LY3537982 for Non-small cell lung cancer | KRAS G12C-mutant non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Have non-small cell lung cancer that is advanced or has spread to another part(s) of the body."}
• {"criterion_text":"- Have cancer with a change in the KRAS G12C gene."}
• {"criterion_text":"- Have a known programmed death-ligand 1 (PD-L1) expression of 0-100%. PD-L1 expression may predict how well the body responds to some types of treatment."}
• {"criterion_text":"- Be able to swallow capsules and/or tablets"}
• {"criterion_text":"- Be well enough to walk and do light work"}

Exclusion criteria

• {"criterion_text":"- Have other types of changes in genes such as EGFR, ALK, BRAF (V600E), HER2, MET (exon 14), ROS1, RET, or NTRK1/2/ that may be targeted treatments."}
• {"criterion_text":"- Have cancer that can be cured with treatments that target a specific part of the body (like surgery or radiation) Have an active infection or any serious medical conditions (other than cancer)"}
• {"criterion_text":"- Have an active infection or any serious medical conditions (other than cancer)"}
• {"criterion_text":"- Have active heart disease causing symptoms; or, history of heart attack or chest pain within 6 months of starting the study."}
• {"criterion_text":"- Have a known history of allergic reaction to components of the study drug (LY3537982), pembrolizumab, pemetrexed or platinum containing drugs"}

Primary endpoints

• {"endpoint_text":"- PFS per RECIST v1.1 by BICR","definition_or_measurement_approach":"Progression-free survival (PFS) assessed per RECIST v1.1 by blinded independent central review (BICR)."}

Methods

• Use of country-specific recruitment materials including posters, brochures, trial-awareness brochures, doctor referral letters and visit cards (documents present for multiple countries e.g. CZ, BE, SE, PT, PL, NO, IT, ES, GR, HU).
• Site lists and study guides distributed to participating sites; study participant contact cards and patient information cards for participants.
• Patient-facing communications and reminders using Greenphire ClinCard materials (fee schedules, cardholder FAQ, messaging templates) and Medable eCOA materials.

Primary sponsor

Full Name

Eli Lilly & Co.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Iqvia Rds Inc.

Responsibilities

Listed sponsor duties include roles with codes [1,12,2] (clinical operations/support roles indicated in sponsor duties)

Name

Pharmaceutical Product Development LLC

Responsibilities

Sponsor duties code 10 listed (role details not expanded in record)

Name

PPD / Pharmaceutical Product Development LLC

Responsibilities

CRO functions indicated (sponsor duties present) as per submission

Third parties

• {"country":"United States","full_name":"Precision for Medicine (aka Quartz Bio)","duties_or_roles":"Sponsor duties codes: 4","organisation_type":"Health care"}
• {"country":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"Negotiation and Execution of Clinical trial agreements with the participating sites, make study payments based on invoices (sponsor duty value provided)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"Sponsor duties codes: 6","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"Sponsor duties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Biotel Research LLC","duties_or_roles":"Sponsor duties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Sponsor duties codes: 6","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"In vitro diagnostics, provide biomarker analysis services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"Sponsor duties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Clinical Trial Reimbursement (value provided)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"Sponsor duties codes: 1, 12, 2","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Sponsor duties codes: 10","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"Sponsor duties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"QIAGEN Manchester Limited","duties_or_roles":"Sponsor duties codes: 4","organisation_type":"Health care"}
• {"country":"United States","full_name":"Biotel Research LLC","duties_or_roles":"Sponsor duties codes: 4","organisation_type":"Pharmaceutical company"}