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Recruiting NCT07190248

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Phase III Interventional Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Calderasib, Pembrolizumab (+) Berahyaluronidase alfa, Pemetrexed, Cisplatin.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Australia, Austria, Belgium +24
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

Overview

Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation. The goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.

Interventions

  • Drug Calderasib
    Administered as an oral tablet
  • Biological Pembrolizumab (+) Berahyaluronidase alfa
    Administered as a SC injection
  • Drug Pemetrexed
    Administered as an IV Infusion
  • Drug Cisplatin
    Administered as an IV Infusion
  • Drug Carboplatin
    Administered as an IV Infusion

Primary outcome measures

  • Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% [Time frame: Up to approximately 48 months]
Secondary outcome measures (12)
  • PFS in All Participants [Time frame: Up to approximately 48 months]
  • Overall Survival (OS) in Participants with PD-L1 TPS ≥1% [Time frame: Up to approximately 62 months]
  • OS in Participants in All Participants [Time frame: Up to approximately 62 months]
  • Overall Response Rate (ORR) in All Participants [Time frame: Up to approximately 48 months]
  • ORR in Participants with PD-L1 TPS ≥1% [Time frame: Up to approximately 48 months]
  • Duration of Response (DOR) [Time frame: Up to approximately 48 months]
  • Number of Participants Who Experienced One or More Adverse Events (AEs) [Time frame: Up to approximately 81 months]
  • Number of Participants Who Discontinued Study Treatment Due to an AE [Time frame: Up to approximately 81 months]
  • Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) (Items 29, 30) on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) [Time frame: Baseline and up to approximately 81 months]
  • Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 [Time frame: Baseline and up to approximately 81 months]
  • Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13) [Time frame: Baseline and up to approximately 81 months]
  • Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 [Time frame: Baseline and up to approximately 81 months]

Eligibility criteria

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c
  • If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has a gastrointestinal disorder affecting absorption
  • Is HIV positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has active autoimmune disease that has required systemic treatment in the past 2 years
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has active infection requiring systemic therapy except those specified by protocol
  • Has history of stem cell/solid organ transplant
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 29 centers
  • Anhui Provincial Cancer Hospital ( Site 2708) — Hefei
  • Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2700) — Beijing
  • Beijing Peking Union Medical College Hospital ( Site 2702) — Beijing
  • The First Affiliated Hospital of Fujian Medical University ( Site 2701) — Fujian
  • Fujian Provincial Cancer Hospital ( Site 2706) — Fuzhou
  • The First Affiliated Hospital of Xiamen University ( Site 2717) — Fuzhou
  • The First Affiliated Hospital.Sun Yat-sen University ( Site 2714) — Guangzhou
  • AFFILIATED CANCER HOSPITAL AND INSTITUTE OF GUANGZHOU MEDICAL UNIVERSITY ( Site 2743) — Guangzhou
  • … and 21 more centers
Japan · 28 centers

Center list to be confirmed — check the primary protocol.

Italy · 12 centers

Center list to be confirmed — check the primary protocol.

United States · 10 centers
  • Central Alabama Research ( Site 0108) — Birmingham
  • University of Connecticut Health Center ( Site 0130) — Farmington
  • Stamford Hospital ( Site 0126) — Stamford
  • Mount Sinai Cancer Center ( Site 0137) — Miami Beach
  • Indiana University Health Arnett Cancer Center ( Site 0116) — Lafayette
  • New England Cancer Specialists ( Site 0139) — Westbrook
  • New York Oncology Hematology, P.C. ( Site 0119) — Albany
  • St. Charles Health System, Inc ( Site 0146) — Bend
  • … and 2 more centers
Brazil · 9 centers
  • CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0412) — Fortaleza
  • Hospital Santa Rita de Cassia ( Site 0403) — Vitória
  • Real Hospital Portugues ( Site 0418) — Recife
  • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa ( Site 0400) — Porto Alegre
  • CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0410) — Florianópolis
  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto USP ( Site 0419) — Ribeirão Preto
  • Faculdade de Medicina do ABC ( Site 0411) — Santo André
  • Hospital Alemao Oswaldo Cruz ( Site 0413) — São Paulo
  • … and 1 more center
France · 8 centers
  • Hopital Europeen Marseille ( Site 1207) — Marseille
  • CHU Caen ( Site 1212) — Caen
  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1209) — Vandœuvre-lès-Nancy
  • Centre Hospitalier de Pau ( Site 1217) — Pau
  • Centre Hospitalier Metropole Savoie Site de Chambery ( Site 1208) — Chambéry
  • Clinique de l'Europe ( Site 1213) — Amiens
  • Groupe Hospitalier Paris Saint Joseph ( Site 1215) — Paris
  • Hôpital Européen Georges Pompidou ( Site 1214) — Paris
Malaysia · 8 centers

Center list to be confirmed — check the primary protocol.

Romania · 8 centers

Center list to be confirmed — check the primary protocol.

Turkey (Türkiye) · 8 centers

Center list to be confirmed — check the primary protocol.

Spain · 7 centers

Center list to be confirmed — check the primary protocol.

Ukraine · 7 centers

Center list to be confirmed — check the primary protocol.

South Korea · 6 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 6 centers

Center list to be confirmed — check the primary protocol.

Australia · 5 centers
  • Genesis Care- Campbelltown ( Site 2907) — Campbelltown
  • Northern Beaches Hospital ( Site 2905) — Frenchs Forest
  • The Prince Charles Hospital ( Site 2903) — Brisbane
  • Mater Hospital Brisbane ( Site 2906) — South Brisbane
  • Peninsula & South Eastern Haematology and Oncology Group ( Site 2908) — Frankston
Greece · 5 centers
  • Agios Andreas Hospital Patras ( Site 1407) — Pátrai
  • Errikos Dunant Hospital Center ( Site 1408) — Athens
  • General Hospital of Athens "Laiko" ( Site 1402) — Athens
  • … and 2 more centers
Israel · 5 centers

Center list to be confirmed — check the primary protocol.

Argentina · 4 centers
  • Instituto Alexander Fleming ( Site 0311) — Ciudad Autónoma de Buenos Aires
  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300) — Mar del Plata
  • Hospital Italiano de Cordoba ( Site 0308) — Córdoba
  • CEMAIC ( Site 0309) — Córdoba
Mexico · 4 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 4 centers

Center list to be confirmed — check the primary protocol.

Austria · 3 centers
  • Klinikum Klagenfurt am Wörthersee ( Site 1002) — Klagenfurt
  • Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1005) — Graz
  • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1001) — Vienna
Chile · 3 centers
  • Centro de Estudios Clínicos SAGA ( Site 0503) — Santiago
  • FALP ( Site 0500) — Santiago
  • Bradfordhill ( Site 0501) — Santiago
Colombia · 3 centers
  • Promotora Médica Las Américas S.A. ( Site 0608) — Medellín
  • Hospital Universitario San Ignacio ( Site 0604) — Bogotá
  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0607) — Bogotá
Guatemala · 3 centers

Center list to be confirmed — check the primary protocol.

Netherlands · 3 centers

Center list to be confirmed — check the primary protocol.

Poland · 3 centers

Center list to be confirmed — check the primary protocol.

Belgium · 2 centers
  • Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3903) — Genk
  • VITAZ ( Site 3902) — Sint-Niklaas
Hungary · 2 centers

Center list to be confirmed — check the primary protocol.

Peru · 2 centers

Center list to be confirmed — check the primary protocol.

Canada · 1 center
  • Cross Cancer Institute ( Site 0203) — Edmonton

Identifiers

NCT: NCT07190248 · 1084-007 · U1111-1307-9569 · 2024-514500-14-00 · MK-1084-007 · KANDLELIT-007 · jRCT2031240722

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗