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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 May 09, 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

Milwaukee, Wisconsin, United States

Charleston, South Carolina, United States

Baltimore, Maryland, United States

Baton Rouge, Louisiana, United States

New Orleans, Louisiana, United States

Chicago, Illinois, United States

New York, New York, United States

Portland, Oregon, United States

Nashville, Tennessee, United States

Portland, Oregon, United States

Tampa, Florida, United States

Saint Louis, Missouri, United States

Cleveland, Ohio, United States

Sapporo, Hokkaido, Japan

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

Detroit, Michigan, United States

Taipei, , Taiwan

Huntsville, Alabama, United States

Boca Raton, Florida, United States

Charlottesville, Virginia, United States

Lexington, Kentucky, United States

Heidelberg, Victoria, Australia

Barcelona, , Spain

Madrid, , Spain

Las Palmas De Gran Canaria, Las Palmas, Spain

Nagoya, Aichi, Japan

Kashiwa, Chiba, Japan

Fukuoka, , Japan

Taipei, , Taiwan

Nashville, Tennessee, United States

Sevilla, , Spain

Genova, , Italy

Taichung, , Taiwan

Tainan, , Taiwan

Kaohsiung, , Taiwan

Zürich, , Switzerland

Beijing, Beijing, China

Hamburg, , Germany

West Columbia, South Carolina, United States

Himeji, Hyogo, Japan

Kanazawa, Ishikawa, Japan

Niigata Shi, Niigata, Japan

Paris, , France

Bunkyo Ku, Tokyo, Japan

Birmingham, , United Kingdom

Manchester, , United Kingdom

Zaragoza, , Spain

Changsha, Hunan, China

Shepparton, Victoria, Australia

Torquay, Devon, United Kingdom

Taoyuan, , Taiwan

Graz, Steiermark, Austria

Porto Alegre, Rio Grande Do Sul, Brazil

Columbia, Missouri, United States

Nürnberg, Bayern, Germany

Shenzhen, Guangdong, China

Kyoto, , Japan

Pune, Maharashtra, India

Edegem, Antwerpen, Belgium

Taipei, , Taiwan

Baden, , Switzerland

Berlin, , Germany

Jerez De La Frontera, Cádiz, Spain

Leuven, Vlaams Brabant, Belgium

Changsha, Hunan, China

Shanghai, Shanghai, China

Palo Alto, California, United States

Shanghai, , China

New York, New York, United States

Hidaka, Saitama, Japan

Yokohama, Kanagawa, Japan

Harbin, Heilongjiang, China

Beijing, Beijing, China

Fribourg, , Switzerland

Shantou, Guangdong, China

Shanghai, Shanghai, China

Gauting, Bayern, Germany

Seoul, , Korea, Republic Of

Springdale, Arkansas, United States

Chattanooga, Tennessee, United States

Saint Petersburg, Florida, United States

West Palm Beach, Florida, United States

Linhai, Zhejiang, China

Badajoz, , Spain

Luoyang, Henan, China

Budapest, , Hungary

Yokohama, Kanagawa, Japan

Tucson, Arizona, United States

Chengdu, Sichuan, China

Jinan, Shandong, China

Vancouver, Washington, United States

Hangzhou, Zhejiang, China

Meldola, Emilia Romagna, Italy

Hangzhou, Zhejiang, China

Berlin, , Germany

Birtinya, Queensland, Australia

Erfurt, Thüringen, Germany

Tianjin, Tianjin, China

Yonago, Tottori, Japan

Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of

Edirne, , Turkey

Porto, , Portugal

Guangzhou, Guangdong, China

Pune, Maharashtra, India

Nanning, Guangxi, China

Changchun, Jilin, China

Wuhan, Hubei, China

Zhuzhou, , China

Gaziantep, , Turkey

Kaohsiung, , Taiwan

Hirakata, Osaka, Japan

Wakayama, , Japan

Paris, île De France, France

Jinan, Shandong, China

Orbassano, Piemonte, Italy

Suzhou, Jiangsu, China

Beijing, Beijing, China

Porto, , Portugal

Xi'an, , China

Adana, , Turkey

Pozuelo De Alarcon, Madrid, Spain

Indianapolis, Indiana, United States

Bunkyo Ku, Tokyo, Japan

Milan, Milano, Italy

Berlin, , Germany

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

Samsun, , Turkey

Lisboa, , Portugal

Zwolle, Overijssel, Netherlands

Linz, Oberösterreich, Austria

Neijiang, , China

New Delhi, Delhi, India

Goyang Si, Kyǒnggi Do, Korea, Republic Of

Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of

Beijing, Xicheng District, China

Heidelberg, Baden Württemberg, Germany

Zhongshan, Guangdong, China

Kfar Saba, Hamerkaz, Israel

Busan, Pusan Kwangyǒkshi, Korea, Republic Of

Anyang, Henan, China

Wien, , Austria

Pittsburgh, Pennsylvania, United States

Londrina, Paraná, Brazil

Grosshansdorf, Schleswig Holstein, Germany

Thessaloniki, Thessaloníki, Greece

Harderwijk, Gelderland, Netherlands

Changhua County, Changhua, Taiwan

Marseille, Bouches Du Rhône, France

Larissa, Thessalía, Greece

Chemnitz, Sachsen, Germany

Portland, Oregon, United States

Hartford, Connecticut, United States

Barretos, São Paulo, Brazil

Amsterdam, Noord Holland, Netherlands

Oslo, , Norway

Tainan City, Tainan, Taiwan

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

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

Pamplona, Navarra, Spain

Worcester, Massachusetts, United States

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

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

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

Heraklion, Irakleío, Greece

London, Kensington And Chelsea, United Kingdom

San Diego, California, United States

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

Suwon Si, Kyǒnggi Do, Korea, Republic Of

Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of

New Taipei City, New Taipei, Taiwan

Bari, Puglia, Italy

Bupyeong Gu, Incheon Gwangyeoksi [Incheon], Korea, Republic Of

Budapest, , Hungary

Drammen, Buskerud, Norway

São Paulo, , Brazil

Kielce, świętokrzyskie, Poland

London, Sutton, United Kingdom

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

Hangzhou, Zhejiang, China

Málaga, , Spain

Chengdu, Sichuan, China

Varanasi, Uttar Pradesh, India

Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of

Coimbra, , Portugal

Chiayi, , Taiwan

Nashville, Tennessee, United States

Gangnam Gu, Seoul Teukbyeolsi [Seoul], Korea, Republic Of

Mumbai, Maharashtra, India

Toulouse, Haute Garonne, France

Bron, Rhône, France

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

Szczecin, Zachodniopomorskie, Poland

Istanbul, , Turkey

Thessaloniki, Kentrikí Makedonía, Greece

Athens, Attikí, Greece

Huddersfield, England, United Kingdom

San Antonio, Texas, United States

Ahmedabad, Gujarat, India

Bucharest, București, Romania

Cologne, Nordrhein Westfalen, Germany

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

Springfield, Illinois, United States

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, Västra Götalands Län [Se 14], Sweden

Izmir, , Turkey

East Sussex, Brighton And Hove, United Kingdom

Walnut Creek, California, United States

Spokane Valley, Washington, United States

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