Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
Condition(s) studied
Investigational drug(s) / intervention(s)
LY3537982: Oral
Pembrolizumab: Intravenous
Cetuximab: Intravenous
Pemetrexed: Intravenous
Cisplatin: Intravenous
Carboplatin: Intravenous
Study summary
The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.
Eligibility
Primary outcome measure(s)
- Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY3537982 monotherapy — Cycle 1 (21 Days)
Measured by the number of patients with dose-limiting toxicities (DLTs) - Phase 1b: To assess the safety and tolerability of LY3537982 when administered alone or in combination with other investigational agents — Cycle 1 (21 Days)
Measured by the number of patients with dose-limiting toxicities (DLTs) - Phase 1b: To determine the optimal dose of LY3537982 to be administered to treatment-naïve participants with advanced NSCLC in combination with pembrolizumab — Estimated up to 2 years
Measured by TEAEs - To determine the optimal dose of LY3537982 to be administered to participants who have received at least one prior oxaliplatin- or irinotecan-containing regimen for advanced or metastatic CRC in combination with cetuximab — Estimated up to 2 years
- To assess the antitumor activity of LY3537982 monotherapy in participants with advanced pancreatic cancer with KRAS G12C mutation — Estimated up to 2 years
Trial sites (49)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| USC Norris Cancer Hospital | Los Angeles | California | |
| Chao Family Comprehensive Cancer Ctr. | Orange | California | |
| Yale-New Haven Hospital | New Haven | Connecticut | |
| AdventHealth Orlando | Orlando | Florida | |
| Florida Cancer Specialists | Sarasota | Florida | |
| Indiana Univ Melvin & Bren Simon Cancer Center | Indianapolis | Indiana | |
| Community Health Network | Indianapolis | Indiana | |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | |
| NYU Langone Health- Long Island | Mineola | New York | |
| NYU Langone | New York | New York | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | |
| Novant Health Cancer Institute - Elizabeth | Charlotte | North Carolina | |
| Novant Health Cancer Institute - Forsyth | Winston-Salem | North Carolina | |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | |
| Sarah Cannon Cancer Center | Nashville | Tennessee | |
| Vanderbilt Univeristy School of Medicine | Nashville | Tennessee | |
| South Texas Accelerated Research Therapeutics (START) | San Antonio | Texas | |
| START Mountain Region | West Valley City | Utah | |
| Inova Health System IRB | Fairfax | Virginia | |
| USO-Virginia Cancer Specialists, PC | Fairfax | Virginia | |
| University of Wisconsin-Madison Hospital and Health Clinic | Madison | Wisconsin | |
| Royal North Shore Hospital | St Leonards | New South Wales | |
| St Vincent's Hospital Sydney | Sydney | New South Wales | |
| Cancer Research SA | Adelaide | South Australia | |
| Peninsula and Southeast Oncology | Frankston | Victoria | |
| Linear Clinical Research | Nedlands | Western Australia | |
| Cross Cancer Institute | Edmonton | Alberta | |
| Princess Margaret Hospital (Ontario) | Toronto | Ontario | |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest | Bordeaux | Aquitaine | |
| Centre Leon Berard | Lyon | Auvergne-Rhône-Alpes | |
| Institut du Cancer de Montpellier - Val d'aurelle | Montpellier | France | |
| Institut Claudius Regaud - IUCT Oncopole | Toulouse | France | |
| Gustave Roussy | Villejuif | France | |
| Aichi Cancer Center Hospital | Nagoya | Aichi-ken | |
| National Cancer Center Hospital East | Kashiwa | Chiba |
+ 9 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Eli Lilly and Company trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04956640 on ClinicalTrials.gov ↗ ← All trials in the USA