A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib

Non-small-cell Lung Cancer Clinical Trial

— ATTENTION  

Official title:

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer With Wild-type Epidermal Growth Factor Receptor

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01377376
• Other study ID #: ARQ197-006
• Status: Terminated
• Phase: Phase 3
• First received: June 17, 2011
• Last updated: December 5, 2016
• Start date: July 2011

Study information

• Verified date: December 2016
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareKorea: Food and Drug AdministrationTaiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine if the combination regimen of ARQ 197 with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have received 1 or 2 prior systemic anti-cancer therapies in the Intent-to-Treat (ITT) population.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria

1. Male or female at least 20 years of age with life expectancy = 3 months

2. Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous NSCLC with wild-type (excluding major activating mutation (exon 19 deletion and/or exon 21 L858R mutation)) EGFR gene status confirmed by a highly sensitive PCR assay

3. Evaluable disease according to RECIST, Version 1.1

4. Received one or two prior lines of systemic anti-cancer therapy for advanced or metastatic disease, one of which must be a platinum-based therapy

5. ECOG performance status of 0 or 1

6. Demonstrate adequate bone marrow, liver, and renal functions, defined as:

• ALT and AST = 2.5 × upper limit of normal (ULN), total bilirubin = 1.5 × ULN, ANC =1.5 × 10^9/L, platelet count =100 × 10^9/L, hemoglobin =9.0 g/dL, and serum creatinine =1.5 mg/dL.

7. Voluntary written informed consent form before performance of any study-specific procedures or tests

Exclusion Criteria

1. Prior therapy with an EGFR inhibitor and/or tivantinib

2. Any systemic anti-tumor treatment for NSCLC or investigational agents within 4 weeks prior to randomization

3. Palliative radiotherapy within 2 weeks, or radiotherapy for curative intent of target lesions within 8 weeks for chest and within 4 weeks for other areas prior to randomization

4. Major surgical procedure within 4 weeks prior to randomization

5. History of cardiac disease

6. Known symptomatic brain metastases

7. Need to breastfeed a child during or within 12 weeks of completing the study

8. Significant gastrointestinal disorder that could interfere with absorption of tivantinib and/or erlotinib

9. History of malignancy other than NSCLC

10. Known infection with HIV, active HBV or HCV

11. Clinically significant interstitial lung diseases detected by CT scan or prior history of such diseases

12. Psychiatric disease that could affect the informed consent process

13. Subjects who wish to have a child and who would not agree to use one or more contraceptive measures that are highly effective

14. Positive serum or urine pregnancy test in female subjects of childbearing potential

15. Any other significant co-morbid condition that, in opinion of the investigator/sub-investigator, would impair study participation or cooperation

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Intervention

Drug:
• ARQ 197 and Erlotinib
Oral twice daily administration of ARQ197 and oral once daily administration of erlotinib
• Placebo and Erlotinib
Oral twice daily administration of placebo and oral once daily administration of erlotinib

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Secondary	Progression free survival			No
Secondary	Objective response rate	Each assessment will be determined based on RECIST criteria version 1.1 by investigator		No
Secondary	Number of patients with adverse events			Yes