Lung Cancer Clinical Trial

eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

Summary

The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.

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Full Description

To evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive NSCLC that have received up to 1 prior chemotherapy regimen and no prior ALK tyrosine kinase inhibitor (TKI), to obtain additional pharmacokinetic (PK) data from sparse PK sampling, to compare the quality of life (QoL) in patients receiving X-396 vs. crizotinib, to evaluate the status of exploratory biomarkers and correlate with clinical outcome, and to obtain germline DNA samples for possible pharmacogenetic analysis in the event that outliers with respect to efficacy, tolerability/safety, or exposure are identified.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive by an FDA-approved assay performed centrally. Patients must be ALK positive by local test prior to submitting tissue to the central lab. Randomization will occur after ALK positive confirmation is received from the central lab. Patients may have received up to 1 prior chemotherapy regimen for metastatic disease, which may also include maintenance therapy. Note that patients that have received adjuvant or neoadjuvant chemotherapy and developed metastatic disease within 6 months from the end of that therapy would be considered to have received 1 prior regimen for metastatic disease.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2. (see Appendix A)
Life expectancy of at least 12 weeks.
Ability to swallow and retain oral medication.

Adequate organ system function, defined as follows:

Absolute neutrophil count (ANC) ≥1.5 x 109/L
Platelets ≥100 x 109/L
Hemoglobin ≥9 g/dL (≥90 g/L) Note that transfusions are allowed to meet the required hemoglobin level
Total bilirubin ≤1.5 times the upper limit of normal (ULN)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN if no liver involvement or ≤5 x ULN with liver involvement.
Creatinine < 1.5 x ULN. If >1.5 x ULN, patient may still be eligible if calculated creatinine clearance >50 mL/min (0.83mL/s) as calculated by the Cockcroft-Gault method.
Brain metastases allowed if asymptomatic at study baseline. Patients with untreated brain metastases must not be on corticosteroids. If patients have neurological symptoms or signs due to CNS metastases, patients need to complete whole brain radiation or focal treatment at least 14 days before start of study treatment and be asymptomatic on stable or decreasing doses of corticosteroids at baseline.
Men with partners of childbearing potential willing to use adequate contraceptive measures during the study and for 90 days after the last dose of study medication.
Women who are not of child-bearing potential, and women of child-bearing potential who agree to use adequate contraceptive measures during the study and for 90 days after the last dose of study medication, and who have a negative serum or urine pregnancy test within 1 week prior to initial trial treatment.
Patients must be >18 years-of-age.
Patients must have measurable disease per RECIST v. 1.1.
Willingness and ability to comply with the trial and follow-up procedures.
Ability to understand the nature of this trial and give written informed consent.

Note the following pertains to patients enrolled in France

In France, a subject will be eligible for inclusion in this study only affiliated to the French Social Security system, and currently benefit from the corresponding rights and cover.

Exclusion Criteria

Patients that have previously received an ALK TKI or PD-1/PD-L1 therapy, and patients currently receiving cancer therapy (i.e., other targeted therapies, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization).
Use of an investigational drug within 21 days prior to the first dose of study drug. Note that to be eligible, any drug-related toxicity should have recovered to Grade 1 or less, with the exception of alopecia.
Any chemotherapy within 4 weeks, or major surgery or radiotherapy within the last 14 days.
Patients with primary CNS tumors and leptomeningeal disease are ineligible.
Patients with a previous malignancy within the past 3 years (other than curatively treated basal cell carcinoma of the skin, in situ carcinoma of the cervix, or any cancer that is considered to be cured and have no impact on PFS and OS for the current NSCLC).
Concomitant systemic use of anticancer herbal medications. These should be stopped prior to study entry.

Patients receiving

strong CYP3A inhibitors (including, but not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, grapefruit, grapefruit juice)
strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St. John's Wort)
CYP3A substrates with narrow therapeutic window (including, but not limited to, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus).
Women who are pregnant or breastfeeding.
Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
Patients at risk for GI perforation.

Clinically significant cardiovascular disease including:

QTcF interval >450 ms for men and >470 ms for women, symptomatic bradycardia <45 beats per minute or other significant ECG abnormalities in the investigator's opinion.
Clinically uncontrolled hypertension in the investigator's opinion (e.g., blood pressure >160/100 mmHg; note that isolated elevated readings considered to not be indicative of uncontrolled hypertension are allowed).

The following within 6 months prior to Cycle 1 Day 1:

Congestive heart failure (New York Heart Class III or IV).
Arrhythmia or conduction abnormality requiring medication. Note: patients with atrial fibrillation/flutter controlled by medication and arrhythmias controlled by pacemakers are eligible.
Severe/unstable angina, coronary artery/peripheral bypass graft, or myocardial infarction.
Cerebrovascular accident or transient ischemia.
Patients who are immunosuppressed (including known HIV infection), have a serious active infection at the time of treatment, have interstitial lung disease/pneumonitis, or have any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment. Patients with controlled hepatitis C, in the investigator's opinion, are allowed. Patients with known hepatitis B must be HBeAg and HB viral DNA negative for enrollment. Note that, because of the high prevalence, all patients in the Asia-Pacific region (except Australia, New Zealand, and Japan) must be tested and, if HBsAg positive, must be HBeAg and HB viral DNA negative for enrollment.
Known hypersensitivity to tartrazine, a dye used in the ensartinib 100 mg capsule.
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled.

Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.

Note the following pertains to patients enrolled in France

In France, a subject will not be eligible when under legal protection.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

290

Study ID:

NCT02767804

Recruitment Status:

Active, not recruiting

Sponsor:

Xcovery Holdings, Inc.

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There are 58 Locations for this study

See Locations Near You

Moffitt Cancer Center
Tampa Florida, 33612, United States
University Cancer & Blood Center
Athens Georgia, 30607, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Sanatorio Parque S.A.
Rosario , , Argentina
Border Medical Oncology Research Unit
Albury New South Wales, 2640, Australia
Chris O'Brien Lifehouse
Camperdown New South Wales, , Australia
Chris O Brien Lifehouse
Camperdown , , Australia
Catholic University of Louvain (UCL) - Site Mont Godinne
Yvoir , 5530, Belgium
Instituto do Câncer do Estado de São Paulo
São Paulo SP, 01246, Brazil
Hospital de Câncer de Barretos - Fundação Pio XII
São Paulo SP, 14784, Brazil
Hospital Haroldo Juaçaba - Instituto do Cancêr do Ceará
Fortaleza , 60351, Brazil
Fundacao do ABC Faculdade de Medicina do ABC
São Paulo , , Brazil
Infirmière recherche Clinique, IUCPQ
Quebec City Quebec, G1V 4, Canada
Anhui Provincial Hospital
Hefei Anhui, 23000, China
Beijing Chao Yang Hospital
Beijing Beijing, 10002, China
Peking Union Medical College Hospital
Beijing Beijing, 10003, China
Peking University Cancer Hospital
Beijing Beijing, 10014, China
Beijing Chest Hospital,Capital Medical University
Beijing Beijing, 10114, China
Fujian Provincial Cancer Hospital
Fuzhou Fujian, 35001, China
Guangdong General Hospital
Guangzhou Guangdong, 51008, China
Fourth Hospital of Hebei Medical University
Shijiazhuang Hebei, 05001, China
Union Hospital of Tongji Medical College of Huazhong Science and Techology University
Wuhan Hubei, 42010, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan Hubei, 43003, China
Hubei Cancer Hospital
Wuhan Hubei, 43007, China
Hunan Cancer Hospital
Changsha Hunan, 41000, China
Nanjing General Hospital
Nanjing Jiangsu, 21000, China
The First Bethune Hospital of Jilin University
Changchun Jilin, 13000, China
Jilin Cancer Hospital
Changchun Jilin, 13001, China
The First Hospital of China Medical University
Shenyang Liaoning, 11000, China
The Affiliated Hospital of Qingdao University
Qingdao Shandong, 26607, China
Shanghai Chest Hospital
Shanghai Shanghai, 20003, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31002, China
Peking University Cancer Hospital
Beijing , 10014, China
Zhejiang Cancer Hospital
Hangzhou , , China
Vítkovická Nemocnice , a.s.
Ostrava-Vitkovice , 70384, Czechia
Krajská zdravotní, a.s., Masarykova nemocnice
Usti nad Labem , 40113, Czechia
CHRU Lille
Lille , 59000, France
Hopital Arnaud de Villeneuve
Montpellier , 34298, France
CHU de Rennes Hôpital Pontchaillou
Rennes , 35033, France
Hopital Saint-Louis
Vellefaux , , France
Charite Campus Virchow-Klinikum
Berlin , 13353, Germany
Lungen Clinic Grosshansdorf
Grosshansdorf , 22927, Germany
Prince of Wales Hospital
Hong Kong , , Hong Kong
Queen Elizabeth Hospital
Hong Kong , , Hong Kong
The University of Hong Kong/Queen Mary Hospital
Hong Kong , , Hong Kong
Prince of Wales Hospital
Sha Tin , , Hong Kong
Hadassah Medical Center
Jerusalem , 91120, Israel
Rabin Medical Center Institute of Oncology, Davidoff Center
Petah Tiqva , 49100, Israel
IEO Istituto Europeo di Oncologia
Milano , 20141, Italy
Centro Operativo Studi Clinici S.C.Oncologia Medica
Perugia , 06132, Italy
Azienda Socio Sanitaria Territoriale (ASST) della Valtellina e dell'Alto Laria
Sondrio , 20121, Italy
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
VU Medical Center
Amsterdam , 1007 , Netherlands
Maastricht University Medical Centre (MUMC)
Maastricht , 6229H, Netherlands
Medical University of Gdansk
Gdańsk , , Poland
Federal State Budgetary Scientific Institution Russian Oncological Scientific Center named after N.N. Blokhin
Moscow , 11547, Russian Federation
LLC "Vitamed"
Moscow , 12130, Russian Federation
Moscow City Oncology Hospital #63
Moscow , 14342, Russian Federation
BIH of Omsk Region "Clinical Oncology Dispensary"
Omsk , , Russian Federation
Pavlov First Medical University
Saint Petersburg , 19702, Russian Federation
Petrov Research Institute of Oncology
Saint Petersburg , , Russian Federation
Hospital del Mar
Barcelona , 08003, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , 08025, Spain
Hospital Vall d'Hebrón
Barcelona , 08035, Spain
Hospital Son Ltatzer
Palma de Mallorca , 07198, Spain
Trakya University Balkan Oncology Hospital
Edirne , 22030, Turkey
Blackpool Victoria Hospital
Blackwood , FY3 8, United Kingdom
Southmead Hospital
Bristol , BS10 , United Kingdom
Kings Mill Hospital
Nottingham , NG17 , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Wirral , CH63 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

290

Study ID:

NCT02767804

Recruitment Status:

Active, not recruiting

Sponsor:


Xcovery Holdings, Inc.

How clear is this clinincal trial information?

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