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A Phase 2, Open-label Study of IMC-1121B in Combination With Paclitaxel and Carboplatin as First-line Therapy in Patients With Stage IIIB/IV Non-small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Non Small Cell Lung Cancer

Thank you

Trial Information

A Phase 2, Open-label Study of IMC-1121B in Combination With Paclitaxel and Carboplatin as First-line Therapy in Patients With Stage IIIB/IV Non-small Cell Lung Cancer

Non-small cell lung cancer (NSCLC) accounts for 75-80% of all lung cancers; and the advanced
stages are associated with poor survival rates with untreated patients having a median
survival rate of approximately 3.9 months.

Angiogenesis is a process that occurs in the health body for wound healing and restoring
blood flow to tissues after injury. It is the physiological proves involving the growth of
new blood vessels from pre-existing vessels. Angiogenesis may be promoted by growth factors
and in diseases such as cancer, where growth factors are over expressed, the body loses the
ability to maintain a balanced angiogenesis. This may embellish the existing supplies of
blood; potentially increasing the delivery of oxygen and nutrients supplies for cancer
growth and survival.

ramucirumab is an angiogenesis inhibitor; and is believed to block the promotion of the
growth factor to forming new blood vessels, thus reducing the amount of blood supplies to
the cancer cells.

In this study, 40 adult patients with NSCLC will be evaluated t=for progression-free
survival at 6 months of ramucirumab administration

Inclusion Criteria:

1. Histologically or cytologically confirmed NSCLC

2. Advanced NSCLC

3. Measurable disease (as defined by Response Evaluation Criteria in Solid Tumors

4. ECOG is ≤ 1

5. Age ≥ 18 years

6. Adequate hematologic function = an absolute neutrophil count (ANC) ≥ 1500/μL,
hemoglobin ≥ 9 g/dL, and a platelet count ≥ 100,000/μL

7. Adequate hepatic function = a total bilirubin ≤ 1.5 mg/dL transaminases and alkaline
phosphatase ≤ 5 x the upper limit of normal (ULN)

8. Adequate renal function serum creatinine ≤ 1.5 x ULN or calculated creatinine
clearance (CrCl) > 60 mL/minute, and urine dipstick for protein < 1+ (ie, either 0 or

9. Adequate coagulation function, INR ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5
seconds above ULN

10. Adequate contraception

11. Signed informed consent

Exclusion Criteria:

1. Untreated CNS metastases

2. Prior bevacizumab therapy

3. Radiologically documented evidence of major blood vessel invasion or encasement by

4. Prior systemic chemotherapy for Stage IIIB/IV NSCLC

5. Prior systemic chemotherapy or radiation therapy for Stage I-IIIA NSCLC < 1 year

6. Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of
the cervix

7. Concurrent treatment with other anticancer therapy, including other chemotherapy,
immunotherapy, hormonal therapy, radiotherapy, chemoembolization,or targeted therapy

8. Ongoing or active infection, symptomatic congestive heart failure,unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements

9. Uncontrolled thrombotic or hemorrhagic disorders

10. Poorly-controlled hypertension

11. Chronic daily treatment with aspirin (> 325 mg/day) or other known inhibitors of
platelet function

12. History of gross hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon)

13. Serious non-healing wound, ulcer, or bone fracture

14. Undergone major surgery or subcutaneous venous access device placement.
Post-operative bleeding complications or wound complications from a surgical
procedures performed in the last 2 months

15. Elective or a planned major surgery to be performed during the course of the trial

16. Peripheral neuropathy ≥ Grade 2 (National Cancer Institute Common Toxicity Criteria
for Adverse Events, Version 3.0 [NCI-CTCAE v 3.0])

17. If female, is pregnant or lactating

18. Radiographic evidence of intratumor cavitation

19. Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of Participants Who are Progression-free (PFS) at 6 months

Outcome Description:

The 6-month progression-free survival (PFS) rate is defined as the proportion of participants that are alive and progression-free 6 months after randomization.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

E-mail: ClinicalTrials@

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC


United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

January 2012

Related Keywords:

  • Non Small Cell Lung Cancer
  • Non small cell Lung Cancer
  • Lung
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



ImClone Investigational SiteDenver, Colorado  80262
ImClone Investigational SiteNew York, New York  10021
ImClone Investigational SiteBakersfield, California  93309
ImClone Investigational SiteDallas, Texas  75230
ImClone Investigational SiteSeattle, Washington  98104