Clinical trial NCT01454934: A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-19
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.


Eligibility criteria: Inclusion:

Subjects must meet all of the following criteria to be included in this study:

1. Histologically or cytologically confirmed diagnosis of NSCLC.
2. Documented evidence of advanced NSCLC not amenable to surgery or radiotherapy.
3. Confirmation of the presence or absence of EGFR mutations prior to study enrolment in all subjects.
4. Subjects must have received at least two prior regimens for advanced NSCLC, which should have included a platinum-based regimen and, in all subjects with tumors harbouring EGFR mutations, an EGFR TKI.
5. Radiographic evidence of disease progression on, or after, the last anti-cancer regimen prior to study entry.
6. Presence of measurable disease.
7. ECOG performance status of 0, 1, or 2.
8. Adequate bone marrow
9. Adequate renal function.
10. Adequate liver function.
11. Female subjects of child-bearing potential must agree to use two forms of highly effective contraception.
12. Male subjects and their female partners who are of child-bearing potential must agree to use two forms of highly effective contraception.
13. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
14. Males or females aged at least 18 years (or any age greater than 18 years as determined by country legislation) at the time of informed consent.

Exclusion:

Subjects who meet any of the following criteria will be excluded from this study:

1. Subjects who have received any anti-cancer therapy within 14 days, or five half-lives of the drug (whichever is longer), prior to randomization.
2. Subjects who have not recovered from toxicities as a result of prior anti-cancer therapy to less than Grade 2.
3. Subjects who have previously been treated, or participated in a study with eribulin, whether treated with eribulin or not. The TPC option must not include the same agent which the subject received in a prior regimen.
4. Peripheral neuropathy more than CTCAE Grade 2.
5. Significant cardiovascular impairment.
6. Subjects with a high probability of Long QT Syndrome, or QTc interval \>500 ms.
7. Subjects with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and do not require treatment or have been adequately treated by local therapy.
8. Any serious concomitant illness.
9. Known HIV positive, or have an infection requiring treatment.
10. Any malignancy that required treatment, or has shown evidence of recurrence (except for NSCLC, non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in-situ) during the 5 years prior to study entry.
11. Female subjects must not be pregnant, and must not be breastfeeding.
12. Hypersensitivity to either HalB or HalB chemical derivatives or both, or to any of the excipients of the eribulin formulation.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization (Day 1) until date of death from any cause, or 37 months
Secondary outcomes:
measure: Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months
measure: Objective Response Rate (ORR)
timeFrame: Randomization (Day 1) to CR or PR
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Pleasant Hill
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Port Saint Lucie
country: United States
state: Florida
city: Decatur
country: United States
state: Illinois
city: Southfield
country: United States
state: Michigan
city: Lebanon
country: United States
state: New Hampshire
city: Lake Success
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Spokane
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Herston
country: Australia
state: Queensland
city: Frankston
country: Australia
state: Victoria
city: Strasbourg
country: France
state: Bas Rhin
city: Marseille Cedex 20
country: France
state: Bouches-du-Rhone
city: Marseille Cedex 9
country: France
state: Bouches-duRhone
city: Bordeaux
country: France
state: Gironde
city: Toulouse Cedex 9
country: France
state: Haute Garonne
city: Limoges
country: France
state: Haute Vienne
city: Rennes Cedex 9
country: France
state: Ille Et Vilaine
city: Saint Herblain
country: France
state: Loire Atlantique
city: Lille
country: France
state: Nord
city: Paris Cedex 12
country: France
state: Paris
city: Pierre Benite cedex
country: France
state: Rhone
city: Villejuif cedex
country: France
state: Val De Marne
city: Aschaffenburg
country: Germany
state: Bayern
city: Gauting
country: Germany
state: Bayern
city: Muenchen
country: Germany
state: Bayern
city: Essen
country: Germany
state: Nordrhein Westfalen
city: Koeln
country: Germany
state: Nordrhein Westfalen
city: Recklinghausen
country: Germany
state: Nordrhein Westfalen
city: Mainz
country: Germany
state: Rheinland Pfalz
city: Halle
country: Germany
state: Sachsen Anhalt
city: Hong Kong
country: Hong Kong
city: Lido di Camaiore
country: Italy
state: Lucca
city: Monza
country: Italy
state: Milano
city: Aviano
country: Italy
state: Pordenone
city: Cremona
country: Italy
city: Milano
country: Italy
city: Siena
country: Italy
city: Nagoya-shi
country: Japan
state: Aichi-Ken
city: Kashiwa-shi
country: Japan
state: Chiba-Ken
city: Fukuoka-shi
country: Japan
state: Fukuoka-Ken
city: Hiroshima-shi
country: Japan
state: Hiroshima-Ken
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Kobe-shi
country: Japan
state: Hygo-Ken
city: Akashi-shi
country: Japan
state: Hyogo-ken
city: Sendai-shi
country: Japan
state: Miyagi-Ken
city: Nigata-shi
country: Japan
state: Nigata-Ken
city: Kurashiki-shi
country: Japan
state: Okayama-Ken
city: Habinko-shi
country: Japan
state: Osaka-Fu
city: Osaka-shi
country: Japan
state: Osaka-Fu
city: Osakasayama-shi
country: Japan
state: Osaka-Fu
city: Sunto-gun
country: Japan
state: Shizuoka-Ken
city: Chuo-ku
country: Japan
state: Tokyo-to
city: Koto-ku
country: Japan
state: Tokyo-To
city: Ube-shi
country: Japan
state: Yamaguchi-Ken
city: Kitaadachi-gun
country: Japan
city: Seongnam-si
country: Korea, Republic of
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
state: Korea
city: Gdansk
country: Poland
city: Mrozy
country: Poland
city: Otwock
country: Poland
city: Sczedin
country: Poland
city: Warsazawa
country: Poland
city: Barnaul
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Singapore
country: Singapore
city: Sabadell
country: Spain
state: Barcelona
city: Terrassa
country: Spain
state: Barcelona
city: Pamplona
country: Spain
state: Navarra
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei City
country: Taiwan
city: Taipei
country: Taiwan
city: London
country: United Kingdom
state: Greater London
city: Manchester
country: United Kingdom
state: Greater Manchester
city: Sutton
country: United Kingdom
state: Surrey
Study officials:
References:
citation: Katakami N, Felip E, Spigel DR, Kim JH, Olivo M, Guo M, Nokihara H, Yang JC, Iannotti N, Satouchi M, Barlesi F. A randomized, open-label, multicenter, phase 3 study to compare the efficacy and safety of eribulin to treatment of physician's choice in patients with advanced non-small cell lung cancer. Ann Oncol. 2017 Sep 1;28(9):2241-2247. doi: 10.1093/annonc/mdx284.