NL-OMON55684
Completed
Phase 2
A Phase II, Randomized, Open-label Platform Trial Utilizing a MastercProtocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants (study 205801) - study 205801 (ENTREE)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- non-small cell lung cancer
- Sponsor
- GlaxoSmithKline
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, age 18 years and above.
- •Histologically or cytologically confirmed diagnosis of NSCLC (squamous or
- •non\-squamous).
- •Documented disease progression during or after a maximum of 2 lines of
- •systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage
- •IV or metastatic disease. For further details: see protocol section 6\.1, item
- •Measurable disease.
- •ECOG performance status 0\-1\.
- •Fresh tumor sample (preferred) or archival tumor tissue obtained at any time
- •from the initial diagnosis to study.
Exclusion Criteria
- •Prior treatment with docetaxel, any of the investigational agents tested in
- •this study, systemic approved or investigational treatment within 30 days,
- •prior radiotherapy within 2 weeks. For further details: see protocol section
- •6\.2, item 1\.
- •Three or more lines of therapy for NSCLC, including patients with BRAF
- •molecular alternations. Patients with known EGFR/ALK/ROS1 molecular alterations
- •are excluded from participation.
- •CNS metastases. Exception: see protocol section 6\.2, item 4\.
- •Autoimmune disease (current en history) that has required systemic treatment
- •within the last 2 years. Replacement therapy is not considered a form of
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
A Phase 1/2 open-label, multi-center, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab in combination with other anti-cancer therapies in participants with lymphomanon-Hodgkin Peripheral T-cell lymfomenHodgkin and non-Hodgkin lymphomaleukemia1002531910025320NL-OMON48105Sanofi-aventis7
Completed
Phase 2
A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults with Metastatic or Locally Advanced Unresectable Solid TumorsNL-OMON48575CytomX Therapeutics, Inc.22
Completed
Not Applicable
A Phase 1b, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 plus Tilsotolimod and Other Therapy Combinations in Subjects with Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaNL-OMON49382AbbVie B.V.2
Completed
Phase 2
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Effect on Microvascular Obstruction of Temanogrel in Subjects Undergoing Percutaneous Coronary InterventioNL-OMON51876Arena Pharmaceuticals, Inc.27
Completed
Not Applicable
A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination with M9241 (NHS-IL12) in Subjects with Locally Advanced, Unresectable, or Metastatic Solid TumorsNL-OMON48631Merck KGaA7