Phase 2 Completed N=124 Randomized Treatment

A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.

Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov NCT00531960 ↗

Enrolled (actual)

124

Serious AEs

31.7%

Results posted

Nov 2014

Primary outcomePrimary: Percentage of Participants With Disease Progression or Death — 72.1; 76.2 percentage of participants

Summary

This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Disease Progression or Death	72.1; 76.2	—
PRIMARY PFS	34.6; 23.4	0.8060
SECONDARY Percentage of Participants Who Died	45.9; 52.4	—
SECONDARY OS	NA; 16.4	0.4063
SECONDARY Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0	44.3; 27.0	0.0444 sig
SECONDARY Percentage of Participants With Disease Control According to RECIST V 1.0	85.2; 73.0	0.0944

Eligibility Criteria

Inclusion Criteria

adult patients, >=18 years of age;
advanced (stage IIIb and IV) non-small cell lung cancer;
measurable disease;
ECOG PS 0-1.

Exclusion Criteria

prior chemotherapy or treatment with another systemic anti-cancer agent;
radiotherapy within 4 weeks prior to first dose of study treatment;
CNS metastases;
other malignancies in past 5 years, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer.

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Data sourced from ClinicalTrials.gov (NCT00531960). 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. Informational only — not medical advice.