National Korányi Institute of Tb and Pulmonology Trials
From Beacon
NCTID: NCT00676507
Title: Phase III Lucanix™ Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy Study Summary: Rationale: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than a placebo as maintenance therapy in treatment of subjects with non-small cell lung cancer. Purpose: This randomized phase III trial is studying vaccine therapy to see how well it works compared with a placebo in treating subjects with stage III or stage IV non-small cell lung cancer. Sponsor: NovaRx Corporation Intervention: Lucanix™ Start Date: 2008-07 Last Updated: 2015-05-08 Number of Patients: 532 Recruitment Status: COMPLETED Condition: Lung Neoplasm
NCTID: NCT05722015
Title: A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77) Study Summary: This study is to assess the pharmacokinetics (PK) and safety of SC MK-3475A vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are MK-3475A subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab coformulated with hyaluronidase Start Date: 2023-02-14 Last Updated: 2023-12-22 Number of Patients: 339 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Non-small Cell Lung Cancer
NCTID: NCT02654587
Title: OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure Study Summary: The aim of this clinical trial was to determine if the therapeutic cancer vaccine OSE2101 (TEDOPI) was more effective than standard chemotherapy (docetaxel or pemetrexed) in treating HLA-A2 positive patients with metastatic NSCLC who progressed after sequential or concurrent chemotherapy and immune checkpoint inhibitor given in first or second-line treatment. The main questions were to compare the survival, the tolerance to treatment and the quality of life of patients between the two arms of treatment (OSE2101 versus standard chemotherapy) Sponsor: OSE Immunotherapeutics Intervention: OSE2101 Start Date: 2016-02-12 Last Updated: 2024-02-02 Number of Patients: 219 Recruitment Status: TERMINATED Condition: Non Small Cell Lung Cancer
NCTID: NCT01630733
Title: A Multinational, Randomized, Open-Label Study of Custirsen In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer Study Summary: The primary objective of the study is to compare overall survival of patients randomized to receiving custirsen in combination with docetaxel (Arm A) with patients randomized to receive docetaxel alone (Arm B). Sponsor: Achieve Life Sciences Intervention: Custirsen Start Date: 2012-09 Last Updated: 2016-07-01 Number of Patients: 700 Recruitment Status: UNKNOWN Condition: Non-Small Cell Lung Cancer
NCTID: NCT02754882
Title: A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer Study Summary: This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). Sponsor: Samsung Bioepis Co., Ltd. Intervention: Bevacizumab Start Date: 2016-07-05 Last Updated: 2019-01-03 Number of Patients: 763 Recruitment Status: COMPLETED Condition: Lung Cancer
NCTID: NCT03296163
Title: A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Study Summary: This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group, equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel) in subjects with Stage IIIB/IV non-squamous NSCLC Sponsor: mAbxience Research S.L. Intervention: MB02 (Bevacizumab Biosimilar Drug) Start Date: 2018-02-06 Last Updated: 2021-04-26 Number of Patients: 627 Recruitment Status: COMPLETED Condition: Non-small Cell Lung Cancer
NCTID: NCT03912389
Title: Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy as First Line Treatment in Patients With Advanced Non-Squamous NSCLC Study Summary: This is a randomized, multicenter, double-blind placebo-controlled phase 3 study of efficacy and safety of BCD-100 in combination with pemetrexed+cisplatin/carboplatin compared to placebo in combination with pemetrexed+cisplatin/carboplatin in subjects with previously untreated metastatic non-squamous NSCLC. The main hypothesis of the study is that BCD-100 in combination with chemotherapy prolongs OS compared to placebo with chemotherapy. Sponsor: Biocad Intervention: BCD-100 Start Date: 2019-06-01 Last Updated: 2020-09-17 Number of Patients: 292 Recruitment Status: UNKNOWN Condition: Non-Squamous Non-Small Cell Neoplasm of Lung
NCTID: NCT02544633
Title: Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET Study Summary: MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene (mutation or amplification <math display="block">increase number of gene copies</math>). Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have previously received treatment with chemotherapy. The number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265 will be administered orally, twice daily. The study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments. Sponsor: Mirati Therapeutics Inc. Intervention: MGCD265 Start Date: 2015-10 Last Updated: 2020-03-04 Number of Patients: 68 Recruitment Status: COMPLETED Condition: Non-Small Cell Lung Cancer
NCTID: NCT01362400
Title: A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer Study Summary: The purpose of this study is to compare the impact of IPI-504 in combination with docetaxel to placebo in combination with docetaxel on life expectancy in patients with Non Small Cell Lung cancer (NSCLC). Docetaxel is an approved chemotherapy for NSCLC. An additional goal of the study is to determine the effect of IPI-504, in combination with docetaxel, verses placebo in, combination with docetaxel, on the growth of cancer Sponsor: Infinity Pharmaceuticals, Inc. Intervention: IPI 504 plus Docetaxel Start Date: 2011-05 Last Updated: 2014-05-19 Number of Patients: 226 Recruitment Status: COMPLETED Condition: Non Small Cell Lung Cancer
NCTID: NCT00373425
Title: A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors Study Summary: This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients. Sponsor: OSI Pharmaceuticals Intervention: Erlotinib Start Date: 2006-09 Last Updated: 2015-09-17 Number of Patients: 1252 Recruitment Status: COMPLETED Condition: Non-small Cell Lung Cancer
NCTID: NCT03098030
Title: Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer Study Summary: This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period <3 months or ≥3 months). Sponsor: United Therapeutics Intervention: Dinutuximab Start Date: 2017-06-01 Last Updated: 2020-12-09 Number of Patients: 483 Recruitment Status: COMPLETED Condition: Small Cell Lung Cancer
NCTID: NCT04738487
Title: Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003) Study Summary: The primary hypotheses are that coformulated pembrolizumab/vibostolimab is superior to pembrolizumab alone with respect to (1) overall survival (OS) in participants with programmed cell death 1 ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%, TPS ≥1% and TPS 1% to 49%; and (2) progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR), in participants with PD-L1 TPS ≥1% and TPS ≥50%. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Start Date: 2021-04-07 Last Updated: 2024-02-15 Number of Patients: 1246 Recruitment Status: RECRUITING Condition: Lung Neoplasms
NCTID: NCT04924101
Title: Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99) Study Summary: The purpose of this study is to evaluate the use of investigational agents (MK-4830, boserolimab (MK-5890) and lenvatinib (MK-7902)) in combination with pembrolizumab (MK-3475) and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCLC). No formal hypothesis testing will be performed for this study. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-07-15 Last Updated: 2023-12-19 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small Cell Lung Cancer
NCTID: NCT04380636
Title: Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are: # Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS) # Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-07-06 Last Updated: 2023-12-19 Number of Patients: 870 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lung Neoplasms
NCTID: NCT05546476
Title: Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15 Study Summary: Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15. Sponsor: Pfizer Intervention: ponsegromab Start Date: 2022-11-21 Last Updated: 2024-02-05 Number of Patients: 188 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
