Phase 1
N=15
A Study of Pertuzumab With Erlotinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02507375 ↗Enrolled (actual)
15
Serious AEs
26.7%
Results posted
Oct 2015
Primary outcome: Primary: Percentage of Participants With Dose Limiting Toxicities (DLTs) — 0; 0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Erlotinib (Drug); Pertuzumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Dose Limiting Toxicities (DLTs) |
0; 0 | — |
| SECONDARY Percentage of Participants Classified as Responders |
20; 33.3; 11.1 | — |
| SECONDARY Percentage of Participants With a Complete Response or Partial Response at the End of Cycles 1, 2, 3, 4, and 6 |
0; 0; 33.3; 11.1; 0; 0 | — |
| SECONDARY Peak Plasma Concentration (Cmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC |
231 | — |
| SECONDARY Time of Cmax (Tmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC |
0.23 | — |
| SECONDARY Terminal Phase Plasma Half-life (t ½) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC |
17.9 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve (AUC) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With Non-small Cell Lung Cancer (NSCLC) |
1780; 3000 | — |
| SECONDARY Clearance (CL) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC |
0.24 | — |
| SECONDARY Volume of Distribution at Steady-state (Vss) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC |
4.9 | — |
Summary
This study will assess the safety and tolerability, and make a preliminary assessment of activity, of a combination of pertuzumab and erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed on at least one prior chemotherapy regimen. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is less than 100 individuals.
Eligibility Criteria
Inclusion Criteria
- Adult patients greater than or equal to 18 years of age
- Histological confirmation of non-small cell lung cancer (NSCLC)
- Locally advanced or metastatic disease
- Failure of at least one prior regimen of standard chemotherapy for locally advanced or metastatic disease
- Life expectancy of more than or equal to 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Baseline Left Ventricular Ejection Fraction (LVEF) of greater than or equal to 50%
- A negative pregnancy test one week prior to treatment and willingness to use contraception among women of childbearing potential
- Availability of histological Formalin-Fixed, Paraffin-Embedded (FFPE) tumor tissue
Exclusion Criteria
- Prior chemotherapy, radiotherapy or immunotherapy within 4 weeks of study Day -8
- Prior treatment with any agent which targets growth factors or their receptors
- Patients who have not recovered from the acute reversible effects of chemotherapy and radiotherapy
- History of clinically significant cardiovascular disease
- History or evidence of central nervous system metastases
- Treatment with any investigational drug within 28 days of the start of the study (day -8)
- Prior cumulative doxorubicin dose of more than 360 mg/m2 or the equivalent
Data sourced from ClinicalTrials.gov (NCT02507375). 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.