Phase 2
Completed N=64
A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before
Source: ClinicalTrials.gov NCT00870870 ↗Enrolled (actual)
64
Serious AEs
68.8%
Results posted
Jun 2018
Primary outcomePrimary: Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] — 31.0; 20.0 percentage of participants
Summary
The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] |
31.0; 20.0 | — |
| SECONDARY Overall Survival (OS) |
11.5; 8.9 | — |
| SECONDARY Progression-Free Survival (PFS) |
4.2; 5.6 | — |
| SECONDARY Time To Progression (TTP) |
5.8; 5.7 | — |
| SECONDARY Duration of Response |
4.8; 4.8 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) or Deaths |
4; 6; 29; 25; 4; 5 | — |
| SECONDARY Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity) |
— | — |
| SECONDARY Maximum Concentration (Cmax) of Cixutumumab at Study Day 1 |
— | — |
| SECONDARY Cmax of Cixutumumab for Cycle 1 |
— | — |
| SECONDARY Cmax of Cixutumumab for Cycle 3 |
— | — |
| SECONDARY Cmax of Cixutumumab Cycle 5 |
— | — |
| SECONDARY Minimum Concentration (Cmin) of Cixutumumab at Study Day 1 |
— | — |
| SECONDARY Cmin of Cixutumumab for Cycle 1 |
— | — |
| SECONDARY Cmin of Cixutumumab for Cycle 3 |
— | — |
| SECONDARY Cmin of Cixutumumab for Cycle 5 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Has histologically or cytologically confirmed, Stage IIIb - IV NSCLC
- Has metastatic disease
- Has a tumor measurable according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Has adequate hematologic function
- Has adequate hepatic function
- Has adequate renal function
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion Criteria
- Has uncontrolled brain metastases
- Has leptomeningeal disease
- Has received previous chemotherapy for NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization)
- Receiving any other investigational agent(s)
- Has a history of treatment with other agents targeting the insulin-like growth factor (IGF) or the epidermal growth factor (EGF) receptor
- Has a known allergy / history of hypersensitivity reaction to any of the treatment components
- Has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range [fasting glucose <160 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN) and hemoglobin A1C≤ 7%] and that they are on a stable dietary or therapeutic regimen for this condition
- Has an uncontrolled intercurrent illness
- Pregnant or lactating
- Has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years
- Has superior vena cava syndrome contraindicating hydration
- Has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure
- Has any National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version (v) 3.0 Grade ≥2 peripheral neuropathy
- Has significant third space fluid retention, requiring repeated drainage
Data sourced from ClinicalTrials.gov (NCT00870870). 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.