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L'essai clinique NCT04302025 pour Cancer du poumon non à petites cellules est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Vue en carte
A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)
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L'essai clinique NCT04302025 est conçu pour étudier le treatment de Cancer du poumon non à petites cellules. Il s'agit d'un essai interventionnel en Phase II. Son statut actuel est : en recrutement. L'essai a débuté le 6 novembre 2020 et vise à recruter 99 participants. Dirigé par Genentech, Inc., l'essai devrait être terminé d'ici le 30 mai 2030. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 17 novembre 2025.
Résumé succinct
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.
Titre officiel
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
Conditions
Cancer du poumon non à petites cellulesAutres identifiants de l'essai
- ML41591
Numéro NCT
Date de début (réel)
2020-11-06
Dernière mise à jour publiée
2025-11-17
Date de fin (estimée)
2030-05-30
Inscription (estimée)
99
Type d'essai
Interventionnel
PHASE
Phase II
Statut
En recrutement
Objectif principal
Traitement
Plan d'attribution
Non aléatoire
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalALK 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. | Alectinib Participants will receive oral alectinib twice per day (BID). résection Participants will receive surgical resection of the primary tumor along with selected lymph nodes per SOC. Chimiothérapie Participants will receive SOC chemotherapy as determined by the treating physician. |
ExpérimentalROS 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. | Entrectinib Participants will receive oral entrectinib daily. résection Participants will receive surgical resection of the primary tumor along with selected lymph nodes per SOC. Chimiothérapie Participants will receive SOC chemotherapy as determined by the treating physician. |
ExpérimentalNTRK 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. | Entrectinib Participants will receive oral entrectinib daily. résection Participants will receive surgical resection of the primary tumor along with selected lymph nodes per SOC. Chimiothérapie Participants will receive SOC chemotherapy as determined by the treating physician. |
ExpérimentalBRAF 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. | Vemurafenib Participants will receive oral vemurafenib BID. Cobimetinib Participants will receive oral cobimetinib daily. résection Participants will receive surgical resection of the primary tumor along with selected lymph nodes per SOC. Chimiothérapie Participants will receive SOC chemotherapy as determined by the treating physician. |
ExpérimentalRET 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. | Pralsetinib Participants will receive oral pralsetinib daily. résection Participants will receive surgical resection of the primary tumor along with selected lymph nodes per SOC. Chimiothérapie Participants will receive SOC chemotherapy as determined by the treating physician. |
ExpérimentalPD-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. | Atezolizumab Atezolizumab will be administered by intravenous (IV) infusion. SBRT Participants will receive SBRT given concurrently, starting with the first dose of atezolizumab. résection Participants will receive surgical resection of the primary tumor along with selected lymph nodes per SOC. |
ExpérimentalKRAS 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. | résection Participants will receive surgical resection of the primary tumor along with selected lymph nodes per SOC. Chimiothérapie Participants will receive SOC chemotherapy as determined by the treating physician. Divarasib 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. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Tyrosine Kinase Inhibitor (TKI) Cohort: Proportion of Participants With Major Pathologic Response (MPR) | MPR is defined as ≤ 10% residual viable tumor cells as scored by local pathologists. | After surgical resection (approximately study Week 8) |
Checkpoint Inhibitor (CPI) Cohort: Pathological Complete Response (pCR) | 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. | After surgical resection (approximately study Week 8) |
KRAS Cohort: Percentage of Participants With 3-5 Grade Adverse Events (AEs) | After surgical resection (approximately study Week 8) | |
KRAS Cohort: Percentage of Participants Without Delays of Surgery due to Treatment-related Adverse Events as Reported by the Investigator | After surgical resection (approximately study Week 8) |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Proportion of Participants With MPR | 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. | After surgical resection (approximately study Week 8) |
Proportion of Participants With pCR | 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. | After surgical resection (approximately study Week 8) |
Pathological Regression Based on Weighted % Viable Tumor Cell Assessment | After surgical resection (approximately study Week 8) | |
Investigator-assessed Response Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | After neoadjuvant treatment (after approximately study Week 8) | |
Pathological Complete Response (pCR) as Assessed by Local and Central Pathology Laboratories | Defined as the absence of any viable tumor in main tumor bed at the time of surgical resection, as assessed by local and central pathology laboratories. | At the time of surgical resection (approximately study Week 8) |
Disease-free Survival (DFS) | 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) | |
Event-free Survival (EFS) | 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) | |
Overall Survival (OS) | From the first dose of study medication to death from any cause, through the end of the study (up to 9 years) | |
Percentage of Participants With Adverse Events (AEs) | Up to 9 years | |
Nodal Downstaging | Defined as percentage of participants with reduced stages in regional lymph nodes at surgery. | After surgical resection (approximately study Week 8) |
Circulating tumor DNA (ctDNA) Clearance Rate | Prior to surgery (before study Week 8) | |
KRAS G12C Cohort: Plasma Concentration of Divarasib at Specified Timepoints | Cycle 1 Day 1, Cycle 2 Day 1 (Cycle= 28 days) |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 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 mediastinoscopyor endo- bronchial ultrasonography is highly encouraged for participants with radiographically suspected mediastinal nodal disease (ie, 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 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
- 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
Genentech, Inc.Contact central de l'essai
Contact: Reference Study ID Number: ML41591 https://forpatients.roche.com/, 888-662-6728, [email protected]
38 Centres de l'essai dans 1 pays
California
City of Hope Comprehensive Cancer Center, Duarte, California, 91010, United States
Retiré
City of Hope - Orange County Lennar Foundation Cancer Center, Irvine, California, 92618, United States
Retiré
USC Norris Cancer Center, Los Angeles, California, 90033, United States
Retiré
Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States
Retiré
University of California Los Angeles - Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States
En recrutement
The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange, Orange, California, 92868, United States
En recrutement
UC Davis Comprehensive Cancer Center, Sacramento, California, 95817, United States
En recrutement
UCSF Helen Diller Family CCC, San Francisco, California, 94158, United States
Retiré
Colorado
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center), Aurora, Colorado, 80045, United States
Retiré
Connecticut
Yale Cancer Center, New Haven, Connecticut, 06511, United States
En recrutement
District of Columbia
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center), Washington D.C., District of Columbia, 20007, United States
En recrutement
Florida
Moffitt Cancer Center, Tampa, Florida, 33612, United States
En recrutement
Illinois
Northwestern University, Chicago, Illinois, 60611, United States
En recrutement
Northwestern Medicine Cancer Center Kishwaukee, DeKalb, Illinois, 60115, United States
En recrutement
Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, 60134, United States
En recrutement
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, 60555, United States
En recrutement
Massachusetts
Boston Medical Center, Boston, Massachusetts, 02118, United States
Retiré
Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
En recrutement
Michigan
University of Michigan, Ann Arbor, Michigan, 48109, United States
En recrutement
Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center, Farmington Hills, Michigan, 48334, United States
Retiré
Minnesota
Mayo Clinic, Rochester, Minnesota, 55905, United States
En recrutement
Missouri
Ellis Fischel Cancer Center, Columbia, Missouri, 65201, United States
En recrutement
Siteman Cancer Center - Washington University Medical Campus, St Louis, Missouri, 63108, United States
En recrutement
New Hampshire
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States
En recrutement
New York
Laura and ISAAC Perlmutter Cancer Center at NYU Langone., New York, New York, 10016, United States
En recrutement
Columbia University Medical Center, New York, New York, 10032, United States
En recrutement
Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
En recrutement
Ohio
University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44016, United States
Retiré
Ohio State University, Columbus, Ohio, 43210, United States
En recrutement
Pennsylvania
AHN Cancer Institute ? Allegheny General Hospital, Pittsburgh, Pennsylvania, 15212, United States
Terminé
Tennessee
Baptist Clinical Research Institute, Memphis, Tennessee, 38120, United States
En recrutement
Tennessee Oncology - Nashville, Nashville, Tennessee, 37203, United States
Retiré
Texas
Kelsey Seybold Clnic, Houston, Texas, 77025, United States
Retiré
University of Texas MD Anderson Cancer Center, Houston, Texas, 77030-4008, United States
En recrutement
Baylor College of Medicine, Houston, Texas, 77030, United States
Retiré
Lumi Research, Kingwood, Texas, 77339, United States
Retiré
Virginia
Virginia Cancer Specialists (Fairfax) - USOR, Fairfax, Virginia, 22031, United States
En recrutement
Washington
Seattle Cancer Care Alliance, Seattle, Washington, 98109, United States
Retiré