An Open-label Study to Determine the Effect of R1507 Plus Tarceva (Erlotinib) on Progression-free Survival in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) With Progressive Disease After Clinical Benefit to Second or Third Line Tarceva Monotherapy.
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 35
- Primary Endpoint
- Percentage of Participants With Progression Free Survival (PFS)
Study Overview
Brief Summary
This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive disease after deriving clinical benefit (defined as response or stable disease after 12 weeks) from second or third line Tarceva monotherapy will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva. Patients will receive R1507 (9mg/kg iv) weekly in combination with Tarceva (150mg oral daily) for up to a maximum of 24 months. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •male or female patients >=18 years with histologically documented inoperable, locally advanced or metastatic (stage IIIB or IV) NSCLC;
- •currently receiving Tarceva monotherapy and having failed at least one standard chemotherapy regimens;
- •prior response or stable disease 12 weeks from start of Tarceva;
- •documented progressive disease at enrollment;
- •measurable disease according to the RECIST criteria;
- •ECOG performance status 0-2;
- •life expectancy >12 weeks.
Exclusion Criteria
- •patients with active CNS lesions;
- •prior treatment with agents acting via IGF-1R inhibition or EGFR targeting;
- •administration with high doses of systemic corticosteroids;
- •radiotherapy in the 4 weeks prior to study start;
- •surgery or significant traumatic injury with in the last 2 weeks prior to study start.
Arms & Interventions
1
Intervention: RG1507 (Drug)
1
Intervention: erlotinib [Tarceva] (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Progression Free Survival (PFS)
Time Frame: 12 weeks
The primary efficacy endpoint is progression-free survival at 12 weeks after start of therapy. A progression-free survival rate at 12 weeks will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 weeks.
Secondary Outcomes
- Duration of Overall Survival(From start of treatment to death; up to the time that all participants ended treatment)
- Participants Achieving Objective Response(Patients were followed from start of therapy until date of first response)
- Time to Best Response(Patients were followed from start of therapy until date of first response)
- Time to Progressive Disease (PD)(From start of therapy to the date of first documentation of PD. Pts who never progress prior to final analysis or are withdrawn from the study without documented progression will be censored at the date of the last valid tumor assessment.)
- Duration of Objective Response(from the date the complete or partial response was first recorded to the date which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken)
- Baseline Electrocardiogram (ECG)(baseline within 28 days of starting treatment (screening visit).)
- Fasting Glucose, Highest Post-Baseline Value(Baseline, Highest Post-Baseline value within the timeframe of post-baseline collection up to when patient discontinued (up to 59 weeks))
- Hemoglobin A1c (HbA1c)(screening)
- Monthly Urine Pregnancy Test in Female Patients of Childbearing Potential(Within 7 days of starting treatment (baseline visit))
- Number of Participants With Positive Results for Human Anti-human Antibody (HAHA) Testing(prior to dosing on week 1 (day 1), week 4 (day 22), week 10 (day 64), final visit, follow up visit and 12 weeks post last dose (up to 71 weeks))
- Electrocardiogram (ECG)(baseline and thereafter as clinically indicated at the discretion of the investigator up to the time that the patient discontinued (up to 59 weeks))
- Population Pharmacokinetics of R1507 and Tarceva(Throughout study)
- Assessment of Potential Predictive and Prognostic Biomarkers.(Throughout study)