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Search / Trial NCT06890598

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.

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

0 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