Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Adenocarcinoma

Adenocarcinoma of Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Adenocarcinoma

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Alectinib

Ceritinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Participants who received LDK378 750mg once daily on a 28 day cycle.

LDK378

Novartis Pharmaceuticals

This was a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and safety of the ALK inhibitor LDK378 when used as single agent in patients with ALK-rearranged stage IIIB or IV NSCLC previously treated with alectinib. Treatment with LDK378 750 mg qd continued until the patient experienced disease progression as determined by the investigator according to RECIST 1.1, unacceptable toxicity that precluded further treatment, pregnancy, start of a new anticancer therapy, discontinued treatment at the discretion of the patient or investigator, lost to follow-up, death, or study was terminated by Sponsor.

Study completed as per protocol. 'Switched to commercial drug' implies that after the primary and secondary objectives were achieved, one patient continued the study treatment as they did not meet the progression disease or AE to be discontinued from the treatment. But after the regulatory approval, Novartis decided to close the study, the 1 patient switched to commercially available drug.

LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib.

A Phase II, Multi-center, Open-label, Single-Arm Study to Evaluate the Efficacy and Safety of Oral LDK378 Treatment for Patients With ALK-Positive Non-Small Cell Lung Cancer Previously Treated With Alectinib

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

ORR, defined as the percentage of participants with a best overall confirmed response of complete response (CR) or partial response (PR) in the whole body as assessed per RECIST 1.1 by the 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; PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

DCR, calculated as the percentage of participants with best overall response of CR, PR, or stable disease (SD) evaluated by investigator per RECIST 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; SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD); PD: taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

TTR, calculated as the time from first dose of LDK378 to first documented response (CR or PR) evaluated by investigator per RECIST 1.1 for participants with confirmed PR or CR.

DOR, calculated as the time from the date of the first documented response (CR or PR) to the first documented disease progression evaluated by investigator per RECIST 1.1 or death due to any cause

PFS, calculated as the time from first dose of LDK378 to date of first documented disease progression evaluated by investigator per RECIST 1.1 or date of death due to any cause

OS was defined as the time from the start date of study drug to the date of death due to any cause.

OIRR, calculated as the percentage of participants with a best overall confirmed response of CR or PR in the brain assessments for participants having measurable brain metastases at baseline

AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment

LDK378 (Ceritinib)

Age, Continuous

Sex: Female, Male

Japanese

Other

Race/Ethnicity, Customized

Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Safety Set in this study is identical to FAS.

Study Director

Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.

Overall Response Rate (ORR) to LDK378 by Investigator Assessment

Disease Control Rate (DCR)

Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib - participants with confirmed PR or CR.

Time to Tumor Response (TTR)

Duration of Response (DOR)

Progression Free Survival (PFS)

Overall Survival (OS)

Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib - participants with measurable brain disease at baseline

Overall Intracranial Response Rate (OIRR)

Total Deaths

Deaths on-treatment

Deaths post-treatment survival follow-up

On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 24 months (treatment duration ranged from 0.4 to to 23.0 months). Deaths post treatment survival follow up were collected after the on treatment period, up to 33 months. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored.

Clinical Database Population: all treated patients and patients who died during screening

Spots Global Cancer Trial Database for LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial