Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Carboplatin

Gemcitabine

Cisplatin

Erlotinib Hydrochloride

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily

erlotinib [Tarceva]

orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application

placebo

1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles

gemcitabine

75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin

cisplatin

5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin

carboplatin

Clinical Trials

This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.

A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.

A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC).

Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than \[\>\]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.

Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for \>16 weeks) per RECIST.

CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.

Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death.

Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization.

PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first.

Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.

Hoffmann-La Roche

The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.

Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.

Placebo Plus Chemotherapy

Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.

Erlotinib Plus Chemotherapy

Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.

Total

Age, Continuous

Sex: Female, Male

Full Analysis Set (FAS): all randomized participants. For analysis, participants were assigned the treatment group to which they were randomized, regardless of the treatment they actually received.

Medical Communications

FAS; for analysis, participants were assigned the treatment group to which they were randomized, regardless of the treatment they actually received.

Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST

Percentage of Participants With Confirmed CR or PR as Assessed by RECIST

FAS; only participants with CR or PR were included in the analysis.

Duration of Response

Time to Progression

Progression-Free Survival (PFS)

Overall Survival

Participants received placebo tablets, orally (PO), on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 milligrams per square meter (mg/m\^2) via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 times \[x\] area under the serum concentration-time curve \[AUC\]), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.

Spots Global Cancer Trial Database for A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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