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

Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (T�rkiye), United Kingdom, United States (ICTRP)

ID di studio ICTRP
NCT06119581 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
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)

Titolo accademico
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)

Titolo pubblico
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)

Malattie studiate
Carcinoma, Non-Small-Cell LungNeoplasm Metastasis (ICTRP)

Intervento studiato
Drug: LY3537982Drug: PembrolizumabDrug: PlaceboDrug: CisplatinDrug: CarboplatinDrug: Pemetrexed (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)

Criteri di inclusione/esclusione
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)

non disponibile

Endpoint primari e secondari
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)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
Loxo Oncology, Inc. (ICTRP)

Contatti aggiuntivi
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)

ID secondari
J3M-MC-JZQB, U1111-1288-0565, 2023-503412-33-00, 18612 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT06119581 (ICTRP)