BI 1361849 (CV9202) + afatinib compared with placebo + afatinib in first-line NSCLC harbouring common EGFR mutations

A randomised, double blind phase I/II trial to investigate efficacy, immunogenicity and safety of intradermally administered BI 1361849 (CV9202) plus afatinib versus placebo plus afatinib as first-line treatment for patients with stage IV adenocarcinoma of the lung harbouring common EGFR mutations. - A study of BI 1361849 (CV9202) plus afatinib in 1st line NSCLC pts harbouring common EGFR mutations

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001477-41-PT

Enrollment

120

Registered

2015-08-17

Start date

2016-01-07

Completion date

Unknown

Last updated

2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced non-small cell lung cancer (adenocarcinoma) stage IV. MedDRA version: 18.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: PT

Interventions

Product Name: BI 1361849 Product Code: BI 1361849 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: no INN available Current Sponsor code: BI 1361849 Other descri

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Pathologically confirmed diagnosis of stage IV adenocarcinoma of the lung ? Documented activating EGFR mutation (Del 19 and/or L858R) determined in tumour tissues ? Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 ? Measurable disease according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: ? Prior systemic chemotherapy for relapsed and/or metastatic NSCLC ? Prior treatment with EGFR targeting small molecules or antibodies ? Known allergy to protamine or fish protein ? Known type I allergy to penicillin or other beta-lactam antibiotics ? Known autoimmune disorder or propensity for severe hypersensitivity reactions

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate efficacy, immunogenicity and safety of BI 1361849 (CV9202) in combination with afatinib, as first-line treatment for patients with stage IV adenocarcinoma of the lung harbouring common EGFR mutations Phase I: To confirm feasibility and safety of the combination of BI 1361849 (CV9202) with afatinib, and to assess immunological responses of BI 1361849 (CV9202) in combination with afatinib in comparison to placebo plus afatinib Phase II (analyses will cover all randomised patients, i.e. will also include all patients randomised during the phase I part of the trial): To assess efficacy, immunogenicity and safety of BI 1361849 (CV9202) in combination with afatinib in comparison to placebo plus afatinib ;Secondary Objective: Not applicable;Primary end point(s): Progression-free survival (PFS) by central independent review according to RECIST 1.1 ;Timepoint(s) of evaluation of this end point: 52, 90 and 156 weeks after randomisation of the last patient.	—

Measure

Time frame

Main Objective: To evaluate efficacy, immunogenicity and safety of BI 1361849 (CV9202) in combination with afatinib, as first-line treatment for patients with stage IV adenocarcinoma of the lung harbouring common EGFR mutations Phase I: To confirm feasibility and safety of the combination of BI 1361849 (CV9202) with afatinib, and to assess immunological responses of BI 1361849 (CV9202) in combination with afatinib in comparison to placebo plus afatinib Phase II (analyses will cover all randomised patients, i.e. will also include all patients randomised during the phase I part of the trial): To assess efficacy, immunogenicity and safety of BI 1361849 (CV9202) in combination with afatinib in comparison to placebo plus afatinib ;Secondary Objective: Not applicable;Primary end point(s): Progression-free survival (PFS) by central independent review according to RECIST 1.1 ;Timepoint(s) of evaluation of this end point: 52, 90 and 156 weeks after randomisation of the last patient.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Overall survival (OS) 2. PFS status at 52 weeks after randomisation by central independent review based on RECIST 1.1 3. PFS2, defined as time (days) from randomisation to either death or disease progression by investigator assessment occurring after initiation of 1st subsequent post trial systemic therapy 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 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung cancer specific supplementary module (EORTC QLQ-LC13) 5. Immune response status which will be determined as a composite of data derived from immunological assessments of blood samples planned to be obtained at week 6 and 13* 6. Discontinuation of vaccination by 13 weeks after randomisation due to an adverse event or patient refusal to continue taking medication* 7. Discontinuation of vaccination by 24 weeks after randomisation due to an adverse event or patient refusal to continue taking medication *These endpoints in particular will be considered to determine whether to proceed to full recruitment (phase II part).;Timepoint(s) of evaluation of this end point: 1. 52, 90 and 156 weeks after randomisation of the last patient. 2. At 52 weeks after randomisation of the last patient. 3. 52, 90 and 156 weeks after randomisation of the last patient. 4. 52, 90 and 156 weeks after randomisation of the last patient. 5. 52 weeks after randomisation of the last patient. 6. 52 weeks after randomisation of the last patient. 7. 52 weeks after randomisation of the last patient.	—

Measure

Time frame

Secondary end point(s): 1. Overall survival (OS) 2. PFS status at 52 weeks after randomisation by central independent review based on RECIST 1.1 3. PFS2, defined as time (days) from randomisation to either death or disease progression by investigator assessment occurring after initiation of 1st subsequent post trial systemic therapy 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 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung cancer specific supplementary module (EORTC QLQ-LC13) 5. Immune response status which will be determined as a composite of data derived from immunological assessments of blood samples planned to be obtained at week 6 and 13* 6. Discontinuation of vaccination by 13 weeks after randomisation due to an adverse event or patient refusal to continue taking medication* 7. Discontinuation of vaccination by 24 weeks after randomisation due to an adverse event or patient refusal to continue taking medication *These endpoints in particular will be considered to determine whether to proceed to full recruitment (phase II part).;Timepoint(s) of evaluation of this end point: 1. 52, 90 and 156 weeks after randomisation of the last patient. 2. At 52 weeks after randomisation of the last patient. 3. 52, 90 and 156 weeks after randomisation of the last patient. 4. 52, 90 and 156 weeks after randomisation of the last patient. 5. 52 weeks after randomisation of the last patient. 6. 52 weeks after randomisation of the last patient. 7. 52 weeks after randomisation of the last patient.

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Countries

Canada, Denmark, France, Germany, Korea, Republic of, Poland, Portugal, Singapore, Spain, Taiwan, Thailand, United States

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH & Co. KG

clintriage.rdg@boehringer-ingelheim.com+18002430127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026