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Taking people in ItalyPhase 3

Tests olomorasib with pembrolizumab in untreated advanced lung cancer with KRAS G12C mutation

Tests olomorasib added to standard drugs in adults with untreated advanced KRAS G12C lung cancer.

Key facts

Who runs it
Eli Lilly and Company
Where
Bari, Bologna, Catania, Milan, Naples, Padova, Rome, Varese, and Verona, ItalySee the 10 sitesAlso in 28 other countries, 407 sites
Trial code
Registry title
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
Status
Recruiting
Phase
Phase 3
People taking part
1,264 people, planned
Started
21 Dec 2023
Expected to end
Jan 2031
Type of study
Interventional, 8 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • LY3537982
  • Pembrolizumab
  • Placebo
  • Cisplatin
  • Carboplatin
  • Pemetrexed
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced lung cancer (non-small cell type) that carries a KRAS G12C gene change and has not yet been treated for the advanced stage.

Age
18 years or older
Sex
All sexes can join
Disease stage
Non-small cell lung cancer, stage IIIB-IIIC or stage IV, that cannot be treated with surgery or radiation meant to remove all of the disease. Disease must be measurable. In the pemetrexed parts, the tumour must be mostly non-squamous.
Earlier treatment
No earlier drug treatment (chemotherapy, immunotherapy, targeted or biological therapy) for advanced or metastatic lung cancer. 1 cycle of standard treatment before enrolment is allowed if treatment was needed right away.
Biomarker or test result
KRAS G12C mutation. Known PD-L1 level: 50% or higher in Part A, 0% to 100% in Part B, below 50% in Part C.

Main reasons for not taking part

  • Another targetable gene change, such as EGFR, ALK, BRAF (V600E), HER2, MET (exon 14), ROS1, RET or NTRK1/2/3
  • Earlier drug treatment for advanced or metastatic lung cancer
  • Active cancer spread to the brain or spinal fluid (central nervous system metastases or carcinomatous meningitis)
  • Mostly squamous cell type, for those receiving pemetrexed and platinum
  • Unable or unwilling to take folic acid or vitamin B12 supplements, for those receiving pemetrexed and platinum

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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:
  • 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
  • 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 known active central nervous system metastases and/or carcinomatous meningitis
  • Have predominantly squamous cell histology for NSCLC
  • Is unable or unwilling to take folic acid or vitamin B12 supplementation

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Which best describes your lung cancer?
  • Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
  • Has your cancer spread to the brain?
  • Has your cancer spread to the lining around the brain or spinal cord?

Where in Italy

Also in 28 other countries, 407 sites

  • Istituto Tumori Bari Giovanni Paolo IIBari, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyTaking people
  • Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
  • IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people
  • Istituto Oncologico VenetoPadova, ItalyTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
  • I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyTaking people
  • Azienda Ospedaliera Ospedale Di Circolo E Fondazione MacchiVarese, ItalyTaking people
  • Azienda Ospedaliera Universitaria Integrata VeronaVerona, ItalyTaking people

About the trial

What the trial wants to find out

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.

The 8 groups in the trial

  • Dose Optimization: LY3537982 Dose Level 1 plus PembrolizumabTreatment being tested

    LY3537982 Dose level 1 administered orally in combination with pembrolizumab administered intravenously (IV) in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

    Treatment: LY3537982 and Pembrolizumab

  • Dose Optimization: LY3537982 Dose Level 2 plus PembrolizumabTreatment being tested

    LY3537982 Dose level 2 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

    Treatment: LY3537982 and Pembrolizumab

  • Safety Lead In: LY3537982 plus Pembrolizumab, Pemetrexed and PlatinumTreatment being tested

    LY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

    Treatment: LY3537982, Pembrolizumab, Cisplatin, Carboplatin, and Pemetrexed

  • Part A: LY3537982 plus PembrolizumabTreatment being tested

    LY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

    Treatment: LY3537982 and Pembrolizumab

  • Part A: Placebo plus PembrolizumabPlacebo, for comparison

    Placebo administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

    Treatment: Pembrolizumab and Placebo

  • Part B: LY3537982 plus Pembrolizumab, Pemetrexed, and PlatinumTreatment being tested

    LY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

    Treatment: LY3537982, Pembrolizumab, Cisplatin, Carboplatin, and Pemetrexed

  • Part B: Placebo plus Pembrolizumab, Pemetrexed, and PlatinumPlacebo, for comparison

    Placebo administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

    Treatment: Pembrolizumab, Placebo, Cisplatin, Carboplatin, and Pemetrexed

  • Part C: LY3537982 plus PembrolizumabTreatment being tested

    LY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

    Treatment: LY3537982 and Pembrolizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression
Plain-language title
Tests olomorasib with pembrolizumab in untreated advanced lung cancer with KRAS G12C mutationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06119581, who can take part
Publications
Record updated
4 November 2026
Under construction, not live – 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 (NCT06119581) – Frontlight Research