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NSCLC clinical trials

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NCT ID: NCT04764188 Active, not recruiting - NSCLC Clinical Trials

An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib

ReAlec
Start date: May 10, 2021
Phase:
Study type: Observational

This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in real-world clinical practice.

NCT ID: NCT04646330 Active, not recruiting - NSCLC Clinical Trials

A Trial of AK104 Plus Anlotinib in NSCLC

Start date: November 18, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This trial is a single arm, two cohorts, phase Ib/II study. All patients are stage IIIB/C or IV NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Cohort 1 includes treatment naïve patients with advanced NSCLC. Cohort 2 includes patients with metastatic or recurrent NSCLC after progression on treatment with PD-1/PD-L1. The primary end point are objective response rate per RECIST1.1 and safety. Secondary end points are progression-free survival and overall survival.

NCT ID: NCT04585035 Active, not recruiting - NSCLC Clinical Trials

Study to Evaluate D-1553 in Subjects With Solid Tumors

Start date: October 2, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1/2, open label study of D-1553 single agent and combination treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation.

NCT ID: NCT04549025 Active, not recruiting - NSCLC Clinical Trials

Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen

SELECT
Start date: October 19, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open-label study to evaluate PD-1 inhibitor JTX-4014 alone and in combination with vopratelimab, an ICOS agonist, in biomarker-selected adult subjects with metastatic NSCLC who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum based chemotherapy regimen.

NCT ID: NCT04419935 Active, not recruiting - NSCLC Clinical Trials

Lymphadenectomy in NSCLC With and Without Adjuvant Therapy

Start date: May 13, 2020
Phase:
Study type: Observational

Adjuvant therapy in patients affected by NSCLC is indicated in surgically treated cases of N2 disease, while the actual guidelines reported the possibility of a case-by-case decision in case of N1 involvement. On the other hand, the actual categorization of patients based on the hilar or mediastinal involvement (N1 or N2) risks to be too ineffective and straightforward for prognosis prediction and an indication of adjuvant treatments. This issue was underlined in the 8th TNM proposal for the N sub-classification, with a final proposal of different subgroups based on the number of involved stations. However, the IASLC committee noted that this proposal presented some limits due overlapping or not statistical significance among some survival curves, so the proposal was not adopted in the staging system. Moreover, the committee stated that the lack of information regarding some data such as the number of the resected or the metastatic nodes might affect the results and limited other proposals. The objectives of this study are: - To evaluate the prognostic role of the kind of lymphadenectomy, the number of the resected and/or metastatic lymph nodes in surgically treated N positive patients in terms of survival. - To evaluate the indication and the role of adjuvant treatments in these patients. - To identify patients with increased risk of early recurrence or poor survival based on the lymph node involvement characteristics In particular, data will be collect in a prospective database including clinical and pathological data, kind of lymphadenectomy, number of resected nodes, number of metastatic nodes, kind and schedule of adjuvant therapy and follow-up status

NCT ID: NCT04392505 Active, not recruiting - Cancer Clinical Trials

Durvalumab(MEDI4736) After chemoRadioTherapy(DART) for NSCLC-a Translational and Biomarker Study

DART
Start date: May 11, 2020
Phase: Phase 2
Study type: Interventional

The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation. The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.

NCT ID: NCT04328844 Active, not recruiting - NSCLC Clinical Trials

A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers

Start date: February 25, 2020
Phase: Phase 1
Study type: Interventional

The objective of study IOA-244-101 is to determine whether IOA-244 is safe and tolerable in cancer patients (Part A). In addition, the study will assess whether IOA-244 can increase the anti-tumour immune response in patients both as monotherapy and in combination pemetrexed/cisplatin/avelumab (Part B Mesothelioma and NSCLC 1st line), in combination with avelumab (Part B Cutaneous Melanoma and NSCLC 2nd/3rd line) and ruxolitinib (Part B Primary Myelofibrosis)

NCT ID: NCT04318938 Active, not recruiting - NSCLC Clinical Trials

Advancing Brigatinib Properties in ALK+ NSCLC Patients by Deep Phenotyping

Start date: March 30, 2020
Phase: Phase 2
Study type: Interventional

This is a prospective, randomized, open-label, multicenter phase II study investigating the advancing Brigatinib properties in anaplastic lymphoma kinase positive non-small cell lung cancer (ALK+ NSCLC) patients by deep phenotyping

NCT ID: NCT04223596 Active, not recruiting - Lung Cancer Clinical Trials

Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients

CUBIK
Start date: May 4, 2020
Phase: Phase 2
Study type: Interventional

This is an open-label, non-randomised, phase II, exploratory, multi-country and multi-centre clinical trial. Chemotherapy-naïve patients with EML4-ALK rearrangement and with locally advanced or metastatic non-small cell lung cancer patients will be selected. Patients enrolled in the study will receive brigatinib 90mg for the first 7 days (D 1-7 at cycle 1) and then 180mg daily thereafter for QW4 cycles of duration (28 days ±3days). Brigatinib will be administered until progression disease, unacceptable toxicity, patient or physician decision to discontinue or death. Brigatinib may continue beyond disease progression per RECIST v1.1 until loss of clinical benefit, unacceptable toxicity, patient or physician decision to discontinue, or death as per SmPC recommendations. Patient accrual is expected to be completed within 1.5 years excluding a run-in-period of 4-6 months. Treatment and follow-up are expected to extend the study duration to a total of 5 years. Patients will be followed for 1 year after the end of treatment independently of the cause of end of treatment. The study will end once survival follow-up has concluded. The trial will end with the preparation of the final report, scheduled for 5.5 years after the inclusion of the first patient approximately.

NCT ID: NCT04077099 Active, not recruiting - NSCLC Clinical Trials

REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer

Start date: January 7, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of the dose escalation (phase 1) part of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of REGN5093 for determination of the maximum tolerated dose (MTD) and/or definition of the recommended phase 2 dose (RP2D) of REGN5093 in patients with MET-altered Non-small cell lung cancer (NSCLC). The primary objective of the dose expansion (phase 2) part of the study is to assess preliminary anti-tumor activity of REGN5093 as measured by the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)