Feasibility Study of Tissue and Blood Collection in Oncogene-addicted and Neoadjuvantly Treated Non Small Cell Lung Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Marsden NHS Foundation Trust

About this trial

This study aims to determine if it is feasible to collect samples of blood and viable lung cancer tissue in patients with either:

* Stage IV mutation-driven NSCLC * Stage II-III NSCLC undergoing neoadjuvant immunotherapy prior to surgery

Viable tissue has been defined by the collaborating pathology department as the presence of viable tumour cells, in accordance with recommendations from the International Association or the Study of Lung Cancer.

In patients with stage IV NSCLC, obtaining adequate samples of viable tissue for advanced testing can be challenging, as sites of cancer that are accessible by biopsy are often small, and contain few viable cancer cells. If obtained, however, viable blood and tissue specimens can be utilised for genetic and other analyses aimed at identifying cancer markers that may offer prognostic information, or that may potentially lead to development of therapies that target these markers in the future.

In patients with stage II-III NSCLC, the use of immunotherapy prior to surgery has been shown to affect the proportion of viable tumour tissue at the time of surgery, although this needs to be further studied. There is a need to better understand the genetic basis of these tumours to improve response rates to immunotherapy prior to surgery.

The study will be open for four years in total. The first three years will consist of recruitment and participant follow up, and the fourth year will consist of follow up only. Data analysis will occur in the fifth year when the study is closed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >/= 18.

Histologically confirmed locally advanced or metastatic NSCLC

ECOG performance score 0-2

Tier 1 ASCO/AMP NSCLC oncogenic variant identified through routine clinical methods, e.g. EGFR, ALK, ROS1, RET, MET, KRAS, BRAF, HER2, NTRK

Disqualifiers

None

Trial population

The Royal Marsden NHS Foundation patients

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 4 trial groups
Group A: Cohort 1A
Group B: Cohort 1B
Group C: Cohort 1C
Group D: Cohort 2

Trial outcomes

Primary outcomes

1

The number of participants with paired samples of blood and viable tissue

The number of participants with paired samples of blood and viable tissue with: * Oncogene-addicted metastatic NSCLC commencing new line of targeted therapy at progression (Cohort 1), and * Early-stage operable NSCLC undergoing neoadjuvant CPI-based therapy (Cohort 2) Viable tissue is defined by the presence of viable tumour cells. Viable tumour cells are defined by those with well-preserved architectural and cytological features, in line with the latest recommendation from the International Association for the Study of Lung Cancer (IASLC), evaluated by a specialist pulmonary pathologist using a haematoxylin \& eosin (H\&E) stained slide.

Time frame
5 years

Secondary outcomes

1

The number of patients with viable tissue samples

The number of patients with viable tissue samples at: * Baseline (sub-cohort 1B) * PD (Cohort 1) * Surgery (Cohort 2)

Time frame
5 years

Other outcomes

1

Exploratory aims

Exploratory aims * The number of genes/proteins associated with disease progression on targeted therapy (Cohort 1) * To measure levels of tumour cell-recognising antibodies in patients on targeted therapy (Cohort 1) * The number of genes/proteins associated with tumour regression (Cohort 2)

Time frame
5 years

Sponsors and contacts

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Royal Marsden NHS Foundation Trust

Lead sponsor

Francis Crick Institute

Collaborator

University of Cambridge

Collaborator

Royal Brompton & Harefield NHS Foundation Trust

Collaborator

Institute of Cancer Research, United Kingdom

Collaborator