Oncogene-addicted Non Small Cell Lung CancerFeStivalNCT07008742
Feasibility Study of Tissue and Blood Collection in Oncogene-addicted and Neoadjuvantly Treated Non Small Cell Lung Cancer
An observational study of Oncogene-addicted Non Small Cell Lung Cancer and Early-stage Operable Non Small Cell Lung Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncogene-addicted Non Small Cell Lung Cancer, Early-stage Operable Non Small Cell Lung Cancer, Non Small Cell Lung Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jun 2025to 1 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Royal Marsden NHS Foundation patients
Who may be able to join
- 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
- Planned to commence targeted therapy (any line of therapy)
- o This includes bispecific antibodies (e.g. amivantamab), and antibody-drug conjugates (e.g. trastuzumab-deruxtecan)
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- Regular follow-up and monitoring for cancer recurrence per standard of care planned at the enrolling site
- Provided written informed consent to participate in the study
- Age >/= 18.
- Histologically confirmed stage II/III operable NSCLC
- Planned to undergo neoadjuvant CPI-based therapy
- Provided written informed consent to participate in the study
Who cannot join
- Patient too medically unstable to commit to sampling required for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Ashling Henderson, +442031865916, Festival@rmh.nhs.uk
About this study
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
Read more
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.
Read the detailed description
Rationale Benchmarking the proportion of patients who are able to provide paired samples of blood and viable tumour tissue is important in oncogene-addicted metastatic NSCLC patients as investigators have now entered the era of genotype-guided post-progression targeted therapies. In the early-stage operable NSCLC context, benchmarking the feasibility of paired samples is of interest as neoadjuvant CPI-based therapy has recently emerged as a new standard of care strategy.
As such, investigators have defined the following cohorts within our study:
Cohort 1: Oncogene-addicted NSCLC, due to commence new line of targeted therapy
- Sub-cohort 1A: treatment naïve, oncogene-addicted NSCLC
- Sub-cohort 1B: pre-treated, oncogene-addicted NSCLC, received prior targeted therapy
- Sub-cohort 1C: pre-treated, oncogene-addicted NSCLC, no prior targeted therapy (can have received chemotherapy/CPI/chemo-CPI) Cohort 2: Early-stage operable NSCLC undergoing neoadjuvant CPI therapy
Primary aim
To estimate the feasibility of collecting paired samples of blood and viable tissue in patients 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.
Secondary aims
To estimate the feasibility of obtaining viable tissue samples at:
- Baseline (sub-cohort 1B)
- PD (Cohort 1)
- Surgery (Cohort 2)
Exploratory aims
- To identify 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)
- To identify genes/proteins associated with tumour regression (Cohort 2)
- Conditions
- Oncogene-addicted Non Small Cell Lung Cancer, Early-stage Operable Non Small Cell Lung Cancer, Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer, Locally Advanced NSCLC - Non-Small Cell Lung Cancer, Stage 2/3 Operable Non Small Cell Lung Cancer
- Keywords
- tissue, blood, feasibility study
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A | Treatment naïve, oncogene-addicted NSCLC | |
| Cohort 1B | Pre-treated, oncogene-addicted NSCLC, received prior targeted therapy | |
| Cohort 1C | Pre-treated, oncogene-addicted NSCLC, no prior targeted therapy (can have received chemotherapy/CPI/chemo-CPI) | |
| Cohort 2 | Early-stage operable NSCLC undergoing neoadjuvant CPI therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start4 Jun 2025
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncogene-addicted Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Francis Crick Institute, University of Cambridge, Royal Brompton & Harefield NHS Foundation Trust, Institute of Cancer Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Professor Sanjay Popat, Consultant Medical Oncologist, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008742
- Sponsor's protocol ID
- CCR5952
- Other IDs
- 336531, 24/LO/0791
- Acronym
- FeStival
- Status last verified
- Jun 2025
- First submitted
- 15 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Tissue and Blood Collection in Oncogene-addicted and Neoadjuvantly Treated Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07008742
- Acronym / sponsor ID
- FeStival / CCR5952
- Conditions
- Oncogene-addicted Non Small Cell Lung Cancer, Early-stage Operable Non Small Cell Lung Cancer, Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer, Locally Advanced NSCLC - Non-Small Cell Lung Cancer, Stage 2/3 Operable Non Small Cell Lung Cancer
- Keywords
- tissue, blood, feasibility study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Francis Crick Institute, University of Cambridge, Royal Brompton & Harefield NHS Foundation Trust, Institute of Cancer Research, United Kingdom
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale Benchmarking the proportion of patients who are able to provide paired samples of blood and viable tumour tissue is important in oncogene-addicted metastatic NSCLC patients as investigators have now entered the era of genotype-guided post-progression targeted therapies. In the early-stage operable NSCLC context, benchmarking the feasibility of paired samples is of interest as neoadjuvant CPI-based therapy has recently emerged as a new standard of care strategy.
As such, investigators have defined the following cohorts within our study:
Cohort 1: Oncogene-addicted NSCLC, due to commence new line of targeted therapy
- Sub-cohort 1A: treatment naïve, oncogene-addicted NSCLC
- Sub-cohort 1B: pre-treated, oncogene-addicted NSCLC, received prior targeted therapy
- Sub-cohort 1C: pre-treated, oncogene-addicted NSCLC, no prior targeted therapy (can have received chemotherapy/CPI/chemo-CPI) Cohort 2: Early-stage operable NSCLC undergoing neoadjuvant CPI therapy
Primary aim
To estimate the feasibility of collecting paired samples of blood and viable tissue in patients 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.
Secondary aims
To estimate the feasibility of obtaining viable tissue samples at:
- Baseline (sub-cohort 1B)
- PD (Cohort 1)
- Surgery (Cohort 2)
Exploratory aims
- To identify 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)
- To identify genes/proteins associated with tumour regression (Cohort 2)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A | – | –Treatment naïve, oncogene-addicted NSCLC |
| Cohort 1B | – | –Pre-treated, oncogene-addicted NSCLC, received prior targeted therapy |
| Cohort 1C | – | –Pre-treated, oncogene-addicted NSCLC, no prior targeted therapy (can have received chemotherapy/CPI/chemo-CPI) |
| Cohort 2 | – | –Early-stage operable NSCLC undergoing neoadjuvant CPI therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Royal Marsden NHS Foundation patients
Key inclusion criteria (12 listed)
- 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
- Planned to commence targeted therapy (any line of therapy)
Key exclusion criteria (1 listed)
- Patient too medically unstable to commit to sampling required for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of participants with paired samples of blood and viable tissue
Time frame: 5 years
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.
1 secondary outcome
The number of patients with viable tissue samples
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Professor Sanjay Popat, Consultant Medical Oncologist principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncogene-addicted Non Small Cell Lung Cancer and Early-stage Operable Non Small Cell Lung Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashling Henderson, Senior Clinical Trial Manager (+44 2031865916, Festival@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants with paired samples of blood and viable tissue (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.