Phase 2
Completed N=153
A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.
Source: ClinicalTrials.gov NCT01998919 ↗Enrolled (actual)
153
Serious AEs
22.2%
Results posted
Jul 2014
Primary outcomePrimary: Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) — 76.9; 80.3 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) |
76.9; 80.3 | — |
| SECONDARY Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST |
53.8; 64.5 | — |
| SECONDARY Percentage of Participants With Confirmed CR or PR as Assessed by RECIST |
24.4; 36.8 | — |
| SECONDARY Duration of Response |
24.1; 38.4 | 0.0075 sig |
| SECONDARY Time to Progression |
24.1; 31.4 | 0.0004 sig |
| SECONDARY Progression-Free Survival (PFS) |
23.4; 30.4 | 0.0001 sig |
| SECONDARY Overall Survival |
75.7; 74.1 | 0.5991 |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;
- measurable disease;
- no previous chemotherapy for non-small cell lung cancer.
Exclusion Criteria
- unstable systemic disease;
- any other malignancies in the last 5 years.
Data sourced from ClinicalTrials.gov (NCT01998919). 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.