Informations générales (source: ClinicalTrials.gov)
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 (SUNRAY-01)
Interventional
Phase 3
Eli Lilly and Company (Voir sur ClinicalTrials)
décembre 2023
octobre 2029
09 juillet 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| HOPITAL FOCH | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine-Lacassagne - 06189 - Nice - Alpes-Maritimes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier intercommunal de Toulon La Seyne sur Mer - 83100 - Toulon - Provence-Alpes-Côte-d'Azur - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Poitiers - 86021 - Poitiers - Vienne - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou - 35033 - Rennes - Ille-et-Vilaine - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard - 69373 - Lyon Cedex08 - Rhône-Alpes - France | Contact (sur clinicalTrials) | ||||
| CHU Bordeaux Haut-Leveque - 33600 - Pessac - Aquitaine - France | Contact (sur clinicalTrials) | ||||
| CHU de Toulouse - Hopital Larrey - 31059 - Toulouse - Haute-Garonne - France | Contact (sur clinicalTrials) | ||||
| CHU Lille - Institut Coeur Poumon - 59037 - Lille Cedex - Nord - France | Contact (sur clinicalTrials) | ||||
| Hôpital Robert Schuman - 57070 - Vantoux - Lorraine - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon - Hopital Louis Pradel - 69677 - Bron - Rhône - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest - 44805 - Saint Herblain - Loire-Atlantique - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - 51726 - Reims - Marne - France | Contact (sur clinicalTrials) | ||||
| Nouvel Hôpital Civil (NHC) - 67091 - Strasbourg - Alsace - France | Contact (sur clinicalTrials) | ||||
| Sainte Catherine Institut du Cancer Avignon Provence - 84918 - Avignon - Vaucluse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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
- Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs
(NSAIDs)
- Is unable or unwilling to take folic acid or vitamin B12 supplementation.