A Study of Pertuzumab With Erlotinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Sponsor
Hoffmann-La Roche
Study ID
NCT02507375
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Erlotinib will be administered as oral tablets.
  • Pertuzumab — DRUG
    Pertuzumab will be administered as intravenous (IV) infusion.

Study Details

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.

Key Dates

First listed
Jul 23, 2015
Start date
Sep 30, 2006
Status verified
Sep 2015
Primary completion
Dec 31, 2008
Completion
Dec 31, 2008

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Participants will receive IV infusion of pertuzumab at a loading dose of 840 mg on Day 1, followed by a dose of 420 mg every 3 weeks. Erlotinib will be administered daily, at a dose level of 100 mg orally (PO).
  • Experimental: Cohort 2
    Participants will receive IV infusion of pertuzumab at a loading dose of 840 mg on Day 1, followed by a dose of 420 mg every 3 weeks. Erlotinib will be administered daily, at a dose level of 150 mg orally (PO).

Primary Outcome Measure

Percentage of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: From baseline to end of the study (up to 42 weeks) ]

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