A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer

NCT02276027 | Completed Phase 2 Results

• 1 other identifier: CINC280X2205
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the anti-tumor activity of single agent BYL719, INC280, LDK378 and MEK162 in advanced NSCLC patients carrying specific molecular alterations. There is a great unmet medical need in NSCLC patients with advanced or metastatic disease. Novel approaches using targeted therapeutic agents for these patient populations with molecular characterization could potentially identify subsets of advanced NSCLC patients who would benefit from targeted kinase inhibition. Study treatments, BYL719, INC280, LDK378 and MEK162, which target PIK3CA, c-MET, ALK/ROS1 and MEK respectively, have shown promising data in either preclinical or clinical lung cancer settings.

Conditions

Adenocarcinoma Lung Cancer; Squamous Cell Lung Carcinoma

Keywords

adenocarcinoma lung cancer,; squamous cell lung carcinoma,; NSCLC

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Overall response rate is the proportion of patients with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria (Overall Response (OR) = CR + PR). Complete Response (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 Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

  Up to 231 weeks

Secondary Outcomes (8)

• Median Overall Survival (OS)

  Up to 231 weeks

• Number of Participants With Progression-free Survival (PFS)

  Up to 231 weeks

• Disease Control Rate (DCR)

  Up to 231 weeks

• Median Duration of Overall Response (DOR)

  Up to 231 weeks

• Number of Participants With Adverse Events

  up to 235 weeks

Study Arms (4)

BYL719 350 mg QD

EXPERIMENTAL

Patient's tumor must have molecular alteration of the PIK3CA gene.

Drug: BYL719

INC280 400 mg BID tab/600 mg BID cap

EXPERIMENTAL

Patient's tumor must have molecular alteration of the c-MET gene.

Drug: INC280

LDK378 750 mg QD

EXPERIMENTAL

Patient's tumor must have ALK or ROS1 gene rearrangement.

Drug: LDK378

MEK162 45 mg BID

EXPERIMENTAL

Patient's tumor must have KRAS, NRAS or BRAF mutation.

Drug: MEK162

Interventions

BYL719 DRUG

BYL719 was dosed as 350 mg once daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take BYL719 exactly as prescribed.

BYL719 350 mg QD

INC280 DRUG

INC280 was dosed as 600 mg (tablet) or 400mg(Capsule) twice daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to takeINC280 exactly as prescribed.

INC280 400 mg BID tab/600 mg BID cap

LDK378 DRUG

LDK378 was dosed as 750 mg once daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take LDK378 exactly as prescribed.

LDK378 750 mg QD

MEK162 DRUG

MEK162 was dosed as 45 mg twice daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take MEK162 exactly as prescribed.

MEK162 45 mg BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced (stage IIIB or stage IV) NSCLC
• Must have specific molecular alterations

You may not qualify if:

• Symptomatic central nervous system (CNS) metastases which are neurologically unstable or requiring increasing doses of steroids within the 4 weeks prior to study entry to control their CNS disease
• Radiation therapy within ≤ 4 weeks prior to study entry, with the exception of limited field palliative radiotherapy for bone pain relief.
• Any other malignancies within the last 5 years before study entry
• Major surgery ≤ 2 weeks prior to study entry or who have not recovered from side effects of such therapy

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Guangzhou, Guangdong, 51000, China

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Alpelisib; capmatinib; ceritinib; binimetinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 27, 2014
• Study Start: January 20, 2015
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: December 16, 2020
• Results First Posted: December 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)