Phase 2
Completed N=30
A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone
Source: ClinicalTrials.gov NCT00265317 ↗Enrolled (actual)
30
Serious AEs
43.7%
Results posted
Jun 2011
Primary outcomePrimary: Progression-Free Survival (PFS) — 12.3; 8.5 Weeks — p=0.3206
Summary
This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
12.3; 8.5 | 0.3206 |
| SECONDARY Percentage of Participants With Objective Response |
4.62; 2.99 | 0.6251 |
| SECONDARY Time to Tumor Progression (TTP) |
12.3; 10.1 | 0.3732 |
| SECONDARY Duration of Response (DR) |
— | — |
| SECONDARY Overall Survival (OS) |
8.2; 7.6 | 0.6171 |
| SECONDARY Percentage of Participants Surviving at 1 Year |
32; 42 | — |
| SECONDARY Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib |
12.96; 11.87 | — |
| SECONDARY AUC(0-24) of Sunitinib |
372.76; 231.61 | — |
| SECONDARY AUC(0-24) of SU-012662 (Metabolite of Sunitinib) |
50.06; 99.57 | — |
| SECONDARY AUC(0-24) of Total Drug (Sunitinib + SU-012662) |
422.93; 331.45 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Erlotinib |
0.99; 0.86 | — |
| SECONDARY Cmax of Sunitinib |
21.61; 13.59 | — |
| SECONDARY Cmax of SU-012662 (Metabolite of Sunitinib) |
3.09; 6.83 | — |
| SECONDARY Cmax of Total Drug (Sunitinib + SU-012662) |
24.51; 20.09 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) for Erlotinib |
— | — |
| SECONDARY AUC(0-inf) for Sunitinib |
— | — |
| SECONDARY AUC(0-inf) for SU-012662 (Metabolite of Sunitinib) |
— | — |
| SECONDARY AUC(0-inf) for Total Drug (Sunitinib + SU-012662) |
— | — |
| SECONDARY Plasma Decay Half-life (t1/2) of Erlotinib |
— | — |
| SECONDARY Plasma Decay Half-life (t1/2) of Sunitinib |
— | — |
| SECONDARY Erlotinib Clearance at Steady State After Oral Administration (CL/F) |
5.52 | — |
| SECONDARY Sunitinib Clearance at Steady State After Oral Administration (CL/F) |
63.28 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib |
2.00; 2.00 | — |
| SECONDARY Tmax for Sunitinib |
6.00; 6.00 | — |
| SECONDARY Tmax for SU-012662 (Metabolite of Sunitinib) |
4.00; 4.00 | — |
| SECONDARY Tmax for Total Drug (Sunitinib + SU-012662) |
6.00; 5.00 | — |
| SECONDARY Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) |
1.46; 1.07; 1.11; 1.00; 1.00; 1.16 | — |
| SECONDARY Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) |
1.14; 1.46; 1.07; 0.99; 0.98; 1.09 | — |
| SECONDARY Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) |
22.94; 21.48; 19.93; 18.58; 22.07; 24.85 | — |
| SECONDARY Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) |
18.80; 22.94; 21.48; 20.58; 17.26; 20.16 | — |
| SECONDARY Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) |
21.02; 19.26; 15.74; 15.38; 15.04; 17.13 | — |
| SECONDARY Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) |
18.08; 21.02; 19.26; 16.41; 15.26; 15.05 | — |
| SECONDARY Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff |
35; 36; 38; 36; 26; 28 | — |
| SECONDARY PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff) |
16.0; 11.7; 8.1; 8.5; 12.3; 8.4 | 0.2247 |
| SECONDARY Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff) |
45; 54; 29; 18; 26; 28 | — |
| SECONDARY PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff) |
16.0; 10.4; 8.1; 8.1; 12.3; 8.4 | 0.3223 |
| SECONDARY Percentage of Participants With EGFR Gene Copy Number Increase |
0; 1; 48; 42; 52; 57 | — |
| SECONDARY PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase |
NA; NA; 12.3; 8.8; 12.0; 8.1 | 0.5526 |
| SECONDARY Percentage of Participants With EGFR Gene Amplification |
0; 0; 48; 43; 52; 57 | — |
| SECONDARY PFS in Subgroups That Were Defined by EGFR Gene Amplification |
12.3; 11.7; 12.0; 8.1 | 0.5839 |
| SECONDARY Percentage of Participants With EGFR Gene Mutation |
6; 1; 32; 28; 62; 70 | — |
| SECONDARY PFS in Subgroups That Were Defined by EGFR Gene Mutation |
19.1; NA; 9.0; 11.7; 12.0; 8.1 | 0.6324 |
| SECONDARY Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations |
9; 6; 34; 28; 57; 66 | — |
| SECONDARY PFS in Subgroups That Were Defined by KRAS Gene Mutation |
20.1; 7.5; 9.5; 12.1; 12.3; 8.3 | 0.2077 |
| SECONDARY Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms |
44.9; 45.6; 9.6; 44.1; 47.1; 8.8 | — |
| SECONDARY PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms |
9.00; 8.10; 17.00; 8.00; NA; 13.00 | 0.7423 |
| SECONDARY Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms |
8.20; 6.20; 6.40; 5.30; 11.60; 16.50 | 0.9486 |
| SECONDARY Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms |
21.3; 52.9; 25.7; 48.5; 44.1; 7.4 | — |
| SECONDARY PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms |
12.30; 19.20; 9.00; 8.00; 12.00; 7.90 | 0.7301 |
| SECONDARY OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms |
12.80; 9.60; 8.20; 6.20; 5.70; 5.60 | 0.8563 |
| SECONDARY Percentage of Participants by Tumor VEGFR Mutation |
— | — |
| SECONDARY Correlation of Polymorphisms in Stem Cell Factor Receptor (c-Kit), FMS-like Tyrosine Kinase 3 Receptor (FLT-3), and c-FMS With Blood Counts |
— | — |
| SECONDARY Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile |
45; 44; 52; 41; 3; 15 | — |
| SECONDARY PFS in Subgroups That Were Defined by RNA Expression Profile |
19.1; 10.9; 12.3; 12.3; 9.5; 8.1 | 0.1667 |
| SECONDARY Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score |
66.49; 62.26; 62.60; 57.43; 61.73; 59.12 | — |
| SECONDARY EORTC-QLQ-C30 Lung Cancer Module (LC13) Score |
21.05; 25.56; 25.71; 26.08; 24.77; 26.03 | — |
| SECONDARY Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg) |
10; 8 | — |
| SECONDARY Number of Participants With BP Greater Than 200/110 mmHg |
1; 0 | — |
| SECONDARY Number of Participants on Anti-hypertensive Medications |
— | — |
| SECONDARY Plasma Concentration of VEGF-C at Baseline |
474.15; 502.10 | 0.3681 |
| SECONDARY Plasma Concentration of Soluble VEGFR-2 at Baseline |
10904.50; 10027 | 0.5982 |
| SECONDARY Plasma Concentration of Soluble VEGFR-3 at Baseline |
23190; 23350 | 0.9807 |
| SECONDARY Plasma Concentration of Soluble KIT (sKIT) at Baseline |
49520; 47242.50 | 0.3945 |
Eligibility Criteria
Inclusion Criteria
- Patients with locally advanced/metastatic non-small cell lung cancer
- Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen
Exclusion Criteria
- Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic inhibitors
- History of or known brain metastases
Data sourced from ClinicalTrials.gov (NCT00265317). 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.