Small-cell Lung CancerDRIVENCT05761977
Durvalumab in Combination With Standard Chemotherapy of Patients With Extensive Stage Small Cell Lung Cancer
An observational study of Small-cell Lung Cancer and Extensive-stage Small-cell Lung Cancer, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
Trial summary
This is a non-interventional, multicenter, prospective observational study and registry of standard clinical practice in patients with Extensive Stage-Small Cell Lung Cancer (ES-SCLC) receiving 1st line treatment with Durvalumab in combination with standard chemotherapy (cisplatin or carboplatin + etoposide) in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-cell Lung Cancer, Extensive-stage Small-cell Lung Cancer
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 31 Mar 2021to Jan 2027
- 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: Patients with Small- Cell Lung Cancer candidates for 1st- line immunotherapy plus platinum based chemotherapy (cisplatin or carboplatin plus etoposide) currently with active disease.
Who may be able to join
- Male or female patients, regardless of race (residents in Greece), no younger than 18 years old at the initiation of treatment.
- Patients with histologically or cytologically confirmed diagnosis of extensive Small Cell Lung Cancer (SCLC)
- Patients who have not received prior systemic treatment for SCLC (chemotherapy or immunotherapy)
- Patients for whom the decision to administer treatment with Durvalumab+chemotherapy has already been taken before their inclusion in the study and is clearly separated from the decision of the physician for the patient's participation in the current study.
- Patients who have provided informed signed consent to participate in the study and to collect and analyze medical data related to the objectives of this study.
Who cannot join
- Patients with current diagnosis of primary cancer other than SCLC who require systemic or other treatment.
- Patients who have previously received chemotherapy or immunotherapy for SCLC
- Patients who are currently receiving or are expected to receive treatment with an investigational drug/medical device/intervention or who have received an investigational medicinal product within 1 month or 5 years half-life of the research agent (whichever is longer) before their initiation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Durvalumab in Combination With Standard Chemotherapy for 1st Line Therapy of Patients With Extensive Stage Small Cell Lung Cancer: A Non-interventional, Prospective Observational Study of Clinical Practice, Quality of Life and Use of Health Resources in Real-world Clinical Practice (DRIVE)
This is a non-interventional, multicenter, prospective observational study and registry of standard clinical practice in patients with Extensive Stage-Small Cell Lung Cancer (ES-SCLC) receiving 1st line treatment with Durvalumab in combination with standard chemotherapy (cisplatin or carboplatin + etoposide) in the approved indication, which will be carried out in Greece. In this study data will be collected prospectively based on real-world clinical practice. A prospective cohort of atients from centers of the Hellenic Cooperative Oncology Group (HeCOG) will be included. The study will be conducted in hospitals and by physicians specialized in lung cancer from different geographical areas of Greece.
Read the detailed description
In this observational prospective study, no changes to current therapeutic practice will be required and all aspects of treatment and clinical management of patients will be in compliance with the local clinical practice and will be left to the discretion of the participating physicians. Patients will be treated in accordance with the study medicine's local prescribing information and standard clinical practice as to the frequency of visits and types of evaluations carried out. The frequency of follow-up visits is set on the basis of standard practice; however, the study-related data will be collected during integration and during the routine clinical visits that will take place after the start of treatment. No visits or measurement/evaluation will be mandatory by the protocol and data collection at the predetermined time-points will be carried out only if the patient visits the center.
Patients will be enrolled during a 12-month recruitment period from HeCOG-participating public and private centers/clinics in Greece with specialization in lung cancer. As part of this study, participating physicians will be asked to follow up each patient for an additional 12 months of treatment at most after last subject is included, or until death, withdrawal of consent, discontinuation of treatment or initiation of new antineoplastic therapy, until completion of the study, or doctor's decision, whichever appears first. Therefore, the maximum period of prospective observation of the study will be 24 months (2 years) from the last patient enrolled in the study. This study will be conducted in accordance with the Guidelines for Good Pharmacoepidemiological Practice, the European General Data Protection Regulation (GDPR) and the applicable regulatory requirements.
- Keywords
- observational study, small- cell lung cancer, extensive-stage small-cell lung cancer, first line treatment
- Medical subject headings
- Small Cell Lung Carcinoma
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 |
|---|---|---|
| Patient with extensive small-cell lung cancer | extensive small-cell lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rates (OS)
The primary objective of the study is to estimate the overall survival rates (OS) at 6,12 and 24 months for patients with extensive small-cell lung cancer treated with Durvalumab in combination with standard 1st-line chemotherapy with platinum-etoposide(cisplatin or carboplatin).
Measured: up to 24 months
Secondary outcomes (11)
Progression free survival (PFS)
Evaluation of PFS from investigator
Measured: in 6, 12 and up to 24 months
Overall response rate (ORR)
Measured: in 6 and up to 12 months
Disease Control Rate
Measured: in 6 and up to 12 months
time to reach a response (TTR)
Measured: up to 12 months
duration of the response (DoR)
Measured: up to 12 months
Assessment of patients characteristics with overall survival 12 months
Measured: up to 12 months
Assessment of patients characteristics with overall survival 24 months
Measured: up to 24 months
time under treatment (ToT)
Measured: up tp 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 with standard of care 1st line treatment
Measured: From date of Informed Consent signatory and every 3 weeks, up to 24 months
Quality of life EQ-5D
Measured: From date of Informed Consent signatory and every 2 months, up to 24 months
number of participants using health resources in daily clinical practice
Measured: From date of Informed Consent signatory and every 3 weeks, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start31 Mar 2021
- Primary completion15 Jan 2026
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helena Linardou, MD, Principal investigator, Metropolitan Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761977
- Sponsor's protocol ID
- HE1R/21
- Acronym
- DRIVE
- Status last verified
- Oct 2026
- First submitted
- 7 Feb 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durvalumab in Combination With Standard Chemotherapy for 1st Line Therapy of Patients With Extensive Stage Small Cell Lung Cancer: A Non-interventional, Prospective Observational Study of Clinical Practice, Quality of Life and Use of Health Resources in Real-world Clinical Practice (DRIVE)
- ClinicalTrials.gov ID
- NCT05761977
- Acronym / sponsor ID
- DRIVE / HE1R/21
- Keywords
- observational study, small- cell lung cancer, extensive-stage small-cell lung cancer, first line treatment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Mar 2023 (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 is a non-interventional, multicenter, prospective observational study and registry of standard clinical practice in patients with Extensive Stage-Small Cell Lung Cancer (ES-SCLC) receiving 1st line treatment with Durvalumab in combination with standard chemotherapy (cisplatin or carboplatin + etoposide) in the approved indication, which will be carried out in Greece. In this study data will be collected prospectively based on real-world clinical practice. A prospective cohort of atients from centers of the Hellenic Cooperative Oncology Group (HeCOG) will be included. The study will be conducted in hospitals and by physicians specialized in lung cancer from different geographical areas of Greece.
Detailed description
In this observational prospective study, no changes to current therapeutic practice will be required and all aspects of treatment and clinical management of patients will be in compliance with the local clinical practice and will be left to the discretion of the participating physicians. Patients will be treated in accordance with the study medicine's local prescribing information and standard clinical practice as to the frequency of visits and types of evaluations carried out. The frequency of follow-up visits is set on the basis of standard practice; however, the study-related data will be collected during integration and during the routine clinical visits that will take place after the start of treatment. No visits or measurement/evaluation will be mandatory by the protocol and data collection at the predetermined time-points will be carried out only if the patient visits the center.
Patients will be enrolled during a 12-month recruitment period from HeCOG-participating public and private centers/clinics in Greece with specialization in lung cancer. As part of this study, participating physicians will be asked to follow up each patient for an additional 12 months of treatment at most after last subject is included, or until death, withdrawal of consent, discontinuation of treatment or initiation of new antineoplastic therapy, until completion of the study, or doctor's decision, whichever appears first. Therefore, the maximum period of prospective observation of the study will be 24 months (2 years) from the last patient enrolled in the study. This study will be conducted in accordance with the Guidelines for Good Pharmacoepidemiological Practice, the European General Data Protection Regulation (GDPR) and the applicable regulatory requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with extensive small-cell lung cancer | – | –extensive small-cell lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Small- Cell Lung Cancer candidates for 1st- line immunotherapy plus platinum based chemotherapy (cisplatin or carboplatin plus etoposide) currently with active disease.
Key inclusion criteria (5 listed)
- Male or female patients, regardless of race (residents in Greece), no younger than 18 years old at the initiation of treatment.
- Patients with histologically or cytologically confirmed diagnosis of extensive Small Cell Lung Cancer (SCLC)
- Patients who have not received prior systemic treatment for SCLC (chemotherapy or immunotherapy)
- Patients for whom the decision to administer treatment with Durvalumab+chemotherapy has already been taken before their inclusion in the study and is clearly separated from the decision of the physician for the patient's participation in the current study.
- Patients who have provided informed signed consent to participate in the study and to collect and analyze medical data related to the objectives of this study.
Key exclusion criteria (3 listed)
- Patients with current diagnosis of primary cancer other than SCLC who require systemic or other treatment.
- Patients who have previously received chemotherapy or immunotherapy for SCLC
- Patients who are currently receiving or are expected to receive treatment with an investigational drug/medical device/intervention or who have received an investigational medicinal product within 1 month or 5 years half-life of the research agent (whichever is longer) before their initiation in this 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
Overall survival rates (OS)
Time frame: up to 24 months
The primary objective of the study is to estimate the overall survival rates (OS) at 6,12 and 24 months for patients with extensive small-cell lung cancer treated with Durvalumab in combination with standard 1st-line chemotherapy with platinum-etoposide(cisplatin or carboplatin).
11 secondary outcomes
Progression free survival (PFS)
Time frame: in 6, 12 and up to 24 months
Overall response rate (ORR)
Time frame: in 6 and up to 12 months
Disease Control Rate
Time frame: in 6 and up to 12 months
time to reach a response (TTR)
Time frame: up to 12 months
duration of the response (DoR)
Time frame: up to 12 months
Assessment of patients characteristics with overall survival 12 months
Time frame: up to 12 months
Assessment of patients characteristics with overall survival 24 months
Time frame: up to 24 months
time under treatment (ToT)
Time frame: up tp 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 with standard of care 1st line treatment
Time frame: From date of Informed Consent signatory and every 3 weeks, up to 24 months
Quality of life EQ-5D
Time frame: From date of Informed Consent signatory and every 2 months, up to 24 months
number of participants using health resources in daily clinical practice
Time frame: From date of Informed Consent signatory and every 3 weeks, up to 24 months
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 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Helena Linardou, MD principal investigator
Metropolitan Hospital of Athens
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 Small-cell Lung Cancer and Extensive-stage Small-cell Lung Cancer, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
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 5 inclusion and 3 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 15 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 1 site in Greece. 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?
Overall survival rates (OS) (time frame: up to 24 months). 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 Oct 2026.