Non-small Cell Lung CancerHAMLETNCT02488850
Determination of Peripheral Immune Cell Activity During Treatment With Either Surgery or Radiotherapy in Patients With Early Stage NSCLC
A study testing Surgery and SABR in people with Non-small Cell Lung Cancer, run by Erasmus Medical Center at 3 sites in Netherlands.
Trial summary
Rationale: An anatomical surgical resection is considered to be the standard of care in fit patients who present with early stage non-small cell lung cancer (NSCLC). However, surgery is less frequently performed in both elderly patients (aged ≥75 years), who represent the fastest-growing group of patients with stage… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Surgery and SABR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesNetherlands
- Study dates
- Dec 2012to 5 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Cytologically or histologically proven cT1-2aN0M0 NSCLC
- Patients ≥ 18 years old
- Patients should be fit to undergo both treatments in accordance with institutional protocols
Who cannot join
- Patients with any signs of any co-existing infectious disease or immunosuppressive treatment (inhalation steroids are permitted)
- Mentally incapacitated subjects
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Antoni van Leeuwenhoek Hospital
Amsterdam
VU Medical Center
Amsterdam
Erasmus MC Cancer Institute
Rotterdam, South Holland, 3015GD
About this study
Official title: Determination of Peripheral Immune Cell Activity During Treatment With Either Surgery or Radiotherapy in Patients With Early Stage Non-small Cell Lung Cancer HAMLET Study
Rationale: An anatomical surgical resection is considered to be the standard of care in fit patients who present with early stage non-small cell lung cancer (NSCLC). However, surgery is less frequently performed in both elderly patients (aged ≥75 years), who represent the fastest-growing group of patients with stage I/II NSCLC, and in patients who have significant co-morbidity. Following the introduction of stereotactic ablative radiotherapy (SABR), an outpatient treatment that is typically delivered in between 3-8 fractions, the median survival of all elderly patients undergoing radiotherapy in The Netherlands increased by 9.3 months. Randomized trials comparing SABR and surgery have yet to be completed and results of the ongoing ACOSOG Z4032 studies will not be available in the within 5 years. A recent data retrospective study comparing both modalities has raised interesting questions about the impact of local therapy on recurrence patterns. It was found that a better loco-regional disease control rate was achieved with SABR.
Objective: To study the effect of surgery and SABR on both immunostimulatory (with primary endpoint CD8 positive cells) and immunosuppressive cells in peripheral blood in patients with early stage non-small cell lung cancer who are treated with either modality.
Read more
Study population: 40 patients with cT1-2aN0M0 either cytologically or histologically proven NSCLC.
Main study parameters/endpoints: To determine whether an increase in CD8 activity can be established after SABR in patients with early stage lung cancer and to compare this increase with that in patients undergoing a surgical intervention. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Only risks in participation are the risks with drawing blood. Subjects will not have any benefits. This pilot study will be used to generate information concerning both treatments useful for the decision to plan a future study in a larger series of patients.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Surgery, SABR
- Keywords
- immune monitoring, T cell activation, early stage
- 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.
SurgeryProcedure or surgery
SABRRadiation
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Active comparator | An anatomical surgical resection of primary tumor Receives: Procedure: Surgery |
| Radiotherapy | Active comparator | Stereotactic Ablative Radiotherapy (SABR), outpatient treatment that is typically delivered in between 3-8 fractions Receives: Radiation: SABR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of IFN-gamma/ Granzyme B producing CD8 T cells
Number and activation status of peripheral CD8+ T cells
Measured: Baseline (week 0)
Number of IFN-gamma/ Granzyme B producing CD8 T cells
Number and activation status of peripheral CD8+ T cells
Measured: Week 1
Number of IFN-gamma/ Granzyme B producing CD8 T cells
Number and activation status of peripheral CD8+ T cells
Measured: Week 2
Number of IFN-gamma/ Granzyme B producing CD8 T cells
Number and activation status of peripheral CD8+ T cells
Measured: Week 3
Number of IFN-gamma/ Granzyme B producing CD8 T cells
Number and activation status of peripheral CD8+ T cells
Measured: Week 6
Secondary outcomes (15)
CD4/CD8 ratio in peripheral blood
Measured: Baseline
CD4/CD8 ratio in peripheral blood
Measured: Week 1
CD4/CD8 ratio in peripheral blood
Measured: Week 2
CD4/CD8 ratio in peripheral blood
Measured: Week 3
CD4/CD8 ratio in peripheral blood
Measured: Week 6
number of regulatory T cells
Measured: Baseline
number of regulatory T cells
Measured: Week 1
number of regulatory T cells
Measured: Week 2
number of regulatory T cells
Measured: Week 3
number of regulatory T cells
Measured: Week 6
Activation marker expression on T cells
Measured: Baseline
Activation marker expression on T cells
Measured: Week 1
Activation marker expression on T cells
Measured: Week 2
Activation marker expression on T cells
Measured: Week 3
Activation marker expression on T cells
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startDec 2012
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Aerts, MD PhD, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488850
- Sponsor's protocol ID
- NL42081.078.12
- Acronym
- HAMLET
- Status last verified
- Nov 2024
- First submitted
- 26 Jun 2015
- Last updated
- 7 Nov 2024
- Results posted
- No
Publications
de Goeje PL, Smit EF, Waasdorp C, Schram MTB, Kaijen-Lambers MEH, Bezemer K, de Mol M, Hartemink KJ, Nuyttens JJME, Maat APWM, Hegmans JPJJ, Hendriks RW, Senan S, Aerts JGJV. Stereotactic Ablative Radiotherapy Induces Peripheral T-Cell Activation in Patients with Early-Stage Lung Cancer. Am J Respir Crit Care Med. 2017 Nov 1;196(9):1224-1227. doi: 10.1164/rccm.201610-2178LE. No abstract available.
PubMed 28345951
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Peripheral Immune Cell Activity During Treatment With Either Surgery or Radiotherapy in Patients With Early Stage Non-small Cell Lung Cancer HAMLET Study
- ClinicalTrials.gov ID
- NCT02488850
- Acronym / sponsor ID
- HAMLET / NL42081.078.12
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- immune monitoring, T cell activation, early stage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 2 Jul 2015 (estimated)
- 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.
Rationale: An anatomical surgical resection is considered to be the standard of care in fit patients who present with early stage non-small cell lung cancer (NSCLC). However, surgery is less frequently performed in both elderly patients (aged ≥75 years), who represent the fastest-growing group of patients with stage I/II NSCLC, and in patients who have significant co-morbidity. Following the introduction of stereotactic ablative radiotherapy (SABR), an outpatient treatment that is typically delivered in between 3-8 fractions, the median survival of all elderly patients undergoing radiotherapy in The Netherlands increased by 9.3 months. Randomized trials comparing SABR and surgery have yet to be completed and results of the ongoing ACOSOG Z4032 studies will not be available in the within 5 years. A recent data retrospective study comparing both modalities has raised interesting questions about the impact of local therapy on recurrence patterns. It was found that a better loco-regional disease control rate was achieved with SABR.
Objective: To study the effect of surgery and SABR on both immunostimulatory (with primary endpoint CD8 positive cells) and immunosuppressive cells in peripheral blood in patients with early stage non-small cell lung cancer who are treated with either modality.
Study population: 40 patients with cT1-2aN0M0 either cytologically or histologically proven NSCLC.
Main study parameters/endpoints: To determine whether an increase in CD8 activity can be established after SABR in patients with early stage lung cancer and to compare this increase with that in patients undergoing a surgical intervention. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Only risks in participation are the risks with drawing blood. Subjects will not have any benefits. This pilot study will be used to generate information concerning both treatments useful for the decision to plan a future study in a larger series of patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Active comparator | Procedure: SurgeryAn anatomical surgical resection of primary tumor |
| Radiotherapy | Active comparator | Radiation: SABRStereotactic Ablative Radiotherapy (SABR), outpatient treatment that is typically delivered in between 3-8 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cytologically or histologically proven cT1-2aN0M0 NSCLC
- Patients ≥ 18 years old
- Patients should be fit to undergo both treatments in accordance with institutional protocols
Key exclusion criteria (2 listed)
- Patients with any signs of any co-existing infectious disease or immunosuppressive treatment (inhalation steroids are permitted)
- Mentally incapacitated subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery | Procedure or surgery | Surgery |
| SABR | Radiation | Radiotherapy |
Primary outcome
Number of IFN-gamma/ Granzyme B producing CD8 T cells
Time frame: Baseline (week 0)
Number and activation status of peripheral CD8+ T cells
Number of IFN-gamma/ Granzyme B producing CD8 T cells
Time frame: Week 1
Number and activation status of peripheral CD8+ T cells
Number of IFN-gamma/ Granzyme B producing CD8 T cells
Time frame: Week 2
Number and activation status of peripheral CD8+ T cells
Number of IFN-gamma/ Granzyme B producing CD8 T cells
Time frame: Week 3
Number and activation status of peripheral CD8+ T cells
Number of IFN-gamma/ Granzyme B producing CD8 T cells
Time frame: Week 6
Number and activation status of peripheral CD8+ T cells
15 secondary outcomes
CD4/CD8 ratio in peripheral blood
Time frame: Baseline
CD4/CD8 ratio in peripheral blood
Time frame: Week 1
CD4/CD8 ratio in peripheral blood
Time frame: Week 2
CD4/CD8 ratio in peripheral blood
Time frame: Week 3
CD4/CD8 ratio in peripheral blood
Time frame: Week 6
number of regulatory T cells
Time frame: Baseline
number of regulatory T cells
Time frame: Week 1
number of regulatory T cells
Time frame: Week 2
number of regulatory T cells
Time frame: Week 3
number of regulatory T cells
Time frame: Week 6
Activation marker expression on T cells
Time frame: Baseline
Activation marker expression on T cells
Time frame: Week 1
Activation marker expression on T cells
Time frame: Week 2
Activation marker expression on T cells
Time frame: Week 3
Activation marker expression on T cells
Time frame: Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Derived from this study: PubMed 28345951de Goeje PL, Smit EF, Waasdorp C, Schram MTB, Kaijen-Lambers MEH, Bezemer K, de Mol M, Hartemink KJ, Nuyttens JJME, Maat APWM, Hegmans JPJJ, Hendriks RW, Senan S, Aerts JGJV. Stereotactic Ablative Radiotherapy Induces Peripheral T-Cell Activation in Patients with Early-Stage Lung Cancer. Am J Respir Crit Care Med. 2017 Nov 1;196(9):1224-1227. doi: 10.1164/rccm.201610-2178LE. No abstract available.
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and SABR in people with Non-small Cell Lung Cancer, run by Erasmus Medical Center at 3 sites in Netherlands.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of IFN-gamma/ Granzyme B producing CD8 T cells (time frame: Baseline (week 0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02488850, which also lists 1 linked publication.
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 7 Nov 2024.