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Rajiv Gandhi Cancer Institute and Research Centre | Clinical Research (Dr D.C.Doval)

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A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C (SUNRAY-01)

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Lilly

Status and phase

Enrolling
Phase 3

Conditions

Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis

Treatments

Drug: Carboplatin
Drug: LY3537982
Drug: Pemetrexed
Drug: Cisplatin
Drug: Placebo
Drug: Pembrolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06119581
2023-503412-33-00 (Other Identifier)
U1111-1288-0565 (Other Identifier)
18612
J3M-MC-JZQB (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess if adding LY3537982 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.

Full description

Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized.

Enrollment

1,016 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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%.
  • 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 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)

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,016 participants in 7 patient groups, including a placebo group

Dose Optimization: LY3537982 Dose Level 1 plus Pembrolizumab
Experimental group
Description:
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:
Drug: Pembrolizumab
Drug: LY3537982
Dose Optimization: LY3537982 Dose Level 2 plus Pembrolizumab
Experimental group
Description:
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:
Drug: Pembrolizumab
Drug: LY3537982
Safety Lead In: LY3537982 plus Pembrolizumab, Pemetrexed and Platinum
Experimental group
Description:
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:
Drug: Pembrolizumab
Drug: Cisplatin
Drug: Pemetrexed
Drug: LY3537982
Drug: Carboplatin
Part A: LY3537982 plus Pembrolizumab
Experimental group
Description:
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:
Drug: Pembrolizumab
Drug: LY3537982
Part A: Placebo plus Pembrolizumab
Placebo Comparator group
Description:
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:
Drug: Pembrolizumab
Drug: Placebo
Part B: LY3537982 plus Pembrolizumab, Pemetrexed, and Platinum
Experimental group
Description:
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:
Drug: Pembrolizumab
Drug: Cisplatin
Drug: Pemetrexed
Drug: LY3537982
Drug: Carboplatin
Part B: Placebo plus Pembrolizumab, Pemetrexed, and Platinum
Placebo Comparator group
Description:
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:
Drug: Pembrolizumab
Drug: Placebo
Drug: Cisplatin
Drug: Pemetrexed
Drug: Carboplatin

Trial contacts and locations

373

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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