Clinical trial NCT01328951: A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase III Study of First-Line Maintenance Tarceva Versus Tarceva at the Time of Disease Progression in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following 4 Cycles of Platinum-Based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-05
Enrollment: 643
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 double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in participants with advanced NSCLC who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will continue until disease progression, death, or unacceptable toxicity. Participants may also be entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.


Eligibility criteria: Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age, or legal age of consent if greater than 18
* Advanced or recurrent (Stage IIIB) or metastatic (Stage IV) NSCLC
* Completion of 4 cycles of platinum-based chemotherapy without progression (end of last chemotherapy cycle less than or equal to \[≤\] 28 days prior to randomization)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* Prior exposure to agents directed at human epidermal growth factor receptor (HER) axis (e.g. erlotinib, gefitinib, cetuximab)
* Participants whose tumors harbor an EGFR-activating mutation
* Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before Screening
* Use of pemetrexed in maintenance setting (pemetrexed allowed during the chemotherapy run-in)
* Participants who have undergone complete tumor resection after responding to the platinum-based chemotherapy during the Screening phase
* Any other malignancies within 5 years, except for curatively resected carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ, or organ-confined prostate cancer
* Central nervous system (CNS) metastases or spinal cord compression that has not been definitely treated with surgery and/or radiation, or treated CNS metastases or spinal cord compression without stable disease for ≥2 months
* Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
* Any inflammatory changes of the surface of the eye

Primary outcomes:
measure: Percentage of Participants Who Died During the Overall Study
timeFrame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)
measure: Overall Survival (OS) as Median Time to Event During the Overall Study
timeFrame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)
measure: Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study
timeFrame: At 1 year
Secondary outcomes:
measure: Percentage of Participants Who Died or Experienced Disease Progression During Blinded Treatment
timeFrame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
measure: Progression-Free Survival (PFS) as Median Time to Event During Blinded Treatment
timeFrame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
measure: Percentage of Participants Event-Free (Alive and No Disease Progression) at 6 Months During Blinded Treatment
timeFrame: At 6 months
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to RECIST During Blinded Treatment
timeFrame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
measure: Percentage of Participants by Best Overall Response According to RECIST During Blinded Treatment
timeFrame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
measure: Percentage of Participants With CR, PR, or SD According to RECIST During Blinded Treatment
timeFrame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
Other outcomes:
Locations:
city: Gilroy
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Kansas City
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Lebanon
country: United States
state: New Hampshire
city: Dayton
country: United States
state: Ohio
city: Chattanooga
country: United States
state: Tennessee
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Belo Horizonte
country: Brazil
state: MG
city: Ijuí
country: Brazil
state: RO
city: Lajeado
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Florianopolis
country: Brazil
state: SC
city: Santo André
country: Brazil
state: SP
city: Gabrovo
country: Bulgaria
city: Haskovo
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
city: Beijing
country: China
city: Beijing
country: China
city: Changchun
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Guangzhou
country: China
city: Harbin
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shantou
country: China
city: Shenyang
country: China
city: Suzhou
country: China
city: Tianjin
country: China
city: Wuhan
country: China
city: Xi'an
country: China
city: Ceske Budejovice
country: Czech Republic
city: Jindrichuv Hradec
country: Czech Republic
city: Nymburk
country: Czech Republic
city: Ostrava - Poruba
country: Czech Republic
city: Praha 8
country: Czech Republic
city: Praha
country: Czech Republic
city: Tabor
country: Czech Republic
city: Bayonne
country: France
city: Compiegne
country: France
city: Gap
country: France
city: Libourne
country: France
city: Lille
country: France
city: Nantes
country: France
city: St Brieuc
country: France
city: Villefranche-sur-Saone
country: France
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Deszk
country: Hungary
city: Farkasgyepu
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Matrahaza
country: Hungary
city: Miskolc
country: Hungary
city: Szolnok
country: Hungary
city: Székesfehérvár
country: Hungary
city: Torokbalint
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Avellino
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Parma
country: Italy
state: Emilia-Romagna
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Legnago
country: Italy
state: Lombardia
city: Treviglio
country: Italy
state: Lombardia
city: S. Giovanni Rotondo
country: Italy
state: Puglia
city: Livorno
country: Italy
state: Toscana
city: Pisa
country: Italy
state: Toscana
city: Verona
country: Italy
state: Veneto
city: Gyeonggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Daugavpils
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Arnhem
country: Netherlands
city: Heerlen
country: Netherlands
city: Hoorn
country: Netherlands
city: Sittard-Geleen
country: Netherlands
city: Zutphen
country: Netherlands
city: Brzozów
country: Poland
city: Krakow
country: Poland
city: Poznan
country: Poland
city: Wodzislaw Slaski
country: Poland
city: Zamosc
country: Poland
city: Baia Mare
country: Romania
city: Braila
country: Romania
city: Brasov
country: Romania
city: Brasov
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Cluj-Napoca
country: Romania
city: Cluj-Napoca
country: Romania
city: Oradea
country: Romania
city: Ploiesti
country: Romania
city: Targu-Mures
country: Romania
city: Banska Bystrica
country: Slovakia
city: Bardejov
country: Slovakia
city: Kosice
country: Slovakia
city: Nove Zamky
country: Slovakia
city: Poprad
country: Slovakia
city: Rimavska Sobota
country: Slovakia
city: Cape Town
country: South Africa
city: Cape Town
country: South Africa
city: George
country: South Africa
city: Port Elizabeth
country: South Africa
city: Pretoria
country: South Africa
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Hat Yai
country: Thailand
city: Muang
country: Thailand
city: Muang
country: Thailand
city: Dnipropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kirovograd
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lutsk
country: Ukraine
city: Sumy
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Vinnytsya
country: Ukraine
city: Zaporizhzhya
country: Ukraine
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: