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 September 18, 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
Baltimore, Maryland, United States
Milwaukee, Wisconsin, United States
Charleston, South Carolina, United States
Baltimore, Maryland, United States
Buffalo, New York, United States
Baton Rouge, Louisiana, United States
New Orleans, Louisiana, United States
Chicago, Illinois, United States
New York, New York, United States
Madrid, Spain
Portland, Oregon, United States
Nashville, Tennessee, United States
Portland, Oregon, United States
Washington, District Of Columbia, United States
Tampa, Florida, United States
Houston, Texas, United States
Saint Louis, Missouri, United States
Cleveland, Ohio, United States
Sapporo, Hokkaido, Japan
Birmingham, Alabama, United States
Portland, Oregon, United States
Saint Louis, Missouri, United States
Chicago, Illinois, United States
Houston, Texas, United States
Jacksonville, Florida, United States
Seattle, Washington, United States
Knoxville, Tennessee, United States
Hackensack, New Jersey, United States
Fort Worth, Texas, United States
Detroit, Michigan, United States
Taipei, Taiwan
Huntsville, Alabama, United States
Huddersfield, United Kingdom
Taichung City, Taiwan
Boca Raton, Florida, United States
Charlottesville, Virginia, United States
Northport, New York, United States
Lexington, Kentucky, United States
Sapporo, Japan
Heidelberg, Victoria, Australia
Perth, Western Australia, Australia
Barcelona, Spain
Madrid, Spain
Las Palmas De Gran Canaria, Las Palmas, Spain
Nagoya, Aichi, Japan
Kashiwa, Chiba, Japan
Fukuoka, Japan
Erfurt, Germany
Beijing, China
Taipei, Taiwan
Paris, France
Nashville, Tennessee, United States
Sevilla, Spain
Genova, Italy
Taichung, Taiwan
Tainan, Taiwan
Perth, Australia
Kaohsiung, Taiwan
Leuven, Belgium
Zürich, Switzerland
Patras, Greece
Seoul, Korea, Republic Of
Seoul, Korea, Republic Of
Beijing, Beijing, China
Hamburg, Germany
West Columbia, South Carolina, United States
Himeji, Hyogo, Japan
Kanazawa, Ishikawa, Japan
Niigata Shi, Niigata, Japan
Seoul, Korea, Republic Of
Paris, France
Yonago, Japan
Bunkyo Ku, Tokyo, Japan
Barcelona, Spain
Birmingham, United Kingdom
Manchester, United Kingdom
Beijing, China
Hirakata, Japan
Seoul, Korea, Republic Of
Zaragoza, Spain
Graz, Austria
Valencia, Spain
Changsha, Hunan, China
Meldola, Italy
Shepparton, Victoria, Australia
Larissa, Greece
Gauting, Germany
Halle, Germany
Chemnitz, Germany
New Brunswick, New Jersey, United States
Natori, Miyagi, Japan
Torquay, Devon, United Kingdom
Nürnberg, Germany
Taoyuan, Taiwan
Heidelberg, Germany
Graz, Steiermark, Austria
Porto Alegre, Rio Grande Do Sul, Brazil
Columbia, Missouri, United States
Nürnberg, Bayern, Germany
Harbin, China
Jerusalem, Israel
Goyang Si, Korea, Republic Of
Shenzhen, Guangdong, China
Kyoto, Japan
Pune, Maharashtra, India
Edegem, Antwerpen, Belgium
Taipei, Taiwan
Baden, Switzerland
Berlin, Germany
Jerez De La Frontera, Cádiz, Spain
Kashiwa, Japan
Seongnam, Korea, Republic Of
Leuven, Vlaams Brabant, Belgium
Changsha, Hunan, China
Shanghai, Shanghai, China
Kanazawa, Japan
Palo Alto, California, United States
Shanghai, China
Madrid, Spain
New York, New York, United States
Hidaka, Saitama, Japan
Yokohama, Kanagawa, Japan
Yangsan, Korea, Republic Of
Harbin, Heilongjiang, China
Beijing, Beijing, China
Fribourg, Switzerland
Shantou, Guangdong, China
Shanghai, Shanghai, China
Gauting, Bayern, Germany
Saint Herblain, France
Seoul, Korea, Republic Of
New Taipei City, Taiwan
Torquay, United Kingdom
Edegem, Belgium
Gjøvik, Norway
Reims, France
Springdale, Arkansas, United States
Jinan, China
Paris, France
Chattanooga, Tennessee, United States
Wuhan, China
Haifa, Israel
Saint Petersburg, Florida, United States
West Palm Beach, Florida, United States
Kfar Saba, Israel
Linhai, Zhejiang, China
Badajoz, Spain
Luoyang, Henan, China
Budapest, Hungary
Yokohama, Kanagawa, Japan
Busan, Korea, Republic Of
Tucson, Arizona, United States
Chengdu, Sichuan, China
Jinan, Shandong, China
Vancouver, Washington, United States
Pamplona, Spain
Hangzhou, China
Hangzhou, Zhejiang, China
Meldola, Emilia Romagna, Italy
Hangzhou, Zhejiang, China
Berlin, Germany
Cheongju Si, Korea, Republic Of
Birtinya, Queensland, Australia
Erfurt, Thüringen, Germany
Heidelberg, Australia
Tianjin, Tianjin, China
Bunkyo Ku, Japan
Linhai, China
Chennai, India
Yonago, Tottori, Japan
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Edirne, Turkey
Pune, India
Porto, Portugal
Grosshansdorf, Germany
Beijing, Beijing, China
Shenzhen, China
Poitiers, France
Ramat Gan, Israel
Guangzhou, Guangdong, China
Guangzhou, China
Bergen, Norway
Pune, Maharashtra, India
Nanning, Guangxi, China
Changchun, Jilin, China
Wuhan, Hubei, China
Zhuzhou, China
Gaziantep, Turkey
Kaohsiung, Taiwan
Porto Alegre, Brazil
Nice, France
Hirakata, Osaka, Japan
Wakayama, Japan
Villejuif, France
Heraklion, Greece
Tilburg, Netherlands
Paris, île De France, France
Jinan, Shandong, China
Orbassano, Piemonte, Italy
Suzhou, Jiangsu, China
Beijing, Beijing, China
Porto, Portugal
Xi'an, China
Seoul, Korea, Republic Of
Adana, Turkey
Changsha, China
Chengdu, China
Guangzhou, China
Pozuelo De Alarcon, Madrid, Spain
Harderwijk, Netherlands
Rome, Italy
Hidaka, Japan
Tianjin, China
La Tronche, France
North Chicago, Illinois, United States
Indianapolis, Indiana, United States
Changsha, China
Amsterdam, Netherlands
Oslo, Norway
Tübingen, Germany
Daegu, Korea, Republic Of
Bunkyo Ku, Tokyo, Japan
Nagoya, Japan
Linz, Austria
Milan, Milano, Italy
Berlin, Germany
Saint Petersburg, Florida, United States
Milan, Italy
Auchenflower, Queensland, Australia
Miami, Florida, United States
Seongnam, Kyǒnggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Fort Myers, Florida, United States
Natal, Rio Grande Do Norte, Brazil
Monza, Italy
Samsun, Turkey
Seoul, Korea, Republic Of
Beijing, China
Suwon Si, Korea, Republic Of
Lisboa, Portugal
Zwolle, Overijssel, Netherlands
Madison, Wisconsin, United States
Linz, Oberösterreich, Austria
Neijiang, China
Pozuelo De Alarcon, Spain
Hwasun Gun, Korea, Republic Of
New Delhi, Delhi, India
Goyang Si, Kyǒnggi Do, Korea, Republic Of
Yokohama, Japan
Niigata Shi, Japan
Birtinya, Australia
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Beijing, Xicheng District, China
Heidelberg, Baden Württemberg, Germany
Zhongshan, Guangdong, China
Kfar Saba, Hamerkaz, Israel
Düsseldorf, Germany
Roeselare, Belgium
Edmonds, Washington, United States
Beijing, China
Busan, Pusan Kwangyǒkshi, Korea, Republic Of
Anyang, Henan, China
Wien, Austria
Pittsburgh, Pennsylvania, United States
Jinan, China
Londrina, Paraná, Brazil
Grosshansdorf, Schleswig Holstein, Germany
Thessaloniki, Thessaloníki, Greece
Harderwijk, Gelderland, Netherlands
Changhua County, Changhua, Taiwan
Marseille, Bouches Du Rhône, France
Kielce, Poland
Larissa, Thessalía, Greece
Chemnitz, Sachsen, Germany
Portland, Oregon, United States
Hartford, Connecticut, United States
Natori, Japan
Palma, Spain
Vantoux, France
Barretos, São Paulo, Brazil
Amsterdam, Noord Holland, Netherlands
Oslo, Norway
Chennai, Tamil Nadu, India
Tainan City, Tainan, Taiwan
Thiruvananthapuram, Kerala, India
Las Palmas De Gran Canaria, Spain
Roeselare, West Vlaanderen, Belgium
Patras, Achaḯa, Greece
Athens, Attikí, Greece
Naples, Napoli, Italy
Poznan, Wielkopolskie, Poland
Tainan City, Tainan, Taiwan
Adana, Turkey
Haifa, Hatsafon, Israel
Jerusalem, Yerushalayim, Israel
New Taipei City, Taiwan
Guangzhou, Guangdong, China
Ramat Gan, Hamerkaz, Israel
São Paulo, Brazil
Barcelona, Barcelona [Barcelona], Spain
Poitiers, Vienne, France
Catania, Sicilia, Italy
Hwasun Gun, Jeonranamdo, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Shepparton, Australia
Pamplona, Navarra, Spain
Verona, Italy
Koto, Japan
Worcester, Massachusetts, United States
Bari, Italy
Palma, Balears [Baleares], Spain
Barcelona, Barcelona [Barcelona], Spain
Madrid, Madrid, Comunidad De, Spain
Santiago De Compostela, A Coruña [La Coruña], Spain
Madrid, Madrid, Comunidad De, Spain
Koto, Tokyo, Japan
Verona, Veneto, Italy
Taichung City, Taichung, Taiwan
Los Angeles, California, United States
Burlington, Vermont, United States
Fortaleza, Ceará, Brazil
Wuhan, Hubei, China
Saint Herblain, Loire Atlantique, France
Tilburg, Noord Brabant, Netherlands
Utrecht, Netherlands
Amsterdam, Noord Holland, Netherlands
Douliu City, Yunlin, Taiwan
Sao Paulo, São Paulo, Brazil
Tübingen, Baden Württemberg, Germany
Monza, Lombardia, Italy
Cheongju Si, Chungcheongbuk Do [Chungbuk], Korea, Republic Of
Valencia, Valenciana, Comunitat, Spain
Antalya, Turkey
Istanbul, Turkey
Villejuif, Val De Marne, France
Bergen, Hordaland, Norway
Orange, California, United States
Rio De Janeiro, Brazil
La Tronche, Isère, France
New Taipei City, New Taipei, Taiwan
Rennes, Ille Et Vilaine, France
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Prague, Praha 8, Czechia
Paris, île De France, France
Breda, Noord Brabant, Netherlands
Westwood, Kansas, United States
Auderghem, Bruxelles Capitale, Région De, Belgium
Belo Horizonte, Minas Gerais, Brazil
Richmond, Virginia, United States
Pessac, Aquitaine, France
Kempten, Bayern, Germany
Campinas, São Paulo, Brazil
Nagaizumi Cho,Sunto Gun, Shizuoka, Japan
Barcelona, Spain
Heraklion, Irakleío, Greece
Nanning, China
London, Kensington And Chelsea, United Kingdom
San Diego, California, United States
Ovidiu, Romania
Pune, India
Donauwörth, Bayern, Germany
Hospitalet, Barcelona [Barcelona], Spain
Belem, Pará, Brazil
Nice, Alpes Maritimes, France
Rome, Roma, Italy
Lyon Cedex08, Rhône Alpes, France
Athens, Attikí, Greece
Sugar Land, Texas, United States
Reims, Marne, France
Natal, Rio Grande Do Norte, Brazil
Cheng Du, Sichuan, China
Ovidiu, Constanța, Romania
Marseille, France
Catania, Italy
Farkasgyepu, Hungary
Suwon Si, Kyǒnggi Do, Korea, Republic Of
Zwolle, Netherlands
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
New Taipei City, New Taipei, Taiwan
Bari, Puglia, Italy
Bupyeong Gu, Korea, Republic Of
Budapest, Hungary
Naples, Italy
Poznan, Poland
Londrina, Brazil
Jerez De La Frontera, Spain
Drammen, Buskerud, Norway
Thessaloniki, Greece
São Paulo, Brazil
Kielce, świętokrzyskie, Poland
London, Sutton, United Kingdom
Seoul, Korea, Republic Of
Banska Bystrica, Banskobystrický Kraj, Slovakia
Foshan, Guangdong, China
Daegu, Taegu Kwangyǒkshi, Korea, Republic Of
Hualien City, Hualien, Taiwan
Deagu, Taegu Kwangyǒkshi, Korea, Republic Of
Cluj, Romania
Taipei City, Taipei, Taiwan
Rennes, France
Hangzhou, Zhejiang, China
Málaga, Spain
Santiago De Compostela, Spain
Chengdu, Sichuan, China
Varanasi, Uttar Pradesh, India
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Coimbra, Portugal
Chiayi, Taiwan
Tainan City, Taiwan
Nashville, Tennessee, United States
Gangnam Gu, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Mumbai, Maharashtra, India
Toulouse, Haute Garonne, France
Bron, Rhône, France
Santiago, Región Metropolitana De Santiago, Chile
Amsterdam, Netherlands
Traralgon, Victoria, Australia
Oceanside, California, United States
Philadelphia, Pennsylvania, United States
Bento Gonçalves, Rio Grande Do Sul, Brazil
Vantoux, Lorraine, France
Halle, Sachsen Anhalt, Germany
Gjøvik, Oppland, Norway
Köln, Nordrhein Westfalen, Germany
Santiago, Región Metropolitana De Santiago, Chile
Tainan City, Taiwan
Szczecin, Zachodniopomorskie, Poland
Istanbul, Turkey
Thessaloniki, Kentrikí Makedonía, Greece
Athens, Attikí, Greece
Lexington, Kentucky, United States
Huddersfield, England, United Kingdom
San Antonio, Texas, United States
Ahmedabad, Gujarat, India
Bucharest, București, Romania
Traralgon, Australia
Cologne, Nordrhein Westfalen, Germany
Sao Paulo, Brazil
Kurralta Park, South Australia, Australia
Fort Wayne, Indiana, United States
Lexington, Kentucky, United States
Bucharest, București, Romania
Liuzhou, China
Adapazarı, Sakarya, Turkey
Rio De Janeiro, Brazil
São Paulo, Brazil
Farkasgyepu, Veszprém, Hungary
Udaipur, Rajasthan, India
Prague, Czechia
Shantou, China
Springfield, Illinois, United States
Douliu City, Taiwan
Changhua County, Taiwan
Anyang, China
The Woodlands, Texas, United States
North Tamworth, New South Wales, Australia
Hefei, Anhui, China
Chongqing, Chongqing, China
Shenzhen, Guangdong, China
Ostrava, Ostrava Město, Czechia
Stuttgart, Baden Württemberg, Germany
Düsseldorf, Nordrhein Westfalen, Germany
Leipzig, Sachsen, Germany
Georgsmarienhütte, Germany
Patna, Bihar, India
Rohtak, Haryana, India
Aurangabad, Maharashtra, India
Yangsan, Kyǒngsangnam Do, Korea, Republic Of
Nam Gu, Taegu Kwangyǒkshi, Korea, Republic Of
Arendal, Aust Agder, Norway
Bratislava, Bratislavský Kraj, Slovakia
Kosice, Slovakia
Göteborg, Sweden
Izmir, Turkey
East Sussex, Brighton And Hove, United Kingdom
Westbrook, Maine, United States
Drammen, Norway
Walnut Creek, California, United States
Spokane Valley, Washington, United States
Providencia, Región Metropolitana De Santiago, Chile
Thalassery, Kerala, India
Namakkal, Tamil Nadu, India
Sakai, Osaka, Japan
Pendik, İstanbul, Turkey
Adapazari, Sakarya, Turkey
Gangnam Gu, Korea, Republic Of
Banska Bystrica, Slovakia
Barretos, Brazil
Deagu, Korea, Republic Of
Athens, Greece
Athens, Greece
Campinas, Brazil
Hospitalet, Spain
Auderghem, Belgium
Belem, Brazil
Thessaloniki, Greece
Bucharest, Romania
Bucharest, Romania
Santiago, Chile
Lyon Cedex08, France
Bupyeong Gu, Korea, Republic Of
Santiago, Chile
Fortaleza, Brazil
Bron, France
Athens, Greece
Stuttgart, Germany
Ostrava, Czechia
Providencia, Chile
Nam Gu, Korea, Republic Of
Bratislava, Slovakia
Göteborg, Sweden
Pendik, Turkey
Baton Rouge, Louisiana, United States
Santiago, Chile
Herne, Nordrhein Westfalen, Germany
Kaohsiung Niao Sung Dist, Taiwan
Wuhan, China
Pessac, France
Auchenflower, Australia
Belo Horizonte, Brazil
Bento Gonçalves, Brazil
Changchun, China
Cheng Du, China
Chengdu, China
Toulouse, France
Cologne, Germany
Donauwörth, Germany
Ahmedabad, India
Thiruvananthapuram, India
Udaipur, India
Varanasi, India
Bunkyo Ku, Japan
Himeji, Japan
Nagaizumi Cho,Sunto Gun, Japan
Yokohama, Japan
Szczecin, Poland
Hualien City, Taiwan
Taipei City, Taiwan
Cherry Hill, New Jersey, United States
Sewell, New Jersey, United States
Philadelphia, Pennsylvania, United States
Kurralta Park, Australia
North Tamworth, Australia
Natal, Brazil
Chongqing, China
Foshan, China
Luoyang, China
Shenzhen, China
Zhongshan, China
Herne, Germany
Köln, Germany
Leipzig, Germany
Aurangabad, India
Mumbai, India
Namakkal, India
Patna, India
Thalassery, India
Orbassano, Italy
Sakai, Japan
Breda, Netherlands
Arendal, Norway
Adapazari, Turkey
East Sussex, United Kingdom
London, United Kingdom
London, United Kingdom
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