A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 2
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 99 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
This trial will evaluate the efficacy and safety of various therapies in participants with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated NSCLC tumors that meet protocol-specified biomarker criteria.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria for Neoadjuvant Therapy:
- Pathologically documented NSCLC:
- Newly diagnosed early-stage NSCLC stages IB, IIA, IIB, IIIA, or selected IIIB (T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the American Joint Committee on Cancer (AJCC)/Union Internationale Contre le Cancer (UICC) NSCLC staging system
- T4 primary NSCLC will be allowed only on the basis of size. Invasion of the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina, and separate tumor nodules in a different ipsilateral lobe is not permitted
- All participants will undergo clinical staging using computed tomography (CT) and positron emission tomography (PET) scanning, as well as brain imaging using magnetic resonance imaging (MRI). Invasive mediastinal staging by either mediastinoscopy or endo-bronchial ultrasonography is highly encouraged for participants with radiographically suspected mediastinal nodal disease (i.e., N2) but not mandated if the CT or PET scans showed no evidence of N2 disease
- Molecular testing results from clinical laboratory improvement amendments (CLIA)-certified laboratories and showing at least one of the following abnormalities: ALK fusion, ROS1 fusion, NTRK1/2/3 fusion; BRAF V600 mutation, RET fusion, PD-L1 expression in ≥ 1% tumor cells as determined by Food and Drug Administration (FDA)-approved test, KRAS G12C mutation
- Measurable disease, as defined by RECIST v1.1
- NSCLC must have a solid or subsolid appearance on CT scan and cannot have a purely ground glass opacity appearance. For subsolid lesions, the tumor size (i.e., clinical T stage) should be measured based on the solid component only, exclusive of the ground glass opacity component
- Evaluated by the attending surgeon prior to study enrollment to verify that the primary tumor and any involved lymph nodes are technically completely resectable and verify that the participant is medically operable
- Adequate pulmonary function to be eligible for surgical resection with curative intent
- Adequate cardiac function to be eligible for surgical resection with curative intent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate hematologic and end-organ function
- Negative hepatitis B surface antigen (HBsAg) test at screening for cohort
- Negative total hepatitits B core antibody (HBcAb) test at screening for cohort, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) test at screening
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening
- Male participants must be willing to use acceptable methods of contraception
- Female participants of childbearing potential must agree to use acceptable methods of contraception
Inclusion Criteria for Adjuvant Therapy (TKI Cohorts and KRAS G12C cohort \[if continuing on Divarasib\]):
- Participants whose tumors lack radiographic progression
- ECOG Performance Status of 0 or 1
- Adequate hematologic and end-organ function
Exclusion Criteria
- NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by virtue of N3 disease
- Any prior therapy for lung cancer, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within 2 years
- Participants with prior lung cancer
- Major surgical procedure within 28 days prior to Cycle 1, Day 1
- Malignancies other than the disease under study within 3 years prior to Cycle 1, Day 1, with the exception of participants with a negligible risk of metastasis or death and with expected curative outcome
- Treatment with an investigational agent for any condition within 4 weeks prior to Cycle 1, Day 1
- Participants known to be positive for human immunodeficiency virus (HIV) are excluded if they meet any of the following criteria: cluster of differentiation 4 (CD4)+ T-cell count of \<350 cells/microliters (cells/µL); detectable HIV viral load; history of an opportunistic infection within the past 12 months; on stable antiretroviral therapy for \<4 weeks
- Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infections, or any active infection that, in the opinion of the investigator, could impact participant safety
- Pregnant or lactating, or intending to become pregnant during the study
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Sin asignación al azar
- Enmascaramiento
- Sin enmascaramiento
ALK Cohort (Enrolment Closed)
Participants will receive up to 8 weeks of alectinib neoadjuvant treatment before undergoing surgical resection per standard of care (SOC). All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with alectinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of alectinib.
Enrolment Closed.
Drug: Alectinib · Procedure: Resection · Drug: Chemotherapy
ROS 1 Cohort (Enrolment Closed)
Participants will receive up to 8 weeks of entrectinib neoadjuvant treatment before undergoing surgical resection per SOC. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with entrectinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of entrectinib.
Enrolment Closed.
Drug: Entrectinib · Procedure: Resection · Drug: Chemotherapy
NTRK Cohort (Enrolment Closed)
Participants will receive up to 8 weeks of entrectinib neoadjuvant treatment before undergoing surgical resection per SOC. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with entrectinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of entrectinib.
Enrolment Closed.
Drug: Entrectinib · Procedure: Resection · Drug: Chemotherapy
BRAF Cohort (No Participants Enrolled, Cohort Closed)
Participants will receive up to 8 weeks of vemurafenib plus cobimetinib neoadjuvant treatment before undergoing surgical resection per SOC. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with vemurafenib plus cobimetinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of of vemurafenib plus cobimetinib.
Cohort closed.
Drug: Vemurafenib · Drug: Cobimetinib · Procedure: Resection · Drug: Chemotherapy
RET Cohort (Cohort closed)
Participants will receive up to 8 weeks of pralsetinib neoadjuvant treatment before undergoing surgical resection per SOC. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with pralsetinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of pralsetinib.
Cohort closed.
Drug: Pralsetinib · Procedure: Resection · Drug: Chemotherapy
PD-L1 Cohort (Enrolment Closed)
Participants with positive programmed death-ligand 1 (PD-L1) in ≥1% tumor cells will receive 4 cycles of atezolizumab neoadjuvant treatment. During neoadjuvant Cycle 1 of atezolizumab, participants will also receive low-dose stereotactic body radiation therapy (SBRT) (8 gray \[Gy\] X 3). Adjuvant treatment consists of SOC treatment as determined by the investigator, per National Comprehensive Cancer Network (NCCN) guidelines.
Enrolment Closed.
Drug: Atezolizumab · Drug: SBRT · Procedure: Resection
KRAS G12C Cohort
Participants will receive up to 8 weeks of divarasib as neoadjuvant treatment before undergoing surgical resection per SOC. PD-L1 negative participants whose tumors have pathological response or lack radiographic progression will be have the option of continuing divarasib alone for up to 3 years or 1-4 cycles of SOC chemotherapy followed by divarasib for 3 years as adjuvant therapy. For participants who test positive PD-L1, they will have the option to receive 1-4 cycles of SOC chemotherapy followed by atezolizumab for up to 16 cycles or SOC alone.
Procedure: Resection · Drug: Chemotherapy · Drug: Divarasib
Alectinib DRUG
Participants will receive oral alectinib twice per day (BID).
Entrectinib DRUG
Participants will receive oral entrectinib daily.
Vemurafenib DRUG
Participants will receive oral vemurafenib BID.
Cobimetinib DRUG
Participants will receive oral cobimetinib daily.
Pralsetinib DRUG
Participants will receive oral pralsetinib daily.
Atezolizumab DRUG
Atezolizumab will be administered by intravenous (IV) infusion.
SBRT DRUG
Participants will receive SBRT given concurrently, starting with the first dose of atezolizumab.
Resection PROCEDURE
Participants will receive surgical resection of the primary tumor along with selected lymph nodes per SOC.
Chemotherapy DRUG
Participants will receive SOC chemotherapy as determined by the treating physician.
Divarasib DRUG
Participants in the KRAS G12C cohort will receive oral divarasib for approximately 8 weeks until the day before surgery as neoadjuvant therapy up to 3 years as adjuvant therapy.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Tyrosine Kinase Inhibitor (TKI) Cohort: Proportion of Participants With Major Pathologic Response (MPR)
Plazo: After surgical resection (approximately study Week 8)
MPR is defined as ≤ 10% residual viable tumor cells as scored by local pathologists.
Checkpoint Inhibitor (CPI) Cohort: Pathological Complete Response (pCR)
Plazo: After surgical resection (approximately study Week 8)
Scored by local pathologists; defined as lack of any viable tumor cells on review of hematoxylin and eosin (H\&E) slides after complete evaluation of a resected lung cancer specimen including all sampled regional lymph nodes.
KRAS G12C Cohort: Percentage of Participants With 3-5 Grade Adverse Events (AEs)
Plazo: After surgical resection (approximately study Week 8)
No informado en este registro.
KRAS G12C Cohort: Percentage of Participants Without Delays of Surgery due to Treatment-related AEs as Reported by the Investigator
Plazo: After surgical resection (approximately study Week 8)
No informado en este registro.
Medidas secundarias
Proportion of Participants With MPR
Plazo: After surgical resection (approximately study Week 8)
Defined as ≤10% residual viable tumor cells) based on surgical resection as defined by Hellmann et al. (2014) and Travis et al. (2020). TKI cohorts: MPR will be scored by a central pathology committee consensus read. CPI cohort: MPR will be scored by local pathologists and central pathology committee consensus read. KRAS G12C cohort: MPR will be scored by local pathologists and central pathology committee consensus read.
Proportion of Participants With pCR
Plazo: After surgical resection (approximately study Week 8)
Defined as lack of any viable tumor cells on review of H\&E slides after complete evaluation of a resected lung cancer specimen, including all sampled regional lymph nodes.
TKI cohorts: pCR will be scored by local pathologists and a central pathology committee consensus read.
CPI cohort: pCR will be scored by a central pathology committee consensus read. KRAS G12C cohort: pCR will be scored by a central pathology committee consensus read.
Pathological Regression Based on Weighted % Viable Tumor Cell Assessment
Plazo: After surgical resection (approximately study Week 8)
No informado en este registro.
Investigator-assessed Response Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Plazo: After neoadjuvant treatment (after approximately study Week 8)
No informado en este registro.
Disease-free Survival (DFS)
Plazo: From the first date of no disease to local or distant recurrence or death from any cause, whichever occurs first, through the end of the study (up to 9 years)
No informado en este registro.
Event-free Survival (EFS)
Plazo: From first dose of study treatment to first documented disease progression per RECIST v1.1, or local or distant disease recurrence as determined by investigator, or death from any cause, whichever occurs first, through the end of study (up to 9 years)
No informado en este registro.
Overall Survival (OS)
Plazo: From the first dose of study medication to death from any cause, through the end of the study (up to 9 years)
No informado en este registro.
Percentage of Participants With AEs
Plazo: Up to 9 years
No informado en este registro.
Nodal Downstaging
Plazo: After surgical resection (approximately study Week 8)
Defined as percentage of participants with reduced stages in regional lymph nodes at surgery.
Circulating tumor DNA (ctDNA) Clearance Rate
Plazo: Prior to surgery (before study Week 8)
No informado en este registro.
KRAS G12C Cohort: Plasma Concentration of Divarasib at Specified Timepoints
Plazo: Neo-adjuvant: pre-dose & 2 hours post-dose on Day 1 of Cycles 1 & 2; Pre-surgery (before Week 8): pre-dose; Adjuvant treatment: pre-dose & 2 hours post-dose on Day 1 of Cycles 1-6, pre-dose on Day 1 of Cycle 9 (each cycle=28 days);
- Treatment completion/discontinuation;
- Disease Progression or Recurrence during Neoadjuvant treatment or Surveillance;
- Unscheduled (Tumor Evaluation and Response) \[Anytime up to 3 years\]
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (24)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
24 centros
University of California Los Angeles - Jonsson Comprehensive Cancer CenterLos Angeles, California, United StatesEstado desconocido
The Center for Cancer Prevention and Treatment at St.Joseph Hospital of OrangeOrange, California, United StatesEstado desconocido
UC Davis Comprehensive Cancer CenterSacramento, California, United StatesEstado desconocido
Yale Cancer CenterNew Haven, Connecticut, United StatesEstado desconocido
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)Washington D.C., District of Columbia, United StatesEstado desconocido
Moffitt Cancer CenterTampa, Florida, United StatesEstado desconocido
Northwestern UniversityChicago, Illinois, United StatesEstado desconocido
Northwestern Medicine Cancer Center KishwaukeeDeKalb, Illinois, United StatesEstado desconocido
Northwestern Medicine Cancer Center DelnorGeneva, Illinois, United StatesEstado desconocido
Northwestern Medicine Cancer Center WarrenvilleWarrenville, Illinois, United StatesEstado desconocido
Dana-Farber Cancer InstituteBoston, Massachusetts, United StatesEstado desconocido
University of MichiganAnn Arbor, Michigan, United StatesEstado desconocido
Mayo ClinicRochester, Minnesota, United StatesEstado desconocido
Ellis Fischel Cancer CenterColumbia, Missouri, United StatesEstado desconocido
Siteman Cancer Center - Washington University Medical CampusSt Louis, Missouri, United StatesEstado desconocido
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire, United StatesEstado desconocido
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.New York, New York, United StatesEstado desconocido
Columbia University Medical CenterNew York, New York, United StatesEstado desconocido
Memorial Sloan Kettering Cancer CenterNew York, New York, United StatesEstado desconocido
Ohio State UniversityColumbus, Ohio, United StatesEstado desconocido
AHN Cancer Institute ? Allegheny General HospitalPittsburgh, Pennsylvania, United StatesEstado desconocido
Baptist Clinical Research InstituteMemphis, Tennessee, United StatesEstado desconocido
University of Texas MD Anderson Cancer CenterHouston, Texas, United StatesEstado desconocido
Virginia Cancer Specialists (Fairfax) - USORFairfax, Virginia, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- Genentech, Inc.
- Inicio del estudio
- 6 nov 2020 Real
- Finalización primaria
- 30 nov 2026 Estimado
- Finalización del estudio
- 30 may 2030 Estimado
- Primera publicación
- 10 mar 2020 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026