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A Randomized Phase 2 Study of Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) With Paclitaxel/Carboplatin or Paclitaxel/Carboplatin Alone in Previously Untreated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Non-Small Cell Lung Cancer

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Trial Information

A Randomized Phase 2 Study of Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) With Paclitaxel/Carboplatin or Paclitaxel/Carboplatin Alone in Previously Untreated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The primary objective of this study is to evaluate the progression-free survival (PFS) in
previously untreated patients with Stage IIIB/IV non-small cell lung cancer (NSCLC) treated
with IMC-3G3 plus paclitaxel and carboplatin versus paclitaxel and carboplatin in the
first-line metastatic setting.

Inclusion Criteria:

1. The patient has histologically or cytologically confirmed Non-Small Cell Lung Cancer
(NSCLC)Stage IIIB with effusion. Mixed Non-Small Cell Lung Cancer (NSCLC) tumors will
be categorized by the predominant cell type. Primary or metastatic site may be used
for histology

2. For squamous cell histology or for centrally located mediastinal masses (< 3 cm from
the carina) identified by computed tomography scan (CT) or chest x-ray, the patient
must undergo a magnetic resonance imaging (MRI) of the chest or I.V. contrast CT scan
within 3 weeks of randomization, to exclude major airway or blood vessel invasion (in
the investigator's opinion) by cancer

3. The patient has measurable disease (Tumors within a previously irradiated field will
be designated as "nontarget" lesions unless progression is documented or a biopsy is
obtained to confirm persistence at least 90 days following completion of radiation

4. The patient's Eastern Cooperative Oncology Group (ECOG) performance status is 0-1

5. The patient's age at the time of study entry is ≥ 18 years

6. The patient has adequate hematologic function as defined by an absolute neutrophil
count (ANC) ≥ 1500/μL, hemoglobin ≥ 9.5 g/dL, and a platelet count ≥ 100,000/μL
obtained within 2 weeks prior to randomization

7. The patient has adequate hepatic function as defined by a total bilirubin ≤ 1.5
mg/dL, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 × the
upper limit of normal ([ULN], or ≤ 5 × the ULN in the presence of known liver

8. The patient has adequate renal function as defined by serum creatinine ≤ 1.5 × the
institutional ULN. If creatinine is above the ULN, the patient's creatinine clearance
(CrCl) is ≥ 60 mL/min

9. The patient has urinary protein ≤ 1+ on dipstick or routine urinalysis; if urine
dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate <
1 g of protein in 24 hours to allow participation

10. The patient has adequate coagulation function, as defined by international normalized
ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above ULN if
not receiving anticoagulation therapy. Patients on full-dose anticoagulation must be
on a stable dose of oral anticoagulant or low molecular weight heparin, have
therapeutic INR, no active bleeding (defined as within 14 days randomization) and no
pathological condition that carries a high risk of bleeding (eg, tumor involving
major vessels or known varices)

11. Because the teratogenicity of IMC-3G3 is not known, women of childbearing potential
(WOCBP) and sexually active males must agree to use adequate contraception (hormonal
or barrier method of birth control; abstinence) prior to randomization and for the
duration of study participation

12. The patient has resolution to Grade ≤ 1 by the National Cancer Institute Common
Terminology Criteria for Adverse Events, Version 4 (NCI-CTCAE v 4.02) of all
clinically significant toxic effects of prior locoregional therapy, surgery,
chemoembolization, or other anticancer therapy. The exceptions for such effects are
events that pertain to the lab values found elsewhere in these inclusion criteria.
(For example, criterion # 6 states that a patient with hemoglobin ≥ 9.5 g/dL is
considered eligible, even though NCI-CTCAE v 4.02 defines this value as Grade 2

13. The patient has a life expectancy of ≥ 3 months

14. The patient has provided signed informed consent

Exclusion Criteria:

1. The patient has untreated central nervous system (CNS) metastases. Patients are
eligible if they are clinically stable, off all steroids after cranial irradiation
(whole brain radiation therapy, focal radiation therapy, stereotactic
radiosurgery)ending at least 2 weeks prior to randomization, or after surgical
resection performed at least 4 weeks prior to randomization

2. The patient has radiologically documented evidence of major blood vessel invasion or
encasement by cancer, or of intratumor cavitation

3. The patient received prior systemic chemotherapy or biologic therapy (eg erlotinib)
for Stage IIIB/IV NSCLC outside of the adjuvant setting. Patients who received prior
cytotoxic chemotherapy or biologic therapy in the adjuvant setting will not be
excluded based on such therapy

4. The patient has a history of another primary cancer, with the exception of a)
curatively resected nonmelanomatous skin cancer b) curatively treated cervical
carcinoma in situ c)other primary solid tumor treated with curative intent, no known
active disease present, and no treatment administered during the last 3 years prior
to randomization

5. The patient is receiving concurrent treatment with other anticancer therapy,
including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy,
chemo-embolization, targeted therapy, or an investigational agent

6. The patient has an uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection requiring parenteral antibiotics, symptomatic congestive
heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance with study requirements

7. The patient has an uncontrolled thrombotic or hemorrhagic disorder

8. The patient has a history of gross hemoptysis (defined as bright red blood or ≥ 1/2
teaspoon) within 2 months of randomization

9. The patient has a serious non-healing wound, ulcer, or bone fracture within 28 days
prior to randomization

10. The patient has undergone major surgery within 28 days prior to randomization

11. The patient has received adjuvant chemotherapy 21 days prior to randomization or has
participated in clinical trials of experimental agents within 28 days prior to

12. The patient has an elective or a planned major surgery to be performed during the
course of the trial

13. The patient has peripheral neuropathy ≥ Grade 2 NCI-CTCAE v 4.02

14. The patient has known human immunodeficiency virus (HIV) positivity

15. The patient, if female, is pregnant or lactating

16. The patient has received previous therapy with any agent that targets PDGF or PDGFR

17. The patient has a known allergy to any of the treatment components

18. The patient has a history of allergic reactions attributed to compounds of chemical
or biologic composition similar to that of IMC-3G3

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival

Outcome Time Frame:

Approximately week 18

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 2010

Completion Date:

June 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung neoplasms
  • IMC-3G3
  • carboplatin
  • paclitaxel
  • PDGFr
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



ImClone Investigational Site Greenwich, Connecticut  06830
ImClone Investigational Site St. Charles, Missouri  63301
ImClone Investigational Site Bakersfield, California  93309
ImClone Investigational Site Jacksonville, Florida  32207
ImClone Investigational Site Decatur, Illinois  62526
ImClone Investigational Site New Orleans, Louisiana  70121
ImClone Investigational Site Cleveland, Ohio  44134
ImClone Investigational Site Portland, Oregon  97239
ImClone Investigational Site Dallas, Texas  75230
ImClone Investigational Site Green Bay, Wisconsin  54307
ImClone Investigational Site Winston-Salem, North Carolina  27103
ImClone Investigational Site Philadelphia, Pennsylvania  19107
ImClone Investigational Site Birmingham, Alabama  35233