Lung Cancer Clinical Trial

LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer

Summary

A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anticancer therapy and/or died. LDK378 was 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. 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. Male and female patients aged 18 or over with ALK-rearranged non-small cell cancer (NSCLC) were screened for eligibility. Patients had to have received no prior crizotinib, and had to be chemotherapy-naïve or been pretreated with cytotoxic chemotherapy (up to three prior lines).

View Eligibility Criteria

Eligibility Criteria

Key Inclusion criteria:

Histologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC that carried an ALK rearrangement, as per the FDA-approved Vysis ALK break-apart FISH assay (Abbott Molecular Inc.)
Age 18 years or older at the time of informed consent.
Patients must have NSCLC that had progressed during or after the last chemotherapy regimen received prior to the first dose of LDK378, if chemotherapy was received
Patients must have been chemotherapy-naive or had received 1-3 lines of cytotoxic chemotherapy to treat their locally advanced or metastatic NSCLC
Patients must have had 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 were not allowed to participate in the study.

Key Exclusion criteria:

Prior treatment with crizotinib, or any other ALK inhibitor investigational agent, for NSCLC
Patients with known hypersensitivity to any of the excipients of LDK378.
Patients with symptomatic central nervous system (CNS) metastases who were neurologically unstable or had 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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

124

Study ID:

NCT01685138

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 50 Locations for this study

See Locations Near You

Massachusetts General Hospital Mass Gen 5
Boston Massachusetts, 02114, United States
Washington University School of Medicine Washington University (16)
Saint Louis Missouri, 63110, United States
Sarah Cannon Research Institute Drug Ship - 4
Nashville Tennessee, 37203, United States
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office
Dallas Texas, 75390, United States
Novartis Investigative Site
St Leonards New South Wales, 2065, Australia
Novartis Investigative Site
Franston Victoria, 3199, Australia
Novartis Investigative Site
Genk , 3600, Belgium
Novartis Investigative Site
Leuven , 3000, Belgium
Novartis Investigative Site
Toronto Ontario, M5G 2, Canada
Novartis Investigative Site
Saskatoon Saskatchewan, S7N 4, Canada
Novartis Investigative Site
Saint Herblain cedex , 44805, France
Novartis Investigative Site
Hong Kong , , Hong Kong
Novartis Investigative Site
Avellino AV, 83100, Italy
Novartis Investigative Site
Genova GE, 16132, Italy
Novartis Investigative Site
Milano MI, 20141, Italy
Novartis Investigative Site
Rozzano MI, 20089, Italy
Novartis Investigative Site
Orbassano TO, 10043, Italy
Novartis Investigative Site
Nagoya Aichi, 464 8, Japan
Novartis Investigative Site
Kashiwa Chiba, 277 8, Japan
Novartis Investigative Site
Fukuoka-city Fukuoka, 811-1, Japan
Novartis Investigative Site
Akashi Hyogo, 673-8, Japan
Novartis Investigative Site
Sayama Osaka, 589 8, Japan
Novartis Investigative Site
Sunto Gun Shizuoka, 411 8, Japan
Novartis Investigative Site
Chuo-ku Tokyo, 104-0, Japan
Novartis Investigative Site
Koto ku Tokyo, 135 8, Japan
Novartis Investigative Site
Seoul Gyeonggi Do, 03080, Korea, Republic of
Novartis Investigative Site
Seoul Korea, 05505, Korea, Republic of
Novartis Investigative Site
Seoul Korea, 06351, Korea, Republic of
Novartis Investigative Site
Seoul , 03722, Korea, Republic of
Novartis Investigative Site
Auckland , 1142, New Zealand
Novartis Investigative Site
Oslo , NO-04, Norway
Novartis Investigative Site
Chelyabinsk , 45408, Russian Federation
Novartis Investigative Site
Moscow , 11547, Russian Federation
Novartis Investigative Site
St-Petersburg , 19702, Russian Federation
Novartis Investigative Site
Singapore , 16961, Singapore
Novartis Investigative Site
Malaga Andalucia, 29010, Spain
Novartis Investigative Site
Badalona Catalunya, 08916, Spain
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
Novartis Investigative Site
Madrid , 28046, Spain
Novartis Investigative Site
Madrid , 28050, Spain
Novartis Investigative Site
Stockholm , SE 17, Sweden
Novartis Investigative Site
Tainan Taiwan ROC, 70403, Taiwan
Novartis Investigative Site
Taipei Taiwan, ROC, 11217, Taiwan
Novartis Investigative Site
Taichung , 407, Taiwan
Novartis Investigative Site
Taipei , 10002, Taiwan
Novartis Investigative Site
Songkla Hat Yai, 90110, Thailand
Novartis Investigative Site
Bangkok , 10330, Thailand
Novartis Investigative Site
Bangkok , 10400, Thailand
Novartis Investigative Site
Bangkok , 10700, Thailand
Novartis Investigative Site
Colchester , CO3 3, United Kingdom
Novartis Investigative Site
London , SE1 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

124

Study ID:

NCT01685138

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider