Phase 3
Completed N=451
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
Source: ClinicalTrials.gov NCT00883779 ↗Enrolled (actual)
451
Serious AEs
32.6%
Results posted
Dec 2015
Primary outcomePrimary: Median Progression Free Survival (PFS) Time — 6.0; 7.6 months — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Progression Free Survival (PFS) Time |
6.0; 7.6 | <0.0001 sig |
| SECONDARY Percentage of Participants Alive and Free From Disease Progression |
6.2; 22.6 | — |
| SECONDARY Median PFS Time Based on Different Subgroups |
6.5; 8.2; 5.8; 5.7; 6.6; 10.9 | <0.0001 sig |
| SECONDARY Median Overall Survival (OS) Time-Overall and Among Different Subgroups |
15.2; 18.2; 15.8; 20.9; 12.4; 10.3 | =0.1213 |
| SECONDARY Percentage of Participants Alive at the End of Study-Overall and Among Different Subgroups |
13.3; 15.9; 14.9; 19.5; 8.8; 3.8 | — |
| SECONDARY 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 |
64.4; 67.3 | =0.5289 |
| SECONDARY Objective Response Rate: Percentage of Participants With a Confirmed Best Overall Response of CR or PR |
17.8; 42.9 | <0.0001 sig |
| SECONDARY Duration of Response |
5.6; 10.3 | <0.0001 sig |
| SECONDARY Time to Progression |
6.5; 7.9 | <0.0001 sig |
| SECONDARY Percentage of Participants With Symptomatic Progression Assessed Using the Lung Cancer Subscale (LCS) |
72.4; 66.4 | — |
| SECONDARY Time to Symptomatic Progression |
6.6; 7.2 | =0.0364 sig |
| SECONDARY Percentage of Participants With Deterioration in Trial Outcome Index (TOI) Using FACT-L Version 4.0 |
75.6; 65.9 | — |
| SECONDARY Time to Deterioration in TOI Using FACT-L Version 4.0 |
5.6; 6.3 | =0.0181 sig |
| SECONDARY Percentage of Participants With Deterioration in Quality of Life (QOL) Using FACT-L Version 4.0 |
79.6; 70.4 | — |
| SECONDARY Time to Deterioration in QOL Using FACT-L Version 4.0 |
4.5; 5.6 | =0.0035 sig |
| SECONDARY Median Follow-up Time During the Study |
50.3; 50.2 | 0.9130 |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00883779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.