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
NCT ID: NCT01328951
Last Updated: 2016-10-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
643 participants
INTERVENTIONAL
2011-09-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Early Erlotinib
Participants will receive blinded erlotinib as 150 mg PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment.
Erlotinib
Erlotinib will be administered as 150 mg PO once daily until disease progression, death, or unacceptable toxicity, as first-line maintenance or as second-line therapy for those who progress while receiving placebo.
Second-Line Chemotherapy
Participants who progress on first-line maintenance erlotinib may receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. The selected chemotherapy will be non-investigational and chosen at the discretion of the Investigator.
Late Erlotinib
Participants will receive blinded placebo tablets PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive second-line erlotinib as 150 mg PO once daily until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment.
Placebo
Placebo will be administered PO once daily as first-line maintenance until disease progression, death, or unacceptable toxicity.
Erlotinib
Erlotinib will be administered as 150 mg PO once daily until disease progression, death, or unacceptable toxicity, as first-line maintenance or as second-line therapy for those who progress while receiving placebo.
Interventions
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Placebo
Placebo will be administered PO once daily as first-line maintenance until disease progression, death, or unacceptable toxicity.
Erlotinib
Erlotinib will be administered as 150 mg PO once daily until disease progression, death, or unacceptable toxicity, as first-line maintenance or as second-line therapy for those who progress while receiving placebo.
Second-Line Chemotherapy
Participants who progress on first-line maintenance erlotinib may receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. The selected chemotherapy will be non-investigational and chosen at the discretion of the Investigator.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Gilroy, California, United States
Washington D.C., District of Columbia, United States
Kansas City, Missouri, United States
Missoula, Montana, United States
Lebanon, New Hampshire, United States
Dayton, Ohio, United States
Chattanooga, Tennessee, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Belo Horizonte, Minas Gerais, Brazil
Lajeado, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Ijuí, Rondônia, Brazil
Florianópolis, Santa Catarina, Brazil
Santo André, São Paulo, Brazil
Gabrovo, , Bulgaria
Haskovo, , Bulgaria
Plovdiv, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Regina, Saskatchewan, Canada
Beijing, , China
Beijing, , China
Changchun, , China
Fuzhou, , China
Guangzhou, , China
Guangzhou, , China
Harbin, , China
Shanghai, , China
Shanghai, , China
Shantou, , China
Shenyang, , China
Suzhou, , China
Tianjin, , China
Wuhan, , China
Xi'an, , China
České Budějovice, , Czechia
Jindřichův Hradec, , Czechia
Nymburk, , Czechia
Ostrava - Poruba, , Czechia
Prague, , Czechia
Prague, , Czechia
Tábor, , Czechia
Bayonne, , France
Compiègne, , France
Gap, , France
Libourne, , France
Lille, , France
Nantes, , France
Saint-Brieuc, , France
Villefranche-sur-Saône, , France
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Deszk, , Hungary
Farkasgyepű, , Hungary
Győr, , Hungary
Gyula, , Hungary
Mátraháza, , Hungary
Miskolc, , Hungary
Székesfehérvár, , Hungary
Szolnok, , Hungary
Törökbálint, , Hungary
Zalaegerszeg, , Hungary
S. Giovanni Rotondo, Apulia, Italy
Avellino, Campania, Italy
Bologna, Emilia-Romagna, Italy
Parma, Emilia-Romagna, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Legnago, Lombardy, Italy
Treviglio, Lombardy, Italy
Livorno, Tuscany, Italy
Pisa, Tuscany, Italy
Verona, Veneto, Italy
Daugavpils, , Latvia
Riga, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Vilnius, , Lithuania
Arnhem, , Netherlands
Heerlen, , Netherlands
Hoorn, , Netherlands
Sittard-Geleen, , Netherlands
Zutphen, , Netherlands
Brzozów, , Poland
Krakow, , Poland
Poznan, , Poland
Wodzisław Śląski, , Poland
Zamość, , Poland
Baia Mare, , Romania
Brasov, , Romania
Brasov, , Romania
Brăila, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Cluj-Napoca, , Romania
Cluj-Napoca, , Romania
Oradea, , Romania
Ploieşti, , Romania
Târgu Mureş, , Romania
Banská Bystrica, , Slovakia
Bardejov, , Slovakia
Košice, , Slovakia
Nové Zámky, , Slovakia
Poprad, , Slovakia
Rimavská Sobota, , Slovakia
Cape Town, , South Africa
Cape Town, , South Africa
George, , South Africa
Port Elizabeth, , South Africa
Pretoria, , South Africa
Gyeonggi-do, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Suwon, , South Korea
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Hat Yai, , Thailand
Muang, , Thailand
Muang, , Thailand
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kirovograd, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Lutsk, , Ukraine
Sumy, , Ukraine
Uzhhorod, , Ukraine
Vinnytsia, , Ukraine
Zaporizhzhya, , Ukraine
Countries
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Other Identifiers
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BO25460
Identifier Type: -
Identifier Source: org_study_id