Non-Small Cell Lung CancerPhase 2NCT01685060
LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib
A Phase 2 study testing LDK378 in people with Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 52 sites in 12 countries.
Trial summary
A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- LDK378
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 52 sitesin 12 countries
- Study dates
- 26 Nov 2012to 29 Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC that carries an ALK rearrangement, as per the FDA-approved FISH assay (Abbott Molecular Inc.).
- Age 18 years or older at the time of informed consent.
- Patients must have NSCLC that has progressed during therapy with crizotinib or within 30 days of the last dose
- Patients must have received 1-3 lines of cytotoxic chemotherapy (of which 1 must have been a platinum doublet) to treat their locally advanced or metastatic NSCLC
- Patients must have a tumor tissue sample available, collected either at the time of diagnosis of NSCLC or any time since.
- Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 2, except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study.
Who cannot join
- Patients with known hypersensitivity to any of the excipients of LDK378.
- Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
- History of carcinomatous meningitis.
- Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
- Clinically significant, uncontrolled heart disease
- Systemic anti-cancer therapy given after the last dose of crizotinib and prior to starting study drug.
Trial locations and contacts
52 sites in 12 countries.
52 sites in 12 countries
United States17 sites
Emory University School of Medicine/Winship Cancer Institute Dept of Oncology
Atlanta, Georgia, 30322
University of Colorado Hospital SC
Aurora, Colorado, 80045
Massachusetts General Hospital Mass General
Boston, Massachusetts, 02114
Levine Cancer Institute SC 1
Charlotte, North Carolina, 28203
University of Chicago Medical Center SC
Chicago, Illinois, 60637
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office
Dallas, Texas, 75390
City of Hope National Medical Center Dept of Oncology 2
Duarte, California, 91010-3000
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, 72703
University of Kansas Cancer Center DeptofUofKansas CancerCenter-2
Kansas City, Kansas, 66160
University of California at Los Angeles Reg-5
Los Angeles, California, 90095
University of Wisconsin Univ Wisc 2
Madison, Wisconsin, 53792
Sarah Cannon Research Institute Drug Ship - 4
Nashville, Tennessee, 37203
Maryland Oncology Hematology, P.A. SC
Rockville, Maryland, 20850
University of California at San Diego, Moores Cancer Ctr SC
San Diego, California, 92103
Seattle Cancer Care Alliance SC-1
Seattle, Washington, 98105
Stanford University Medical Center Stanford Cancer Center(2)
Stanford, California, 94304
Cancer Center of Kansas Dept of CCK
Wichita, Kansas, 67214-3728
Japan9 sites
Novartis Investigative Site
Akashi, Hyōgo, 673-8558
Novartis Investigative Site
Chuo-ku, Tokyo, 104-0045
Novartis Investigative Site
Fukuoka, 811-1395
Novartis Investigative Site
Kashiwa, Chiba, 277-8577
Novartis Investigative Site
Koto, Tokyo, 135-8550
Novartis Investigative Site
Nagoya, Aichi-ken, 464-8681
Novartis Investigative Site
Okayama, Okayama-ken, 700-8558
Novartis Investigative Site
Sayama, Osaka, 589-8511
Novartis Investigative Site
Sunto-gun, Shizuoka, 411-8777
Italy6 sites
Novartis Investigative Site
Avellino, AV, 83100
Novartis Investigative Site
Livorno, LI, 57124
Novartis Investigative Site
Milan, MI, 20141
Novartis Investigative Site
Monza, MB, 20900
Novartis Investigative Site
Parma, PR, 43100
Novartis Investigative Site
Perugia, PG, 06129
Spain4 sites
Novartis Investigative Site
A Coruña, Galicia, 15006
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Madrid, 28046
Novartis Investigative Site
Seville, Andalusia, 41013
Canada3 sites
Novartis Investigative Site
Edmonton, Alberta, T6G 1Z2
Novartis Investigative Site
Oshawa, Ontario, L1G 2B9
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Netherlands3 sites
Novartis Investigative Site
Amsterdam, 1081 HV
Novartis Investigative Site
Groningen, 9713 GZ
Novartis Investigative Site
Maastricht, 5800
South Korea3 sites
Novartis Investigative Site
Seoul, Korea, 03080
Novartis Investigative Site
Seoul, Korea, 03722
Novartis Investigative Site
Seoul, Korea, 06351
France2 sites
Novartis Investigative Site
Marseille, 13915
Novartis Investigative Site
Paris, 75970
Germany2 sites
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
Novartis Investigative Site
Heidelberg, 69120
About this study
Official title: A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Adult Patients With ALK-activated Non-small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib
A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- LDK378
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, ALK, LDK378, Ceritinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDK378Drug
Also called Ceritinib
Ceritinib/LDK378 was supplied as 150 mg hard gelatin capsules and were administered orally, once-daily at a dose of 750 mg on a continuous dosing schedule (5 x 150 mg capsules).
| Study group | Role | What they receive |
|---|---|---|
| LDK378 | Experimental | Patients treated with ceritinib/LDK378 750 mg once-daily, fasted Receives: Drug: LDK378 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) to LDK378 Per Investigator Assessment
ORR per RECIST 1.1 calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: 6 cycles of 28 days up to 24 weeks
Secondary outcomes (11)
ORR Per Blinded Independent Review Committee (BIRC) Assessment
ORR (CR+PR) by BIRC is calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by BIRC. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: 6 cycles of 28 days up to 24 weeks
Duration of Response (DOR) by Investigator
DOR, calculated as the time from the date of the first confirmed CR or PR to the first documented progression or death due to any cause, by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: 6 cycles of 28 days up to 24 weeks
Duration of Response (DOR) by BIRC
DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer, by BIRC (Blinded Imaging Review Committee). CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: 6 cycles of 28 days up to 24 weeks
Disease Control Rate (DCR)
DCR was calculated as the percentage of patients with best overall response of CR, PR, SD, or non-CR non-PD (NCRNPD), per RECIST 1.1 by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD (NCRNPD): refers to best overall responses that are neither CR nor PD per RECIST 1.1 criteria for patients with non-measurable disease only at baseline.
Measured: 6 cycles of 28 days up to 24 weeks
Time to Response (TTR) Per Investigator
TTR is the time from date of start of treatment to the first CR or PR observed which were confirmed afterwards.
Measured: 6 cycles of 28 days up to 24 weeks
Time to Response (TTR) Per BIRC
TTR is the time from date of start of treatment to the first CR or PR observed which are confirmed afterwards.
Measured: 6 cycles of 28 days up to 24 weeks
Progression-free Survival (PFS) Per Investigator
PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment.
Measured: 6 cycles of 28 days up to 24 weeks
Progression-free Survival (PFS) Per BIRC
PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment.
Measured: 6 cycles of 28 days up to 24 weeks
Overall Intracranial Response Rate (OIRR) Per Investigator
OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline.
Measured: 6 cycles of 28 days up to 24 weeks
Overall Intracranial Response Rate (OIRR) Per BIRC
OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline.
Measured: 6 cycles of 28 days up to 24 weeks
Overall Survival (OS)
OS, defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.
Measured: 6 cycles of 28 days up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study start26 Nov 2012
- Primary completion29 Mar 2016
- Study completion29 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685060
- Sponsor's protocol ID
- CLDK378A2201
- Other IDs
- 2012-003432-24
- Status last verified
- May 2017
- First submitted
- 4 Sep 2012
- Last updated
- 19 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hida T, Satouchi M, Nakagawa K, Seto T, Matsumoto S, Kiura K, Nokihara H, Murakami H, Tokushige K, Hatano B, Nishio M. Ceritinib in patients with advanced, crizotinib-treated, anaplastic lymphoma kinase-rearranged NSCLC: Japanese subset. Jpn J Clin Oncol. 2017 Jul 1;47(7):618-624. doi: 10.1093/jjco/hyx045.
PubMed 28369553Crino L, Ahn MJ, De Marinis F, Groen HJ, Wakelee H, Hida T, Mok T, Spigel D, Felip E, Nishio M, Scagliotti G, Branle F, Emeremni C, Quadrigli M, Zhang J, Shaw AT. Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non-Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2. J Clin Oncol. 2016 Aug 20;34(24):2866-73. doi: 10.1200/JCO.2015.65.5936. Epub 2016 Jul 18.
PubMed 27432917
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Adult Patients With ALK-activated Non-small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib
- ClinicalTrials.gov ID
- NCT01685060
- Acronym / sponsor ID
- CLDK378A2201
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, ALK, LDK378, Ceritinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2012 (actual)
- Primary completion
- 29 Mar 2016 (actual)
- Study completion
- 29 Mar 2016 (actual)
- First posted
- 13 Sep 2012 (estimated)
- Results
- Posted 8 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDK378 | Experimental | Drug: LDK378Patients treated with ceritinib/LDK378 750 mg once-daily, fasted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC that carries an ALK rearrangement, as per the FDA-approved FISH assay (Abbott Molecular Inc.).
- Age 18 years or older at the time of informed consent.
- Patients must have NSCLC that has progressed during therapy with crizotinib or within 30 days of the last dose
- Patients must have received 1-3 lines of cytotoxic chemotherapy (of which 1 must have been a platinum doublet) to treat their locally advanced or metastatic NSCLC
- Patients must have a tumor tissue sample available, collected either at the time of diagnosis of NSCLC or any time since.
Key exclusion criteria (6 listed)
- Patients with known hypersensitivity to any of the excipients of LDK378.
- Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
- History of carcinomatous meningitis.
- Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
- Clinically significant, uncontrolled heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LDK378Also: CeritinibCeritinib/LDK378 was supplied as 150 mg hard gelatin capsules and were administered orally, once-daily at a dose of 750 mg on a continuous dosing schedule (5 x 150 mg capsules). | Drug | LDK378 |
Primary outcome
Overall Response Rate (ORR) to LDK378 Per Investigator Assessment
Time frame: 6 cycles of 28 days up to 24 weeks
ORR per RECIST 1.1 calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
11 secondary outcomes
ORR Per Blinded Independent Review Committee (BIRC) Assessment
Time frame: 6 cycles of 28 days up to 24 weeks
Duration of Response (DOR) by Investigator
Time frame: 6 cycles of 28 days up to 24 weeks
Duration of Response (DOR) by BIRC
Time frame: 6 cycles of 28 days up to 24 weeks
Disease Control Rate (DCR)
Time frame: 6 cycles of 28 days up to 24 weeks
Time to Response (TTR) Per Investigator
Time frame: 6 cycles of 28 days up to 24 weeks
Time to Response (TTR) Per BIRC
Time frame: 6 cycles of 28 days up to 24 weeks
Progression-free Survival (PFS) Per Investigator
Time frame: 6 cycles of 28 days up to 24 weeks
Progression-free Survival (PFS) Per BIRC
Time frame: 6 cycles of 28 days up to 24 weeks
Overall Intracranial Response Rate (OIRR) Per Investigator
Time frame: 6 cycles of 28 days up to 24 weeks
Overall Intracranial Response Rate (OIRR) Per BIRC
Time frame: 6 cycles of 28 days up to 24 weeks
Overall Survival (OS)
Time frame: 6 cycles of 28 days up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28369553Hida T, Satouchi M, Nakagawa K, Seto T, Matsumoto S, Kiura K, Nokihara H, Murakami H, Tokushige K, Hatano B, Nishio M. Ceritinib in patients with advanced, crizotinib-treated, anaplastic lymphoma kinase-rearranged NSCLC: Japanese subset. Jpn J Clin Oncol. 2017 Jul 1;47(7):618-624. doi: 10.1093/jjco/hyx045.
- Derived from this study: PubMed 27432917Crino L, Ahn MJ, De Marinis F, Groen HJ, Wakelee H, Hida T, Mok T, Spigel D, Felip E, Nishio M, Scagliotti G, Branle F, Emeremni C, Quadrigli M, Zhang J, Shaw AT. Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non-Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2. J Clin Oncol. 2016 Aug 20;34(24):2866-73. doi: 10.1200/JCO.2015.65.5936. Epub 2016 Jul 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
52 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LDK378 in people with Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 52 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Japan, Italy, Spain, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) to LDK378 Per Investigator Assessment (time frame: 6 cycles of 28 days up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01685060, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2017.