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RecruitingLast updated: 8 May 2024

SUNRAY-01: This study is assessing whether a new targeted therapy in combination with standard of care anti-cancer drugs (including immunotherapy and chemotherapy) is more effective than just standard of care in participants with untreated advanced non-small cell lung cancer with a KRAS G12C mutationA 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

Clinical summary

Summary

This study has three parts: Dose Optimisation, Experimental Part A and Experimental Part B. 

Dose Optimisation:The first part is seeking to determine the optimal dose of  a new targeted therapy (called LY3537982). Eligible participants will randomly be allocated to receive LY3537982 (dose level 1 or 2) plus Pembrolizumab immunotherapy.

Experimental Part A: Participants will randomly be allocated to receive LY3537982 in combination with Pembrolizumab immunotherapy, or receive Placebo in combination with Pembrolizumab immunotherapy.

Experimental Part B: Safety Lead-In (single-arm, non-randomised) Participants will receive LY3537982 in combination with pembrolizumab immunotherapy, pemetrexed chemotherapy, and platinum chemotherapy (cisplatin or carboplatin).

Participants will randomly be allocated to receive LY3537982 in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin), or receive Placebo in combination with pembrolizumab, pemetrexed chemotherapy , and platinum chemotherapy (cisplatin or carboplatin).

All treatment cycles are 21 days. LY3537982 and its placebo will be administered orally. Pemroblizumab, pemetrexed and platinum (cisplatin or carboplatin) will be administered intravenously. All participants may continue to receive treatment until discontinuation criteria are met.

Conditions

This trial is treating patients with Locally advanced or metastatic non-small cell lung cancer with KRAS G12C-Mutant

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

Trial Acronym

SUNRAY-01

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT06119581
  • 18612, J3M-MC-JZQB, U1111-1288-0565, 2023-503412-33-00

Trial sponsor

Eli Lilly and Company

Scientific Title

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

Eligibility

Inclusion

  • 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%.
  • 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 and after study intervention for at least 180 days

Exclusion

  • 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)

  • Squamous cell and/or mixed small cell/nonsmall cell histology is not permitted.
  • Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Is unable or unwilling to take folic acid or vitamin B12 supplementation.

Inclusion

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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