New lung cancer pill aims to outperform current standard

NCT ID NCT02767804

Disease control Sponsor: Xcovery Holdings, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether a new drug called ensartinib works better than the current standard crizotinib for people with ALK-positive non-small cell lung cancer. About 290 participants who have had up to one prior chemotherapy but no prior ALK inhibitor are randomly assigned to receive either drug. The main goal is to see how long the cancer stays under control, with additional checks on overall survival and brain tumor response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Ensartinib (X-396) and crizotinib (Xalkori)
What this could lead to: If ensartinib works better than crizotinib, it could become a new first-choice targeted therapy for ALK-positive lung cancer, potentially slowing tumor growth longer.
What could go wrong: This is a late-stage trial, but results are not yet final. Ensartinib may not prove superior to crizotinib, and side effects could be similar or worse. The study only includes patients who haven't had prior ALK inhibitors, so findings may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

290 people

The number who actually took part.

Started

Jun 2016

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. 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. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2. (see Appendix A) 3. Life expectancy of at least 12 weeks. 4. Ability to swallow and retain oral medication. 5. Adequate organ system function, defined as follows: 1. Absolute neutrophil count (ANC) ≥1.5 x 109/L 2. Platelets ≥100 x 109/L 3. Hemoglobin ≥9 g/dL (≥90 g/L) Note that transfusions are allowed to meet the required hemoglobin level 4. Total bilirubin ≤1.5 times the upper limit of normal (ULN) 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN if no liver involvement or ≤5 x ULN with liver involvement. 6. 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. 6. 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. 7. 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. 8. 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. 9. Patients must be \>18 years-of-age. 10. Patients must have measurable disease per RECIST v. 1.1. 11. Willingness and ability to comply with the trial and follow-up procedures. 12. 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 1. 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). 2. 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. 3. Any chemotherapy within 4 weeks, or major surgery or radiotherapy within the last 14 days. 4. Patients with primary CNS tumors and leptomeningeal disease are ineligible. 5. 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). 6. Concomitant systemic use of anticancer herbal medications. These should be stopped prior to study entry. 7. Patients receiving 1. strong CYP3A inhibitors (including, but not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, grapefruit, grapefruit juice) 2. strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St. John's Wort) 3. CYP3A substrates with narrow therapeutic window (including, but not limited to, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus). 8. Women who are pregnant or breastfeeding. 9. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications. 10. Patients at risk for GI perforation. 11. Clinically significant cardiovascular disease including: 1. 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. 2. 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: 1. Congestive heart failure (New York Heart Class III or IV). 2. Arrhythmia or conduction abnormality requiring medication. Note: patients with atrial fibrillation/flutter controlled by medication and arrhythmias controlled by pacemakers are eligible. 3. Severe/unstable angina, coronary artery/peripheral bypass graft, or myocardial infarction. 4. Cerebrovascular accident or transient ischemia. 12. 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. 13. Known hypersensitivity to tartrazine, a dye used in the ensartinib 100 mg capsule. 14. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. 15. 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. 16. 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 17. In France, a subject will not be eligible when under legal protection.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

Anhui Provincial Hospital

Hefei, Anhui, 230001, China
Asan Medical Center

Seoul, 05505, South Korea
Azienda Socio Sanitaria Territoriale (ASST) della Valtellina e dell'Alto Laria

Sondrio, 20121, Italy
BIH of Omsk Region "Clinical Oncology Dispensary"

Omsk, Russia
Beijing Chao Yang Hospital

Beijing, Beijing Municipality, 100020, China
Beijing Chest Hospital,Capital Medical University

Beijing, Beijing Municipality, 101149, China
Blackpool Victoria Hospital

Blackwood, FY3 8NR, United Kingdom
Border Medical Oncology Research Unit

Albury, New South Wales, 2640, Australia
CHRU Lille

Lille, 59000, France
CHU de Rennes Hôpital Pontchaillou

Rennes, 35033, France
Catholic University of Louvain (UCL) - Site Mont Godinne

Yvoir, 5530, Belgium
Centro Operativo Studi Clinici S.C.Oncologia Medica

Perugia, 06132, Italy
Charite Campus Virchow-Klinikum

Berlin, 13353, Germany
Chris O Brien Lifehouse

Camperdown, Australia
Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia
Federal State Budgetary Scientific Institution Russian Oncological Scientific Center named after N.N. Blokhin

Moscow, 115478, Russia
Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China
Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350014, China
Fundacao do ABC Faculdade de Medicina do ABC

São Paulo, Brazil
Guangdong General Hospital

Guangzhou, Guangdong, 510080, China
Hadassah Medical Center

Jerusalem, 9112001, Israel
Hopital Arnaud de Villeneuve

Montpellier, 34298, France
Hopital Saint-Louis

Vellefaux, France
Hospital Haroldo Juaçaba - Instituto do Cancêr do Ceará

Fortaleza, 60351-010, Brazil
Hospital Son Ltatzer

Palma de Mallorca, 07198, Spain
Hospital Vall d'Hebrón

Barcelona, 08035, Spain
Hospital de Câncer de Barretos - Fundação Pio XII

São Paulo, São Paulo, 14784-400, Brazil
Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain
Hospital del Mar

Barcelona, 08003, Spain
Hubei Cancer Hospital

Wuhan, Hubei, 430079, China
Hunan Cancer Hospital

Changsha, Hu'nan, 410006, China
IEO Istituto Europeo di Oncologia

Milan, 20141, Italy
Infirmière recherche Clinique, IUCPQ

Québec, Quebec, G1V 4G5, Canada
Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, 01246-000, Brazil
Jilin Cancer Hospital

Changchun, Jilin, 130012, China
Kings Mill Hospital

Nottingham, NG17 4JL, United Kingdom
Krajská zdravotní, a.s., Masarykova nemocnice

Ústí nad Labem, 40113, Czechia
LLC "Vitamed"

Moscow, 121309, Russia
Lungen Clinic Grosshansdorf

Großhansdorf, 22927, Germany
Maastricht University Medical Centre (MUMC)

Maastricht, 6229HX, Netherlands
Medical University of Gdansk

Gdansk, Poland
Moffitt Cancer Center

Tampa, Florida, 33612, United States
Moscow City Oncology Hospital #63

Moscow, 143423, Russia
Nanjing General Hospital

Nanjing, Jiangsu, 210002, China
Pavlov First Medical University

Saint Petersburg, 197022, Russia
Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China
Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China
Peking University Cancer Hospital

Beijing, 100142, China
Petrov Research Institute of Oncology

Saint Petersburg, Russia
Prince of Wales Hospital

Hong Kong, Hong Kong
Prince of Wales Hospital

Shatin, Hong Kong
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Queen Elizabeth Hospital

Hong Kong, Hong Kong
Rabin Medical Center Institute of Oncology, Davidoff Center

Petah Tikva, 49100, Israel
Sanatorio Parque S.A.

Rosario, Argentina
Seoul National University Hospital

Seoul, 03080, South Korea
Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China
Southmead Hospital

Bristol, BS10 5NB, United Kingdom
The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266071, China
The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
The First Bethune Hospital of Jilin University

Changchun, Jilin, 130000, China
The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China
The University of Hong Kong/Queen Mary Hospital

Hong Kong, Hong Kong
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, 430030, China
Trakya University Balkan Oncology Hospital

Edirne, 22030, Turkey (Türkiye)
Union Hospital of Tongji Medical College of Huazhong Science and Techology University

Wuhan, Hubei, 420104, China
University Cancer & Blood Center

Athens, Georgia, 30607, United States
VU Medical Center

Amsterdam, 1007 MB, Netherlands
Vítkovická Nemocnice , a.s.

Ostrava-Vitkovice, 70384, Czechia
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China
Zhejiang Cancer Hospital

Hangzhou, China

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