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NCT06119581Recruiting

A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

Official recordSimplified version

Summary

The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.

Inclusion criteria

• Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy. • Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label). • Must have disease with evidence of KRAS G12C mutation. • Must have known programmed death-ligand 1 (PD-L1) expression • Part A: Greater than or equal to (≥)50 percent (%). • Part B: 0% to 100%. • Part C: \<50%. • Must have measurable disease per RECIST v1.1. • Must have an ECOG performance status of 0 or 1. • Estimated life expectancy ≥12 weeks. • Ability to swallow capsules. • 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 a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1/2/3. • Have had any of the following prior to randomization: \-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC. \--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated: • Have known active central nervous system metastases and/or carcinomatous meningitis. Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B) • Have predominantly squamous cell histology for NSCLC • Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed • Is unable or unwilling to take folic acid or vitamin B12 supplementation.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 3
Study type
Interventional
Countries
Switzerland, France, Germany, Italy, Austria, United States, Australia, Belgium, Brazil, Canada, China, Czechia, Denmark, Greece, Hungary, India, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Romania, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
Sponsor
Eli Lilly and Company(Industry)
Protocol no.
18612
Conditions
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
Interventions
Drug

Treatments studied

  • LY3537982
  • Pembrolizumab
  • Placebo
  • Cisplatin
  • Carboplatin
  • Pemetrexed

Locations · 414

  • Lausanne, SwitzerlandCHUV (centre hospitalier universitaire vaudois)Recruiting at this site
  • Winterthur, SwitzerlandKantonsspital WinterthurRecruiting at this site
  • Avignon, FranceSainte Catherine Institut du Cancer Avignon ProvenceRecruiting at this site
  • Bron, FranceHospices Civils de Lyon - Hopital Louis PradelRecruiting at this site
  • Lille, FranceCHU Lille - Institut Coeur PoumonRecruiting at this site
  • Lyon Cedex08, FranceCentre Leon BerardRecruiting at this site
  • Nice, FranceCentre Antoine-LacassagneRecruiting at this site
  • Paris, FranceInstitut CurieRecruiting at this site
  • Pessac, FranceCHU Bordeaux Haut-LevequeRecruiting at this site
  • Poitiers, FranceCentre Hospitalier Universitaire de PoitiersRecruiting at this site
  • Reims, FranceInstitut Jean GodinotRecruiting at this site
  • Rennes, FranceCentre Hospitalier Universitaire de Rennes - Hôpital PontchaillouRecruiting at this site
  • Saint-Herblain, FranceInstitut de Cancérologie de l'OuestRecruiting at this site
  • Strasbourg, FranceNouvel Hôpital Civil (NHC)Recruiting at this site
  • Suresnes, FranceHôpital FochRecruiting at this site
  • Toulon, FranceCentre Hospitalier intercommunal de Toulon La Seyne sur MerRecruiting at this site
  • Toulouse, FranceCHU de Toulouse - Hopital LarreyRecruiting at this site
  • Vandœuvre-lès-Nancy, FranceCentre Hospitalier Régional Universitaire de Nancy - Hôpitaux de BraboisRecruiting at this site
  • Vantoux, FranceHôpital Robert SchumanRecruiting at this site
  • Villejuif, FranceGustave RoussyRecruiting at this site
  • Berlin, GermanyEvangelische Lungenklinik BerlinRecruiting at this site
  • Berlin, GermanyCharité Campus Virchow-KlinikumRecruiting at this site
  • Berlin, GermanyHelios Klinikum Emil von Behring Berlin-ZehlendorfRecruiting at this site
  • Chemnitz, GermanyKlinikum ChemnitzRecruiting at this site
  • Cologne, GermanyMV-Zentrum für Onkologie und HämatologieRecruiting at this site
  • Donauwörth, GermanyOnkologiezentrum DonauwörthRecruiting at this site
  • Erfurt, GermanyHELIOS Klinikum ErfurtRecruiting at this site
  • Freiburg im Breisgau, GermanyUniversitaetsklinikum FreiburgRecruiting at this site
  • Gauting, GermanyAsklepios Fachkliniken München-GautingRecruiting at this site
  • Georgsmarienhütte, GermanyFranziskus-Hospital HarderbergRecruiting at this site

In total, worldwide, 414 of the 416 sites listed in the registry are recruiting; the other 2 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: October 7, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

+ 384 more locations

Other identifiers

  • J3M-MC-JZQB · other identifier
  • U1111-1288-0565 · other identifier
  • 2023-503412-33-00 · other identifier
  • 2023 · NIH grant

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.