Small Cell Lung Cancer Limited StagePhase 2NCT04602533
Efficacy and Safety of Standard of Care Plus Durvalumab in Patients With Limited Disease Small Cell Lung Cancer (DOLPHIN)
A Phase 2 study testing Durvalumab in people with Small Cell Lung Cancer Limited Stage, run by Michael Hopp at 15 sites in Germany.
Trial summary
Combination of concomitant Radio-Chemotherapy showed a significant improvement (Takada) of OS and PFS in limited disease SCLC patients. This clinical trial is a prospective, multicenter, randomized, open-label, parallel group phase II investigator initiated trial (ITT) to evaluate the efficacy and safety of Durvalumab… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer Limited Stage
- What is being tested?
- Durvalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 15 sitesGermany
- Study dates
- 21 Dec 2020to 31 Dec 2026
- Phase
- Phase 2
- 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
Who may be able to join
- Signed and dated informed consent of the subject must be available before start of any specific trial procedures
- Male or female ≥ 18 years
- Histological confirmed limited disease small cell lung cancer (stage 2 and 3; T1a-4, N1-3, M0 according UICC8 criteria; if primarius is not eligible as RECIST1.1 target lesion (in cases with T1a and T1b) at least one lymph node must meet RECIST1.1 criteria for target lesion (≥15 mm short axis))
- Availability of tumor tissue or fresh tumor material for translational research by central lab testing
- ECOG PS 0 - 1
- At least one measurable lesion according RECIST 1.1
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- Body weight > 30 kg
- Adequate normal organ function
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x109/L
- Platelet count ≥ 100 x109/L
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal
- Serum Bilirubin ≤ 1.5 x institutional upper limit of normal
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min for Carboplatin, ≥ 60 mL/min for Cisplatin, calculated by the Cockcroft-Gault formula
- Life expectancy of at least 12 weeks in the discretion of the investigator
- Ability of subject to understand nature, importance and individual consequences of clinical trial
Who cannot join
- Extensive disease small cell lung cancer (Tx, Nx, M1; stage IV)
- Major surgical process within 28 day prior first dose of IMP and/or Radiochemotherapy
- History of allogenic organ transplantation
- Active or prior documented autoimmune or inflammatory disorder (including inflammatory bowel disease [e.g. colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome or Wegener syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement
Show all 25Show fewer
- Patients with any chronic skin condition that not required systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- Patients with celiac disease controlled by diet alone
- Uncontrolled intercurrent illness (i.e. active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, serious chronic gastrointestinal conditions (i.e. diarrhea), psychiatric illness)
- History of another primary malignancy in the last 5 years, except adequately treated nonmelanoma skin cancer, adequately treated carcinoma in situ (without evidence of disease)
- History of leptomeningeal carcinomatosis, or brain metastases
- Known HIV positive and/or active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Current or prior use of immunosuppressive medication within 14 days before the first dose.The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IMP
- Participation in another clinical trial with an investigational product within the last 30 days (unless during follow-up period of an interventional study)
- Known hypersensitivity to one of the ingredients
- Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial
- Pregnancy, lactation and contraception
- Women who are pregnant, nursing or who plan to become pregnant while in the trial
- Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at informed consent, for the duration of drug treatment and for the drug out washout period (90 days after last dose of Durvalumab and/or 6 months after last dose of cisplatin/carboplatin and etoposide).
- Patients who are legally institutionalized
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Germany15 sites
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074
Lungenklinik Köln-Merheim
Cologne, North Rhine-Westphalia, 51109
Helios Kliniken Erfurt
Erfurt, Thuringia, 99089
KEM GmbH
Essen, North Rhine-Westphalia, 45136
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Universitätsklinikum Gießen Marburg
Giessen, Hesse, 35392
Asklepios Klinikum Hamburg
Hamburg, 21075
Lungenklinik Hemer
Hemer, North Rhine-Westphalia, 58675
Klinikverbund Allgäu gGmbH
Immenstadt im Allgäu, Bavaria, 87509
Klinikum Kassel GmbH-Klinik für Onkologie und Hämatologie
Kassel, Hesse, 34125
Johannes Wesling Klinikum Minden
Minden, North Rhine-Westphalia, 32429
Asklepios Fachkliniken Muenchen Gauting
München Gauting, Bavaria, 82131
Sana-Klinikum Offenbach
Offenbach, Hesse, 63069
Klinikum Ernst von Bergmann
Potsdam, Brandenburg, 14467
Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, 18059
About this study
Official title: A Phase II Randomized Study to Evaluate the Efficacy and Safety of Cisplatin or Carboplatin / Etoposide and Concomitant Radiotherapy Combined With Durvalumab Followed by Maintenance Therapy With Durvalumab Versus Cisplatin or Carboplatin / Etoposide and Concomitant Radiotherapy in Patients With Limited Disease Small Cell Lung Cancer
Combination of concomitant Radio-Chemotherapy showed a significant improvement (Takada) of OS and PFS in limited disease SCLC patients. This clinical trial is a prospective, multicenter, randomized, open-label, parallel group phase II investigator initiated trial (ITT) to evaluate the efficacy and safety of Durvalumab in combination with Cisplatin/Etoposide/Radiotherapy in patients with limited disease small-cell lung cancer (SCLC).
Read the detailed description
The trial is subdivided in a safety run-in phase and a randomized part with the induction phase (Radiochemotherapy ± Durvalumab and including prophylactic cranial irradiation (PCI; if clinically indicated and according to local standard)) followed by the maintenance phase. The trial starts with the safety run-in phase of 6 patients in Durvalumab group. After the completion of the first cycle of all 6 patients a safety interim analysis will be performed. Study should be discontinued if ≥ 2 out of 6 patients within safety run-in phase (first cycle):
- show more than 2 AEs CTCAE grade ≥3 related to study drug Durvalumab
- or develop pneumonitis (CTCAE grade ≥2)
- or drop out, Otherwise, the trial can continue with randomization. Eligible patients will be randomized to Durvalumab group or standard of care group 2:1.
The safety interim analysis was performed in Q4 2021. The independent DMC has recommended the continuation of the trial.
Induction phase:
Durvalumab group: Cisplatin (75 mg/m² (BSA) D1#) or alternatively Carboplatin (AUC 5 D1) and Etoposide (100 mg/m² (BSA) D1-3) once every 3 weeks for 4-6 cycles and concomitant Radiotherapy (60±6 Gy, 1.8-2 Gy/d or 45±1.5 Gy (1.5 Gy per fraction twice daily, with 4 hours or more between fractions) with start at latest at beginning of cycle 3, ideally during cycle 1) and additional Durvalumab (1500 mg once every 3 weeks) for 4-6 cycles according to randomization followed by prophylactic cranial irradiation (PCI, if clinically indicated and according to local standard at any time after completion of radio-chemotherapy))
Control group: Cisplatin (75 mg/m² (BSA) D1#) or alternatively Carboplatin (AUC 5 D1) and Etoposide (100 mg/m² (BSA) D1-3) once every 3 weeks for 4-6 cycles and concomitant Radiotherapy (60±6 Gy, 1.8-2 Gy/d or 45±1.5 Gy (1.5 Gy per fraction twice daily, with 4 hours or more between fractions with start at latest at beginning of cycle 3, ideally during cycle 1) followed by prophylactic cranial irradiation (PCI, if clinically indicated and according to local standard at any time after completion of radio-chemotherapy)
# Due to the potential toxicity of Cisplatin 75 mg/m² D1, a Cisplatin split dose with 40 mg/m² on D1 and D8 is alternatively allowed. A switch from Cisplatin to Carboplatin AUC 5 D1 (due to new contraindication to Cisplatin) or split dose Carboplatin (AUC 2.5 D1 and D8) is also allowed. In case of initial contraindication to Cisplatin (i.e. renal dysfuction) at baseline, treatment can be started with Carboplatin once every 3 weeks (q21) AUC 5 D1, or split dose AUC 2.5 D1 and D8. A simultaneous administration of platinum-based chemotherapy (preferred Cisplatin) and radiotherapy for at least 2 cycles should be performed.
Maintenance phase:
In Durvalumab group patients will be treated with Durvalumab once every 4 weeks until disease progression (radiologic or clinical progression) or unacceptable toxicities, if patients show at least stable disease after induction phase. Patients with PD after induction phase will have EoT visit and will be followed up until death.
Patients in control group will have EoT visit and will receive standard of care treatment until PD and thereafter will be followed up until death.
- Conditions
- Small Cell Lung Cancer Limited Stage
- Being tested
- Durvalumab, standard of care
- Keywords
- LD-SCLC, lung cancer, durvalumab
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called IMFINZI®
Induction phase: Durvalumab (1500 mg once every 3 weeks) for 4-6 cycles in combination with standard of care (Radiochemotherapy) Maintenance phase: Durvalumab (1500 mg once every 4 weeks) until PD or unacceptable toxicities.
standard of careDrug
Radiochemotherapy: Cisplatin (75 mg/m² (BSA) D1#) or alternatively Carboplatin (AUC 5 D1) and Etoposide (100 mg/m² (BSA) D1-3) once every 3 weeks for 4-6 cycles and concomitant Radiotherapy (60±6 Gy, 1.8-2 Gy/d or 45±1.5 Gy (1.5 Gy per fraction twice daily, with 4 hours or more between fractions) with start at latest at beginning of cycle 3, ideally during cycle 1) followed by prophylactic cranial irradiation (PCI, if clinically indicated and according to local standard at any time after completion of radio-chemotherapy))
A simultaneous administration of platinum-based chemotherapy (preferred Cisplatin) and radiotherapy for at least 2 cycles should be performed.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab | Experimental | Induction phase: Durvalumab (1500 mg once every 3 weeks) for 4-6 cycles in combination with standard of care (Radiochemotherapy)
Maintenance phase: Durvalumab (1500 mg once every 4 weeks) until PD or unacceptable toxicities. Receives: Drug: Durvalumab |
| standard of care | Other | Induction phase: Radiochemotherapy according to guideline
Maintenance: Standard of care Receives: Drug: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) after 18 months according to iRECIST
Measured: 18 months
Secondary outcomes (8)
Progression-free survival (PSF) after other assessments
Time between first application of trial medication to date of disease progression or death due to any cause
Measured: 12 months
Overall survival (OS)
Time between first application of trial medication to date of death due to any cause
Measured: 18 months
Overall response rate (ORR)
Complete Response or Partial Response according to iRECIST
Measured: 18 months
Disease control rate (DCR)
Complete Response, Partial Response or Stable Disease according to iRECIST
Measured: 18 months
Quality of Life Questionnaire - Cancer 30 (QLQ-C30)
Symptom control assessed by patient-reported quality of life (QoL) with QLQ-C30. The score ranges from 0 to 100. The higher the score the better the outcome.
Measured: 18 months
Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13)
Symptom control assessed by patient-reported quality of life (QoL) with QLQ-LC13. The scores ranges from 0 to 100. The higher the score the better the outcome.
Measured: 18 months
EuroQol five dimension scale (EQ-5D)
Symptom control assessed by patient-reported quality of life (QoL) with EQ-5D. The score consists of 5 items on a three step scale and a VAS scale ranging from 0 to 100. The lower the score on the three step scales the better the outcome and the higher the score on the VAS scale the better the outcome.
Measured: 18 months
Adverse Events
Treatment emergent adverse events during treatment
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start21 Dec 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 Cancer Limited StageStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Hopp
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Michael Hopp, Johannes Gutenberg University Mainz
- Investigators
- Thomas Wehler, Prof, Principal investigator, Universitätsklinikum Gießen Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602533
- Sponsor's protocol ID
- Dolphin
- Other IDs
- 2020-001050-22
- Status last verified
- Feb 2026
- First submitted
- 20 Oct 2020
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study to Evaluate the Efficacy and Safety of Cisplatin or Carboplatin / Etoposide and Concomitant Radiotherapy Combined With Durvalumab Followed by Maintenance Therapy With Durvalumab Versus Cisplatin or Carboplatin / Etoposide and Concomitant Radiotherapy in Patients With Limited Disease Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04602533
- Acronym / sponsor ID
- Dolphin
- Conditions
- Small Cell Lung Cancer Limited Stage
- Keywords
- LD-SCLC, lung cancer, durvalumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Michael HoppUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Oct 2020 (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.
Combination of concomitant Radio-Chemotherapy showed a significant improvement (Takada) of OS and PFS in limited disease SCLC patients. This clinical trial is a prospective, multicenter, randomized, open-label, parallel group phase II investigator initiated trial (ITT) to evaluate the efficacy and safety of Durvalumab in combination with Cisplatin/Etoposide/Radiotherapy in patients with limited disease small-cell lung cancer (SCLC).
Detailed description
The trial is subdivided in a safety run-in phase and a randomized part with the induction phase (Radiochemotherapy ± Durvalumab and including prophylactic cranial irradiation (PCI; if clinically indicated and according to local standard)) followed by the maintenance phase. The trial starts with the safety run-in phase of 6 patients in Durvalumab group. After the completion of the first cycle of all 6 patients a safety interim analysis will be performed. Study should be discontinued if ≥ 2 out of 6 patients within safety run-in phase (first cycle):
- show more than 2 AEs CTCAE grade ≥3 related to study drug Durvalumab
- or develop pneumonitis (CTCAE grade ≥2)
- or drop out, Otherwise, the trial can continue with randomization. Eligible patients will be randomized to Durvalumab group or standard of care group 2:1.
The safety interim analysis was performed in Q4 2021. The independent DMC has recommended the continuation of the trial.
Induction phase:
Durvalumab group: Cisplatin (75 mg/m² (BSA) D1#) or alternatively Carboplatin (AUC 5 D1) and Etoposide (100 mg/m² (BSA) D1-3) once every 3 weeks for 4-6 cycles and concomitant Radiotherapy (60±6 Gy, 1.8-2 Gy/d or 45±1.5 Gy (1.5 Gy per fraction twice daily, with 4 hours or more between fractions) with start at latest at beginning of cycle 3, ideally during cycle 1) and additional Durvalumab (1500 mg once every 3 weeks) for 4-6 cycles according to randomization followed by prophylactic cranial irradiation (PCI, if clinically indicated and according to local standard at any time after completion of radio-chemotherapy))
Control group: Cisplatin (75 mg/m² (BSA) D1#) or alternatively Carboplatin (AUC 5 D1) and Etoposide (100 mg/m² (BSA) D1-3) once every 3 weeks for 4-6 cycles and concomitant Radiotherapy (60±6 Gy, 1.8-2 Gy/d or 45±1.5 Gy (1.5 Gy per fraction twice daily, with 4 hours or more between fractions with start at latest at beginning of cycle 3, ideally during cycle 1) followed by prophylactic cranial irradiation (PCI, if clinically indicated and according to local standard at any time after completion of radio-chemotherapy)
# Due to the potential toxicity of Cisplatin 75 mg/m² D1, a Cisplatin split dose with 40 mg/m² on D1 and D8 is alternatively allowed. A switch from Cisplatin to Carboplatin AUC 5 D1 (due to new contraindication to Cisplatin) or split dose Carboplatin (AUC 2.5 D1 and D8) is also allowed. In case of initial contraindication to Cisplatin (i.e. renal dysfuction) at baseline, treatment can be started with Carboplatin once every 3 weeks (q21) AUC 5 D1, or split dose AUC 2.5 D1 and D8. A simultaneous administration of platinum-based chemotherapy (preferred Cisplatin) and radiotherapy for at least 2 cycles should be performed.
Maintenance phase:
In Durvalumab group patients will be treated with Durvalumab once every 4 weeks until disease progression (radiologic or clinical progression) or unacceptable toxicities, if patients show at least stable disease after induction phase. Patients with PD after induction phase will have EoT visit and will be followed up until death.
Patients in control group will have EoT visit and will receive standard of care treatment until PD and thereafter will be followed up until death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Durvalumab | Experimental | Drug: DurvalumabInduction phase: Durvalumab (1500 mg once every 3 weeks) for 4-6 cycles in combination with standard of care (Radiochemotherapy) Maintenance phase: Durvalumab (1500 mg once every 4 weeks) until PD or unacceptable toxicities. |
| standard of care | Other | Drug: standard of careInduction phase: Radiochemotherapy according to guideline Maintenance: Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed and dated informed consent of the subject must be available before start of any specific trial procedures
- Male or female ≥ 18 years
- Histological confirmed limited disease small cell lung cancer (stage 2 and 3; T1a-4, N1-3, M0 according UICC8 criteria; if primarius is not eligible as RECIST1.1 target lesion (in cases with T1a and T1b) at least one lymph node must meet RECIST1.1 criteria for target lesion (≥15 mm short axis))
- Availability of tumor tissue or fresh tumor material for translational research by central lab testing
- ECOG PS 0 - 1
Key exclusion criteria (25 listed)
- Extensive disease small cell lung cancer (Tx, Nx, M1; stage IV)
- Major surgical process within 28 day prior first dose of IMP and/or Radiochemotherapy
- History of allogenic organ transplantation
- Active or prior documented autoimmune or inflammatory disorder (including inflammatory bowel disease [e.g. colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome or Wegener syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.). The following are exceptions to this criterion:
- Uncontrolled intercurrent illness (i.e. active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, serious chronic gastrointestinal conditions (i.e. diarrhea), psychiatric illness)
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 |
|---|---|---|
| DurvalumabAlso: IMFINZI®Induction phase: Durvalumab (1500 mg once every 3 weeks) for 4-6 cycles in combination with standard of care (Radiochemotherapy) Maintenance phase: Durvalumab (1500 mg once every 4 weeks) until PD or unacceptable toxicities. | Drug | Durvalumab |
| standard of careRadiochemotherapy: Cisplatin (75 mg/m² (BSA) D1#) or alternatively Carboplatin (AUC 5 D1) and Etoposide (100 mg/m² (BSA) D1-3) once every 3 weeks for 4-6 cycles and concomitant Radiotherapy (60±6 Gy, 1.8-2 Gy/d or 45±1.5 Gy (1.5 Gy per fraction twice daily, with 4 hours or more between fractions) with start at latest at beginning of cycle 3, ideally during cycle 1) followed by prophylactic cranial irradiation (PCI, if clinically indicated and according to local standard at any time after completion of radio-chemotherapy)) A simultaneous administration of platinum-based chemotherapy (preferred Cisplatin) and radiotherapy for at least 2 cycles should be performed. | Drug | standard of care |
Primary outcome
Progression-free survival (PFS)
Time frame: 18 months
Progression-free survival (PFS) after 18 months according to iRECIST
8 secondary outcomes
Progression-free survival (PSF) after other assessments
Time frame: 12 months
Overall survival (OS)
Time frame: 18 months
Overall response rate (ORR)
Time frame: 18 months
Disease control rate (DCR)
Time frame: 18 months
Quality of Life Questionnaire - Cancer 30 (QLQ-C30)
Time frame: 18 months
Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13)
Time frame: 18 months
EuroQol five dimension scale (EQ-5D)
Time frame: 18 months
Adverse Events
Time frame: 18 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 27 Feb 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.
Thomas Wehler, Prof principal investigator
Universitätsklinikum Gießen Marburg
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab in people with Small Cell Lung Cancer Limited Stage, run by Michael Hopp at 15 sites in Germany.
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 16 inclusion and 25 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Progression-free survival (PFS) (time frame: 18 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 27 Feb 2026.