Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

no intervention, it is a retrospective study .

no intervention

The goal of this observational study is to learn about in invasive non-small cell lung cancer patients who underwent pulmonary resection with systematic lymph node dissection from April 2008 to July 2022 . The main question it aims to answer are: determine the situation of zero risk mediastinal lymph metastases and the different lymph node metastatic patterns of tumors with different characteristics.

Participants will provide personal information to analyze. and there is not a comparison group.

A Study of Lymph Node Metastatic Pattern Based Incorporating Tumor Location, GGO Components and Size for Non-small Cell Lung Cancer

A Retrospective Study of Lymph Node Metastatic Pattern Based Incorporating Tumor Location, GGO Components and Size for Non-small Cell Lung Cancer Involving Patients in Thoracic Surgery Fudan University Shanghai Cancer Center From April 2008 to July 2022. Data Were Analyzed From October 2022 to July 2023 to Further Elaborated the Different Nodal Metastatic Pattern in Different Tumors and Identify the Characteristics of Patient Group Without Lymph Node Metastasis.

We counted the number of participants with no mediastinal lymph metastases after systematic lymph node dissection and tried to determine the situation of zero risk mediastinal lymph metastases after our analyses.

Fudan University

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Transitional Cell

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Head and Neck Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W

SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W

mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W

The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides

IO102-IO103 in combination with pembrolizumab

Eva Ehrnrooth Chief Medical Officer, MD, PhD

Anita Vedel Christiansen Director Clinical Operations, MSc Pharm

Victoria Villaflor, MD

Jonathan Riess, MD

Ezra Cohen, MD

Santosh Nair, MD

Enrico Castellucci, MD

Danae Hamouda, MD

Christopher Ryan, MD

Lova Sun, MD

Timothy McCarthy, MD

Enriqueta Felip, MD

Marc Cucurull, MD

Joaquim Bosch, MD

Pilar Garrido, MD

Jaime Rubio Perez, MD

Luis Paz-Ares, MD

Laura Medina, MD

Teresa Garcia Manrique, MD

Paloma Martin, MD

Julio Lambea, MD

Paul Shaw, MD PhD

James Spicer, MD

Jonathan W Riess, MD, MSc

A Phase II Multi-Arm (basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination with pembrolizumab, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of Head or Neck (SCCHN), or Metastatic Urothelial Bladder Cancer (mUBC)

Naturally occurring IDO/PD-L1 specific T-cells recognize MHC-bound IDO/PD-L1 peptides, and are able to eliminate IDO expressing or PD-L1 expressing immune regulatory cells and cancer cells. Activation of IDO or PD-L1 specific T-cells through vaccination with the IDO and PD-L1 peptides (IO102-IO103) will boost natural killing of cancer cells and counteract immune regulatory mechanisms in the tumor microenvironment. Thus, IDO/PD-L1 specific T-cells may both directly support anti-cancer immunity by killing target T-cells but also indirectly by releasing pro-inflammatory cytokines in the microenvironment to boost additional anti-cancer immunity.

This is a non comparative, open label, unblinded, multi-arm (basket) trial of IO102-IO103 in combination with pembrolizumab in three indications: NSCLC, SCCHN or mUBC. The primary objective of the trial is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab in the frontline treatment in each of the different metastatic solid tumour indications with the intent to expand a specific arm if a clinically meaningful signal is observed based on primary endpoint (dual target of either ORR or PFS by investigator assessment according to RECIST v.1.1).

Approximately 90 patients will be enrolled and treated; approximately 30 patients in each arm. All eligible patients will receive treatment for up to 2 years with IO102-IO103 (IO102 85μg and IO103 185μg) SC Q3W in combination with pembrolizumab IV 200mg Q3W.

All participants receive IO102-IO103 for three different indications.

IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC

A Phase II Multi-Arm (Basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination With Pembrolizumab, as First-Line Treatment for Patients With Metastatic NSCLC, SCCHN, or Metastatic mUBC

Biomarkers will be assessed and correlated both to the clinical response (after treatment) and the induced immunological response

PFS is defined as the time from first treatment with IMP to the first documented disease progression (based on iRECIST) or death from any cause. Per iRECIST disease progression should be confirmed by the site 4 to 8 weeks after site-assessed first radiologic evidence of PD (iUPD). The event date used for calculation for progression free survival should be the first date progression criteria is met (iUPD) providing that progression is confirmed at the next assessment.If a patient is not known to have progressed or died then they will be censored at the date of the last disease assessment. If a patient progresses after they have 2 or more missed disease assessment visits then they will be censored at the date of the last non missing disease assessment.

Target ORR according to RECIST v1.1 or PFS Rate at 6 months as per investigator assessments.

PFS is defined as the time from first treatment with IMP to the first documented disease progression (based on disease evaluation done locally for all patients in accordance with RECIST v.1.1) or death from any cause. If a patient is not known to have progressed or died then they will be censored at the date of the last disease assessment. If a patient progresses after they have 2 or more missed disease assessment visits then they will be censored at the date of the last non missing disease assessment.

DoR will be measured from the date of first observed objective response until disease progression or death (whichever is earlier). Date of progression and censoring will be handled in the same way as for PFS (evaluation done locally for all patients in accordance with RECIST v.1.1). The time of the initial response will be defined as the latest of the dates contributing towards the first visit response of PR or CR. If a patient does not progress following a response, then their duration of response will use the PFS censoring time.

CRR is defined as the number (%) of patients with a visit response of CR. Evaluation of response will be done locally for all patients in accordance with RECIST v.1.1.

DCR is defined as the number (%) of patients with a visit response of PR or CR or SD. Evaluation of response will be done locally for all patients in accordance with RECIST v.1.1.

Overall survival is defined as the time from first dose of IMP until death from any cause. Patients not known to have died will be censored at the date last known to be alive. After disease progression, all patients are expected to be followed every 12 weeks to confirm their survival status. These follow-up visits/contacts continue until the last planned overall survival analysis.

In the subset of responding patients, TTR is defined as the time from first dose of IMP until the date of the first observed partial or complete response. Evaluation of response will be done locally for all patients in accordance with RECIST v.1.1.

Theradex

Almac

NeoGenomics

Merck Sharp & Dohme LLC

IO Biotech

Baduanjin 12 mins per day, 5 days per week.

Walk 30mins then Baduanjin 12 mins per day, 5 days per week.

usual care

Walk

Baduanjin exercise is moderate in intensity and short in duration (a set of Baduanjin takes about 12 minutes). Baduanjin consists of the sitting and standing practicing form. The sitting Baduanjin exercise conforms to the aspects of low-intensity and long-term aerobic activity, which is suitable for the rehabilitation training of patients who are in stable condition during hospitalization. The standing Baduanjin is more suitable for patients with sequential rehabilitation after discharge and can be adjusted based on the patient's condition

Baduanjin

Walk 30mins then Baduanjin 12mins per day, 5 times per week.

Baduanjin plus walk

Chun Hou Huang, PhD

Chun Hou Huang, Phd

Lung cancer (LC) is the leading cause of cancer-related death and is the most frequent cancer in both sexes.Respectable lung tumor with abnormal lung function, usually because of tobacco use, have chronic obstructive pulmonary disease (COPD), coronary artery disease, and/or old age as underlying comorbidities. Until recent, most exercise prescribed using aerobic exercise programs. Baduanjin is a type of movement-based mind-body intervention. It is a form of traditional practice designed to promote physical and psychological health, manage symptoms, and relieve stress during illness. The impacts of a Baduanjin exercise-based cardiopulmonary rehabilitation program for patients recovering from respectable lung tumor on Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan), lung function and heart rate variability has yet to be assessed. This trial evaluates whether the Baduanjin exercise would provide effective lung function, meridian energy and HRV in patients following lung operative.

Baduanjin Exercise on Meridian Energy, Lung Function and Heart Rate Variability in Patients Undergoing Lung Operative.

Baduanjin Exercise on Lung Operative

The electrical conductance of the acupuncture points of human subject can be measured by a computerized testing instrument with a very low electrical current. Ryodoraku theory has been shown to be a supplementary diagnostic method for selective diseases and a useful parameter for evaluating therapeutic effects of acupuncture. The electrical conductance of an acupoint was measured using a Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan) operating at DC 12V and 0 to 200A. The method and procedure of the MEAD is based on the Ryodoraku theory and is similar to equipment used in previous studies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Lymph Node Metastatic Pattern Based Incorporating Tumor Location, GGO Components and Size for Non-small Cell Lung Cancer	NCT06161935	Lung Cancer Non...	no intervention	18 Years -	Fudan University
IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC	NCT05077709	Lung Cancer Non... Head and Neck S... Urothelial Carc...	IO102-IO103 in ...	18 Years -	IO Biotech
Baduanjin Exercise on Meridian Energy, Lung Function and Heart Rate Variability in Patients Undergoing Lung Operative.	NCT04669730	Lung Cancer Non...	usual care Walk Baduanjin Baduanjin plus ...	20 Years - 70 Years	Tzu Chi University
A Study of Lymph Node Metastatic Pattern Based Incorporating Tumor Location, GGO Components and Size for Non-small Cell Lung Cancer	NCT06161935	Lung Cancer Non...	no intervention	18 Years -	Fudan University

Spots Global Cancer Trial Database for lung cancer non small cell