Non small cell lung cancer stage III after concurrent chemoradiation therapy MedDRA version: 20.0 Level: PT Classification code 10029520 Term: Non-small cell lung cancer stage IIIA System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version
Conditions
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To explore whether BI 1361849 (CV9202) prolongs progression-free survival (PFS) in comparison to placebo (sham-vaccine). ;Secondary Objective: - To determine whether BI 1361849 (CV9202) prolongs overall survival (OS). - To assess other efficacy criteria. - To analyse immunogenicity of BI 1361849 (CV9202). - To assess the safety and tolerability of BI 1361849 (CV9202). ;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. ;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: PFS status at 52 weeks after randomisation. 2: PFS2, defined as time (days) from randomisation to either death or disease progression by investigator assessment occurring after initiation of 1st subsequent systemic anti-cancer therapy. 3: Immune response status. 4: Symptomatic progression, defined as time (days) from randomisation to an increase of at least 10 points from baseline for one or more of cough (Q1, QLQ-LC13), dyspnoea (Q3-5, QLQ-LC13) or chest pain (Q10, QLQ-LC13) based on the EORTC QLQ-LC13. 5: Discontinuation of study treatment by 24 weeks after randomisation either due to an adverse event not related to tumour or due to patient withdrawal from study treatment for drug associated reasons. 6: Overall survival (OS), defined as time (days) from the date of randomisation to the date of death. ;Timepoint(s) of evaluation of this end point: 1: 52 weeks after randomization 2: 52, 90 and 156 weeks after the last patient was randomized and follow-up until 3.5 years after the last randomization 3: 52 weeks after the last patient has been randomized 4: 52, 90 and 156 weeks after the last patient was randomized and follow-up until 3.5 years after the last randomization 5: 24 weeks after randomization 6: 52, 90 and 156 weeks after the last patient was randomized and follow-up until 3.5 years after the last randomization 6: 52, 90 and 156 weeks after the last patient was randomized and follow-up until 3.5 years after the last randomization 6: 52, 90 and 156 weeks after the last patient was randomized and follow-up until 3.5 years after the last randomization | — |
Countries
Belgium, Canada, Denmark, France, Germany, Japan, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Spain, Taiwan, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed