NCT03851445ClinicalTrials.gov

Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer

LUNGMAP: A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-Map Screening Study)

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.

التواصل مع هذه الدراسة

باختصار

المرحلة 2 / المرحلة 3مطلوب 10,000 مشارك1,229 موقعاًدولة واحدة

الفئات

علم الأورام68%الجهاز التنفسي32%

مسجَّلة في سجل واحد

ClinicalTrials.govNCT03851445فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل شهرين

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Not stated: Registered after enrolment began (about 16 days after the recorded start)First posted 2019-02-22; recorded start 2019-02-06
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 72 other studies in this databaseCounted from the lead sponsor named in the record (SWOG Cancer Research Network)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: research network.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 1229 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration3/5
Registered within 30 days of the study start
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEGA

A very large study: 10,000 participants (target), run at 1,229 sites.

How this score is built

Enrolment38/40
10,000 participants (target)
Site count25/25
1,229 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 121 months
Sponsor scale7/10
SWOG Cancer Research Network has led 72 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

ملخص

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

Primary Objective of the Master Protocol (LUNGMAP) The primary objective of this screening study is to test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol. Secondary Objectives 1. Screening Success Rate Objective To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study. Screen success rates will be evaluated for the total screened population and by the subset of patients screened following progression on previous therapy or pre-screened on current therapy. 2. Translational Medicine Objectives 1. To evaluate circulating tumor DNA (ctDNA) and compare to the FMI Foundation tissue molecular profiling results in patients who submit a new biopsy for screening. 2. To establish a tissue/blood repository. Ancillary Study S1400GEN Objectives The Lung-MAP Screening Study includes an ancillary study evaluating patient and physician attitudes regarding the return of somatic mutation findings suggestive of a germline mutation. Participation in this study is optional. 1. Primary Objective To evaluate patient attitudes and preferences about return of somatic mutation findings suggestive of a germline mutation in the Lung-MAP Screening Study. 2. Secondary Objectives 1. To evaluate Lung-MAP study physician attitudes and preferences about return of somatic mutation findings suggestive of a germline mutation in the Lung-MAP Screening Study. 2. To evaluate Lung-MAP patients' and study physicians' knowledge of cancer genomics. 3. To evaluate Lung-MAP patients' and study physicians' knowledge of the design of the Lung-MAP Screening Study. 4. To explore whether physician and patient knowledge of cancer genomics and attitudes and preferences about return of genomic profiling findings are correlated.

الحالات

Previously Treated Non-Small Cell Lung Cancer

الأهلية

الأهلية
الجنس	الجميع
الأعمار	18 Years – لا حد أقصى
المتطوعون الأصحّاء	لا

الأهلية كما كُتبت في السجل

5.1 Registration Step 0: 1. Patients who need the fresh biopsy must also submit whole blood for ctDNA testing (see Section 15.3). These patients must be registered to Step 0 to obtain a patient ID number for the submission. Patients registered to Step 0 are not registered to the LUNGMAP protocol. To participate in LUNGMAP, patients must be registered to Step 1 after evaluation of patient eligibility, including tumor tissue adequacy, per protocol Section 5.1, Step 1. Patients registered at Step 0 must use the same SWOG patient ID for registration at Step 1. Step 1: 2. Patients must have pathologically proven non-small cell lung cancer (all histologic types) confirmed by tumor biopsy and/or fine-needle aspiration. Disease must be Stage IV as defined in Section 4.0, or recurrent. The primary diagnosis of non-small cell lung cancer should be established using the current WHO/IASLC-classification of Thoracic Malignancies. All histologies, including mixed, are allowed. 3. Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment. These criteria are: 1. Screening at progression on prior treatment: To be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (Stages I-IV) and must have progressed during or following their most recent line of therapy. * For patients whose prior systemic therapy was for Stage I-III disease only (i.e. patient has not received any treatment for Stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy. For patients treated with consolidation anti-PD-1 or anti-PD-L1 therapy for Stage III disease, disease progression on consolidation anti-PD-1 or anti-PD-L1 therapy must have occurred within one year from the date or initiation of such therapy. * For patients whose prior therapy was for Stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen or anti-PD-1/PD-L1 therapy, alone or in combination (e.g. Nivolumab or Pembrolizumab). 2. Pre-Screening prior to progression on current treatment: To be eligible for pre-screening, current treatment must be for Stage IV or recurrent disease and patient must have received at least one dose of the current regimen. Patients must have previously received or currently be receiving a platinum-based chemotherapy regimen or anti-PD-1/PD-L1 therapy, alone or in combination (e.g. Nivolumab or Pembrolizumab). Patients on first-line treatment are eligible upon receiving Cycle 1, Day 1 infusion. Note: Patients will not receive their sub-study assignment until they progress and the LUNGMAP Notice of Progression is submitted. 4. Patients must have adequate tumor tissue available, defined as ≥ 20% tumor cells and ≥ 0.2 mm3 tumor volume. * The local interpreting pathologist must review the specimen. * The pathologist must sign the LUNGMAP Local Pathology Review Form confirming tissue adequacy prior to Step 1 registration. Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform CLIA biomarker profiling, PD-L1, and c-MET IHC (see Section 15.2). If archival tumor material is exhausted, then a new fresh tumor biopsy that is formalin-fixed and paraffin-embedded (FFPE) must be obtained. Patients who need the fresh biopsy must also submit whole peripheral blood for ctDNA testing. A tumor block or FFPE slides 4-5 microns thick must be submitted. Bone biopsies are not allowed. If FFPE slides are to be submitted, at least 12 unstained slides plus an H\&E stained slide, or 13 unstained slides must be submitted. However, it is strongly recommended that 20 FFPE slides be submitted. Note: Previous next-generation DNA sequencing (NGS) will be repeated if done outside this study for sub-study assignment. Patients must agree to have any tissue that remains after testing retained for the use of sub-study Translational Medicine (TM) studies at the time of consent the patient is enrolled in. 5. Patients with known EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, or BRAF V600E mutation are not eligible unless they have progressed following all standard of care targeted therapy. EGFR/ALK/ROS/BRAF testing is not required prior to Step 1 registration, as it is included in the Foundation One testing for screening/pre-screening. 6. Patients must have Zubrod performance status 0-1 (see Section 10.2) documented within 28 days prior to Step 1 registration. 7. Patients must be ≥ 18 years of age. 8. Patients must also be offered participation in banking for future use of specimens as described in Section 15.0. 9. Patients must be willing to provide prior smoking history as required on the LUNGMAP Onstudy Form. 10. As a part of the OPEN registration process (see Section 13.4 for OPEN access instructions) the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system. 11. Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. 12. U.S. patients who can complete the survey and the interview by telephone or email in English must be offered participation in the S1400GEN Survey Ancillary Study if local institution's policies allow participants to receive the Amazon gift card (see Sections 15.7 and 18.5). Patients at institutions that cannot offer the survey must still participate in the main study.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسة	تدخّلية
المرحلة	المرحلة 2 / المرحلة 3
التخصيص	غير منطبق
نموذج التدخّل	SEQUENTIAL
الغرض الأساسي	SCREENING
التعمية	NONE (0)
التجنيد	مطلوب 10,000 مشارك

الجهة الراعية والمتعاونون

SWOG Cancer Research Network الجهة الراعية
National Cancer Institute (NCI) المتعاونون

الأذرع والتدخلات

Lung-MAP ScreeningOTHER
This is a screening study and does not have an intervention. LUNGMAP is an overarching umbrella study to which patients are screened and then assigned to a treatment sub-study. The treatment sub-studies are standalone trials and have their own NCT numbers. The Lung-MAP Study is considered a single study under one IND, consisting of the Screening Protocol and multiple sub-studies. Each sub-study protocol operates independently and has its own version date.

التدخلات

دواء Screening Platform
The screening study tests patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol.

مقاييس النتائج

مقياس النتيجة الأولي
Screening Success (Prescreening-to-sub-study Assignment)
Pre-screening-to-sub-study assignment will be measured among pre-screened patients and the proportion of patients assigned to a sub-study (which is triggered by the submission of the notice of progression form, see Section 14.0). Note: Patients screened at progression are notified of their sub-study assignment within 1 day of the biomarker results being reported to SWOG.
الإطار الزمني Up to 3 years
مقياس النتيجة الأولي
Screening Success (Tissue Submission)
The tissue submission will be measured by the proportion of patients who register to this screening study for whom a tissue sample is submitted.
الإطار الزمني Up to 3 years
مقياس النتيجة الأولي
Screening Success (Adequate Tissue)
Adequate tissue will be measured by the proportion of patients who submitted a specimen for whom genomic results were successfully obtained, if multiple platforms are being used (e.g. both FMI and IHC), these rates will be summarized by the individual assays and combined. These rates are summarized for the entire screened population and by screening type (screened at progression versus pre-screened prior to progression). The rates are evaluated for both the initial submission success rates and the overall success rate accounting for new tissue submissions following an unsuccessful result.
الإطار الزمني Up to 3 years
مقياس النتيجة الأولي
Screening Success (Notice of Intention Not to Register Submission)
Screening success will be measured by the reasons for non-participation collection on the LungMAP Notice of Intention not to Register Form. The proportions of patients with this form submitted are summarized overall and by screening type. The reasons for submission are summarized overall and by screening type.
الإطار الزمني Up to 3 years
مقياس النتيجة الأولي
Screening Success (Match to Biomarker-Driven Sub-Study)
Match to Biomarker-Driven Sub-Study will be measured by successful biomarker screening, the proportion assigned to a biomarker-driven substudy.
الإطار الزمني Up to 3 years
مقياس النتيجة الأولي
Screening Success (Assignment Success)
Assignment Success will be measured by the proportion of patients assigned to a sub-study who are registered to a sub-study, these rates are summarized overall and among biomarker-driven and non-match sub-study assignments, separately. In addition, these rates are summarized by screening type.
الإطار الزمني Up to 3 years

التواريخ

التواريخ
تاريخ البدء	6 فبراير 2019 (فعلي)
الإتمام الأولي	28 يناير 2029 (تقديري)
الإتمام	28 يناير 2029 (تقديري)
أول نشر	22 فبراير 2019 (فعلي)
آخر تحديث	18 مايو 2026
النتائج منشورة	غير مذكور في سجل السجل
آخر تأكيد للحالة	مايو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

950 موقعاً قيد التجنيد

United States

United States
المنشأة	المدينة	الولاية أو المنطقة	الحالة
Providence Regional Cancer System-Aberdeen	Aberdeen	Washington	قيد التجنيد
Hendrick Medical Center	Abilene	Texas	قيد التجنيد
Riverwood Healthcare Center	Aitkin	Minnesota	قيد التجنيد
Phoebe Putney Memorial Hospital	Albany	Georgia	مُعلَّق
Lovelace Medical Center-Saint Joseph Square	Albuquerque	New Mexico	نشط، دون تجنيد
Presbyterian Kaseman Hospital	Albuquerque	New Mexico	قيد التجنيد
New Mexico Oncology Hematology Consultants	Albuquerque	New Mexico	مُعلَّق
University of New Mexico Cancer Center	Albuquerque	New Mexico	قيد التجنيد
Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	قيد التجنيد
Aultman Alliance Community Hospital	Alliance	Ohio	قيد التجنيد
MyMichigan Medical Center Gratiot	Alma	Michigan	قيد التجنيد
MyMichigan Medical Center Alpena	Alpena	Michigan	قيد التجنيد
OSF Saint Anthony's Health Center	Alton	Illinois	قيد التجنيد
UPMC Altoona	Altoona	Pennsylvania	قيد التجنيد
The Don and Sybil Harrington Cancer Center	Amarillo	Texas	قيد التجنيد
American Fork Hospital / Huntsman Intermountain Cancer Center	American Fork	Utah	مُعلَّق
Mary Greeley Medical Center	Ames	Iowa	قيد التجنيد
McFarland Clinic - Ames	Ames	Iowa	قيد التجنيد
Community Hospital of Anaconda	Anaconda	Montana	قيد التجنيد
Kaiser Permanente-Anaheim	Anaheim	California	قيد التجنيد
Anchorage Radiation Therapy Center	Anchorage	Alaska	مُعلَّق
Alaska Breast Care and Surgery LLC	Anchorage	Alaska	قيد التجنيد
Alaska Oncology and Hematology LLC	Anchorage	Alaska	قيد التجنيد
Alaska Women's Cancer Care	Anchorage	Alaska	قيد التجنيد
Anchorage Oncology Centre	Anchorage	Alaska	مُعلَّق
Katmai Oncology Group	Anchorage	Alaska	قيد التجنيد
Providence Alaska Medical Center	Anchorage	Alaska	قيد التجنيد
Anchorage Associates in Radiation Medicine	Anchorage	Alaska	قيد التجنيد
AnMed Health Cancer Center	Anderson	South Carolina	قيد التجنيد
UI Health Care Mission Cancer and Blood - Ankeny Clinic	Ankeny	Iowa	قيد التجنيد
Trinity Health Saint Joseph Mercy Hospital Ann Arbor	Ann Arbor	Michigan	قيد التجنيد
University of Michigan Rogel Cancer Center	Ann Arbor	Michigan	قيد التجنيد
Luminis Health Anne Arundel Medical Center	Annapolis	Maryland	مُعلَّق
Langlade Hospital and Cancer Center	Antigo	Wisconsin	قيد التجنيد
Kaiser Permanente-Deer Valley Medical Center	Antioch	California	قيد التجنيد
Ascension Saint Elizabeth Hospital	Appleton	Wisconsin	قيد التجنيد
PCR Oncology	Arroyo Grande	California	قيد التجنيد
Cone Health Cancer Center at Asheboro	Asheboro	North Carolina	مُعلَّق
Cone Health MedCenter Asheboro	Asheboro	North Carolina	قيد التجنيد
Randolph Hospital	Asheboro	North Carolina	مُعلَّق
Mission Hospital	Asheville	North Carolina	نشط، دون تجنيد
AdventHealth Infusion Center Asheville	Asheville	North Carolina	قيد التجنيد
Northwest Wisconsin Cancer Center	Ashland	Wisconsin	قيد التجنيد
Duluth Clinic Ashland	Ashland	Wisconsin	قيد التجنيد
King's Daughter's Medical Center	Ashland	Kentucky	قيد التجنيد
OhioHealth O'Bleness Hospital	Athens	Ohio	قيد التجنيد
Emory Saint Joseph's Hospital	Atlanta	Georgia	قيد التجنيد
Grady Health System	Atlanta	Georgia	قيد التجنيد
Emory University Hospital Midtown	Atlanta	Georgia	قيد التجنيد
Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	قيد التجنيد

يُدرَج 1,179 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT03851445