Resumen

This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses: Hypothesis 1: Combination of calderasib and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Hypothesis 2: Combination of calderasib plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
Provides an archival tumor tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, PD-L1 status, and biomarker research
If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to \< Grade 1 or baseline
If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)
If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable

Criterios de exclusión

Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC
Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible
Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
Has known history of, or active, neurologic paraneoplastic syndrome
Has an active infection requiring systemic therapy, with exceptions
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has one or more of the following ophthalmological findings/conditions: intraocular pressure \>21 mmHg and/or any diagnosis of glaucoma, diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative disease
Has received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention
Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not required corticosteroids, and not have had radiation pneumonitis
Has known active central nervous system metastases and/or carcinomatous meningitis
Known additional malignancy that is progressing or has required active treatment within the past 3 years
Has active autoimmune disease that has required systemic treatment in the past 2 years
Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Is HIV-infected and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has history of allogenic tissue/solid organ transplant
Has not fully recovered from any effects of major surgical procedure

Ubicaciones

AUSTRAL MEDICAL CENTER ( Site 0302)

CABA, Buenos Aires, Argentina

COMPLETED

Centro Oncologico Korben ( Site 0304)

CABA, Buenos Aires, Argentina

Study Coordinator · 1157507952

RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)

Mar del Plata, Buenos Aires, Argentina

Study Coordinator · 02234963224

RECRUITING

Fundacion Estudios Clinicos ( Site 0306)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +543412221472

RECRUITING

Sanatorio Parque ( Site 0301)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +54341420-0222

RECRUITING

A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Calderasib

Placebo

Pembrolizumab

Ubicaciones

AUSTRAL MEDICAL CENTER ( Site 0302)

Centro Oncologico Korben ( Site 0304)

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)

Fundacion Estudios Clinicos ( Site 0306)

Sanatorio Parque ( Site 0301)

Patrocinadores

Contactos

Toll Free Number