Clinical trial to compare the anti-cancer vaccine BI 1361849 (CV9202) versus placebo in patients with non-small cell lung cancer after completion of chemoradiation therapy

Phase 1

Conditions: on small cell lung cancer stage III after concurrent chemoradiation therapy
MedDRA version: 18.0Level: PTClassification code 10029520Term: Non-small cell lung cancer stage IIIASystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.0Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-004959-30-NO

Lead Sponsor: Boehringer Ingelheim Norway KS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 199998

Inclusion Criteria

-Histopathologically and/or cytologically confirmed inoperable, locally advanced non-small cell lung cancer (NSCLC) Stage IIIA or IIIB at diagnosis, absence of metastases confirmed by radiological evaluation including brain imaging (Computer tomography (CT) or Magnetic Resonance Imaging (MRI) and/or Positron emission tomography scan).
-Previous concurrent chemoradiation therapy with the last chemotherapy dose administered >= 28 days and the last radiation dose received <= 84 days before randomisation.
-Chemotherapy must have been platinum-based and consisted of 2 to 4 three-weekly or four-weekly cycles of doublet chemotherapy, and concurrent radiotherapy dose was 60 to 70 Gy in fractions of 1.8 - 2.0 Gy (daily biologically equivalent doses) and not conventional 2-dimensional therapy. Overlap of radiotherapy with a minimum of 2 cycles of the platinum-based chemotherapy is required. A deviation of up to 3 days from an exact overlap is acceptable.
-Patient has radiologically assessed objective response (Complete Response, Partial Response) or at least stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as response to chemoradiation at the first post-chemoradiation imaging maintained at the last imaging prior to randomisation.
-Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

-Proton therapy was part of the prior chemoradiation therapy to treat NSCLC.
-Malignant effusion at diagnosis or any other time prior to start of chemoradiation. Malignancy of effusion must be excluded by analysis of the fluid, e.g. for pleural effusion by samples taken at 2 separate paracentesis time points, being negative for exudate and for blood and malignant cells. If at screening effusion is too small to be amenable to paracentesis and in the view of the investigator is unlikely to reflect malignancy, the patient is eligible.
-Distant metastasis. Absence of brain metastasis needs to be confirmed by imaging (CT, MRI) after chemoradiation therapy and prior to randomisation.
-Any previous or ongoing systemic treatment of NSCLC before randomisation, other than completed concurrent chemoradiation therapy as defined in this protocol. Supportive or alternative / complementary treatment with no relevant effect on the immune system is permitted.
-Major surgery (based on investigator's judgement) for NSCLC other than diagnostic or staging biopsies prior to randomisation.
-Condition requiring chronic immunosuppressive treatment including systemic steroid doses of >= 10 mg prednisone equivalent per day.
-Major inflammatory events including colitis, thyroiditis, or hepatitis within 28 days before randomisation.
-Known pre-existing interstitial lung disease, including pneumonitis of Common Terminology Criteria for Adverse Events grade >1 at screening.
-Known autoimmune disorder (incl. type I diabetes, rheumatoid arthritis, multiple autoimmune endocrine disorders) or immunodeficiency.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: -To explore whether BI 1361849 (CV9202) prolongs progression-free survival (PFS) in comparison to placebo (sham-vaccine).<br>;Secondary Objective: -To determine whether BI 1361849 (CV9202) prolongs overall survival (OS).<br>-To assess other efficacy criteria.<br>-To analyse immunogenicity of BI 1361849 (CV9202).<br>-To assess the safety and tolerability of BI 1361849 (CV9202).<br>;Primary end point(s): 1: Progression-free survival (PFS), defined as time (days) from the date of randomisation to the date of progression or to the date of death, whichever occurs first.<br>;Timepoint(s) of evaluation of this end point: 1: 52, 90 and 156 weeks after the last patient was randomized and follow-up until 3.5 years after the last randomization<br>

Secondary Outcome Measures

Name	Time	Method

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