Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE2
Total Enrollment
33 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-05-20
Study Completion Date
2026-12-28
Brief Summary
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Stage III NSCLC is a heterogeneous group of tumors with a wide spectrum of clinical presentations. Across this wide spectrum of heterogeneity, there is no single definitive therapeutic approach and the definition of the most effective treatment approach needs a multidisciplinary approach. In this trial we want to test in ALK positive stage III locally advanced NSCLC patients, the efficacy of Alectinib to induce tumor shrinkage when administered before surgery and to reduce the possibility of disease recurrence, with a limited risk of toxicity related, in long term administration after surgery.
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Detailed Description
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Conditions
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Non Small Cell Lung Cancer
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Alectinib
The treatment will be administrated as neoadjuvant 8 weeks before surgery. After surgical intervention the treatment will be administered up to 96 weeks. Treatment will be discontinued in case of unacceptable toxicity or disease progression.
Group Type
EXPERIMENTAL
Alectinib
Intervention Type
DRUG
600 mg p.o. (four 150 mg capsules) twice daily with food (within 30 minutes after a meal, in the morning and evening).
Interventions
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Alectinib
600 mg p.o. (four 150 mg capsules) twice daily with food (within 30 minutes after a meal, in the morning and evening).
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years.
* Histologically or cytologically confirmed adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
* Documented ALK-positive disease according to an FDA-approved and CE-marked test.
* Locally advanced NSCLC in stage III according to the 8th American Joint Committee on Cancer TNM edition, defined potentially resectable (any T with N2, T4N0-1).
* Documentation that the patient is a candidate for surgical resection of their lung cancer after multidisciplinary discussion.
* Patients must be treatment-naive for NSCLC and eligible to receive treatment with Alectinib.
* Measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with CT scan.
* Brain magnetic resonance imaging (MRI) or CT scan showing no evidence of metastatic disease.
* Positron emission tomography (PET)-computed tomography (CT) showing radiographic stage III lung cancer (mediastinal staging biopsy is allowed but not required).
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1.
* Ability to swallow oral medications.
* Adequate haematological function defined by white blood cell (WBC) count ≥ 2.500/mm3 with absolute neutrophil count (ANC) ≥ 1.500/mm3, platelet count ≥ 100.000/mm3 and haemoglobin ≥ 9 g/dL.
* Adequate hepatic function defined by a total bilirubin ≤ 1.5 x the upper limit of normal (ULN) range (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL), serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 if liver function test elevations are due to liver metastases).
* Adequate renal function defined by a serum creatinine ≤ 1.5 x ULN or an estimated creatinine clearance of ≥ 30 mL/minute for patients with creatinine levels above institutional limits (if using the Cockcroft-Gault formula).
* Histologically or cytologically confirmed adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
* Documented ALK-positive disease according to an FDA-approved and CE-marked test.
* Locally advanced NSCLC in stage III according to the 8th American Joint Committee on Cancer TNM edition, defined potentially resectable (any T with N2, T4N0-1).
* Documentation that the patient is a candidate for surgical resection of their lung cancer after multidisciplinary discussion.
* Patients must be treatment-naive for NSCLC and eligible to receive treatment with Alectinib.
* Measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with CT scan.
* Brain magnetic resonance imaging (MRI) or CT scan showing no evidence of metastatic disease.
* Positron emission tomography (PET)-computed tomography (CT) showing radiographic stage III lung cancer (mediastinal staging biopsy is allowed but not required).
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1.
* Ability to swallow oral medications.
* Adequate haematological function defined by white blood cell (WBC) count ≥ 2.500/mm3 with absolute neutrophil count (ANC) ≥ 1.500/mm3, platelet count ≥ 100.000/mm3 and haemoglobin ≥ 9 g/dL.
* Adequate hepatic function defined by a total bilirubin ≤ 1.5 x the upper limit of normal (ULN) range (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL), serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 if liver function test elevations are due to liver metastases).
* Adequate renal function defined by a serum creatinine ≤ 1.5 x ULN or an estimated creatinine clearance of ≥ 30 mL/minute for patients with creatinine levels above institutional limits (if using the Cockcroft-Gault formula).
Exclusion Criteria
* Female patients with childbearing potential should be using adequate contraceptive measures and should not be breastfeeding during the study and for 90 days following the last dose of Alectinib. They and must have a negative serum pregnancy test within 7 days prior to the first dose of study drug.
* Female patients must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
* Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments;
* Women under 50 years old would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment with LH and FSH levels in the post-menopausal range for the institution;
* Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
* Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception for at least 14 days prior to administration of the first dose of study treatment, during the study, and for 90 days following the last dose of Alectinib.
* Ability to comply with protocol requirements.
* Ability to provide written informed consent. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.
* Prior treatment with any systemic anti-cancer therapy for locally advanced NSCLC including chemotherapy, biologic therapy, including ALK-TKI, immunotherapy or any investigational drug.
* Non-resectable stage III and stage IV disease with distant metastases (including malignant pleural effusion) identified on PET-CT scan or biopsy.
* Any concurrent and/or active malignancy that has required treatment within 2 years of the first dose of study drug.
* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol; or known active infection including hepatitis B (HBV), hepatitis C (HCV) and human immunodeficiency virus (HIV); screening for chronic conditions is not required; patients with HBV with negative HBV viral load on appropriate antiviral therapy will be permitted, if able to continue appropriate antiviral therapy throughout treatment period.
* Any severe infection, including COVID-19, within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infections.
* History of organ transplant.
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of Alectinib.
* Any of the following cardiac criteria:
* Mean resting corrected QT interval (QTc)\>470 msec, obtained from 3 electrocardiograms (ECGs)
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval \>250msec, symptomatic bradycardia \<45 beats/minute.
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
* Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry.
* History of hypersensitivity to active or inactive excipients of Alectinib or drugs with a similar chemical structure or class to Alectinib. This includes, but is not limited to, patients with galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption.
* Administration of strong/potent cytochrome P450 (CYP)3A inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with Alectinib except for oral corticosteroids up to 20 mg of prednisolone equivalent per day.
* Involvement in the planning and/or conduct of the study (applies to both investigator staff and/or staff at the study site).
* Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
* Female patients must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
* Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments;
* Women under 50 years old would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment with LH and FSH levels in the post-menopausal range for the institution;
* Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
* Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception for at least 14 days prior to administration of the first dose of study treatment, during the study, and for 90 days following the last dose of Alectinib.
* Ability to comply with protocol requirements.
* Ability to provide written informed consent. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.
* Prior treatment with any systemic anti-cancer therapy for locally advanced NSCLC including chemotherapy, biologic therapy, including ALK-TKI, immunotherapy or any investigational drug.
* Non-resectable stage III and stage IV disease with distant metastases (including malignant pleural effusion) identified on PET-CT scan or biopsy.
* Any concurrent and/or active malignancy that has required treatment within 2 years of the first dose of study drug.
* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol; or known active infection including hepatitis B (HBV), hepatitis C (HCV) and human immunodeficiency virus (HIV); screening for chronic conditions is not required; patients with HBV with negative HBV viral load on appropriate antiviral therapy will be permitted, if able to continue appropriate antiviral therapy throughout treatment period.
* Any severe infection, including COVID-19, within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infections.
* History of organ transplant.
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of Alectinib.
* Any of the following cardiac criteria:
* Mean resting corrected QT interval (QTc)\>470 msec, obtained from 3 electrocardiograms (ECGs)
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval \>250msec, symptomatic bradycardia \<45 beats/minute.
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
* Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry.
* History of hypersensitivity to active or inactive excipients of Alectinib or drugs with a similar chemical structure or class to Alectinib. This includes, but is not limited to, patients with galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption.
* Administration of strong/potent cytochrome P450 (CYP)3A inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with Alectinib except for oral corticosteroids up to 20 mg of prednisolone equivalent per day.
* Involvement in the planning and/or conduct of the study (applies to both investigator staff and/or staff at the study site).
* Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Gruppo Oncologico Italiano di Ricerca Clinica
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - I.R.S.T.
Meldola, Forlì-Cesena, Italy
Site Status
UOC Oncologia Medica Ospedale Versilia USL Toscana Nord Ovest
Lido di Camaiore, Lucca, Italy
Site Status
A.S.S.T - Monza Ospedale San Gerardo
Monza, Monza Brianza, Italy
Site Status
Centro di Riferimento Oncologico (CRO) - IRCCS Aviano
Aviano, Pordenone, Italy
Site Status
SSD oncologia polmonare - AOU San Luigi Gonzaga
Orbassano, Torino, Italy
Site Status
IRCCS Istittuo Tumori Giovanni Paolo II
Bari, , Italy
Site Status
Azienda Ospedaliero Universitaria Policlinico S.Orsola-Malpighi
Bologna, , Italy
Site Status
Oncologia Medica - PO Rodolico -AOU "Policlinico - Vittorio Emanuele"
Catania, , Italy
Site Status
SODc Oncologia Medica - Azienda Ospedaliera-Universitaria Careggi
Florence, , Italy
Site Status
Oncologia Medica 2 - IRCCS AOU Policlinico San Martino - IST
Genova, , Italy
Site Status
Dipartimento Oncologia e Ematologia - Azienda Ospedaliero-Universitaria di Modena
Modena, , Italy
Site Status
U.O.C Pneumologia ad Indirizzo Oncologico - Azienda Ospedaliera Dei Colli
Napoli, , Italy
Site Status
Istituto Oncologico Veneto (IOV)
Padua, , Italy
Site Status
UOC di Oncologia Medica - AOU di Parma
Parma, , Italy
Site Status
Ospedale S. Maria della Misericordia
Perugia, , Italy
Site Status
IFO Istituto Regina Elena
Roma, , Italy
Site Status
UOSD Pneumologia Oncologica- Ospedale San Camillo
Roma, , Italy
Site Status
Fondazione Policlinico Universitario 'A. Gemelli' IRCCS. Università Cattolica del Sacro Cuore
Roma, , Italy
Site Status
Humanitas Research Hospital - Medical Oncology
Rozzano, , Italy
Site Status
Dipartimento di Oncologia Medica - Università di Verona
Verona, , Italy
Site Status
Countries
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Italy
References
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Hida T, Nokihara H, Kondo M, Kim YH, Azuma K, Seto T, Takiguchi Y, Nishio M, Yoshioka H, Imamura F, Hotta K, Watanabe S, Goto K, Satouchi M, Kozuki T, Shukuya T, Nakagawa K, Mitsudomi T, Yamamoto N, Asakawa T, Asabe R, Tanaka T, Tamura T. Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3 trial. Lancet. 2017 Jul 1;390(10089):29-39. doi: 10.1016/S0140-6736(17)30565-2. Epub 2017 May 10.
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Sakamoto H, Tsukaguchi T, Hiroshima S, Kodama T, Kobayashi T, Fukami TA, Oikawa N, Tsukuda T, Ishii N, Aoki Y. CH5424802, a selective ALK inhibitor capable of blocking the resistant gatekeeper mutant. Cancer Cell. 2011 May 17;19(5):679-90. doi: 10.1016/j.ccr.2011.04.004.
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Kodama T, Hasegawa M, Takanashi K, Sakurai Y, Kondoh O, Sakamoto H. Antitumor activity of the selective ALK inhibitor alectinib in models of intracranial metastases. Cancer Chemother Pharmacol. 2014 Nov;74(5):1023-8. doi: 10.1007/s00280-014-2578-6. Epub 2014 Sep 10.
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Seto T, Kiura K, Nishio M, Nakagawa K, Maemondo M, Inoue A, Hida T, Yamamoto N, Yoshioka H, Harada M, Ohe Y, Nogami N, Takeuchi K, Shimada T, Tanaka T, Tamura T. CH5424802 (RO5424802) for patients with ALK-rearranged advanced non-small-cell lung cancer (AF-001JP study): a single-arm, open-label, phase 1-2 study. Lancet Oncol. 2013 Jun;14(7):590-8. doi: 10.1016/S1470-2045(13)70142-6. Epub 2013 Apr 30.
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Pataer A, Kalhor N, Correa AM, Raso MG, Erasmus JJ, Kim ES, Behrens C, Lee JJ, Roth JA, Stewart DJ, Vaporciyan AA, Wistuba II, Swisher SG; University of Texas M. D. Anderson Lung Cancer Collaborative Research Group. Histopathologic response criteria predict survival of patients with resected lung cancer after neoadjuvant chemotherapy. J Thorac Oncol. 2012 May;7(5):825-32. doi: 10.1097/JTO.0b013e318247504a.
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BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html
Lung Cancer Survival Rates: 5-Year Survival Rates for Lung Cancer
https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf
National Comprehensive Cancer Network. Non-small cell lung cancer (Version 3.2020).
Other Identifiers
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GOIRC-01-2020
Identifier Type: -
Identifier Source: org_study_id
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RECRUITING
PHASE3
A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)
NCT05170204
RECRUITING
PHASE3
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
NCT01871805
COMPLETED
PHASE1/PHASE2
Study of Plasma NGS for Assessment, Characterization, Evaluation of Patients With ALK Resistance
NCT03833934
COMPLETED
A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)
NCT06624059
ACTIVE_NOT_RECRUITING
PHASE3
Alectinib in Combination With Bevacizumab in ALK Positive NSCLC
NCT03779191
COMPLETED
PHASE2
An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
NCT00932451
COMPLETED
PHASE2
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
NCT04644315
TERMINATED
PHASE2
Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer
NCT02521051
TERMINATED
PHASE1/PHASE2
A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC
NCT03202940
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
NCT06095505
RECRUITING
PHASE2
Chemotherapy Combined with ICIs in First-line Alectinib Failed Patients with ALK-rearranged NSCLC
NCT04997382
COMPLETED
PHASE2
Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
NCT05061550
RECRUITING
PHASE2
Anti-angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer
NCT00094094
COMPLETED
PHASE2
KN046 in Subjects With Advanced Squamous Non-small Cell Lung Cancer
NCT04474119
UNKNOWN
PHASE3
A Study of Combination Therapy in NSCLC
NCT04544644
UNKNOWN
PHASE2
Study of S-588410 After Adjuvant Chemotherapy for Completely Resected Non-small- Cell Lung Cancer
NCT02410369
UNKNOWN
PHASE2
An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
NCT00932893
COMPLETED
PHASE3
Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer
NCT04362072
COMPLETED
PHASE4
A Study of Necitumumab and Abemaciclib in Participants With Non-Small Cell Lung Cancer (NSCLC)
NCT02411591
COMPLETED
PHASE1
This Phase II/III, Multicenter Study is Designed to Evaluate the Safety and Clinical Activity of AL3810 in Patients
NCT04254471
UNKNOWN
PHASE2/PHASE3
AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer
NCT05904379
RECRUITING
PHASE1/PHASE2
A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung
NCT01154140
COMPLETED
PHASE3
Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)
NCT05200481
ACTIVE_NOT_RECRUITING
PHASE2
A Study of Anti-PD-1 AK105 in Patients With Metastatic Squamous Non-small Cell Lung Cancer
NCT03866993
COMPLETED
PHASE3