Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer
Source: ClinicalTrials.gov NCT02272413 ↗No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response Rate (ORR), Based on Unconfirmed Response Assessment, as Assessed by Central Imaging Review Until 18 Weeks After the Start of Treatment |
54.0; 63.1 | — |
| SECONDARY Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin® |
52.50; 45.10; 16.70; 13.10; 6.60; 5.50 | — |
| SECONDARY Progression-Free Survival (PFS) Time as Determined by Investigator Assessment |
8.34; 9.00 | — |
| SECONDARY Overall Survival (OS) Time |
15.57; 19.48 | — |
| SECONDARY Duration of Response (DOR) as Determined by Investigator Assessment |
7.66; 8.94 | — |
Eligibility Criteria
Inclusion criteria
Adult patients aged >=18 years with histologically or cytologically confirmed advanced nonsquamous non-small cell lung cancer (nsNSCLC). Mixed tumors should be categorized according to the predominant histology.
Note: NSCLC should be predominantly nonsquamous. Recurrent or metastatic disease (Stage IV) with an indication for therapy with paclitaxel + carboplatin + Avastin®.
Patients harboring tumors with unknown or without activating epidermal growth factor receptor (EGFR) / anaplastic lymphoma receptor tyrosine kinase (ALK) mutation maybe included provided chemotherapy is standard of care. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on independent central review.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
Adequate hepatic, renal, and bone marrow function:
Life expectancy > 6 months based on clinical judgment. Further inclusion criteria apply.
Exclusion criteria
Prior therapy with monoclonal antibodies or small molecule inhibitors against Vascular Endothelial Growth Factor (VEGF) or VEGF receptors, including Avastin®.
Prior systemic therapy for metastatic disease. Prior systemic anticancer therapy or radiotherapy for locally advanced nsNSCLC if completed Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy).
History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. Thrombotic or hemorrhagic event =< 6 months prior to Screening. Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT02272413). 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.