A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Having Received Tarceva Monotherapy.

NCT00773383 | Terminated Phase 2 Results

• 2 other identifiers: NO217462008-001762-85
• Study Type: interventional
• Target: 35
• Locations: 4 countries
• Sites: 16

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Progression Free Survival (PFS)

  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.

  12 weeks

Secondary Outcomes (13)

• 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 Pts who never progress prior to final analysis or are withdrawn from the study without documented progression will be censored at the date of the last valid tumor assessment.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

Study Arms (1)

1

EXPERIMENTAL

Drug: RG1507; Drug: erlotinib [Tarceva]

Interventions

RG1507 DRUG

iv 9mg/kg weekly

1

erlotinib [Tarceva] DRUG

150mg oral daily

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (16)

Unknown Facility

Santa Monica, California, 90404, United States

Location

Unknown Facility

Miami, Florida, 33101, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Hickory, North Carolina, 28602, United States

Location

Unknown Facility

Calgary, Alberta, T2N 4N2, Canada

Location

Unknown Facility

Ottawa, Ontario, K1H 8L6, Canada

Location

Unknown Facility

Montreal, Quebec, H3A 1A1, Canada

Location

Unknown Facility

Montreal, Quebec, H3G 1A4, Canada

Location

Unknown Facility

Marseille, 13015, France

Location

Unknown Facility

Paris, 75230, France

Location

Unknown Facility

Villejuif, 94805, France

Location

Unknown Facility

Gdansk, 80-211, Poland

Location

Unknown Facility

Lublin, 20-950, Poland

Location

Unknown Facility

Poznan, 60-569, Poland

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

RG-1507 monoclonal antibody; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: November 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: June 24, 2013
• Results First Posted: September 16, 2011

Record last verified: 2013-06

Locations

US (6); FR (3); PL (3); CA (4)