A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

NCT00883779 | Completed Phase 3 Results

• 1 other identifier: MO22201
• Study Type: interventional
• Target: 451
• Locations: 7 countries
• Sites: 26

Brief Summary

This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Median Progression Free Survival (PFS) Time

  Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. PFS is the time (in months) between the date of randomization and the date of first documented disease progression or death from any cause, whichever comes first. Participants who had neither progressed nor died at the time of data cut-off or who were lost to follow-up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow up for progression of disease, whichever was last. Participants without post baseline tumor assessments who were known to be alive were censored at the time of randomization. Analysis was performed using Kaplan-Meier method.

  Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])

Secondary Outcomes (15)

• Percentage of Participants Alive and Free From Disease Progression

  Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])

• Median PFS Time Based on Different Subgroups

  Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])

• Median Overall Survival (OS) Time-Overall and Among Different Subgroups

  Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years])

• Percentage of Participants Alive at the End of Study-Overall and Among Different Subgroups

  Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years])

• Non-Progression Rate: Percentage of Participants With a Confirmed Best Overall Response of Either Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for At Least 16 Weeks

  Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])

Study Arms (2)

1

EXPERIMENTAL

Drug: Platinum chemotherapy (cisplatin or carboplatin); Drug: erlotinib [Tarceva]; Drug: gemcitabine

2

PLACEBO COMPARATOR

Drug: Placebo; Drug: Platinum chemotherapy (cisplatin or carboplatin); Drug: gemcitabine

Interventions

Placebo DRUG

po on days 15-28 of each 4 week cycle until disease progression

2

Platinum chemotherapy (cisplatin or carboplatin) DRUG

cisplatin --75mg/m2 oon day 1 of each 4 week cycle for 6 cycles or carboplatin--5xAUC on day 1 of each 4 week cycle for 6 cycles

1; 2

erlotinib [Tarceva] DRUG

150mg po on days 15-28 of each 4 week cycle until disease progression

1

gemcitabine DRUG

1250mg/m2 iv on days 1 and 8 of each 4 week cycle for 6 cycles

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, \>=18 years of age;
• advanced (stage IIIB/IV)non-small cell lung cancer;
• measurable disease;
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

You may not qualify if:

• prior exposure to agents directed at the HER axis;
• prior chemotherapy or systemic anti-tumor therapy after advanced disease;
• unstable systemic disease;
• any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
• brain metastasis or spinal cord compression.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (26)

Unknown Facility

Beijing, 100021, China

Location

Unknown Facility

Beijing, 100142, China

Location

Unknown Facility

Beijing, 101149, China

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Unknown Facility

Guangzhou, 510060, China

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Guangzhou, China

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Unknown Facility

Hangzhou, China

Location

Unknown Facility

Nanjing, 210029, China

Location

Unknown Facility

Shanghai, 200030, China

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Unknown Facility

Shanghai, 200433, China

Location

Unknown Facility

Hong Kong, 852, Hong Kong

Location

Unknown Facility

Hong Kong, Hong Kong

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Unknown Facility

Shatin, Hong Kong

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Unknown Facility

Jakarta, 13230, Indonesia

Location

Unknown Facility

Surabaya, 60286, Indonesia

Location

Unknown Facility

Yogyakarta, 55284, Indonesia

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Unknown Facility

Manila, 1000, Philippines

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Unknown Facility

Pasig, 1605, Philippines

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Unknown Facility

Quezon City, 1104, Philippines

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Unknown Facility

Gyeonggi-do, 410-769, South Korea

Location

Unknown Facility

Taichung, 407, Taiwan

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Unknown Facility

Taipei, 100, Taiwan

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Unknown Facility

Taipei, 116, Taiwan

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Unknown Facility

Taipei, Taiwan

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Unknown Facility

Bangkok, 10400, Thailand

Location

Unknown Facility

Bangkok, 10700, Thailand

Location

Unknown Facility

Chiang Mai, 50200, Thailand

Location

Related Publications (1)

• Wu YL, Lee JS, Thongprasert S, Yu CJ, Zhang L, Ladrera G, Srimuninnimit V, Sriuranpong V, Sandoval-Tan J, Zhu Y, Liao M, Zhou C, Pan H, Lee V, Chen YM, Sun Y, Margono B, Fuerte F, Chang GC, Seetalarom K, Wang J, Cheng A, Syahruddin E, Qian X, Ho J, Kurnianda J, Liu HE, Jin K, Truman M, Bara I, Mok T. Intercalated combination of chemotherapy and erlotinib for patients with advanced stage non-small-cell lung cancer (FASTACT-2): a randomised, double-blind trial. Lancet Oncol. 2013 Jul;14(8):777-86. doi: 10.1016/S1470-2045(13)70254-7. Epub 2013 Jun 17.

  PMID: 23782814 DERIVED

MeSH Terms

Interventions

Cisplatin; Carboplatin; Erlotinib Hydrochloride; Gemcitabine

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 20, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 14, 2015
• Results First Posted: December 14, 2015

Record last verified: 2015-11

Locations

TH (3); ID (3); PH (3); CN (9); HK (3); KR (1); TW (4)