Phase 3
Completed N=889
A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov NCT00556712 ↗Enrolled (actual)
889
Serious AEs
9.5%
Results posted
Feb 2015
Primary outcomePrimary: Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008) — 89.5; 79.9 percentage of participants
Summary
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008) |
89.5; 79.9 | — |
| PRIMARY PFS in All Participants (Data Cutoff 17 May 2008) |
11.1; 12.3 | <0.0001 sig |
| PRIMARY Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) |
15.0; 25.0 | — |
| PRIMARY Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008) |
89.4; 79.5 | — |
| PRIMARY PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008) |
11.1; 12.3 | < 0.0001 sig |
| PRIMARY Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008) |
16.0; 27.0 | — |
| SECONDARY Percentage of All Participants Who Died (Data Cutoff 12 January 2012) |
87.1; 82.0 | — |
| SECONDARY Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012) |
11.0; 12.4 | 0.0097 sig |
| SECONDARY Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012) |
45.0; 50.0 | — |
| SECONDARY Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012) |
87.5; 80.5 | — |
| SECONDARY OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012) |
11.0; 12.8 | 0.0050 sig |
| SECONDARY Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012) |
47.0; 52.0 | — |
| SECONDARY Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008) |
89.8; 77.4 | — |
| SECONDARY PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) |
9.0; 11.0 | 0.1768 |
| SECONDARY Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) |
11.0; 22.0 | — |
| SECONDARY Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008) |
50.8; 41.9 | — |
| SECONDARY OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) |
10.2; 8.6 | 0.4797 |
| SECONDARY Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008) |
20.0; 42.0 | — |
| SECONDARY Time to Progression (Data Cutoff 17 May 2008) |
11.3; 12.3 | <0.0001 sig |
| SECONDARY Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008) |
15.0; 26.0 | — |
| SECONDARY Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008) |
5.4; 11.9 | 0.0006 sig |
| SECONDARY Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) |
0.7; 0.9; 4.7; 11.0; 45.4; 48.6 | — |
| SECONDARY Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008) |
1.3; 5.5 | 0.0007 sig |
| SECONDARY Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) |
0.4; 0.5; 0.9; 4.8; 0.0; 0.2 | — |
| SECONDARY Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008) |
50.8; 60.6; 27.4; 40.8 | 0.0035 sig |
| SECONDARY Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008) |
44.1; 47.7 | — |
| SECONDARY Time to Symptom Progression (Data Cutoff 17 May 2008) |
17.6; 18.3 | 0.3787 |
| SECONDARY Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008) |
35.0; 41.0 | — |
| SECONDARY Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008) |
43.1; 50.9 | — |
| SECONDARY Time to Deterioration in TOI (Data Cutoff 17 May 2008) |
18.9; 18.1 | 0.5385 |
| SECONDARY Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008) |
41.0; 39.0 | — |
| SECONDARY Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008) |
51.7; 55.3 | — |
| SECONDARY Time to Deterioration in QoL (Data Cutoff 17 May 2008) |
12.3; 12.6 | 0.6530 |
| SECONDARY Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008) |
34.0; 32.0 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) |
20.85; 20.96; 20.84; 20.98; 16.92; 16.77 | — |
| SECONDARY Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) |
0.22; -0.47; -0.24; 0.23; -0.41; 0.29 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- histologically documented, locally advanced , recurrent or metastatic NSCLC;
- measurable disease;
- no disease progression after 4 cycles of platinum-based chemotherapy.
Exclusion Criteria
- unstable systemic disease;
- any other malignancies in the last 5 years.
Data sourced from ClinicalTrials.gov (NCT00556712). 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.