- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05015010
Alectinib in Neo-adjuvant Treatment of Stage III NSCLC (ALNEO)
Phase II, Open-label, Single-arm, Multicenter Study to Assess the Activity and Safety of ALectinib as NEO-adjuvant Therapy in Patients With Anaplastic Lymphoma Kinase-positive (ALK+) Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC): ALNEO Trial
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Bari, Italy, 70124
- Recruiting
- IRCCS Istittuo Tumori Giovanni Paolo II
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Contact:
- Domenico Galetta, Dr
- Phone Number: +39 055 7948406
- Email: galetta@oncologico.bari.it
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Bologna, Italy, 40138
- Recruiting
- Azienda Ospedaliero Universitaria Policlinico S.Orsola-Malpighi
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Contact:
- Francesco Gelsomino, Dr
- Phone Number: +39 0512142265
- Email: francesco_gelsomino@aosp.bo.it
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Catania, Italy, 95125
- Recruiting
- Oncologia Medica - PO Rodolico -AOU "Policlinico - Vittorio Emanuele"
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Contact:
- Hector Soto Para, Dr
- Phone Number: +390953781496
- Email: hsotoparra@policlinico.unict.it
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Firenze, Italy
- Recruiting
- SODc Oncologia Medica - Azienda Ospedaliera-Universitaria Careggi
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Contact:
- Francesca Mazzoni, Dr
- Phone Number: +39 0498215608
- Email: mazzonifr@aou-careggi.toscana.it
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Genova, Italy, 16132
- Recruiting
- Oncologia Medica 2 - IRCCS AOU Policlinico San Martino - IST
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Contact:
- Carlo Genova, Dr
- Phone Number: +390105558918
- Email: carlo.genova@hsanmartino.it
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Modena, Italy, 41124
- Recruiting
- Dipartimento Oncologia e Ematologia - Azienda Ospedaliero-Universitaria di Modena
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Contact:
- Federica Bertolini, Dr
- Phone Number: +39 0594223864
- Email: bertolini.federica@policlinico.mo.it
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Napoli, Italy, 80131
- Recruiting
- U.O.C Pneumologia ad Indirizzo Oncologico - Azienda Ospedaliera Dei Colli
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Contact:
- Danilo Rocco, Dr
- Phone Number: +390817064300
- Email: danilorocc@yahoo.it
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Padova, Italy, 35128
- Recruiting
- Istituto Oncologico Veneto (IOV)
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Contact:
- Giulia Pasello, Dr
- Phone Number: 0498215608
- Email: giulia.pasello@iov.veneto.it
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Parma, Italy, 43126
- Recruiting
- UOC di Oncologia Medica - AOU di Parma
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Contact:
- Alessandro Leonetti, Dr
- Phone Number: +390521702316
- Email: aleonetti@ao.pr.it
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Perugia, Italy, 06129
- Recruiting
- Ospedale S. Maria Della Misericordia
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Contact:
- Giulio Metro, Dr
- Phone Number: +390755784212
- Email: giulio.metro@ospedale.perugia.it
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Roma, Italy, 00144
- Recruiting
- IFO Istituto Regina Elena
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Contact:
- Fabiana Letizia Cecere, Dr
- Phone Number: 0652666919
- Email: fabianacecere@gmail.com
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Contact:
- Cecere
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Roma, Italy, 00152
- Recruiting
- UOSD Pneumologia Oncologica- Ospedale San Camillo
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Contact:
- Rita Migliorino, Dr
- Phone Number: +39 068704670
- Email: mmigliorino@scamilloforlanini.rm.it
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Roma, Italy, 00168
- Recruiting
- Fondazione Policlinico Universitario 'A. Gemelli' IRCCS. Università Cattolica del Sacro Cuore
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Contact:
- Emilio Bria, Dr
- Phone Number: +390630154277
- Email: emilio.bria@policlinicogemelli.it
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Rozzano, Italy, 20089
- Recruiting
- Humanitas Research Hospital - Medical Oncology
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Contact:
- Luca Toschi, Dr
- Phone Number: +39 0223903836
- Email: luca.toschi@humanitas.it
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Verona, Italy, 37135
- Recruiting
- Dipartimento di Oncologia Medica - Università di Verona
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Contact:
- Sara Pilotto, Dr
- Phone Number: +390458128124
- Email: sara.pilotto@univr.it
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Forlì-Cesena
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Meldola, Forlì-Cesena, Italy, 47014
- Recruiting
- IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - I.R.S.T.
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Contact:
- Angelo Del Monte, Dr
- Phone Number: +39 0543739100
- Email: angelo.delmonte@irst.emr.it
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Lucca
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Lido Di Camaiore, Lucca, Italy, 55041
- Recruiting
- UOC Oncologia Medica Ospedale Versilia USL Toscana Nord Ovest
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Contact:
- Andrea Camerini, Dr
- Phone Number: +3905846058753
- Email: andreacamerini@katamail.com
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Monza Brianza
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Monza, Monza Brianza, Italy, 20900
- Recruiting
- A.S.S.T - Monza Ospedale San Gerardo
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Contact:
- Diego Cortinovis, Dr
- Phone Number: +39 0392339678
- Email: d.cortinovis@asst-monza.it
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Pordenone
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Aviano, Pordenone, Italy
- Recruiting
- Centro di Riferimento Oncologico (CRO) - IRCCS Aviano
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Contact:
- Alessandra Bearz, Dr
- Phone Number: 0434 659 294
- Email: abearz@cro.it
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Torino
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Orbassano, Torino, Italy, 10043
- Recruiting
- SSD oncologia polmonare - AOU San Luigi Gonzaga
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Contact:
- Francesco Passiglia, Dr
- Phone Number: +39 0119026978
- Email: passi.f@live.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
- Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks before trial inclusion date, and otherwise noted in other inclusion/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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 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.
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600 mg p.o. (four 150 mg capsules) twice daily with food (within 30 minutes after a meal, in the morning and evening).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Pathological Response (MPR)
Time Frame: From the treatment start until surgery - 12 weeks period (8 weeks of neoadjuvant therapy; surgery should be done within 2-4 weeks afterwards.
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Percentage of residual viable tumor cells histologically detected in the resected primary tumor and all resected lymph nodes after surgery ≤10%.
Evaluation by Blinded Independent Pathology Reviewer (BIPR).
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From the treatment start until surgery - 12 weeks period (8 weeks of neoadjuvant therapy; surgery should be done within 2-4 weeks afterwards.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathological Complete Response
Time Frame: From the treatment start until surgery - 12 weeks period (8 weeks of neoadjuvant therapy; surgery should be done within 2-4 weeks afterwards.
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The absence of residual viable tumor cells in all surgical specimens (resected primary tumor and all resected lymph nodes) as evaluated by BIPR.
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From the treatment start until surgery - 12 weeks period (8 weeks of neoadjuvant therapy; surgery should be done within 2-4 weeks afterwards.
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Objective response
Time Frame: Pre-surgical radiological evaluation (after 8 weeks of neoadjuvant therapy start)
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Complete Response (CR) or a Partial Responses (PR) based on the Investigator's assessment and measured according to standard RECIST criteria v1.1
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Pre-surgical radiological evaluation (after 8 weeks of neoadjuvant therapy start)
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Event-free survival (EFS)
Time Frame: From the trial inclusion date to either the date of disease recurrence/progression or the date of death, monitored up to 3 years after surgery.
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The length of time after the trial inclusion the patient remains free of recurrence/progression or death, whatever the cause.
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From the trial inclusion date to either the date of disease recurrence/progression or the date of death, monitored up to 3 years after surgery.
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Disease-free survival (DFS)
Time Frame: From the date of surgical resection to either the date of disease recurrence or the date of death monitored up to 3 years after surgery.
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The length of time after surgical resection the patient remains free of recurrence/progression or death, whatever the cause.
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From the date of surgical resection to either the date of disease recurrence or the date of death monitored up to 3 years after surgery.
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Overall survival (OS)
Time Frame: From the date of trial inclusion to the date of death monitored up to 3 years after surgery.
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The length of time after the trial inclusion the patient remains alive
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From the date of trial inclusion to the date of death monitored up to 3 years after surgery.
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Adverse Events (AE)
Time Frame: From the date of the trial inclusion until 30 days (90 days in case of AE serious/special interest) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first
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Untoward medical events occurring after trial inclusion. Adverse Events are defined and graded according to Common Terminology Criteria for Adverse Events [CTCAE] version 5.0. Adverse event of special interest are cases of potential drug-induced liver, suspected transmission of an infectious agent by the study treatment, Interstitial Lung Disease. Serious adverse events is any AE occurring at any dose that results in death; is life-threatening (i.e., in the opinion of the Investigator, the subject is at immediate risk of death from the AE); requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay); results in persistent or significant disability/incapacity (a substantial disruption of the subject's ability to conduct normal life functions); is a congenital anomaly/birth defect; constitutes an important medical event. |
From the date of the trial inclusion until 30 days (90 days in case of AE serious/special interest) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first
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Tissue and cell-free (plasma) biomarkers
Time Frame: From the time of diagnosis up to 3 years after surgery
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Characterization of Anaplastic Lymphoma Kinase fusion partner on DNA extracted from tissue biopsy and on cell-free nucleic acid (cfNA) (both cfDNA and cfRNA) extracted from plasma sample.
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From the time of diagnosis up to 3 years after surgery
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Collaborators and Investigators
Publications and helpful links
General Publications
- Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8.
- Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.
- 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.
- Peters S, Camidge DR, Shaw AT, Gadgeel S, Ahn JS, Kim DW, Ou SI, Perol M, Dziadziuszko R, Rosell R, Zeaiter A, Mitry E, Golding S, Balas B, Noe J, Morcos PN, Mok T; ALEX Trial Investigators. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Aug 31;377(9):829-838. doi: 10.1056/NEJMoa1704795. Epub 2017 Jun 6.
- 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.
- NSCLC Meta-analysis Collaborative Group. Preoperative chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual participant data. Lancet. 2014 May 3;383(9928):1561-71. doi: 10.1016/S0140-6736(13)62159-5. Epub 2014 Feb 25.
- Detterbeck FC, Boffa DJ, Kim AW, Tanoue LT. The Eighth Edition Lung Cancer Stage Classification. Chest. 2017 Jan;151(1):193-203. doi: 10.1016/j.chest.2016.10.010. Epub 2016 Oct 22.
- Huber RM, De Ruysscher D, Hoffmann H, Reu S, Tufman A. Interdisciplinary multimodality management of stage III nonsmall cell lung cancer. Eur Respir Rev. 2019 Jul 8;28(152):190024. doi: 10.1183/16000617.0024-2019. Print 2019 Jun 30.
- Postmus PE, Kerr KM, Oudkerk M, Senan S, Waller DA, Vansteenkiste J, Escriu C, Peters S; ESMO Guidelines Committee. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv1-iv21. doi: 10.1093/annonc/mdx222. No abstract available.
- Nicholson AG, Chansky K, Crowley J, Beyruti R, Kubota K, Turrisi A, Eberhardt WE, van Meerbeeck J, Rami-Porta R; Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions; Staging and Prognostic Factors Committee Advisory Boards and Participating Institutions. The International Association for the Study of Lung Cancer Lung Cancer Staging Project: Proposals for the Revision of the Clinical and Pathologic Staging of Small Cell Lung Cancer in the Forthcoming Eighth Edition of the TNM Classification for Lung Cancer. J Thorac Oncol. 2016 Mar;11(3):300-11. doi: 10.1016/j.jtho.2015.10.008. Epub 2015 Dec 24.
- Rocco G, Nason K, Brunelli A, Varela G, Waddell T, Jones DR. Management of stage IIIA (N2) non-small cell lung cancer: A transatlantic perspective. J Thorac Cardiovasc Surg. 2016 May;151(5):1235-8. doi: 10.1016/j.jtcvs.2016.01.035. Epub 2016 Mar 17. No abstract available.
- Yoon SM, Shaikh T, Hallman M. Therapeutic management options for stage III non-small cell lung cancer. World J Clin Oncol. 2017 Feb 10;8(1):1-20. doi: 10.5306/wjco.v8.i1.1.
- Lewis J, Gillaspie EA, Osmundson EC, Horn L. Before or After: Evolving Neoadjuvant Approaches to Locally Advanced Non-Small Cell Lung Cancer. Front Oncol. 2018 Jan 23;8:5. doi: 10.3389/fonc.2018.00005. eCollection 2018.
- Situ D, Lin Y. Neoadjuvant strategy for stage IIIA-N2 non-small cell lung cancer: chemoradiation or chemotherapy alone? J Thorac Dis. 2017 Sep;9(9):2746-2748. doi: 10.21037/jtd.2017.08.23. No abstract available.
- Muller IB, de Langen AJ, Giovannetti E, Peters GJ. Anaplastic lymphoma kinase inhibition in metastatic non-small cell lung cancer: clinical impact of alectinib. Onco Targets Ther. 2017 Sep 13;10:4535-4541. doi: 10.2147/OTT.S109493. eCollection 2017.
- 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.
- Vavala T, Novello S. Alectinib in the treatment of ALK-positive non-small cell lung cancer: an update on its properties, efficacy, safety and place in therapy. Ther Adv Med Oncol. 2018 Aug 3;10:1758835918789364. doi: 10.1177/1758835918789364. eCollection 2018.
- Lin JJ, Riely GJ, Shaw AT. Targeting ALK: Precision Medicine Takes on Drug Resistance. Cancer Discov. 2017 Feb;7(2):137-155. doi: 10.1158/2159-8290.CD-16-1123. Epub 2017 Jan 25.
- Song Z, Wang M, Zhang A. Alectinib: a novel second generation anaplastic lymphoma kinase (ALK) inhibitor for overcoming clinically-acquired resistance. Acta Pharm Sin B. 2015 Jan;5(1):34-7. doi: 10.1016/j.apsb.2014.12.007. Epub 2015 Jan 24.
- 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.
- 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.
- Gadgeel SM, Gandhi L, Riely GJ, Chiappori AA, West HL, Azada MC, Morcos PN, Lee RM, Garcia L, Yu L, Boisserie F, Di Laurenzio L, Golding S, Sato J, Yokoyama S, Tanaka T, Ou SH. Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a phase 1/2 study. Lancet Oncol. 2014 Sep;15(10):1119-28. doi: 10.1016/S1470-2045(14)70362-6. Epub 2014 Aug 18.
- Shaw AT, Gandhi L, Gadgeel S, Riely GJ, Cetnar J, West H, Camidge DR, Socinski MA, Chiappori A, Mekhail T, Chao BH, Borghaei H, Gold KA, Zeaiter A, Bordogna W, Balas B, Puig O, Henschel V, Ou SI; study investigators. Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trial. Lancet Oncol. 2016 Feb;17(2):234-242. doi: 10.1016/S1470-2045(15)00488-X. Epub 2015 Dec 19. Erratum In: Lancet Oncol. 2017 Mar;18(3):e134.
- Ou SH, Ahn JS, De Petris L, Govindan R, Yang JC, Hughes B, Lena H, Moro-Sibilot D, Bearz A, Ramirez SV, Mekhail T, Spira A, Bordogna W, Balas B, Morcos PN, Monnet A, Zeaiter A, Kim DW. Alectinib in Crizotinib-Refractory ALK-Rearranged Non-Small-Cell Lung Cancer: A Phase II Global Study. J Clin Oncol. 2016 Mar 1;34(7):661-8. doi: 10.1200/jco.2015.63.9443. Epub 2015 Nov 23.
- Yang JC, Ou SI, De Petris L, Gadgeel S, Gandhi L, Kim DW, Barlesi F, Govindan R, Dingemans AC, Crino L, Lena H, Popat S, Ahn JS, Dansin E, Golding S, Bordogna W, Balas B, Morcos PN, Zeaiter A, Shaw AT. Pooled Systemic Efficacy and Safety Data from the Pivotal Phase II Studies (NP28673 and NP28761) of Alectinib in ALK-positive Non-Small Cell Lung Cancer. J Thorac Oncol. 2017 Oct;12(10):1552-1560. doi: 10.1016/j.jtho.2017.06.070. Epub 2017 Jul 6.
- Novello S, Mazieres J, Oh IJ, de Castro J, Migliorino MR, Helland A, Dziadziuszko R, Griesinger F, Kotb A, Zeaiter A, Cardona A, Balas B, Johannsdottir HK, Das-Gupta A, Wolf J. Alectinib versus chemotherapy in crizotinib-pretreated anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer: results from the phase III ALUR study. Ann Oncol. 2018 Jun 1;29(6):1409-1416. doi: 10.1093/annonc/mdy121.
- Zhang C, Li SL, Nie Q, Dong S, Shao Y, Yang XN, Wu YL, Yang Y, Zhong WZ. Neoadjuvant Crizotinib in Resectable Locally Advanced Non-Small Cell Lung Cancer with ALK Rearrangement. J Thorac Oncol. 2019 Apr;14(4):726-731. doi: 10.1016/j.jtho.2018.10.161. Epub 2018 Nov 5.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOIRC-01-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Clinical Trials on Non Small Cell Lung Cancer
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WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
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University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
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University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
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AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
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National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
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Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
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Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
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Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
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National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
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Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
Clinical Trials on Alectinib
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Aarhus University HospitalRoche Pharma AGEnrolling by invitationLung Cancer | ALK Gene Mutation | Resistance, Disease | MutationDenmark
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Hoffmann-La RocheCompletedCarcinoma, Non-Small-Cell LungFrance
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Hoffmann-La RocheCompletedNon-Small Cell Lung CancerKorea, Republic of
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ETOP IBCSG Partners FoundationHoffmann-La RocheTerminatedNon-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer RecurrentIreland, Spain, Belgium, Italy, Netherlands, Switzerland
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Dana-Farber Cancer InstituteGenentech, Inc.TerminatedALK-positive Non-small Cell Lung Cancer (NSCLC) | RET-positive Non-small Cell Lung Cancer (NSCLC) | RET-positive Thyroid CancerUnited States
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University Medical Center GroningenRadboud University Medical Center; Maastricht University Medical Center; Erasmus... and other collaboratorsRecruitingCarcinoma, Non-Small-Cell Lung | Lung Cancer | Drug Monitoring | Anaplastic Lymphoma Kinase Gene Mutation | Anaplastic Lymphoma Kinase Gene TranslocationNetherlands, France
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Hoffmann-La RocheActive, not recruitingNSCLCBelgium, Australia, China, Croatia, Finland, Turkey, Italy, Israel, Serbia, Austria, Romania, Peru, Lithuania, Colombia, Portugal, Czechia, Cuba, Russian Federation, Bulgaria, Vietnam, Uruguay, United Arab Emirates, Argentina, Chile, Pa...
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PfizerCompletedNon-Small-Cell Lung CarcinomaUnited States
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Hoffmann-La RocheCompletedHepatic ImpairmentCzechia, Slovakia
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Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator...Not yet recruitingNon-small Cell Lung CancerUnited States