NSCLCELDAPTNCT02284308

Elderly With Locally Advanced Lung Cancer: Deciding Through Geriatric Assessment on the Optimal Treatment Strategy

An observational study of NSCLC, run by Maastricht Radiation Oncology at 22 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

There is no detailed information available on benefits and harms of intensified treatment with concurrent RCHT among a subpopulation of elderly patients. Reliable tools are needed to distinguish the subgroup of fit patients from frail patients. Read more about this study

Who is it for?: Ages 75 years and older
Conditions the study is for: NSCLC
How many people: 180 participants
Where: 22 sitesNetherlands
Study dates: Jul 2016to 18 Dec 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 75 years and older
All sexes
No healthy volunteers
Older adult

Study population: Patients aged ≥ 75 years, with any subtype of NSCLC, stage III

Who may be able to join

Any subtype of pathologically proven NSCLC, primary UICC Stage III disease;
Age ≥ 75 years;
No surgery or adjuvant chemotherapy for NSCLC in the last year;
No prior radiotherapy to the ipsilateral thorax or mediastinum;
No clinical superior vena cava syndrome;
No diagnosis of other cancer within the last 3-years (except in situ carcinoma's and / or non-melanoma skin cancer);
Written informed consent

Who cannot join

None listed.

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

Netherlands22 sites

Ziekenhuisgroep Twente
Almelo, 7609 PP
Gelre ziekenhuis
Apeldoorn, 7334 DZ
Radiotherapiegroep Arnhem
Arnhem, 6815 AD
Rijnstate
Arnhem, 6815 AD
Deventer Hospital
Deventer, 7416 SE
Gelderse Vallei
Ede, 6716 RP
Catharina Ziekenhuis
Eindhoven, 5623 EJ
Máxima MC
Eindhoven, 5631 BM
Medisch Spectrum Twente
Enschede, 7500 KA
Rivas Zorggroep
Gorinchem, 4200 AB
Groen Hart Ziekenhuis
Gouda, 2803 HH
Zuyderland
Heerlen, 6419 PC
Maastro
Maastricht, 6229 ET
MUMC+
Maastricht, 6229 HX
Canisius-Wilhelmina Hospital
Nijmegen, 6532 SZ
Laurentius Hospital
Roermond, 6043 VC
Maasstad Ziekenhuis
Rotterdam, 3079 DZ
Ikazia Ziekenhuis
Rotterdam, 3083 AN
Haga Ziekenhuis
The Hague, 2504 LN
Haaglanden MC
The Hague, 2512 VA
VieCuri MC
Venlo, 5912 BL
Zaans MC
Zaandam, 1502 DV

Other trials in Netherlands

About this study

Official title: ELDAPT: Elderly With Locally Advanced Lung Cancer: Deciding Through Geriatric Assessment on the oPtimal Treatment Strategy

Read the detailed description

Lung cancer is a problem of the elderly: 30% of the lung cancer patients are aged ≥ 75 years. Due to underrepresentation of elderly patients in clinical trials there is a lack of evidence to select the optimal treatment strategy for these patients. Concurrent radiochemotherapy (RCHT) has been recognised as the standard treatment of stage III NSCLC patients with a good performance status. Evidence for this treatment was gained in clinical trials that mostly excluded elderly patients. Furthermore, the survival gain obtained with combined RCHT, comes with a significant increase in toxicity. Therefore, information on benefits and harms of intensified treatment with concurrent RCHT among a subpopulation of medically fit elderly patients is still lacking. Moreover, reliable tools are needed to distinguish the subgroup of fit patients from frail patients, i.e. those expected to experience important toxicity.

Conditions: NSCLC
Keywords: NSCLC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02284308
Study group	Role	What they receive
Patients with any subtype of NSCLC, primary UICC Stage III, age ≥ 75 years		All registered patients will undergo a geriatric assessment to assess vulnerability. Based on this assessment, patients are offered treatment according to the discretion of the physician and patient.

What is being measured

The primary outcome is the main question the study is designed to answer.

Correlation GA with QAS (quality adjusted survival)
To corellate results of the geriatric assessment with quality-adjusted survival (QAS) after radical intent therapy in patients with stage III NSCLC ≥75 years
Measured: 5 years

Secondary outcomes (6)

Geriatric assessment
To perform a geriatric assessment in stage III NSCLC patients to distinguish patients fit enough to undergo intensified treatment and to develop a reliable and clinically applicable geriatric screening instrument to guide treatment decisions in stage III NSCLC
Measured: Baseline
Medical comparison between treatments
To compare different treatment strategies for fit elderly patients with respect to overall and quality adjusted survival
Measured: 5 years
Cost-effectiveness
To compare cost-effectiveness of sequential and concurrent RCHT for fit elderly patients with stage III NSCLC
Measured: End of study
Development and validation of geriatric screening instrument
To develop and validate a clinically applicable geriatric screening instrument that enables appropriate treatment stratification in the elderly NSCLC patient
Measured: 5 years
Flow chart
To develop a flow chart for cost-effective clinical decision-making, in clinical practice
Measured: 5 years
Predictive value
To determine the predictive value of saliva biomarkers on QAS in elderly patients with stage III NSCLC
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201618 Dec 2029

First posted6 Nov 2014 (estimated)
Study startJul 2016
Primary completion1 Jan 2025
Study completion18 Dec 2029 (estimated)

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 NSCLCStudies of the same condition, open and under way.
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: Prospective
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02284308
Sponsor's protocol ID: ELDAPT
Acronym: ELDAPT
Status last verified: Oct 2026
First submitted: 30 Oct 2014
Last updated: 30 Oct 2026
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Driessen EJM, van Loon JGM, Maas HA, Dingemans AC, Janssen-Heijnen MLG. Geriatric Assessment for Older Patients with Non-small Cell Lung Cancer: Daily Practice of Centers Participating in the NVALT25-ELDAPT Trial. Lung. 2018 Aug;196(4):463-468. doi: 10.1007/s00408-018-0116-8. Epub 2018 Apr 12.
PubMed 29651598

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All NSCLC trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ELDAPT: Elderly With Locally Advanced Lung Cancer: Deciding Through Geriatric Assessment on the oPtimal Treatment Strategy
ClinicalTrials.gov ID: NCT02284308
Acronym / sponsor ID: ELDAPT / ELDAPT
Conditions: NSCLC
Keywords: NSCLC
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 180 participants (actual)
Lead sponsor: Maastricht Radiation OncologyUniversity, hospital or other
Collaborators: Dutch Society of Physicians for Pulmonology and Tuberculosis, Erasmus Medical Center, VieCuri Medical Centre, AstraZeneca, Dutch Cancer Society
Study start: Jul 2016 (actual)
Primary completion: 1 Jan 2025 (actual)
Study completion: 18 Dec 2029 (estimated)
First posted: 6 Nov 2014 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with any subtype of NSCLC, primary UICC Stage III, age ≥ 75 years	–	–All registered patients will undergo a geriatric assessment to assess vulnerability. Based on this assessment, patients are offered treatment according to the discretion of the physician and patient.

Who may qualify

Ages: 75 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
Study population: Patients aged ≥ 75 years, with any subtype of NSCLC, stage III

Key inclusion criteria (7 listed)

Any subtype of pathologically proven NSCLC, primary UICC Stage III disease;
Age ≥ 75 years;
No surgery or adjuvant chemotherapy for NSCLC in the last year;
No prior radiotherapy to the ipsilateral thorax or mediastinum;
No clinical superior vena cava syndrome;

Key exclusion criteria (0 listed)

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

Correlation GA with QAS (quality adjusted survival)
Time frame: 5 years
To corellate results of the geriatric assessment with quality-adjusted survival (QAS) after radical intent therapy in patients with stage III NSCLC ≥75 years

6 secondary outcomes

Geriatric assessment
Time frame: Baseline
Medical comparison between treatments
Time frame: 5 years
Cost-effectiveness
Time frame: End of study
Development and validation of geriatric screening instrument
Time frame: 5 years
Flow chart
Time frame: 5 years
Predictive value
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 30 Oct 2026.
Derived from this study: PubMed 29651598Driessen EJM, van Loon JGM, Maas HA, Dingemans AC, Janssen-Heijnen MLG. Geriatric Assessment for Older Patients with Non-small Cell Lung Cancer: Daily Practice of Centers Participating in the NVALT25-ELDAPT Trial. Lung. 2018 Aug;196(4):463-468. doi: 10.1007/s00408-018-0116-8. Epub 2018 Apr 12.
Individual participant dataSharing planned: No

Related trials for NSCLC

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.

Judith van Loon, MD, PhD principal investigator

Maastro (radiotherapist)

Anne-Marie Dingemans, MD, PhD principal investigator

Erasmus Medical Center

Mariska Janssen-Heijnen, PhD principal investigator

VieCuri Medical Centre

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of NSCLC, run by Maastricht Radiation Oncology at 22 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 7 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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?

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?

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?

Correlation GA with QAS (quality adjusted survival) (time frame: 5 years). 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 NCT02284308, 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 30 Oct 2026.