Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments ldk378, pemetrexed + cisplatin or pemetrexed + carboplatin
Phase phase 3
Target ALK
Sponsor Novartis Pharmaceuticals
Start date July 2013
End date June 2018
Trial size 374 participants
Trial identifier NCT01828099, 2013-000319-26, CLDK378A2301

Summary

The primary purpose of the study is to compare the antitumor activity of LDK378 versus reference chemotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ldk378
Oral LDK378 750 mg once daily
(Active Comparator)
pemetrexed + cisplatin or pemetrexed + carboplatin
Pemetrexed 500 mg/m² plus cisplatin 75 mg/m² every 21 days for 4 cycles followed by pemetrexed 500 mg/m² every 21 days or pemetrexed 500 mg/m² plus carboplatin AUC 5-6 every 21 days for 4 cycles followed by pemetrexed 500 mg/m² every 21 days

Primary Outcomes

Measure
Progression Free Survival (PFS)
time frame: Month 33

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: Month 33
Overall Response Rate (ORR)
time frame: Month 33
Duration of Response (DOR)
time frame: Month 33
Disease Control Rate (DCR)
time frame: Month 33
Time to response (TTR)
time frame: Month 33
Patient Reported Outcomes
time frame: Screening, followed by every 6 weeks until Month 33 after Month 33 every 9 weeks.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patient has a histologically or cytologically confirmed diagnosis of non-squamous Non-small cell lung cancer (NSCLC) that is Anaplastic lymphoma kinase (ALK) positive as assessed by the Ventana Immunohistochemistry (IHC) test. The test will be performed at Novartis designated central laboratories. 2. Patient has newly diagnosed stage IIIB (who are not a candidate for definitive multimodality therapy) or stage IV NSCLC or relapsed locally advanced or metastatic NSCLC not previously treated with any systemic anti-cancer therapy (e.g. cytotoxic drugs, monoclonal antibody therapy, crizotinib or other ALK inhibitors, or other targeted therapies, either experimental or not), with exception of neo-adjuvant or adjuvant therapy 3. 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 Exclusion Criteria: 1. Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate) 2. Patient with a history of severe hypersensitivity reaction to platinum containing drugs, pemetrexed or any known excipients of these drugs. 3. 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.

Additional Information

Official title A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Novartis.