Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

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Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

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Vaccines

Immunomodulating Agents

Participants will receive up to a maximum of six vaccinations over six weeks. Each weekly AST-VAC2 vaccination will be administered as a split dose via two intradermal injections at a target dose defined as 1 x 10\^7 viable cells. There is no dose escalation planned during the study; only one dose level will be explored.

AST-VAC2

This clinical study is looking at a vaccine called AST-VAC2 in adult patients with advanced non-small cell lung cancer (NSCLC). The main aim of the study: If the dose can be given safely to patients, learn more about the potential side effects of the vaccine and how they can be managed and also what happens to AST-VAC2 inside the body (looking for effects in the blood, skin or tumour).

This clinical study is looking at a vaccine called AST-VAC2. AST-VAC2 has been designed to potentially help the immune system attack the cancer. This is a new vaccine which looks promising in laboratory studies but it has never been tested in man.

Dendritic cells occur naturally in your body as part of the immune system however these dendritic cells have a special role in finding proteins in the body which are associated with cancer and it is hoped that the vaccine will train the immune system to recognise these proteins and attack the cancer.

Some cancers tend to have more of a certain type of protein (part of the body's building blocks that make up cells) called 'hTERT' and it has been shown in laboratory studies (and also studies in patients using a similar type of vaccine), that targeting hTERT can lead to destruction of cancer cells by the immune system. AST-VAC2 will target the hTERT protein.

Human Leukocyte Antigen (HLA) is another type of protein. An HLA pre-screening test will be able to show if a person is positive or negative for a specific HLA protein (AST-VAC2 can only work with some types of HLA), as being positive for the protein may mean there is a better chance of the vaccine attacking the cancer. Patients who are positive for the specific HLA type will be asked to consent to the vaccine. Those patients who are negative for the HLA type will not be eligible for the trial.

AST-VAC2 Vaccine in Patients With Non-small Cell Lung Cancer

A Cancer Research UK Phase I Trial of AST-VAC2 (Allogeneic Dendritic Cell Vaccine) Administered Weekly Via Intradermal Injection in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Number of SAEs, NSAEs and Grade ≥3 AEs overall and number of SAEs, NSAEs and Grade ≥3 AEs related to AST-VAC2. AEs categorised according to Medical Dictionary for Regulatory Activities version (v) 25.0 and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.02 or protocol specific grading system for injection site reactions (ISRs). AEs assessed by the reporting study doctors for a causal relationship to AST-VAC2. Related are those AEs with a causality of possible, probable or highly probable.

Number of participants experiencing ISRs Grade 1 to 4 according to protocol-specific grading of ISRs.

Immunological response in whole blood (peripheral blood mononuclear cells) by human telomerase reverse transcriptase (hTERT) specific T cells measured by enzyme-linked immunospot (ELISPOT), with a durable peripheral immune response defined as a change in one validated assay at two time points after at least two vaccinations (where a change is defined as 2.5 fold change over baseline \[after removal of background\], assay control and \>35 spots/10\^6 cells).

Immunological response in whole blood (peripheral blood mononuclear cells) by hTERT specific T cells measured by ELISPOT and presented as mean fold change in spots/10\^6 cells (after removal of background) from baseline to each timepoint assessed.

Number of participants with complete response, partial response, stable disease, progressive disease or who were not evaluable at radiological disease assessment (computerised tomography and/or magnetic resonance imaging) at the End of Vaccination visit according to irRC.

Number of participants alive at 2 years post their first vaccination.

Spots Global Cancer Trial Database for allogeneic vaccine