Agents, Immunological

All subjects will receive four cycles of durvalumab with SABR concurrent at cycle 2, then will be evaluated for MRD. Subjects in this arm have no detectable ctDNA at MRD landmark and will receive no further therapy.

All subjects will receive four cycles of durvalumab with SABR concurrent at cycle 2, then will be evaluated for MRD. Subjects in this arm have detectable ctDNA at MRD landmark and are randomized to no further therapy.

All subjects will receive four cycles of durvalumab with SABR concurrent at cycle 2, then will be evaluated for MRD. Subjects in this arm have detectable ctDNA at MRD landmark and are randomized to eight additional cycles of durvalumab

Subjects will receive durvalumab 1500mg IV every four weeks for four cycles, undergo assessment for residual disease, then a subset of subjects will receive an additional eight cycles of durvalumab.

Subjects will receive stereotactic radiation therapy concurrent with cycle 2 of durvalumab to a dose of 48Gy in four fractions. Fractionation may be modified for central tumors.

Stereotactic Body Radiotherapy

After four cycles of durvalumab, subjects will be evaluated at the MRD Landmark for residual ctDNA to determine subsequent treatment assignment.

Circulating Tumor DNA assay

Layla Mahmud

Islam Mohamed, MD

Sanjay Rao, MD

Devin Schellenberg, MD

Angela Chan, MD

Shilo Lefresne, MD

Barb Melosky, MD

Julianna Caon, MD

Zia Poonja, MD

Anand Swaminath, MD

Peter Ellis, MD

The SCION Trial is a clinical trial in patients with early stage non-small cell lung cancer. The purpose of the trial is to investigate whether it is safe and effective to combine standard radiation treatment with a drug called durvalumab, a type of immunotherapy. In addition, the study will use a blood test to look for cancer cell DNA to determine how long treatment with durvalumab should last. Both the use of durvalumab and the use of the blood test are new strategies for managing early stage non-small cell lung cancer.

PURPOSE The intent of the study is to determine whether disease control in early non-small cell lung cancer (NSCLC) achieved by stereotactic ablative body radiotherapy (SABR) can be augmented locally, regionally, and distantly by safely combining it with durvalumab. Moreover, the study will assess whether patients who are likeliest to benefit from extended treatment with durvalumab can be predicted by assaying for molecular residual disease (MRD) after initial treatment using the AVENIO assay for circulating tumor DNA (ctDNA).

HYPOTHESIS Combining SABR and Durvalumab in patients with T1-2 N0 M0 NSCLC reduces the overall relapse rate at 18 months by 50% compared with historical controls treated with SABR alone, from 19.3% to 9.7%.

OBJECTIVES Primary

• To determine the overall relapse rate at 18 months in patients with T1-2 N0 M0 NSCLC treated with SABR and Durvalumab.

Secondary

* To determine rates of Local Relapse, Regional Nodal Relapse, Distant Relapse, and Second Primary Lung Cancer in patients with T1-2 N0 M0 NSCLC treated with SABR and Durvalumab.
* To determine rates of Overall Survival, Cause-Specific Survival, and Relapse Free Survival in patients with T1-2 N0 M0 NSCLC treated with SABR and Durvalumab
* To determine rates of pneumonitis, immune-related toxicity, adverse events, serious adverse events in patients with T1-2 N0 M0 NSCLC treated with SABR and Durvalumab.
* To determine the rate of MRD detection using the AVENIO ctDNA assay in patients with T1-2 N0 M0 NSCLC treated with SABR and Durvalumab.
* To compare clinical outcomes between patients with detectable versus undetectable MRD using the AVENIO ctDNA assay following treatment with SABR and Durvalumab.
* To compare clinical outcomes between patients with detectable MRD using the AVENIO ctDNA assay following treatment with SABR and Durvalumab who receive extended Durvalumab versus no further therapy.

STUDY DESIGN Subjects who meet the eligibility criteria will be candidates for enrolment. All subjects will receive one infusion of Durvalumab every 4 weeks for four cycles (4 weeks = 1 cycle), with SABR delivered concurrently with cycle 2. Subjects will be assessed at baseline using the AVENIO assay initially on tumor tissue. This will allow the subsequent evaluation for molecular residual disease (MRD) following cycle 4 to be tumor-informed, and ultrasensitive. Subjects with no detectable ctDNA at the MRD assessment will receive no further therapy. Subjects with detectable ctDNA at the MRD assessment will be randomized to receive either no further therapy or 8 additional cycles of q4w Durvalumab. Safety will be evaluated by recording the occurrence of adverse events, serious adverse events, and laboratory abnormalities, with special attention to pneumonitis and immune-related toxicity.

Future research will be enabled through the collection of biospecimens. Subjects will separately consent to the optional collection of these biospecimens. Blood samples collected for this purpose at multiple timepoints (0, 4, 12, 24 months) will be archived in a biorepository created for this study operated by the BC Cancer Tumour Tissue Repository (Victoria, BC). Stool samples collected for this purpose at multiple timepoints (0, 4, and 12 months) will be archived in the Oncomicrobiome Repository (Montreal, QC).

Study subjects will be analyzed as a single cohort with respect to the primary outcome, with comparison to historical controls. Treatment assignment based on biomarker status after initial treatment.

SCION: SABR and Checkpoint Inhibition Of NSCLC

A Phase II Study of Circulating Tumor DNA Directed Consolidation Durvalumab (MEDI4736) Following Induction and Concurrent Durvalumab With SABR for Stage I NSCLC. SCION: SABR and Checkpoint Inhibition Of NSCLC

Fraction of subjects experiencing relapse at 18 months following initial therapy

Evaluation of radiographic response by CT and PET/CT

Recurrence at irradiated primary tumor site

Recurrence in a hilar or mediastinal node

Proportion of subjects surviving lung cancer in the absence of other causes of death

Proportion of subjects surviving without relapse

Proportion of subjects diagnosed with a second primary lung cancer at a site beyond the treatment volume

Proportion of subjects with detectable ctDNA on MRD Landmark assay

Number and severity of serious adverse events

Number and severity of subjects experiencing pneumonitis

Number and severity of subjects experiencing immune-related adverse events

AstraZeneca

Ozmosis Research Inc.

University of British Columbia

Clinical Assistant Professor

Pembrolizumab

Immune Checkpoint Inhibitors

pembrolizumab 200 mg every 3 weeks till 1 year or disease recurrence or intolerable toxicity.

jhingook Kim, MD

hyunjung Shin

jingook Kim, PhD

A single center, open-label, single arm study in patients who have solid or micropapillary adenocarcinoma with pathologic stage I and primary tumor no more than 4 cm. Pembrolizumab 200 mg every 3 weeks

This is a single center, open-label, single arm study in patients who have solid or micropapillary adenocarcinoma with pathologic stage I and primary tumor no more than 4 cm. Patients will be treated with pembrolizumab 200 mg every 3 weeks till 1 year or disease recurrence or intolerable toxicity.

Postoperative Pembrolizumab for the Patients Who Have Solid Predominant or Micropapillary Lung Adenocarcinoma With Pathologic Stage I and Primary Tumor Than 4 cm

Samsung Medical Center

Professor

Adenocarcinoma in situ is defined as a small (≤3 cm) localized nodule with lepidic growth, mostly non-mucinous.

Minimally invasive adenocarcinoma defined as a small (≤3 cm) solitary adenocarcinoma with a predominantly lepidic pattern and ≤5 mm invasion in greatest dimension.

Invasive adenocarcinoma is a malignant epithelial tumor with glandular differentiation, mucin production, or pneumocyte marker expression. The tumors show an acinar, papillary, micropapillary, lepidic, or solid growth pattern, with either mucin or pneumocyte marker expression. The invasive ademocarcinoma component should be present in at least one focus measuring \>5mm in greatest dimension.

To predict the invasiveness of patients with small-sized lung adenocarcinoma intraoperatively based on multi-modal information.

Invasiveness diagnosis

Xueyun Tan, MD

Yang Jin, PHD

The goal of this observational study is to improve the intraoperative diagnosis accuracy of invasiveness for small-sized lung adenocarcinoma by combining multi-modal information. The main question it aims to answer is whether multi-modal information have great value of prediction on the invasiveness for small-sized lung adenocarcinoma. Since a promising limited resection is largely based on intraoperative frozen section diagnosis, there is a growing demand on the high-accuracy of timely pathology diagnosis. The multi-modal information of participants will be collected retrospectively.

Improving the Intraoperative Diagnosis Accuracy of Invasiveness for Small-sized Lung Adenocarcinoma

Improving the Intraoperative Diagnosis Accuracy for Pre-invasive and Invasive Small-sized Lung Adenocarcinoma Node by Combining Multi-modal Information

The final pathology diagnosis after resection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Application of Detecting Circulating Tumor Cells in the Accurate Treatment of Early Stage Lung Adenocarcinoma	NCT02951897	Lung Adenocarci... Diagnoses Disea... Circulating Tum... Treatment	lobectomy segmentecomy chemotherapy（pe... Lymphadenectomy CanPatrolTM to ...	45 Years - 70 Years	Third Military Medical University
SCION: SABR and Checkpoint Inhibition Of NSCLC	NCT04944173	Non Small Cell ... Carcinoma, Non-... Non-small Cell ... Lung Cancer Lung Cancer Sta... Lung Adenocarci... Lung Squamous C...	Durvalumab Stereotactic Bo... Circulating Tum...	18 Years -	University of British Columbia
Postoperative Pembrolizumab for the Patients Who Have Solid Predominant or Micropapillary Lung Adenocarcinoma With Pathologic Stage I and Primary Tumor Than 4 cm	NCT03254004	Lung Adenocarci...	Pembrolizumab	20 Years -	Samsung Medical Center
Postoperative Pembrolizumab for the Patients Who Have Solid Predominant or Micropapillary Lung Adenocarcinoma With Pathologic Stage I and Primary Tumor Than 4 cm	NCT03254004	Lung Adenocarci...	Pembrolizumab	20 Years -	Samsung Medical Center
Postoperative Pembrolizumab for the Patients Who Have Solid Predominant or Micropapillary Lung Adenocarcinoma With Pathologic Stage I and Primary Tumor Than 4 cm	NCT03254004	Lung Adenocarci...	Pembrolizumab	20 Years -	Samsung Medical Center
Postoperative Pembrolizumab for the Patients Who Have Solid Predominant or Micropapillary Lung Adenocarcinoma With Pathologic Stage I and Primary Tumor Than 4 cm	NCT03254004	Lung Adenocarci...	Pembrolizumab	20 Years -	Samsung Medical Center
Improving the Intraoperative Diagnosis Accuracy of Invasiveness for Small-sized Lung Adenocarcinoma	NCT05830812	Lung Adenocarci...	Invasiveness di...	20 Years - 80 Years	Wuhan Union Hospital, China

Spots Global Cancer Trial Database for lung adenocarcinoma, stage i