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Open-Label Phase 1b Study of Erlotinib Plus Bevacizumab and IMO-2055 in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Chemotherapy for Advanced or Metastatic Disease

Phase 1
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

Thank you

Trial Information

Open-Label Phase 1b Study of Erlotinib Plus Bevacizumab and IMO-2055 in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Chemotherapy for Advanced or Metastatic Disease

Phase 1b study of escalating doses of weekly subcutaneous IMO-2055 combined with fixed
standard dose regimens of oral erlotinib (daily) and IV bevacizumab (every 3 weeks) in
patients with previously treated advanced NSCLC.

Inclusion Criteria


Patients must satisfy all the following inclusion criteria in order to be eligible for the

1. Signed written informed consent

2. AJCC stage 3 or 4 histologically proven NSCLC not amenable to curative therapy and
for whom erlotinib and bevacizumab therapy would be appropriate

3. Radiological assessment within 21 days prior to inclusion, if measurable disease is

4. Age ≥ 18 years

5. ECOG performance status 0 or 1

6. Patient has received at least one standard platinum-containing chemotherapy regimen
appropriate for his/her lung cancer, in the opinion of the investigator, prior to


Patients with any of the following will be excluded from participation in the study:


1. Squamous cell carcinoma, except for patients with no intrathoracic disease or small
peripheral lesions only.

2. Known central nervous system (CNS) metastases (Note: patients with brain metastases
which have been controlled for ≥ 4 months without the use of steroid are eligible).

Prior Treatments

3. Less than 4 weeks between registration and the last receipt of chemotherapy,
biotherapy, radiotherapy or major surgery

4. Concurrent or planned hormonal agents such as replacement therapy, oral
contraceptives, or anti-cancer therapy, e.g. Megace. (A prior history of such therapy
is not exclusionary.)

5. Administration of any investigational agent (therapeutic or diagnostic), including
any investigational compound for the treatment of NSCLC, within 4 weeks prior to
first study dosing Other Concomitant Medications

6. High dose oral or intravenous corticosteroids. (Note: topical, inhaled and
intra-articular corticosteroids are allowed. Prophylactic antihistamines are allowed
before administration of bevacizumab

7. Use of any medication which is a strong inhibitor or inducer of cytochrome P450
isoform CYP3A4 (see Appendix 5)

8. Therapeutic dosing with warfarin >1 mg/day

9. Chronic daily use of aspirin (> 325 mg/day) or other full-dose NSAIDs with
anti-platelet activity

10. Inability to take oral medication or requirement for IV alimentation or total
parenteral nutrition with lipids, or prior surgical procedures affecting absorption

11. The following laboratory results, within 10 days of first study drug administration:

- Hemoglobin ≤ 9.0 g/dL Absolute neutrophil count ≤ 1.5 x 109/L Platelet count ≤
100 x 109/L

- International Normalized Ratio (INR) > 1.3 (only if the subject is on warfarin
[< 1 mg per day]) during 28 days prior to enrollment.

- aPTT > Upper Limit of Normal (ULN) during 28 days prior to enrollment.

- Serum creatinine ≥ 1.5 x ULN and creatinine clearance (by Cockcroft-Gault
formula) <60 mL/min

- Serum bilirubin ≥ 1.5 x ULN

- Proteinuria: UPC ≥ 1.0 or ≥ 2+ proteinuria by urine dipstick, unless a 24-hour
urine demonstrates <1.0 g/24 hours

- ALT or AST ≥ 2.5 x ULN (≥ 5 x ULN if liver metastases)

- Alkaline phosphatase ≥ 2.5 x ULN

- Albumin ≤ 2.5 g/L

- Women of child bearing potential: positive pregnancy test (serum). Other
Conditions or Procedures

12. Any clinically significant adverse events from any prior chemotherapy, surgery or
radiotherapy which has not yet resolved to CTCAE v3.0 grade ≤ 1

13. Known hypersensitivity to any oligodeoxynucleotide (ODN), EGFR-inhibitor or

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

15. Patients with a history or current neoplasm other than the entry diagnosis, except
for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
and except for other cancers treated for cure and with a disease-free survival
greater than 5 years.

16. Pregnant or breast-feeding women

17. Men or women of childbearing potential who refuse or who are unable to use an
acceptable means of contraception

18. History of clinically significant hemoptysis within 3 months prior to registration
unless definitively treated with surgery or radiation

19. Any medical conditions that would impose excessive risk to the patient, such as
uncontrolled hypertension (systolic >150 mmHg or diastolic >100 mmHg per JNC 7
guidelines, congestive heart failure NYHA Class 2-4, uncontrolled or unstable angina,
myocardial infarction within the previous 6 months, ventricular arrhythmia, infection
requiring parental or oral anti-infective treatment, any altered mental status or any
psychiatric condition that would interfere with understanding the informed consent,
uncontrolled seizures, chronic hepatitis or cirrhosis, known human immunodeficiency
virus (HIV) infection, known hepatitis B surface antigen (HBsAg) positive or
uncontrolled diabetes. (Note: testing for HIV infection of HBsAg is not part of the
screening assessments performed by the central laboratory).

20. Pre-existing autoimmune or antibody-mediated diseases, including, but not limited to,
the following: systemic lupus erythematosus, rheumatoid arthritis, multiple
sclerosis, Sjogren's syndrome and autoimmune thrombocytopenia

21. Evidence of bleeding diathesis or coagulopathy or other serious or acute internal
bleeding within 6 months prior to registration

22. CNS bleeding; history or clinical evidence of CNS stroke (hemorrhagic or thrombotic)
within the last 6 months

23. History of allogeneic organ transplant

24. Brain biopsy within 12 weeks of first study dosing

25. Minor surgical procedure, central venous catheter placement, fine needle aspirations
or core biopsy within 7 days prior to first study dosing

26. Anticipation of need for a major surgical procedure during the course of the study

27. Unwilling or unable to comply with the protocol for the duration of the study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To determine the recommended dosage of IMO-2055 when combined with erlotinib and bevacizumab in patients with AJCC stage 3 or 4 histologically proven non-small cell lung cancer (NSCLC).

Outcome Time Frame:

Assessed on a weekly basis at patient visits.

Safety Issue:


Principal Investigator

Phil Breitfeld, MD

Investigator Role:

Study Director

Investigator Affiliation:

EMD Serono


United States: Food and Drug Administration

Study ID:

EMR 200068-200



Start Date:

September 2007

Completion Date:

March 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Phase 1b
  • Non-Small Cell Lung Cancer
  • Advanced or Metastatic Disease
  • Prior chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis



Virginia Oncology Associates Newport News, Virginia  23606
Cancer Therapy and Research Center San Antonio, Texas  78229
Mary Crowley Medical Research Center Dallas, Texas  75246
Tyler Cancer Center Tyler, Texas  75702
Northwest Cancer Specialists Vancouver, Washington  98664
Cancer Centers of Florida Orlando, Florida  32806
Central Indiana Cancer Centers Indianapolis, Indiana  46227
New York Oncology Hematology P.C. Albany, New York  12208
Yakima Valley Memorial Hospital/North Shore Cancer Lodge Yakima, Washington  98902