Alectinib in Neo-adjuvant Treatment of Stage III NSCLC

Non Small Cell Lung Cancer Clinical Trial

— ALNEO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05015010
• Other study ID #: GOIRC-01-2020
• Status: Recruiting
• Phase: Phase 2
• Start date: May 20, 2021
• Est. completion date: May 28, 2026

Study information

• Verified date: September 2022
• Source: Gruppo Oncologico Italiano di Ricerca Clinica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: May 28, 2026
• Est. primary completion date: May 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Alectinib
600 mg p.o. (four 150 mg capsules) twice daily with food (within 30 minutes after a meal, in the morning and evening).

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico (CRO) - IRCCS Aviano	Aviano	Pordenone
Italy	IRCCS Istittuo Tumori Giovanni Paolo II	Bari
Italy	Azienda Ospedaliero Universitaria Policlinico S.Orsola-Malpighi	Bologna
Italy	Oncologia Medica - PO Rodolico -AOU "Policlinico - Vittorio Emanuele"	Catania
Italy	SODc Oncologia Medica - Azienda Ospedaliera-Universitaria Careggi	Firenze
Italy	Oncologia Medica 2 - IRCCS AOU Policlinico San Martino - IST	Genova
Italy	UOC Oncologia Medica Ospedale Versilia USL Toscana Nord Ovest	Lido Di Camaiore	Lucca
Italy	IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - I.R.S.T.	Meldola	Forlì-Cesena
Italy	Dipartimento Oncologia e Ematologia - Azienda Ospedaliero-Universitaria di Modena	Modena
Italy	A.S.S.T - Monza Ospedale San Gerardo	Monza	Monza Brianza
Italy	U.O.C Pneumologia ad Indirizzo Oncologico - Azienda Ospedaliera Dei Colli	Napoli
Italy	SSD oncologia polmonare - AOU San Luigi Gonzaga	Orbassano	Torino
Italy	Istituto Oncologico Veneto (IOV)	Padova
Italy	UOC di Oncologia Medica - AOU di Parma	Parma
Italy	Ospedale S. Maria della Misericordia	Perugia
Italy	Fondazione Policlinico Universitario 'A. Gemelli' IRCCS. Università Cattolica del Sacro Cuore	Roma
Italy	IFO Istituto Regina Elena	Roma
Italy	UOSD Pneumologia Oncologica- Ospedale San Camillo	Roma
Italy	Humanitas Research Hospital - Medical Oncology	Rozzano
Italy	Dipartimento di Oncologia Medica - Università di Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Oncologico Italiano di Ricerca Clinica

Country where clinical trial is conducted

Italy, 

References & Publications (27)

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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. Review. — View Citation

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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. — View Citation

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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. — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Pathological Response (MPR)	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).	From the treatment start until surgery - 12 weeks period (8 weeks of neoadjuvant therapy; surgery should be done within 2-4 weeks afterwards.
Secondary	Pathological Complete Response	The absence of residual viable tumor cells in all surgical specimens (resected primary tumor and all resected lymph nodes) as evaluated by BIPR.	From the treatment start until surgery - 12 weeks period (8 weeks of neoadjuvant therapy; surgery should be done within 2-4 weeks afterwards.
Secondary	Objective response	Complete Response (CR) or a Partial Responses (PR) based on the Investigator's assessment and measured according to standard RECIST criteria v1.1	Pre-surgical radiological evaluation (after 8 weeks of neoadjuvant therapy start)
Secondary	Event-free survival (EFS)	The length of time after the trial inclusion the patient remains free of recurrence/progression or death, whatever the cause.	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.
Secondary	Disease-free survival (DFS)	The length of time after surgical resection the patient remains free of recurrence/progression or death, whatever the cause.	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.
Secondary	Overall survival (OS)	The length of time after the trial inclusion the patient remains alive	From the date of trial inclusion to the date of death monitored up to 3 years after surgery.
Secondary	Adverse Events (AE)	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
Secondary	Tissue and cell-free (plasma) biomarkers	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.	From the time of diagnosis up to 3 years after surgery

External Links

•   Lung Cancer Survival Rates: 5-Year Survival Rates for Lung Cancer
•   National Comprehensive Cancer Network. Non-small cell lung cancer (Version 3.2020).