Editing National Korányi Institute of Tb and Pulmonology Trials

'''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 &amp; 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 &lt;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 &amp; 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 &amp; 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 &amp; 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