1. S1400 Lung Master Protocol SWOG FALL meeting September 16, 2016
LUNG-MAP
S1400 Lung Master Protocol
SWOG FALL meeting
September 16, 2016

2. Welcome SWOG ECOG-ACRIN NRG CCTG Alliance S1400 Master Protocol
Karen Kelly, MD
swog lung cancer committee chair
David Gandara, md
Study Co-Chair, Medical Oncology

3. Study Updates Vassiliki Papadimitrakopoulou, MD
Study Chair, Medical Oncology

4. Where are we now? IRB Approvals: 736 sites
318 sites with at least 1 patient
accrued
Accruals:
979 patients registered to S1400
459 patients from SWOG sites
712 patients notified of their sub-study assignment
359 patients registered to a sub-study
S1400B: 26
S1400D: 32
S1400I: 104
Closed Sub-studies/treatment: 197
SWOG STATISTICAL CENTER and CTSU AS OF
9/12/2016
Update

5. Current Status of Sub-Studies
S1400A [MEDI4736]
Closed 11/18/2015
S1400B [GDC-0032]
Actively accruing
S1400C [Palbociclib]
Closed 9/1/2016
S1400D [AZD4745]
Actively accruing
S1400I [Nivolumab/Ipilimumab]
Suggestions on what to states

6. Study Design Updates Revision #5 (August 2016)
Request for Amendments (RAs) for MEDI4736, GDC-0032, Palbociclib, AZD4547
S1400I: Addition of Patient Reported Outcomes
the option of enrolling to a new sub-study following progression on another sub-study
Revision #6 (Expected Winter 2016)
New Sub-Study, S1400G: a biomarker-driven study including a PARP inhibitor

7. Overview of Upcoming Changes
Subsequent Revision:
S1400F: a non-match study for patients who have failed prior nivolumab
Concept Redesign approved; Protocol submission for CTEP Sub-Protocol Review soon
Proposed Sub-Studies:
S1400K: a biomarker-driven study of ABBV-399 in c-MET positive patients
Very early in development
Not sure if detailed information should be added. Do we want to show progress on adding new sub-studies?

8. Study Logistics
Mary Redman, PhD
Study Lead Biostatistician

9. S1400 Registration: Pre-screening Option
Evaluate eligibility, consent patient*, and confirm evaluable tissue**
* Use pre-screening consent; ** Need Pathology Form sign off
Register to S1400 in OPEN
Submit tissue to FMI within 1 day after registration
If Patient will not be registered to a sub-study for any reason
Note: Can change decision
Continue current treatment
Follow-up per protocol
Submit Notice of Intention Not to Register Form in Rave ®
Upon Progression: Submit S1400 Notice of Progression in Rave ®
Sub-study assignment
(received within 1 day from Notice of Progression if at least 16 days since tissue submission)
Follow-up for 3 years

10. S1400 Registration: Screening at Progression Option
Evaluate eligibility, consent patient*, and confirm evaluable tissue**
* Use Screen at PD consent; ** Need Pathology Form sign off
Register to S1400 in OPEN
Submit tissue to FMI within 1 day after registration
If Patient will not be registered to a sub-study for any reason
Note: Can change decision
Wait to receive sub-study assignment from SWOG
Submit Notice of Intention Not to Register Form in Rave ®
Sub-study assignment
(received within 16 days following tissue submission)
Follow-up for 3 years

11. Sub-study Registration: From Sub-study Assignment
Sub-study common and specific eligibility criteria
If patient is assigned to sub-study and meets sub-study common eligibility criteria but does NOT meet study-specific eligibility criteria
Submit Request for Sub-study Reassignment Form in Rave
If patient IS eligible for and consents to assigned sub-study
Register to S1400X sub-study in OPEN after receiving sub-study assignment
Protocol treatment within 7 working days of sub-study registration
Follow-up, obtain and submit specimens and forms per
sub-study protocol
If patient is not going to register to a sub-study for any reason
Follow-up for 3 years
Submit Notice of Intention not to Register Form in Rave
Separate out into 3 slides

12. Notice of Intention Not to Register Reasons: Within last 3 months
Reason (N=74) %
Not eligible for any sub-study
41%
Patient Death
15%
Symptomatic deterioration
Preference to receive nivolumab
12%
Investigator decision 5%
Tissue Inadequate
Patient refusal 4%
Not eligible for screening at PD/prescreening reg. 3%

13. New Sub-study Registration Option (In Revision #5 v.7/19/16)
Patients who progress on a Lung-MAP sub-study may register to another Lung-MAP sub-study, if eligible for one of the other studies
Progress on Lung-MAP sub-study
If Patient will not be registered to new sub- study for any reason
Note: Can change decision
Evaluate Common Eligibility Criteria
Submit the Request for New Sub-study Assignment
(See S1400 main Protocol Section 14)
Submit Notice of Intention Not to Register Form in Rave ®
Sub-study assignment
(received within 1 day following request submission)
Follow-up per current Sub-study
Follow-up per new Sub-study

14. Data Submission Requirements
All data is submitted electronically:
Medidata Rave®
TRIAD application
SWOG Specimen Tracking System
All case report forms & specified source documentation
Radiology images
All specimens
Protocol Section 14 for submission schedule
Protocol Section 14 for schedule
Protocol Section 15 for details
Protocol Section 15 for details and schedule
Forms due on Monthly Expectation Report
Queries in Rave at each disease assessment
Protocol page example resources: Master Forms Set, TRIAD Fact Sheet)
CRA Workbench example resources: ORP Manual, BSA Calculator, expectation & ineligible patient reports
Mary: I suggest referring the attendees to the handout: S1400 Registration and Study Flow schema, the Tissue Specifications information sheet, and the Who Do I Ask Contact Sheet.
Timely submission of data is critical to trial success!
Many resources available to help:
Protocol abstract page on SWOG.org and CTSU.org (ex: Master Forms Set, TRIAD Fact Sheet)
SWOG CRA Workbench (ex: ORP Manual, BSA Calculator, reports)
Lung-MAP Data Coordinators: or call (206)

15. S1400I Patient Reported Outcomes
Mary Redman, PhD
Study Lead Biostatistician

16. S1400I PRO Overview
The Patient Reported Outcomes (PRO) Study will look at capturing the complex symptom profile experienced by patients, which may result from the disease, the therapy, or both. The study will consist of PRO and EQ-5D Questionnaires.
The S1400I trial structure provides an ideal setting for evaluating the information provided by PRO measures and assessing how well PRO measures track with disease symptoms and other clinical outcomes.
The purpose of the EQ-5D is to obtain preliminary survivorship status for this group of patients at the three yearly follow-up assessments for clinical status.

17. Assessment Schedule
PRO assessment schedule built on existing clinical assessments: B 1 2 3 4 5 6 7 8 9 10 11 12 13 24 36
Y 1
Y 2
Y 3
Weeks
PRO
EQ-5D
PRO
PRO
EQ-5D
PRO
EQ-5D
PRO
EQ-5D
PRO
PRO
EQ-5D
PRO
EQ-5D
PRO
EQ-5D
EQ-5D
EQ-5D
EQ-5D
S1400I Clinical Assessment Schedule
S1400I PRO Sub-study Assessment Schedule
S1400I EQ-5D Questionnaire Assessment Schedule

18. PRO Data Submission Data Submission Requirements Master Forms
Data must be submitted according to the protocol requirements for patients registered to S1400I after 9/1/2016 and participating in the S1400I PRO study (refer to S1400I Section 14.4)
Master Forms
Master forms can be found on the protocol abstract page on the SWOG website ( and CTSU website (
Data Submission Procedures
In addition to completing electronic forms, upload the patient-completed questionnaires via the Source Documentation: PRO form in Medidata Rave.

19. PRO Training and Contacts
Staff involved in the collection of quality of life/PRO data in SWOG trials should review the Patient Reported Outcome Training narrated slide program available on the SWOG website ( CRA Training, Tools of the Trade).
Nurse PRO/QOL Study Coordinator
Susan S. Tavernier, PhD, APRN-CNS, AOCN
Assistant Professor
Accelerated Nursing Program Coordinator
Idaho State University School of Nursing
Phone: 208/

20. Quality Assurance and Monitoring
Elaine Armstrong, ms
SWOG Quality Assurance Manager

21. QA/Monitoring Common Problems
Regulatory: For sites using the CIRB:
Consent forms deviate from the approved boilerplate language
Unable to determine when consent versions were implemented
Patient Case Review: Eligibility
S1400: Failure to confirm ≥ 20% tumor cells by local pathologist
S1400B & S1400D: Failure to continue with scheduled procedures per study calendar when treatment is delayed
End of Study: Failure to capture labs (revised calendars coming soon)

22. QA/Monitoring Common Problems
Patient Signing the correct consent form
Mixing up the screening consent and the prescreening consent
Patient Case Review: Treatment
Failure to dose reduce per protocol
Failure to document compliance to oral drugs
Patient Case Review: Adverse Events
Failure to report adverse events
Patient Case Review: Data Quality
Delinquent data
Failure to collect and submit specimens

23. Accrual Enhancement Committee
Roy Herbst, MD, PhD
Study co-Chair, Medical Oncology

24. AEC: How We Drive Trial Enrollment
Recruit New Participants:
Social Media Campaigns
Webinars
Press/Media
Promotional Video
Outreach to Lung Cancer Advocacy Groups
Outreach to Lung Cancer Physicians
The Funnel
Screening/Prescreening
Protocol Revisions/New Sub-studies
Help Sites Already Accruing:
Phone Outreach
Tracking Data
Troubleshooting
Materials
Training
Lung-MAP.org Website
Medical Affairs Liaison
Leadership Calls/ s to PIs
Provide Extra Support for High Accruing Sites:
Accrual Planning
Frequent Contact with Site Staff
Personalized Materials
Personalized Social Media
Personalized Outreach to Patient Advocates
Investigator Teleconferences
Our Advisors:
Trial Oversight Committee
Trial Leadership Team
Site Coordinators Committee
Public Affairs Committee

25. AEC: Communication Materials
Protocol Card
Promotional Video
Infographics for Social Media Promotion
E-Brochure for Patient Distribution
Website Search Engine Optimization

26. Protocol Card- Front

27. Protocol Card- Back

28. Site Coordinators Committee (SCC)
Jessica Jordan, BA
Site Coordinator Committee Chair

29. Site Coordinators Committee (SCC)
Meet your new Lung-MAP Site Coordinators Committee (SCC)
Joan Aresco
Jessica Jordan
Nichole Rykbos
Jamie Arnett
Steffany Lim
Stephanie Smith
Wanda M. Burdette
Kathy Malatesta
Tyler Workman
Lavinia Dobrea
Joan Moore

30. SCC Meetings
July 8, 2016:
7 member Working Group reviewed 63 applications
11 of 12 members were selected
12th member will be a Canadian site representative to be chosen later this year
Aug 10, 2016
First SCC Conference Call
Sept 15, 2016
First face-to-face SCC meeting

31. SCC Mission
To represent study site staff at the nursing, CRA, data management, and regulatory levels by providing feedback to and from the study leadership to enhance accrual and improve study management.

32. SCC Activities: Review & recommend accrual materials and strategies
Review changes to study procedures and updates to data collection forms
Provide content for the Lung-MAP newsletter
Assist with planning, development, and implementation of staff training tools
Participate in Update meetings
Assist in promoting the study and encouraging accrual

33. Questions? Contact us at LungmapSCC@crab.org
Have a concern or question?
Want an opportunity to work with the Site Coordinator Committee members?
Do you have an accrual strategy or materials you would like to share?
Do you have tracking forms or procedures to help you manage Lung-MAP at your site?
Send us the information or materials and
include your name, study site, and contact info.
Contact us at

34. Questions? Thank you for your time.
Update
The slides presented today will be available on the SWOG website S1400 Protocol Abstract page Other Study Materials S1400 Group Meeting Materials link