Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
Launched by ELI LILLY AND COMPANY · Mar 21, 2025
Trial Information
Current as of April 29, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called olomorasib, which is being tested alongside standard treatments for patients with a specific type of lung cancer known as KRAS G12C-mutant non-small cell lung cancer (NSCLC). The main goal is to see if combining olomorasib with other medications (pembrolizumab or durvalumab) works better than using these medications alone with a placebo (a substance with no active treatment). There are two parts to the study: one for patients who have had surgery for their cancer but still have some remaining tumor, and another for patients whose cancer cannot be surgically removed.
To be eligible for this trial, participants must have a confirmed diagnosis of NSCLC with a specific mutation (KRAS G12C) and be in certain stages of their disease. They should also be in fairly good health, able to swallow pills, and meet other health requirements. The trial may last up to three years, and participants will receive regular check-ups and monitoring throughout the study to assess how well the treatment is working and to manage any side effects. This trial is actively recruiting patients of all genders, aged between 65 and 74.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Histological or cytological confirmation of NSCLC.
- • Part A
- • 1. Clinical Stage II-IIIB (N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.
- • 2. Pathologic Stage II-IIIB (N2) NSCLC treated with initial upfront resection.
- • Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.
- • Must have disease with evidence of KRAS G12C mutation.
- • Must have known programmed death-ligand 1 (PD-L1) expression
- • Must have an ECOG performance status of 0 or 1.
- • Able to swallow oral medication.
- • Must have adequate laboratory parameters.
- • Contraceptive use should be consistent with local regulations for those participating in clinical studies.
- • Women of childbearing potential must
- • Have a negative pregnancy test.
- • Not be breastfeeding during treatment
- Exclusion Criteria:
- • Have known changes in the EGFR or ALK genes.
- • Have another type of cancer that is progressing or required active treatment within the past 3 years before screening.
- • Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
- • Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.
About Eli Lilly And Company
Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
West Columbia, South Carolina, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Shepparton, Victoria, Australia
Traralgon, Victoria, Australia
Linz, Oberösterreich, Austria
Graz, Steiermark, Austria
Wien, , Austria
Edegem, Antwerpen, Belgium
Rio De Janeiro, , Brazil
Barretos, São Paulo, Brazil
Rio De Janeiro, , Brazil
Campinas, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
São Paulo, , Brazil
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
São Paulo, , Brazil
New Taipei City, New Taipei, Taiwan
New Taipei City, New Taipei, Taiwan
São Paulo, , Brazil
Rennes, Ille Et Vilaine, France
Manchester, , United Kingdom
La Tronche, Isère, France
Columbia, Missouri, United States
Banska Bystrica, Banskobystrický Kraj, Slovakia
Saint Louis, Missouri, United States
Suwon Si, Kyǒnggi Do, Korea, Republic Of
Bunkyo Ku, Tokyo, Japan
Seongnam, Kyǒnggi Do, Korea, Republic Of
Taipei, , Taiwan
Yangsan, Kyǒngsangnam Do, Korea, Republic Of
Miami, Florida, United States
Walnut Creek, California, United States
Fort Wayne, Indiana, United States
Westwood, Kansas, United States
Hartford, Connecticut, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Portland, Oregon, United States
Portland, Oregon, United States
Portland, Oregon, United States
Boca Raton, Florida, United States
Portland, Oregon, United States
Oslo, , Norway
Philadelphia, Pennsylvania, United States
London, Kensington And Chelsea, United Kingdom
Charlottesville, Virginia, United States
London, Sutton, United Kingdom
Birmingham, , United Kingdom
Spokane Valley, Washington, United States
Niigata Shi, Niigata, Japan
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Bunkyo Ku, Tokyo, Japan
Houston, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Yonago, Tottori, Japan
The Woodlands, Texas, United States
Wakayama, , Japan
Richmond, Virginia, United States
Kurralta Park, South Australia, Australia
Heidelberg, Victoria, Australia
Seattle, Washington, United States
Vancouver, Washington, United States
Milwaukee, Wisconsin, United States
North Tamworth, New South Wales, Australia
Neijiang, , China
Tianjin, Tianjin, China
Hangzhou, Zhejiang, China
Auchenflower, Queensland, Australia
Birtinya, Queensland, Australia
Vantoux, Lorraine, France
Ostrava, Ostrava Město, Czechia
Hangzhou, Zhejiang, China
Prague, Praha 8, Czechia
Hangzhou, Zhejiang, China
Nice, Alpes Maritimes, France
Linhai, Zhejiang, China
Paris, , France
Paris, île De France, France
Paris, île De France, France
Pessac, Aquitaine, France
Marseille, Bouches Du Rhône, France
Heidelberg, Baden Württemberg, Germany
Stuttgart, Baden Württemberg, Germany
Tübingen, Baden Württemberg, Germany
Toulouse, Haute Garonne, France
Farkasgyepu, Veszprém, Hungary
Athens, Attikí, Greece
Budapest, , Hungary
Budapest, , Hungary
Athens, Attikí, Greece
Patna, Bihar, India
New Delhi, Delhi, India
Ahmedabad, Gujarat, India
Heraklion, Irakleío, Greece
Thessaloniki, Kentrikí Makedonía, Greece
Kashiwa, Chiba, Japan
Sapporo, Hokkaido, Japan
Himeji, Hyogo, Japan
Thessaloniki, Thessaloníki, Greece
Larissa, Thessalía, Greece
Kanazawa, Ishikawa, Japan
Yokohama, Kanagawa, Japan
Koto, Tokyo, Japan
Fukuoka, , Japan
Yokohama, Kanagawa, Japan
Kyoto, , Japan
Cheongju Si, Chungcheongbuk Do [Chungbuk], Korea, Republic Of
Hirakata, Osaka, Japan
Bupyeong Gu, Incheon Gwangyeoksi [Incheon], Korea, Republic Of
Hwasun Gun, Jeonranamdo, Korea, Republic Of
Goyang Si, Kyǒnggi Do, Korea, Republic Of
Hidaka, Saitama, Japan
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Nagaizumi Cho,Sunto Gun, Shizuoka, Japan
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Deagu, Taegu Kwangyǒkshi, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Nam Gu, Taegu Kwangyǒkshi, Korea, Republic Of
Harderwijk, Gelderland, Netherlands
Breda, Noord Brabant, Netherlands
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, , Korea, Republic Of
Tilburg, Noord Brabant, Netherlands
Daegu, Taegu Kwangyǒkshi, Korea, Republic Of
Amsterdam, Noord Holland, Netherlands
Amsterdam, Noord Holland, Netherlands
Bratislava, Bratislavský Kraj, Slovakia
Kosice, , Slovakia
Zwolle, Overijssel, Netherlands
Utrecht, , Netherlands
Arendal, Aust Agder, Norway
Santiago De Compostela, A Coruña [La Coruña], Spain
Palma, Balears [Baleares], Spain
Taichung City, Taichung, Taiwan
Barcelona, Barcelona [Barcelona], Spain
Tainan City, Tainan, Taiwan
Tainan City, Tainan, Taiwan
Barcelona, Barcelona [Barcelona], Spain
Taipei City, Taipei, Taiwan
Hospitalet, Barcelona [Barcelona], Spain
Barcelona, , Spain
Kaohsiung, , Taiwan
Taichung, , Taiwan
Tainan, , Taiwan
Taipei, , Taiwan
Douliu City, Yunlin, Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Chiayi, , Taiwan
Kaohsiung, , Taiwan
Antalya, , Turkey
Edirne, , Turkey
Adapazarı, Sakarya, Turkey
Adana, , Turkey
Adana, , Turkey
Huntsville, Alabama, United States
Gaziantep, , Turkey
Istanbul, , Turkey
Tucson, Arizona, United States
Springdale, Arkansas, United States
Los Angeles, California, United States
Indianapolis, Indiana, United States
Istanbul, , Turkey
Izmir, , Turkey
Samsun, , Turkey
Nanning, Guangxi, China
Harbin, Heilongjiang, China
Anyang, Henan, China
Luoyang, Henan, China
East Sussex, Brighton And Hove, United Kingdom
Torquay, Devon, United Kingdom
Huddersfield, England, United Kingdom
Wuhan, Hubei, China
Wuhan, Hubei, China
Changsha, Hunan, China
Changsha, Hunan, China
Gauting, Bayern, Germany
Kfar Saba, Hamerkaz, Israel
Ramat Gan, Hamerkaz, Israel
Haifa, Hatsafon, Israel
Kempten, Bayern, Germany
Jerusalem, Yerushalayim, Israel
Meldola, Emilia Romagna, Italy
Nürnberg, Bayern, Germany
Cologne, Nordrhein Westfalen, Germany
Monza, Lombardia, Italy
Düsseldorf, Nordrhein Westfalen, Germany
Milan, Milano, Italy
Köln, Nordrhein Westfalen, Germany
Naples, Napoli, Italy
Orbassano, Piemonte, Italy
Halle, Sachsen Anhalt, Germany
Bari, Puglia, Italy
Rome, Roma, Italy
Catania, Sicilia, Italy
Chemnitz, Sachsen, Germany
Verona, Veneto, Italy
Genova, , Italy
Leipzig, Sachsen, Germany
Aurangabad, Maharashtra, India
Mumbai, Maharashtra, India
Nagoya, Aichi, Japan
Pune, Maharashtra, India
Busan, Pusan Kwangyǒkshi, Korea, Republic Of
Gangnam Gu, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Pune, Maharashtra, India
Udaipur, Rajasthan, India
Poznan, Wielkopolskie, Poland
Szczecin, Zachodniopomorskie, Poland
Kielce, świętokrzyskie, Poland
Coimbra, , Portugal
Varanasi, Uttar Pradesh, India
Lisboa, , Portugal
Badajoz, , Spain
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Porto, , Portugal
Saint Petersburg, Florida, United States
Cleveland, Ohio, United States
Porto, , Portugal
Bucharest, București, Romania
Bucharest, București, Romania
Liuzhou, , China
Tampa, Florida, United States
West Palm Beach, Florida, United States
Chicago, Illinois, United States
Ovidiu, Constanța, Romania
Cluj, , Romania
Guangzhou, Guangdong, China
Shantou, Guangdong, China
Beijing, Xicheng District, China
Beijing, Beijing, China
Chongqing, Chongqing, China
Shenzhen, Guangdong, China
Shenzhen, Guangdong, China
Foshan, Guangdong, China
Zhongshan, Guangdong, China
Guangzhou, Guangdong, China
Zhuzhou, , China
Oceanside, California, United States
Palo Alto, California, United States
Suzhou, Jiangsu, China
San Diego, California, United States
Chicago, Illinois, United States
Springfield, Illinois, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Baton Rouge, Louisiana, United States
Changchun, Jilin, China
Xi'an, , China
Worcester, Massachusetts, United States
Detroit, Michigan, United States
New York, New York, United States
Jinan, Shandong, China
Jinan, Shandong, China
Shanghai, Shanghai, China
Shanghai, , China
Shanghai, Shanghai, China
Cheng Du, Sichuan, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Saint Herblain, Loire Atlantique, France
Reims, Marne, France
Lyon Cedex08, Rhône Alpes, France
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Bron, Rhône, France
Villejuif, Val De Marne, France
Auderghem, Bruxelles Capitale, Région De, Belgium
Poitiers, Vienne, France
Donauwörth, Bayern, Germany
Leuven, Vlaams Brabant, Belgium
Roeselare, West Vlaanderen, Belgium
Grosshansdorf, Schleswig Holstein, Germany
Hefei, Anhui, China
Fortaleza, Ceará, Brazil
Belo Horizonte, Minas Gerais, Brazil
Londrina, Paraná, Brazil
Belem, Pará, Brazil
Beijing, Beijing, China
Beijing, Beijing, China
Natal, Rio Grande Do Norte, Brazil
Bento Gonçalves, Rio Grande Do Sul, Brazil
Erfurt, Thüringen, Germany
Berlin, , Germany
Porto Alegre, Rio Grande Do Sul, Brazil
Berlin, , Germany
Jerez De La Frontera, Cádiz, Spain
Berlin, , Germany
Las Palmas De Gran Canaria, Las Palmas, Spain
Madrid, Madrid, Comunidad De, Spain
Georgsmarienhütte, , Germany
Hamburg, , Germany
Patras, Achaḯa, Greece
Madrid, , Spain
Madrid, Madrid, Comunidad De, Spain
Athens, Attikí, Greece
Rohtak, Haryana, India
Drammen, Buskerud, Norway
Pozuelo De Alarcon, Madrid, Spain
Bergen, Hordaland, Norway
Pamplona, Navarra, Spain
Valencia, Valenciana, Comunitat, Spain
Málaga, , Spain
Sevilla, , Spain
Zaragoza, , Spain
Göteborg, Västra Götalands Län [Se 14], Sweden
Baden, , Switzerland
Fribourg, , Switzerland
Zürich, , Switzerland
Gjøvik, Oppland, Norway
Saint Louis, Missouri, United States
Changhua County, Changhua, Taiwan
Hualien City, Hualien, Taiwan
Patients applied
Trial Officials
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported