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Safety and Efficacy Phase I/IIa Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Non Small Cell Lung Cancer

Thank you

Trial Information

Safety and Efficacy Phase I/IIa Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

Medical Need:

Lung cancer is the leading cause of cancer mortality in developed countries; about 87% of
lung cancers are of the NSCLC type. Patients with more advanced but non-metastatic disease
(IIIA or IIIB) usually undergo chemotherapy and/or radiation therapy, with or without
secondary surgical resection. Patients with progression after chemotherapy and/or
radiotherapy may receive second-line treatment with targeted therapies. Despite these
aggressive treatments, only about 5% of patients with metastatic disease survive for 5 or
more years. Given these dismal statistics, it is clear that new therapeutic approaches for
treatment of NSCLC are urgently needed.

Potential Benefits:

CV9201 is an mRNA-based vaccine for the treatment of human NSCLC that is based on CureVac's
RNActive® technology.

As an mRNA-based vaccine, CV9201 features several advantages over other approaches: it is
highly specific, there is no restriction to the patient's MHC genotype, and it does not need
to cross the nuclear membrane to be active. Finally, in the absence of reverse
transcriptase, RNA can not be integrated into the genome.

For the planned first-in-man study, CV9201 will be administered in 5 doses. The phase I part
of this phase I/IIa study is a dose finding study, to determine the RD for the phase IIa

Inclusion Criteria:

1. Male or female and age ≥ 18 yrs and ≤ 75

2. Histologically or cytologically confirmed and documented stage IIIB /IV NSCLC

3. Documented stable disease or objective response according to RECIST criteria after
initial chemotherapy or chemo-radiotherapy for advanced, unresectable disease:

- Patients must have received a minimum of two cycles of standard chemotherapy,
and adequate and effective radiotherapy if used in conjunction with chemotherapy
(sequentially or concomitantly). Prophylactic brain radiation is allowed.

- Surgery, radiotherapy and/ or chemotherapy can have been previously administered
for non-advanced disease.

- All therapies must be completed 4 weeks before start of study treatment.

4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0 - 1

5. Life expectancy > 6 months as assessed by the investigator

6. Adequate organ function:

- Bone marrow function: hemoglobin ≥ 100 g/L; white blood cell count (WBC) ≥ 3.0 x
109/L; lymphocyte count ≥ 1.0 x 109/L; absolute neutrophil count (ANC) ≥ 1.5 x
109/L; platelet count ≥ 100 x 109/L

- Hepatic: aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times
upper limit of normal (ULN) (≤ 5 x ULN if hepatic metastases present); bilirubin
≤ 1.5 x ULN

- Renal: Creatinine ≤ 2 mg/ dL and creatinine clearance ≥ 45 mL/ min

7. Patients of child-producing potential must agree to use contraception while enrolled
in the study and for one month after the last immunization

8. Written informed consent must be obtained prior to conducting any study-specific

Exclusion Criteria:

1. History of anti-cancer therapy for advanced disease other than initial chemotherapy
or chemo-radiotherapy or surgery

2. Immunotherapy within 4 weeks prior to study enrollment, including cytokines such as
G-CSF, GM-CSF or interferons

3. Treatment with investigational anti-cancer agents during initial therapy for advanced
disease or any investigational agents within 4 weeks prior to study enrollment

4. Concurrent anti-tumor therapy or concurrent immunotherapy such as lectins, unspecific
immunostimulants, etc.

5. Previous anti-cancer immunotherapy comprising RNA-transfected dendritic cells or DNA
vaccines targeting any tumor-associated antigens

6. Concurrent systemic steroids except topical (inhaled, topical, nasal) for the last 28
days, except replacement therapy

7. Concurrent major surgery or planned surgery

8. Prior splenectomy

9. Documented history of active autoimmune disorders requiring systemic
immunosuppressive therapy, (e.g., sarcoidosis, lupus erythematosus, rheumatoid
arthritis, glomerulonephritis or systemic vasculitis), excepting autoimmune
thyroiditis with only thyroid hormone replacement and stable disease > 1 year

10. Primary or secondary immune deficiency

11. Active allergy requiring continuous medication or active infections requiring
anti-infectious therapy

12. Seropositive for HIV, HBV or HCV

13. History of other malignancies over the last 5 years (except basal cell carcinoma of
the skin or carcinoma in situ of the cervix)

14. Uncontrolled medical condition considered as high risk for the treatment with an
investigational drug including unstable diabetes mellitus, vena-cava-syndrome, known
ascites and/or uncontrolled pleural effusion.

15. Brain metastases (symptomatic or asymptomatic) or leptomeningeal involvement

16. Symptomatic congestive heart failure (NYHA 3 and 4); unstable angina pectoris within
6 months prior to enrollment; significant cardiac arrhythmia, history of stroke or
transient ischemic attack

17. History of seizures, encephalitis or multiple sclerosis

18. Gastric ulcer or inflammatory bowel disease or Crohn's disease or ulcerative colitis;
no active diverticulitis

19. Active drug abuse or chronic alcoholism

20. Patients being committed to an institution by virtue of an order issued either by the
judicial or the administrative authorities

Type of Study:


Study Design:

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

Outcome Measure:

Phase I: Determination of the recommended dose (RD) for exploration in the phase IIa part of the study

Outcome Time Frame:

During the first 2-3 month of Phase I

Safety Issue:


Principal Investigator

Alexander Knuth, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UniversitätsSpital Zürich


Germany: Paul-Ehrlich-Institut

Study ID:




Start Date:

May 2009

Completion Date:

February 2012

Related Keywords:

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