protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02459795 | 7.3.2 | Submitting an Expedited Safety Report to the IRB | 7.3.2 Submitting an Expedited Safety Report to the IRB | Oncereceives all supporting documentation for the reported event, the MedicalMonitor, in conjunction with Perrigo, will determine if the safety report is eligible for expeditedreview.will log the initial event and will notify Perrigo that an event has been report... | [] |
NCT02459795 | 7.4.1 | Pregnancy | 7.4.1 Pregnancy At the time a Principal Investigator or delegated staff becomes aware that a study participant became pregnant following study participation, the Principal Investigator or Study Coordinator will report the pregnancy immediately by phone and/or by faxing a completed Pregnancy Report to within one working... | [] |
NCT02459795 | 7.5 | Post Study Adverse Events | 7.5 Post Study Adverse Events | [] |
NCT02459795 | 7.5.1 | Non-serious Adverse Events | 7.5.1 Non-serious Adverse Events Adverse events that are identified at the last assessment visit (or the early termination visit) must be recorded on the AE eCRF with the status of the AE noted. | [] |
NCT02459795 | 7.5.2 | Serious Adverse Events | 7.5.2 Serious Adverse Events Serious adverse events that are identified on the last assessment visit (or the early termination visit) must be recorded on the AE eCRF page and reported to Perrigo according to the procedures outlined above. Subjects with unresolved previously reported serious adverse events, or any new s... | [] |
NCT02459795 | 8 | STATISTICAL ANALYSIS | 8. STATISTICAL ANALYSIS The sections that follow highlight sample size determination and the planned analyses for this study. A statistical analysis plan (SAP) will be prepared separately from this protocol which gives descriptions of the statistical methods, models, hypotheses and subject populations to be analyzed. T... | [] |
NCT02459795 | 8.1 | Statistical Analysis Plan | 8.1 Statistical Analysis Plan | [] |
NCT02459795 | 8.1.1 | Analysis Populations | 8.1.1 Analysis Populations The following populations are defined for the purpose of analyses: Intent-to-Treat (ITT) (safety population): Any subject that was randomized and received and used study medication. - Modified Intent-to-Treat (mITT): Any subject that was randomized, met eligibility criteria, received and used... | [] |
NCT02459795 | 8.1.2 | Planned Analysis | 8.1.2 Planned Analysis All subjects who received study medication will be evaluated for safety. The efficacy analysis will be conducted on both the PP and the mITT subject populations. Two-sided hypothesis testing will be conducted for tests. Resulting p-values less than 0.05 will be considered statistically significan... | [] |
NCT02459795 | 8.1.3 | Sample Size Considerations | 8.1.3 Sample Size Considerations | Protocol No: PRG-NY-15-002 | | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT02459795 | 8.1.5 | Safety and Adverse Events Analysis | 8.1.5 Safety and Adverse Events Analysis The frequency and percent of subjects with adverse events will be summarized by MedDRA (Version 15.1) system organ class and preferred term and by severity and relationship to study drug for all three treatment groups. The adverse events reported by at least five percent of the ... | [] |
NCT02459795 | 8.2 | Comparability of Subjects at Baseline | 8.2 Comparability of Subjects at Baseline The statistical significance of any treatment group difference in the distribution of categorical variables such as gender will be tested using Cochran–Mantel–Haenszel (CMH) test for general association adjusted for site. Continuous variables, such as age, will be analyzed usin... | [] |
NCT02459795 | 9 | CONSENT/ASSENT CONSIDERATIONS AND PROCEDURES | 9. CONSENT/ASSENT CONSIDERATIONS AND PROCEDURES It will be made clear to the subject that, for the purposes of the study, they are consenting only for topical application of medication or vehicle. Investigators may discuss the availability of the study and the possibility for entry with a potential subject without firs... | [] |
NCT02459795 | 9.1 | Subject Confidentiality | 9.1 Subject Confidentiality All participants are concerned for the individual subject's privacy and, therefore, all subject data will be identified only by a subject identification number and subject initials. However, in compliance with federal guidelines regarding the monitoring of clinical studies and in fulfillment... | [] |
NCT02459795 | 10.2 | Source Documents | 10.2 Source Documents Source documents are defined as the results of original observations and activities of a clinical investigation. Source documents will include, but are not limited to, progress notes and screening logs. All source documents pertaining to this study will be maintained by the investigators and made ... | [] |
NCT02459795 | 10.3 | File Management at the Study Site | 10.3 File Management at the Study Site It is the responsibility of the investigator to ensure that the study center file is maintained in accordance with Section 8 of the International Conference on Harmonization (ICH) Guideline for Good Clinical Practices (GCP). | [] |
NCT02459795 | 10.4 | Records Retention at the Study Site | 10.4 Records Retention at the Study Site FDA regulations require all investigators participating in clinical drug studies to maintain detailed clinical data for one of the following periods: - a) A period of at least two years following the date on which a New Drug Application is approved by the FDA; - b) A period of t... | [] |
NCT02459795 | 11 | QUALITY CONTROL AND QUALITY ASSURANCE | 11. QUALITY CONTROL AND QUALITY ASSURANCE | [] |
NCT02459795 | 11.1 | Monitoring | 11.1 Monitoring Perrigo has ethical, legal and scientific obligations to carefully follow this study in a detailed and orderly manner in accordance with established research principles and FDA regulations. All medical records (source documents) of the subjects participating in this study must be presented for review an... | [] |
NCT02459795 | 11.2 | Auditing | 11.2 Auditing Perrigo (or representative) may conduct audits at the study center(s). Audits will include, but are not be limited to, drug supply, presence of required documents, the informed consent process, and comparison of case report forms with source documents. The investigator agrees to participate with audits co... | [] |
NCT02459795 | 12 | ETHICS AND RESPONSIBILITY | 12. ETHICS AND RESPONSIBILITY This study must be conducted in compliance with the protocol, the United States Food and Drug Administration (FDA) regulations, any other countries regulations, and ICH GCP Guidelines. | [] |
NCT02459795 | 13 | USE OF INFORMATION AND PUBLICATION | 13. USE OF INFORMATION AND PUBLICATION All information supplied by Perrigo in connection with this study and not previously published, is considered confidential information. This information includes, but is not limited to, data, materials (i.e. the clinical protocol, eCRFs), equipment, experience (whether of a scient... | [
"REFERENCES"
] |
NCT02537951 | 1 | INTRODUCTION AND RATIONALE | 1. INTRODUCTION AND RATIONALE Painful polyneuropathy is a form of neuropathic pain that occurs when thin Aδ or C nerve fibers become damaged. The exact incidence and prevalence of painful polyneuropathy is not known, but it is estimated that painful neuropathy occurs in 5% of the general population (1). Painful polyneu... | [
"OBJECTIVES",
"Primary Objective:",
"STUDY DESIGN"
] |
NCT02537951 | 2 | STUDY POPULATION | 2. STUDY POPULATION | [] |
NCT02537951 | 2.1 | Population (base) | 2.1 Population (base) | [] |
NCT02537951 | 2.2 | Inclusion criteria | 2.2 Inclusion criteria In order to be eligible to participate in this study, a subject must meet all of the following criteria: -10 healthy volunteers | [] |
NCT02537951 | 2.3 | Exclusion criteria | 2.3 Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study: - -younger than 18 years - -ready existing neuropathy - -allergy to local anaesthetics | [] |
NCT02537951 | 2.4 | Sample size calculation | 2.4 Sample size calculation AFI of the fingertip is a completely new application, there are no data on the basis of which a sample-size calculation can be done. It is a pilot study. The results of this pilot will serve to calculate a sample size for a follow-up study. | [] |
NCT02537951 | 3 | TREATMENT OF SUBJECTS | 3. TREATMENT OF SUBJECTS - 3.1 Investigational product/treatment - 3.2 the intervention with lidocaine / prilocaine cream and with capsaicin 8% patches is not the aim of the study, but serves as a negative control. - 3.3 Use of co-intervention (if applicable) n.a. 3.4 Escape medication (if applicable) n.a. | [] |
NCT02537951 | 4 | INVESTIGATIONAL PRODUCT | 4. INVESTIGATIONAL PRODUCT | 4.1 | Name and description of investigational product(s) | |------|---------------------------------------------------------------------| | 4.2 | Summary of findings from non-clinical studies | | n.a. | | | 4.3 | Summary of findings from clinical studies | | n.a. | | | 4.4 | Summary of know... | [] |
NCT02537951 | 5 | NON-INVESTIGATIONAL PRODUCT | 5. NON-INVESTIGATIONAL PRODUCT | [] |
NCT02537951 | 5.1 | Name and description of non-investigational product(s) | 5.1 Name and description of non-investigational product(s) - -lidocaine/prilocaine creme (EMLA) - -capsaicine 8% patch (Qutenza) | [] |
NCT02537951 | 5.2 | Summary of findings from non-clinical studies | 5.2 Summary of findings from non-clinical studies - -EMLA: zie de SPC, http://db.cbg-meb.nl/IB-teksten/h11015.pdf - -Qutenza: zie de SPC, http://www.astellas.nl/sites/default/files/SmPC%20Qutenza.pdf | [] |
NCT02537951 | 5.3 | Summary of findings from clinical studies | 5.3 Summary of findings from clinical studies - -EMLA: zie de SPC, http://db.cbg-meb.nl/IB-teksten/h11015.pdf - -Qutenza: zie de SPC, http://www.astellas.nl/sites/default/files/SmPC%20Qutenza.pdf | [] |
NCT02537951 | 5.4 | Summary of known and potential risks and benefits | 5.4 Summary of known and potential risks and benefits - -EMLA 5% (from SmPC) Common (>1/100): Transient local reactions at the application site such as paleness, erythema (redness) and oedema. An initial and usually mild sensation of burning, itching or warmth at the application site. Uncommon (1/1000 to 1/100): An ini... | [] |
NCT02537951 | 5.5 | Description and justification of route of administration and dosage | 5.5 Description and justification of route of administration and dosage - -the route and dosage of lidocaine/prilocaine and the capsaicin patch is being used according to the SmPCs of lidocaine/prilocaine and the capsaicin patch. - -studies using cutaneous capsaicin patch 8% have demonstrated that this regimen is suita... | [] |
NCT02537951 | 5.6 | Dosages, dosage modifications and method of administration | 5.6 Dosages, dosage modifications and method of administration - -the route and dosage of lidocaine/prilocaine and the capsaicin patch is being used according to the SmPCs of lidocaine/prilocaine and the capsaicin patch. - -a small patch of 8% capsaicin will be applied to the middle finger for 60 minutes. | [] |
NCT02537951 | 5.7 | Preparation and labelling of Non Investigational Medicinal Product | 5.7 Preparation and labelling of Non Investigational Medicinal Product - -lidocaine/prilocaine cream will be present at the outpatient clinic of the Dept. of Neurology and supplied from regular pharmacy stock - -capsaicin 8% patches will be delivered to Erasmus MC by the manufacturer in their original packaging, cut to... | [] |
NCT02537951 | 5.8 | Drug accountability | 5.8 Drug accountability All treatments for the study will be dispensed from the Department of Clinical Pharmacy of Erasmus MC. Drug accountability will be done in accordance with the pertaining SOPs of the pharmacy. Unused lidocaine/prilocaine crème will be returned to the pharmacy at the end of the clinical phase. Was... | [
"METHODS"
] |
NCT02537951 | 5.9 | Study parameters/endpoints | 5.9 Study parameters/endpoints | [] |
NCT02537951 | 5.9.1 | Main study parameter/endpoint | 5.9.1 Main study parameter/endpoint - magnitude and time course of the flavoprotein response - -linearity of the electrical stimulation with the flavoprotein response - -block of the flavoprotein response by lidocaine / prilocaine cream and 8% capsaicin patches | [] |
NCT02537951 | 5.9.2 | Secondary study parameters/endpoints (if applicable) | 5.9.2 Secondary study parameters/endpoints (if applicable) n.a. | [] |
NCT02537951 | 5.9.3 | Other study parameters (if applicable) | 5.9.3 Other study parameters (if applicable) n.a. | [] |
NCT02537951 | 5.10 | Randomisation, blinding and treatment allocation | 5.10 Randomisation, blinding and treatment allocation n.a. | [] |
NCT02537951 | 5.11 | Study procedures | 5.11 Study procedures 1) Each subject will undergo a series of electrical stimuli (5Hz, for 10 seconds) with AFI measurement. Each stimulus strength (0.5, 0.6, 0.7, 0.8, 0.9 and 1.0 mA) will be administered twice. The stimulus is interrupted when the pain intensity exceeds 7. Thereafter, a (non-painful) 2000Hz, 1.0mA s... | [] |
NCT02537951 | 5.12 | Withdrawal of individual subjects | 5.12 Withdrawal of individual subjects Subjects can leave the study at any time for any reason if they wish to do so without any consequences. The investigator can decide to withdraw a subject from the study for urgent medical reasons. | [] |
NCT02537951 | 5.12.1 | Specific criteria for withdrawal (if applicable) | 5.12.1 Specific criteria for withdrawal (if applicable) n.a. | [] |
NCT02537951 | 5.13 | Replacement of individual subjects after withdrawal | 5.13 Replacement of individual subjects after withdrawal If test subjects lose weight, other test subjects will be approached, so that there are at least 10 participants in the (pilot) study | [] |
NCT02537951 | 5.14 | Follow-up of subjects withdrawn from treatment | 5.14 Follow-up of subjects withdrawn from treatment subjects will be followed-up after withdrawal if medically required. | [] |
NCT02537951 | 5.15 | Premature termination of the study | 5.15 Premature termination of the study n.a. | [] |
NCT02537951 | 6 | SAFETY REPORTING | 6. SAFETY REPORTING | [] |
NCT02537951 | 6.1 | Section 10 WMO event | 6.1 Section 10 WMO event In accordance to section 10, subsection 1, of the WMO, the investigator will inform the subjects and the reviewing accredited METC if anything occurs, on the basis of which it appears that the disadvantages of participation may be significantly greater than was foreseen in the research proposal... | [] |
NCT02537951 | 6.2 | AEs, SAEs and SUSARs | 6.2 AEs, SAEs and SUSARs | [] |
NCT02537951 | 6.2.1 | Adverse events (AEs) | 6.2.1 Adverse events (AEs) Adverse events are defined as any undesirable experience occurring to a subject during the study, whether or not considered related to [the investigational product / the experimental intervention]. All adverse events reported spontaneously by the subject or observed by the investigator or his... | [] |
NCT02537951 | 6.2.2 | Serious adverse events (SAEs) | 6.2.2 Serious adverse events (SAEs) A serious adverse event is any untoward medical occurrence or effect that at any dose: - results in death; - is life threatening (at the time of the event); - requires hospitalisation or prolongation of existing inpatients' hospitalisation; - results in persistent or significant disa... | [] |
NCT02537951 | 6.2.3 | Suspected unexpected serious adverse reactions (SUSARs) | 6.2.3 Suspected unexpected serious adverse reactions (SUSARs) n.a. | [] |
NCT02537951 | 6.3 | Annual safety report | 6.3 Annual safety report n.a. | [] |
NCT02537951 | 6.4 | Follow-up of adverse events | 6.4 Follow-up of adverse events All AEs will be followed until they have abated, or until a stable situation has been reached. Depending on the event, follow up may require additional tests or medical procedures as indicated, and/or referral to the general physician or a medical specialist. SAEs need to be reported til... | [] |
NCT02537951 | 6.5 | [Data Safety Monitoring Board (DSMB) / Safety Committee] | 6.5 [Data Safety Monitoring Board (DSMB) / Safety Committee] n.a. | [] |
NCT02537951 | 7 | STATISTICAL ANALYSIS | 7. STATISTICAL ANALYSIS | [] |
NCT02537951 | 7.1 | Primary study parameter(s) | 7.1 Primary study parameter(s) -corelation coefficients between stimulus strength and AFI signal amplitude will be calculated. The statistical significance of the correlation will be calculated using linear regression analysis. -repeated-measures ANOVAs will be performed between baseline recordings and recordings 1 hou... | [] |
NCT02537951 | 7.2 | Secondary study parameter(s) | 7.2 Secondary study parameter(s) n.a. | [] |
NCT02537951 | 7.3 | Other study parameters | 7.3 Other study parameters n.a. | [] |
NCT02537951 | 7.4 | Interim analysis (if applicable) | 7.4 Interim analysis (if applicable) n.a. | [] |
NCT02537951 | 8 | ETHICAL CONSIDERATIONS | 8. ETHICAL CONSIDERATIONS | [] |
NCT02537951 | 8.1 | Regulation statement | 8.1 Regulation statement The study will be conducted according to the principles of the Declaration of Helsinki (Fortaleza Brazil, October 2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) | [] |
NCT02537951 | 8.2 | Recruitment and consent | 8.2 Recruitment and consent 8.3 Subjects are recruited by colleagues, not subordinates, to approach the principal investigator orally. After this, a patient information form will be provided. Test subjects have a week to think about participation. | [] |
NCT02537951 | 8.4 | Objection by minors or incapacitated subjects (if applicable) | 8.4 Objection by minors or incapacitated subjects (if applicable) n.a. | [] |
NCT02537951 | 8.5 | Benefits and risks assessment, group relatedness | 8.5 Benefits and risks assessment, group relatedness 8.6 The importance, namely the development of a new diagnostic tool for painful neuropathy, in our view weighs against the minimal discomfort (in terms of time-load / risk) that goes with it. | [] |
NCT02537951 | 8.7 | Compensation for injury | 8.7 Compensation for injury The sponsor/investigator has a liability insurance which is in accordance with article 7, subsection 9 of the WMO. The sponsor (also) has an insurance which is in accordance with the legal requirements in the Netherlands (Article 7 WMO and the Measure regarding Compulsory Insurance for Clini... | [] |
NCT02537951 | 8.8 | Incentives (if applicable) | 8.8 Incentives (if applicable) The subjects do not receive financial compensation for participating in the study. | [] |
NCT02537951 | 9 | ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION | 9. ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION | [] |
NCT02537951 | 9.1 | Handling and storage of data and documents | 9.1 Handling and storage of data and documents The subjects are coded with a number from 1-10, in the order in which they participate in the study. | [] |
NCT02537951 | 9.2 | Monitoring and Quality Assurance | 9.2 Monitoring and Quality Assurance n.a. | [] |
NCT02537951 | 9.3 | Amendments | 9.3 Amendments A 'substantial amendment' is defined as an amendment to the terms of the METC application, or to the protocol or any other supporting documentation, that is likely to affect to a significant degree: - the safety or physical or mental integrity of the subjects of the trial; - the scientific value of the t... | [] |
NCT02537951 | 9.4 | Annual progress report | 9.4 Annual progress report Not applicable, since the planned study period is 4 months | [] |
NCT02537951 | 9.5 | End of study report | 9.5 End of study report The sponsor will notify the accredited METC and the competent authority of the end of the study within a period of 90 days. The end of the study is defined as the last patient's last visit. In case the study is ended prematurely, the sponsor will notify the accredited METC and the competent auth... | [] |
NCT02537951 | 9.6 | Public disclosure and publication policy | 9.6 Public disclosure and publication policy This pilot study will be registered at clinicaltrials.gov. The results of this study will be published, if applicable. The authorship guidelines of the Vancouver Protocol (http://www.icmje.org/) will be followed regarding co-authorship. | [] |
NCT02537951 | 10 | STRUCTURED RISK ANALYSIS | 10.STRUCTURED RISK ANALYSIS | [] |
NCT02537951 | 10.1 | Potential issues of concern | 10.1 Potential issues of concern - a. Level of knowledge about mechanism or action - -for lidocaine / prilocaine cream and capsaicin 8% patches see section 5.2 With regard to the safety of the neurometer: the electrical stimulus is generated by a low voltage source, or a battery. For safety reasons, the Neurometer is c... | [] |
NCT02537951 | 10.2 | Synthesis | 10.2 Synthesis There is a minimal risk of moderately severe burning pain in the fingertip after application of the capsaicin 8% patch, despite lidocaine / prilocaine ointment an hour before. In that case an ice pack or paracetamol can be prescribed, because the pain always changes after 180 minutes. | [] |
NCT02537951 | 11 | REFERENCES | 11.REFERENCES - 1. Dieleman JP, Kerklaan J, Huygen FJ, Bouma PA, Sturkenboom MC. Incidence rates and treatment of neuropathic pain conditions in the general population. Pain. 2008;137(3):681-8. - 2. Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily ... | [] |
NCT02574078 | 1.3 | Objectives | 1.3 Objectives The primary, secondary, and exploratory objectives are summarized in Table 1.3-1. Table 1.3-1: Study Objectives Revised Protocol No.: 05 Approved 930090414 6.0v 6.0 Table 1.3-1: Study Objectives | | Primary Objectives | Secondary Objectives | |-------------------------------------------------------------... | [] |
NCT02574078 | 2 | ETHICAL CONSIDERATIONS | 2 ETHICAL CONSIDERATIONS | [] |
NCT02574078 | 2.1 | Good Clinical Practice | 2.1 Good Clinical Practice This study will be conducted in accordance with Good Clinical Practice (GCP), as defined by the International Conferenceon Harmonisation (ICH) and in accordance with the ethical principles underlying European Union Directive 2001/20/EC and the United States Code of Federal Regulations, Title ... | [] |
NCT02574078 | 2.2 | Institutional Review Board/Independent Ethics Committee | 2.2 Institutional Review Board/Independent Ethics Committee Before study initiation, the investigator must have written and dated approval/favorable opinion from the IRB/IEC for the protocol, consent form, subject recruitment materials (eg, advertisements), and any other written information to be provided to subjects. ... | [] |
NCT02574078 | 2.3 | Informed Consent | 2.3 Informed Consent Investigators must ensure that subjects are clearly and fully informed about the purpose, potential risks, and other critical issues regarding clinical studies in which they volunteer to participate. In situations where consent cannot be given to subjects, their legally acceptable representatives (... | [] |
NCT02574078 | 3 | INVESTIGATIONAL PLAN | 3 INVESTIGATIONAL PLAN | [] |
NCT02574078 | 3.1 | Study Design and Duration | 3.1 Study Design and Duration This is an open-label, Phase 1/2, Master Protocol, containing 5 sub-studies (sub-protocols)that will each enroll a unique patient population. Subjects with recurrent locally advanced or Stage 4 SQ or NSQ NSCLC, with an ECOG PS of 0-2, will receive either first-line or maintenance therapy w... | [] |
NCT02574078 | 3.1.1 | Treatment Group A: Maintenance, NSQ, PS 0-1, EGFRwtand ALKwt | 3.1.1 Treatment Group A: Maintenance, NSQ, PS 0-1, EGFRwtand ALKwt Following first-line therapy with 4 to 6 cycles of Investigator's Choice of chemotherapy regimens (carboplatinor cisplatinplus paclitaxel plus bevacizumab or carboplatinor cisplatinplus pemetrexed), subjects showing no signs of progression, will be rand... | [] |
NCT02574078 | 3.1.2 | Treatment Group B: Maintenance, SQ, PS 0-1 | 3.1.2 Treatment Group B: Maintenance, SQ, PS 0-1 Following initial therapy with 4 to 6 cycles of Investigator's Choice of chemotherapy regimens (carboplatin or cisplatin plus paclitaxel, carboplatinor cisplatinplus gemcitabine, carboplatin or cisplatin plus docetaxel, carboplatin or cisplatin plus albumin bound paclita... | [] |
NCT02574078 | 3.1.3 | Treatment Group C: First-line, NSQ and SQ, PS 2, EGFRwt and ALKwt | 3.1.3 Treatment Group C: First-line, NSQ and SQ, PS 2, EGFRwt and ALKwt Subjects assigned to Group C will be randomized (1:1) to receive first-line therapy with either: 4 to 6 cycles of Investigator's Choice of chemotherapy (Arm A) or single-agent nivolumab (Arm B). The list of Investigator's Choice chemotherapy regime... | [] |
NCT02574078 | 3.1.4 | Treatment Group D: First-line, PS 0-2, EGFRmut | 3.1.4 Treatment Group D: First-line, PS 0-2, EGFRmut Subjects in Group D will be randomized (1:1) to treatment with erlotinib monotherapy or the combination therapy (erlotinib plus nivolumab) as follows: - Arm A: erlotinib 150 mg QD - Arm B: nivolumab 240 mg every 2 weeks + erlotinib 150 mg QD Treatment for both arms w... | [] |
NCT02574078 | 3.1.5 | Treatment Group E: First-line, PS 0-2, ALK-positive | 3.1.5 Treatment Group E: First-line, PS 0-2, ALK-positive Subjects in Group E will receive the combination therapy of nivolumab (240 mg every 2 weeks) and crizotinib (250 mg BID). On-study tumor assessments will begin at Week 9 and will be performed every 8 weeks (± 1 week) forup to2 years.The study design schematic is... | [] |
NCT02574078 | 3.1.6 | Enrollment Period | 3.1.6 Enrollment Period Subjects will be enrolled using an Interactive WebResponse System (IWRS). During the screening and enrollment period, a subject will provide signed informed consent and their study eligibility will be established. Additionally, to determine PD-L1 status, tumor tissue (archival or recent tumor bi... | [] |
NCT02574078 | 3.1.7 | Randomization | 3.1.7 Randomization Subjects meeting enrollment criteria for Groups A, B, C, or D will be randomized to treatment arms as described i[n Sections 3.1.1](#page-42-1)[, 3.1.2](#page-44-1)[, 3.1.3,](#page-45-1) o[r 3.1.4.](#page-46-1)An interactive web response system (IWRS) will be utilized for randomization. Subjects in ... | [] |
NCT02574078 | 3.1.8 | Treatment Period | 3.1.8 Treatment Period In all treatment groups, treatment will be administered according the dosages and cycles as described i[n Sections 3.1.1](#page-42-1)[, 3.1.2](#page-44-1)[, 3.1.3](#page-45-1)[, 3.1.4](#page-46-1), [or 3.1.5.](#page-47-1) | [] |
NCT02574078 | 3.1.9 | Study Duration | 3.1.9 Study Duration As per Amendments 03 and 04, enrollment has closedfor all groups. The study is expected to end when the last subject in Group D has completed up to 2 years of treatment. The approximate duration of the study is up to 4.5 years.For Group D, the study duration will concludewhen the primary analysis t... | [] |
NCT02574078 | 3.2 | Post Study Access to Therapy | 3.2 Post Study Access to Therapy At the conclusion of the study, participants who continue to demonstrate clinical benefit will be eligible to receive BMS supplied study treatment for the maximum treatment duration specified in protoco[l Section 4.5.1.](#page-65-1)Study treatment will be provided via an extension of th... | [] |
NCT02574078 | 3.3 | Study Population | 3.3 Study Population Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria. For entry into the study, the following criteria MUST be met. Note: asper ... | [] |
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