Clinical trial NCT02507375: A Study of Pertuzumab With Erlotinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Official title: Phase Ib, Open-label, Multi-center Study of the Combination of Pertuzumab and Erlotinib in Patients With Locally Advanced or Metastatic (Stage IIIb/IV) NSCLC After Failure of at Least One Prior Chemotherapy Regimen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Squamous
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-07-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Percentage of Participants With Dose Limiting Toxicities (DLTs)
timeFrame: From baseline to end of the study (up to 42 weeks)
Secondary outcomes:
measure: Percentage of Participants Classified as Responders
timeFrame: within 18 weeks
measure: Percentage of Participants With a Complete Response or Partial Response at the End of Cycles 1, 2, 3, 4, and 6
timeFrame: From baseline to the end of the study (up to 42 weeks)
measure: Peak Plasma Concentration (Cmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
timeFrame: on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion
measure: Time of Cmax (Tmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
timeFrame: on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion
measure: Terminal Phase Plasma Half-life (t ½) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
timeFrame: on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion
measure: 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)
timeFrame: on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion
measure: Clearance (CL) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
timeFrame: on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion
measure: Volume of Distribution at Steady-state (Vss) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
timeFrame: on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
city: Barcelona
country: Spain
city: Manchester
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: