A global placebo-controlled study of LY3537982 in combination with Pembrolizumab and LY3537982 in combination with Pembrolizumab, Pemetrexed, and platinum for first-line treatment of patients with KRAS G12C-mutated advanced non-small cell lung cancer
Zusammenfassung der Studie
The main reason for your participation in this study is not to treat your disease, but to answer the following research question(s): Safety introduction part: To find out which dose of LY3537982 should be added to the standard treatment with Pembrolizumab, Pemetrexed, and Cisplatin or Carboplatin to support cancer control over a longer period. Dose optimization part: To find out which dose of LY3537982 should be administered in addition to Pembrolizumab to keep the cancer under control compared to the standard treatment with Pembrolizumab alone over a longer period. Part A: To find out if the addition of LY3537982 in addition to Pembrolizumab helps to keep the cancer under control compared to the standard treatment with Pembrolizumab alone over a longer period and whether this works better. Part B: To find out which dose of LY3537982 should be administered in addition to Pembrolizumab to keep the cancer under control compared to the standard treatment with Pembrolizumab alone over a longer period.
(BASEC)
Untersuchte Intervention
Part A: LY3537982/Placebo - Capsules taken orally twice daily. Pembrolizumab - 200 mg as a 30-minute intravenous (i.v.) infusion on the first day of each 21-day treatment cycle.
Part B: LY3537982/Placebo - Capsules taken orally twice daily. Intravenous (i.v.) infusion of Pembrolizumab, Pemetrexed, Carboplatin, or Cisplatin on Day 1 of each 3-week cycle. Cisplatin or Carboplatin are administered only in the first 4 cycles.
Dose optimization part: LY3537982 50 or 100 mg, taken orally twice daily. Pembrolizumab - 200 mg as a 30-minute intravenous (i.v.) infusion on the first day of each 21-day treatment cycle.
Safety introduction part: LY3537982 capsules taken orally twice daily. Intravenous (i.v.) infusion of Pembrolizumab, Pemetrexed, Carboplatin, or Cisplatin on Day 1 of each 3-week cycle. Cisplatin or Carboplatin are administered only in the first 4 cycles.
(BASEC)
Untersuchte Krankheit(en)
KRAS G12C-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC)
(BASEC)
1. Your lung cancer is at a specific stage allowed by the study and cannot be treated with a therapy aimed at cure (e.g., surgery or radiation therapy). 2. You have a certain mutation in a gene (referred to as KRAS G12C) in your tumor. 3. You have a known expression level of a protein (the so-called programmed cell death ligand 1) in your tumor. (BASEC)
Ausschlusskriterien
1. You have received certain treatments for your cancer that are not allowed in the study. The investigator will discuss these with you. 2. You have certain mutations in your cancer genes that are not allowed in the study. 3. Your cancer has spread to the brain or certain parts of your nervous system and requires another treatment. The investigator will discuss with you whether this applies to you. (BASEC)
Studienstandort
Lausanne, Winterthur
(BASEC)
Sponsor
Sponsor: Eli Lilly and Company / Sponsor Rep: Eli Lilly (Suisse) SA, Corinne Wijkstroem
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Laetitia Mauti
+41 52 266 23 73
laetitia.mauti@clutterksw.chWinterthur Cantonal Hospital
(BASEC)
Wissenschaftliche Auskünfte
Eli Lilly and Company,
1-317-615-4559
clinical_inquiry_hub@lilly.com(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
24.09.2024
(BASEC)
ICTRP Studien-ID
NCT06119581 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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 (BASEC)
Wissenschaftlicher Titel
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 (ICTRP)
Öffentlicher Titel
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 (ICTRP)
Untersuchte Krankheit(en)
Carcinoma, Non-Small-Cell LungNeoplasm Metastasis (ICTRP)
Untersuchte Intervention
Drug: LY3537982Drug: PembrolizumabDrug: PlaceboDrug: CisplatinDrug: CarboplatinDrug: Pemetrexed (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)
Ein-/Ausschlusskriterien
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. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE);Part A and Part B: Progression-Free Survival (PFS) (ICTRP)
Part A and Part B: Overall Survival (OS);Part A and Part B: PFS;Part A and Part B: Overall Response Rate (ORR): Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR);Part A and Part B: Duration of Response (DOR);Part A and Part B: Disease Control Rate (DCR): Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD);Part A and Part B: Time to Response (TTR);Part A and Part B: Intracranial Overall Response Rate (ORR);Part A and Part B: Intracranial Duration of Response (DoR);Part A and Part B: PFS2;Part A and Part B: Changes in NSCLC-related symptoms as measured by NSCLC-SAQ;Part A and Part B: Time to Worsening of NSCLC-related Symptoms as Measured by NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ);Part A and Part B: Changes in physical function, as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning subscale and IL19;Part A and Part B: Time to Deterioration in Physical Function, as Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning Subscale and IL19;Part A and Part B: Proportion of Time with High Side-Effect Burden, as Measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT-GP5);Part A and Part B: Change from Baseline in Overall Health-related Quality of Life, as Measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Loxo Oncology, Inc. (ICTRP)
Weitere Kontakte
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST);There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, clinical_inquiry_hub@lilly.com, 1-317-615-4559, Eli Lilly and Company, (ICTRP)
Sekundäre IDs
J3M-MC-JZQB, U1111-1288-0565, 2023-503412-33-00, 18612 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT06119581 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar