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

NCT ID: NCT01377376

Last Updated: 2016-12-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31

Brief 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.

Conditions

Non-small-cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ARQ 197

ARQ 197 and Erlotinib

Group Type: EXPERIMENTAL

ARQ 197 and Erlotinib

Intervention Type: DRUG

Oral twice daily administration of ARQ197 and oral once daily administration of erlotinib

Placebo

Placebo and Erlotinib

Group Type: PLACEBO_COMPARATOR

Placebo and Erlotinib

Intervention Type: DRUG

Oral twice daily administration of placebo and oral once daily administration of erlotinib

Interventions

ARQ 197 and Erlotinib

Oral twice daily administration of ARQ197 and oral once daily administration of erlotinib

Intervention Type: DRUG

Placebo and Erlotinib

Oral twice daily administration of placebo and oral once daily administration of erlotinib

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Osaka, , Japan

Countries

Japan

References

Yoshioka H, Azuma K, Yamamoto N, Takahashi T, Nishio M, Katakami N, Ahn MJ, Hirashima T, Maemondo M, Kim SW, Kurosaki M, Akinaga S, Park K, Tsai CM, Tamura T, Mitsudomi T, Nakagawa K. A randomized, double-blind, placebo-controlled, phase III trial of erlotinib with or without a c-Met inhibitor tivantinib (ARQ 197) in Asian patients with previously treated stage IIIB/IV nonsquamous nonsmall-cell lung cancer harboring wild-type epidermal growth factor receptor (ATTENTION study). Ann Oncol. 2015 Oct;26(10):2066-72. doi: 10.1093/annonc/mdv288. Epub 2015 Jul 7.

Reference Type: DERIVED

PMID: 26153496 (View on PubMed)

Other Identifiers

ARQ197-006

Identifier Type: -

Identifier Source: org_study_id