AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 3NCT01828112

LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib

A Phase 3 study testing Ceritinib, Pemetrexed and Docetaxel in people with Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 97 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Ceritinib, Pemetrexed and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
231 participants
Where
97 sitesin 20 countries
Study dates
28 Jun 2013to 10 Nov 2023
Phase
Phase 3
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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by the FDA approved Abbott FISH Test.
  • Patient has stage IIIB or IV diagnosis and must have received one or two prior regimens (including platinum- doublet) of cytotoxic chemotherapy for the treatment of locally advanced or metastatic NSCLC.
  • Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
  • Patients must have received previous treatment with crizotinib for the treatment of locally advanced or metastatic NSCLC.

Who cannot join

  • Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
  • Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
  • Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.

Trial locations and contacts

97 sites in 20 countries.

97 sites in 20 countries

United States13 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Memorial Cancer Institute

    Hollywood, Florida, 33021

  • Uni Of Iowa Hospitals And Clinics

    Iowa City, Iowa, 52242

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Loyola University Medical Center

    Marywood, Illinois, 60153

  • University Of Miami

    Miami, Florida, 33136

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Texas Oncology-Sugarland

    Sugar Land, Texas, 77479

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma, 74136

  • Texas Oncology Cancer Care and Research Center

    Waco, Texas, 76712

Other trials in United States

Japan12 sites

  • Novartis Investigative Site

    Akashi, Hyōgo, 673-8558

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 811-1395

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-8582

  • Novartis Investigative Site

    Hirakata, Osaka, 573-1191

  • Novartis Investigative Site

    Kashiwa, Chiba, 277 8577

  • Novartis Investigative Site

    Koto Ku, Tokyo, 135 8550

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 464 8681

  • Novartis Investigative Site

    Niigata, 951 8520

  • Novartis Investigative Site

    Okayama, Okayama-ken, 700-8558

  • Novartis Investigative Site

    Osaka, Osaka, 541-8567

  • Novartis Investigative Site

    Ōsaka-sayama, Osaka, 589 8511

  • Novartis Investigative Site

    Takatsuki, Osaka, 569-8686

Other trials in Japan

Spain11 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Barcelona, Catalonia, 08028

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Madrid, 28222

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Seville, Andalusia, 41013

  • Novartis Investigative Site

    Valencia, Valencia, 46010

Other trials in Spain

Italy10 sites

  • Novartis Investigative Site

    Avellino, AV, 83100

  • Novartis Investigative Site

    Aviano, PN, 33081

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Monza, MB, 20900

  • Novartis Investigative Site

    Orbassano, TO, 10043

  • Novartis Investigative Site

    Perugia, PG, 06129

  • Novartis Investigative Site

    Pisa, PI, 56124

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123

  • Novartis Investigative Site

    Roma, RM, 00189

  • Novartis Investigative Site

    Verona, VR, 37126

Other trials in Italy

France9 sites

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Brest, 29609

  • Novartis Investigative Site

    Caen, 14021

  • Novartis Investigative Site

    Le Mans, 72000

  • Novartis Investigative Site

    Marseille, Bouches Du Rhone, 13915

  • Novartis Investigative Site

    Mulhouse, 68070

  • Novartis Investigative Site

    Paris, 75970

  • Novartis Investigative Site

    Strasbourg, F 67085

  • Novartis Investigative Site

    Suresnes, 92150

Other trials in France

Germany8 sites

  • Novartis Investigative Site

    Bad Berka, 99438

  • Novartis Investigative Site

    Cologne, 51109

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Esslingen am Neckar, 73730

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Tübingen, 72076

  • Novartis Investigative Site

    Ulm, 89081

Other trials in Germany

South Korea5 sites

  • Novartis Investigative Site

    Seoul, Seocho Gu, 06591

  • Novartis Investigative Site

    Seoul, 03080

  • Novartis Investigative Site

    Seoul, 03722

  • Novartis Investigative Site

    Seoul, 05505

  • Novartis Investigative Site

    Seoul, 06351

Other trials in South Korea

United Kingdom5 sites

  • Novartis Investigative Site

    Aberdeen, Grampian Region, AB25 2ZN

  • Novartis Investigative Site

    Cheltenham, Gloucestershire, GL53 7AN

  • Novartis Investigative Site

    Leicester, LE1 5WW

  • Novartis Investigative Site

    London, SE1 9RT

  • Novartis Investigative Site

    Southampton, SO30 3JB

Other trials in United Kingdom

Belgium4 sites

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Edegem, 2650

  • Novartis Investigative Site

    Leuven, 3000

Other trials in Belgium

Russia3 sites

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Moscow Region Istra Village, 143423

  • Novartis Investigative Site

    Saint Petersburg, 197022

Other trials in Russia

Turkey (Türkiye)3 sites

  • Novartis Investigative Site

    Ankara, 06230

  • Novartis Investigative Site

    Istanbul, TUR, 34098

  • Novartis Investigative Site

    Pendik Istanbul, Turkey, 34899

Other trials in Turkey (Türkiye)

Hong Kong2 sites

  • Novartis Investigative Site

    Hong Kong

  • Novartis Investigative Site

    Pokfulam

Other trials in Hong Kong

Ireland2 sites

  • Novartis Investigative Site

    Dublin, DO4

  • Novartis Investigative Site

    Limerick, Co Limerick, V94 YX29

Other trials in Ireland

Israel2 sites

  • Novartis Investigative Site

    Kfar Saba, 44281

  • Novartis Investigative Site

    Ramat Gan, 52621

Other trials in Israel

Singapore2 sites

  • Novartis Investigative Site

    Singapore, 119074

  • Novartis Investigative Site

    Singapore, 168583

Other trials in Singapore

Switzerland2 sites

  • Novartis Investigative Site

    Lucerne, 6000

  • Novartis Investigative Site

    Sankt Gallen, 9007

Other trials in Switzerland

Canada1 site

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Lebanon1 site

  • Novartis Investigative Site

    El Achrafiyé, 166830

Other trials in Lebanon

Netherlands1 site

  • Novartis Investigative Site

    Groningen, 9713 GZ

Other trials in Netherlands

Portugal1 site

  • Novartis Investigative Site

    Lisbon, 1649 035

Other trials in Portugal

About this study

Official title: A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib

The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), while also had the choice to continue with pemetrexed treatment.

Read the detailed description

A total of 231 patients were randomized to one of the two treatment arms in a 1:1 ratio. Randomization was stratified by World Health Organization (WHO) performance status (0 versus 1-2) and whether the patient had brain metastases at screening. The study was planned to be ended once the final overall survival (OS) analysis was performed (at the earliest of approximately 196 deaths observed or statistical significance reached at earlier OS interim analysis).

Following an agreement between Novartis and European Medicines Agency (EMA) in May 2023 to terminate the trial earlier, this study was completed when the total number of deaths was 190. Patients who had Response Evaluation Criteria In Solid Tumors (RECIST)-defined disease progression as confirmed by the Blinded Independent Review Committee (BIRC), but who, in the opinion of the Investigator, had continued clinical benefit from study treatment on either the chemotherapy arm or the ceritinib arm, continued to receive treatment. These patients continued assessments in the treatment phase. In addition, only patients randomized to the chemotherapy arm were allowed to crossover to receive ceritinib therapy (extension treatment [ET] phase) after BIRC-confirmed, RECIST-defined disease progression, and provided they met the eligibility requirements.

Being tested
Ceritinib, Pemetrexed, Docetaxel
Keywords
Non-Small Cell Lung Cancer, ALK, LDK378, Non-small cell lung carcinoma (NSCLC), treatment of lung cancer after first metastasis, lung cancer, lung adenocarcinoma, Non small cell lung carcinoma, Non small cell lung cancer, NSCLC, chemotherapy, ALK-positive, ALK-rearranged advanced non-small cell lung cancer, crizotinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Adenocarcinoma of Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CeritinibDrug

    Ceritinib was the investigational treatment and was provided as 150 mg hard gelatin capsules for oral use. The dose was 750 mg once daily.

  • PemetrexedDrug

    Pemetrexed was one of the chemotherapy treatments. Pemetrexed, a reconstituted solution, was intravenously administered over 10 minutes at 500 mg/m^2 every 21 days.

  • DocetaxelDrug

    Docetaxel was one of the chemotherapy treatments. Docetaxel, a reconstituted solution, was intravenously administered over 1 hour, at 75 mg/m^2 every 21 days.

Study groups in NCT01828112
Study groupRoleWhat they receive
CeritinibExperimentalCeritinib 750 mg
Receives: Drug: Ceritinib
ChemotherapyActive comparatorChemotherapy as determined by BIRC
Receives: Drug: Pemetrexed; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) Per Blinded Independent Review Committee (BIRC)

    PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.

    Measured: From the date of randomization to the date of first radiologically documented disease progression or death due to any cause up to approximately 24 months

Secondary outcomes (25)

  1. Overall Survival (OS)

    OS was defined as time from date of randomization to date of death due to any cause.

    Measured: Up to approximately 114 months

  2. Progression Free Survival (PFS) Per Investigator Assessment

    PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.

    Measured: Up to approximately 84 months

  3. Overall Response Rate (ORR) Per BIRC

    ORR was defined as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR): (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST), v. 1.1. 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; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 54 months

  4. Overall Response Rate (ORR) Per Investigator Assessment

    ORR was defined as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR): (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST), v. 1.1. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 93 months

  5. Duration of Response (DOR) Per BIRC

    DOR defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 54 months

  6. Duration of Response (DOR) Per Investigator Assessment

    DOR defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 93 months

  7. Disease Control Rate (DCR) Per BIRC

    DCR was defined as the percentage of participants with best overall response of CR, PR, or stable disease (SD). CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

    Measured: Up to approximately 54 months

  8. Disease Control Rate (DCR) Per Investigator Assessment

    DCR was defined as the percentage of participants with best overall response of CR, PR, or stable disease (SD). CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

    Measured: Up to approximately 93 months

  9. Time to Response (TTR) Per BIRC

    TTR was defined as the time from date of randomization to date of first documented response (CR or PR). CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 52 weeks

  10. Time to Response (TTR) Per Investigator Assessment

    TTR was defined as the time from date of randomization to date of first documented response (CR or PR). CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 45 weeks

  11. Overall Intracranial Response Rate (OIRR) Per BIRC

    OIRR was defined as the ORR based on lesions in brain (target, nontarget lesions (and new lesions, if applicable) and calculated as the percentage of patients with a best overall confirmed response of CR or PR in the brain per modified RECIST 1.1 as assessed by BIRC neuroradiologist. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 18 months

  12. Intracranial Disease Control Rate (IDCR) Per BIRC

    IDCR was defined as the DCR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated as the proportion of patients with a best overall response of CR or PR or SD (or non-CR/nonPD) in the brain per modified RECIST 1.1 as assessed by BIRC neuro-radiologist. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

    Measured: Up to approximately 18 months

  13. Duration of Intracranial Response (DOIR) Per BIRC

    DOIR was defined as the DOR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated from the time of first documented response of CR or PR to the date of the first documented disease progression in the brain or death due to any cause per modified RECIST 1.1 as assessed by BIRC neuro-radiologist. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 18 months

  14. Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)

    The EORTC QLQ-C30 questionnaire contained 30 items and was composed of both multi-item scales and single item measures. These included five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global health status/quality of life (QoL) scale.

    All of the scales and single items ranged from 0 to 100. A high scale score represented a higher response level. Thus, a high score for a functional scale indicated a high/healthy level of functioning, a high score for the QoL indicated high QoL, but a high score for a symptom scale/single item indicated a high level of symptomatology/problems. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.

    Measured: Screening and treatment phase up to 92 months

  15. EORTC QLQ-LC13 Time to Definitive Deterioration

    The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms. QLQ-LC13 time to definitive deterioration was defined as the time from randomization to the earliest date a patient shows a 10 point or higher increase from baseline in any of the ALCLC13 scores related to pain in chest, cough, or dyspnea (with no later change below this threshold), or death due to any cause. Each cycle was 21 days.

    Measured: Screening and treatment phase up to 92 months

  16. Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)

    The LCSS patient scale uses a 24-hour recall period and contains nine items: six measuring major symptoms for lung cancer (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain), and three summary items related to total symptom distress, normal activity status, and overall quality of life. The total scale used is a 100 mm visual analog scale to measure the intensity of patient responses, with zero corresponding to the lowest rating (best status) and 100 representing the highest rating (worst status). The total score was calculated as the mean of the 9 items. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.

    Measured: Screening and treatment phase up to 92 months

  17. Least Squares Mean Scores on the EQ-5D-5L Index

    The EQ-5D descriptive classification consists of five dimensions of health: mobility, self-care, usual activities, anxiety/depression and pain/discomfort. Patients are requested to select the statement which best describes their condition on that day for each dimension. EQ-5D-5L index scores can range from -0.59 to 1, where 1 is the best possible health state. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.

    Measured: Screening and treatment phase up to 92 months

  18. Least Squares Mean Scores on the EQ-5D Visual Analogue Scale (VAS)

    The EQ-5D descriptive classification consists of five dimensions of health: mobility, self-care, usual activities, anxiety/depression and pain/discomfort. Patients are requested to select the statement which best describes their condition on that day for each dimension. EQ VAS scores can range from 0 to 100, where 100 is the best possible health state. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.

    Measured: Screening and treatment phase up to 92 months

  19. Cmax for Ceritinib

    The observed maximum plasma concentration following administration

    Measured: Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.

  20. Tmax for Ceritinib

    The time to reach peak or maximum concentration

    Measured: Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.

  21. Tlast for Ceritinib

    The time to last quantifiable concentration

    Measured: Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.

  22. AUC0-24h for Ceritinib

    The area under the plasma concentration-time curve calculated from time zero to 24 hours

    Measured: Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.

  23. Mean Accumulation Ratio (Racc) for Ceritinib

    Accumulation ratio calculated using AUC0-24 values obtained from a dosing interval at steady-state (Cycle 2, Day 1) divided by AUC0-24 on Cycle 1, Day 1.

    Measured: Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.

  24. Clearance Rate at Steady State (CLss/F) for Ceritinib

    The apparent total body clearance from plasma. CLss/F is calculated from AUC0-24 assuming steady state (CLss/F=Dose/AUC0-24).

    Measured: Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.

  25. Post-Hoc: All Collected Deaths

    Pre-treatment deaths: from day of patient's informed consent to the day before first dose of study treatment. On-treatment deaths: from first dose of study treatment to 30 days following the last dose of study treatment at the end of treatment phase. For crossover patients, from first dose of ceritinib at the extension treatment phase to 30 days following the last dose. Survival Follow-up deaths: from Day 31 after last dose of study treatment to the data cut-off date.

    Measured: Pre-treatment and on-treatment deaths: Up to approximately 8 years. Post-treatment survival follow-up deaths: Up to an additional 2.5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2013 (estimated)
  2. Study start28 Jun 2013
  3. Primary completion26 Jan 2016
  4. Study completion10 Nov 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01828112
Sponsor's protocol ID
CLDK378A2303
Other IDs
2012-005637-36
Status last verified
Jan 2025
First submitted
2 Apr 2013
Last updated
7 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Kiura K, Imamura F, Kagamu H, Matsumoto S, Hida T, Nakagawa K, Satouchi M, Okamoto I, Takenoyama M, Fujisaka Y, Kurata T, Ito M, Tokushige K, Hatano B, Nishio M. Phase 3 study of ceritinib vs chemotherapy in ALK-rearranged NSCLC patients previously treated with chemotherapy and crizotinib (ASCEND-5): Japanese subset. Jpn J Clin Oncol. 2018 Apr 1;48(4):367-375. doi: 10.1093/jjco/hyy016.

    PubMed 29474558

  • Shaw AT, Kim TM, Crino L, Gridelli C, Kiura K, Liu G, Novello S, Bearz A, Gautschi O, Mok T, Nishio M, Scagliotti G, Spigel DR, Deudon S, Zheng C, Pantano S, Urban P, Massacesi C, Viraswami-Appanna K, Felip E. Ceritinib versus chemotherapy in patients with ALK-rearranged non-small-cell lung cancer previously given chemotherapy and crizotinib (ASCEND-5): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017 Jul;18(7):874-886. doi: 10.1016/S1470-2045(17)30339-X. Epub 2017 Jun 9.

    PubMed 28602779

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ceritinib, Pemetrexed and Docetaxel in people with Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 97 sites in 20 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 4 inclusion and 3 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 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Japan, Spain, Italy, France and 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 27 Jul 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?

Progression Free Survival (PFS) Per Blinded Independent Review Committee (BIRC) (time frame: From the date of randomization to the date of first radiologically documented disease progression or death due to any cause up to approximately 24 months). 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 NCT01828112, 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 7 Feb 2025.

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