AMG 102 and Erlotinib for Advanced Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT01233687 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants That Experienced a Dose Limiting Toxicity |
— | — |
| PRIMARY Disease Control Rate (DCR) |
60 | — |
| SECONDARY Objective Response Rate (ORR/Clinical Response) |
8.8 | — |
| SECONDARY Progression-free Survival (PFS) |
2.6 | — |
| SECONDARY Overall Survival (OS) |
6.6 | — |
Eligibility Criteria
Patients must have baseline evaluations performed prior to the first dose of study drug and must meet all inclusion and exclusion criteria. Results of all baseline evaluations, which assure that all inclusion and exclusion criteria have been satisfied, must be reviewed by a Physician Investigator prior to enrollment of that patient. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent must be obtained from the patient prior to enrollment. The following criteria apply to all patients enrolled onto the study unless otherwise specified.
Inclusion Criteria
- Patients with recurrent or progressive advanced stage Non-small cell lung cancer (NSCLC,no SCLC component) who have been treated with at least one and a maximum of two prior chemotherapy regimens for advanced NSCLC. Chemotherapy as part of initial potentially curative therapy (given as part of adjuvant or concomitant chemoradiotherapy) that was completed grade 2) within 7 days of enrollment.
- A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
- Untreated brain metastases.
- A major surgical procedure or significant traumatic injury within 28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study per inclusion criterion 3.1. In addition, if a patient has not yet recovered from prior minor surgery (such as central venous access device or fine needle aspiration biopsy).
- Thrombosis or vascular ischemic events within the last twelve months, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction
- Concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except for the use of low dose coumarin-type anticoagulants or low molecular weight heparin for prophylaxis against central venous catheter thrombosis
- Presence of peripheral edema > Grade 2 (CTCAE version 4).
Data sourced from ClinicalTrials.gov (NCT01233687). 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.