Phase 2
Completed N=38
Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung (NSCLC)
Source: ClinicalTrials.gov NCT00735904 ↗
Enrolled (actual)
38
Serious AEs
39.5%
Results posted
Jan 2013
Primary outcomePrimary: Percentage of Participants With Objective Response (OR) — 39.5 Percentage of participants
Summary
This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR) |
39.5 | — |
| SECONDARY Overall Survival (OS) |
14.2 | — |
| SECONDARY Progression Free Survival (PFS) |
6.2 | — |
| SECONDARY Duration of Response (DR) |
5.78 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically- or cytologically-confirmed diagnosis of squamous NSCLC Stage IIIB with malignant effusion (fluid cytology demonstrating malignant cells required), Stage IV, or recurrent disease after definitive local therapy
- Candidate for primary treatment with cisplatin and gemcitabine
- Presence of measurable disease by RECIST
- Adequate organ function as defined by the following criteria: ECOG performance status of 0 or 1
Exclusion Criteria
- Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC.
- One or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by CT or MRI.
- History of hemoptysis > ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment
- NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment
- Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
- Untreated brain metastases.
- Need for therapeutic anticoagulation, regular use of aspirin (> 325 mg/day), NSAID or other medications known to inhibit platelet function.
Data sourced from ClinicalTrials.gov (NCT00735904). 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.