A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors.

Start Date17 Sep 2024

Sponsor / Collaborator

Amgen, Inc.

NCT06396598 / RecruitingNot ApplicableIIT

SyMPLER: Patient- and Caregiver-Triggered Palliative Referrals Via an Electronic Symptom Monitoring Program

This clinical trial evaluates earlier symptom management through remote electronic symptom monitoring (such as through an app on patient's phone), and accessibility of palliative care self-referral by patients with thoracic cancer and caregivers by proxy (legal representative). Thoracic cancer occurs in the chest and often causes symptoms for patients. Patients and/or their caregivers are often unable to attend in-person clinic visits for various reasons. The most frequently reported symptom by patients at initial palliative care consultations is pain, and caregivers' most common concerns are pain management for the patient, stress reduction, and fears about patient decline. Earlier palliative care referral can help control these symptoms before they worsen, providing a better quality of life for patients and caregivers. improve physical and emotional functioning for patients and caregivers in cancer care. This study may help researchers learn how an electronic symptom monitoring program may provide an earlier and more accessible way for patients with thoracic cancer to receive palliative care.

Start Date09 Feb 2024

Sponsor / Collaborator

Ohio State University Comprehensive Cancer Center

[+1]

CTR20231987 / RecruitingPhase 1

评价注射用CBP-1019在晚期胸部恶性肿瘤患者中安全性和耐受性、药代动力学及初步疗效的Ⅰ期临床研究

[Translation] A Phase I clinical study to evaluate the safety and tolerability, pharmacokinetics and preliminary efficacy of CBP-1019 for injection in patients with advanced thoracic malignancies

1）Ⅰa期：评估注射用CBP-1019在晚期肺癌患者中的安全性和耐受性；确定CBP-1019在晚期肺癌患者的最大耐受剂量（MTD）和Ⅱ期推荐剂量（RP2D）； 2）Ⅰb期：评估注射用CBP-1019在晚期肺癌患者中的客观缓解率（ORR）。

[Translation]

1) Phase Ia: Evaluate the safety and tolerability of CBP-1019 for injection in patients with advanced lung cancer; determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of CBP-1019 in patients with advanced lung cancer; 2) Phase Ib: Evaluate the objective response rate (ORR) of CBP-1019 for injection in patients with advanced lung cancer.

Start Date16 Oct 2023

Sponsor / Collaborator

Coherent Biopharma Hefei Co. Ltd.

100 Clinical Results associated with Advanced Malignant Thoracic Neoplasm

100 Translational Medicine associated with Advanced Malignant Thoracic Neoplasm

0 Patents (Medical) associated with Advanced Malignant Thoracic Neoplasm

Literatures (Medical) associated with Advanced Malignant Thoracic Neoplasm

01 Aug 2024·European Journal of Cancer

Prospective cardiovascular events in patients with advanced thoracic cancer treated with immune checkpoint inhibitor

Article

Author: Houard, Valérie ; Mazieres, Julien ; Veillon, Rémi ; Vergnenegre, Charlotte ; Rabeau, Audrey ; Verdy, Guillaume ; Zysman, Maeva ; Faure, Maxime ; Toublanc, Anne-Claire ; Bardel, Claire ; Dos Santos, Pierre

INTRODUCTIONMyocarditis is the most lethal cardiovascular immune related adverse events with a low incidence, depending on the studies. We prospectively studied the potential interest of a systematic screening to early detect immune related myocarditis and confirm the incidence of immune-induced myocarditis in advanced lung cancer and the impact of troponin systematic screening in early detection of other major cardiovascular events (MACE).MATERIAL AND METHODSThis prospective bicentric study includes adults who received at least one dose of immune checkpoint inhibitor (ICI) for advanced lung cancer. Cardiac biomarkers dosage, ECG and transthoracic echography (TTE) were done at baseline. Diagnosis of myocarditis was based on European Society of Cardiology recommendations. MACEs were reported during the observation period.RESULTSAmong 298 patients, 5 (1.68 %) immune-induced myocarditis occurred, all being asymptomatic with at first troponin elevation, treated by corticosteroids and ICI's discontinuation. No attributable death occurred, and no specific clinical characteristics were identified with myocarditis onset. Three patients were rechallenged with ICI after troponin normalization in the absence of other therapeutic options. Recurrence occurred in 2 patients, with a re-increase of troponin and a de novo modification of the ECG. Systematic cardiovascular screening also led to 14 cardiovascular diseases detection and 11 MACEs during ICI.CONCLUSIONSystematic cardiovascular screening has uncovered slightly more immuno-induced myocarditis cases than reported previously, but without altering treatment strategies due to their subclinical nature. Additionally, it helps detecting other cardiovascular diseases in this comorbid population.

01 Apr 2024·Annals of Nuclear Medicine

Simultaneous evaluation of brain metastasis and thoracic cancer using semiconductor 11C-methionine PET/CT imaging

Article

Author: Nagao, Michinobu ; Sakai, Shuji ; Ueda, Kaori ; Yamamoto, Atsushi ; Kaneko, Koichiro

OBJECTIVETo investigate the potential of whole-body digital ¹¹C-methionine (MET) PET/CT imaging for simultaneous evaluation of thoracic cancer patients suspected of local recurrence (LR) after stereotactic radiosurgery (SRS) for brain metastasis.METHODSA total of 45 lung or breast cancer patients suspected of LR after SRS were investigated using brain and whole-body MET-PET/CT scans. We compared the tumor-to-normal ratio (TNR) and maximum standardized uptake values (SUVmax) between patients with LR and radiation necrosis (RN) and performed receiver operating characteristic (ROC) analyses. We also investigated associations among extracranial recurrence, intracranial recurrence, primary site, and initial treatment type.RESULTSA total of 44 LR and 14 RN lesions were analyzed. In the ROC analyses for differentiating LR from RN, TNR showed higher area under the curve (AUC) (0.82) than SUVmax (0.79), and the cutoff TNR value (2.12) was higher than current cutoff values of conventional PET systems. The whole-body scans detected extracranial recurrences in 31.1% of the patients. Recurrence rates were not significantly correlated with existence of intracranial recurrence or primary site, but patients who underwent non-surgical treatment (consisting of stage III/ IV patients according to the Union for International Cancer Control TNM classification or small-cell lung cancer patients) showed significantly higher recurrence than the surgically treated patients (68.8% vs. 10.3%, p = 0.0001).CONCLUSIONIn digital MET-PET/CT imaging, TNR was a more useful parameter to differentiate LR from RN than SUVmax, and the cutoff value was higher than those with conventional PET systems. Additional whole-body scans could detect extracranial recurrence and would be especially useful for advanced thoracic cancer patients who underwent non-surgical treatment.

01 Jan 2024·Acta Cytologica

Pitfalls in Respiratory Tract Cytopathology

Review

Author: Wheeldon, Leonie ; Maddox, Anthony

Background: Cytopathology is integral to the investigation and diagnosis of respiratory disease, and, in the last decade or so, transbronchial needle aspiration by endobronchial ultrasound has made possible diagnosis and staging of malignant thoracic tumours at a single procedure. In addition, interventional teams increasingly include cytopathologists and cytotechnologists who, by providing rapid onsite evaluation, ensure efficient sampling of intrathoracic targets with the ultimate goal of accurate diagnosis as well as sufficient material for comprehensive predictive testing. Nonetheless, “traditional” cytological investigations such as bronchial washings, brushings, and lavages are still carried out for investigation of both suspected neoplastic and non-neoplastic conditions, and all these procedures still produce specimens in which florid benign cells mimic malignancy, while truly neoplastic cells lurk quietly in the background. Furthermore, even when neoplasia is not suspected, issues in preparation and interpretation may render a final assessment inaccurate and, therefore, clinically unhelpful or misleading. In this overview, we have tried to adopt a format partly modelled on the passage of a specimen from clinical acquisition to laboratory endpoint, thus taking in potential pitfalls in communication, clinical interaction, transport, and clinic-based preparation, as well as in morphology, immunocytochemistry, and suitability for predictive testing. It is not exhaustive but highlights areas that may frequently be encountered or are part of our personal experience. Summary: The account highlights potential pitfalls in respiratory cytopathology at key stages of the process from acquisition to reporting and presents these in both flow diagram and tabular form. We hope this is useful for the increasingly collaborative roles of cytotechnologist and cytopathologist and their wider involvement in the clinical investigative teams. Key Messages: Correct clinical and radiological information is crucially important and promotes the correct acquisition and processing of cytopathological specimens. Cross-discipline collaborative working ensures the most efficient use of the specimen such that diagnoses and predictive tests are performed on optimal material, reducing the potential for misinterpretation. Nonetheless, even with optimal material, morphological mimics and atypical antigen expression may mislead and render accurate diagnosis challenging.

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