Small Cell Lung CarcinomaPhase 2GUIDANCENCT06419179
Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in HRD Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC)
A Phase 2 study testing Durvalumab and Olaparib in people with Small Cell Lung Carcinoma, run by University of Cologne at 1 site in Germany.
Trial summary
Maintenance durvalumab (MEDI4736) and olaparib (AZD2281) after standard 1st line treatment (carboplatin/ cisplatin, etoposide, durvalumab) in HRD positive extensive disease (ED) small-cell lung cancer (SCLC) Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- Durvalumab and Olaparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- 9 Oct 2024to 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed, histologically documented advanced or metastatic small-cell lung cancer (UICC stage III which is not amenable to curative radiochemotherapy or stage IV). [...]
- Either de novo biopsies collected as part of routine clinical practice or archival tumor samples (taken ≤6 months prior to screening) are acceptable.
- Planned or ongoing treatment with carboplatin/cisplatin, etoposide, durvalumab as 1st-line SoC. Pre-screening must begin no later than the start of the 3rd cycle to allow sufficient time for molecular analyses. [...]
- Available radiographic chest and abdominal CT or MRI scans performed up to 42 days before initial first line treatment with carboplatin/cisplatin, etoposide and durvalumab.
- At least one measurable site of disease as defined by RECIST v1.1 criteria.
- [...]
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- Completed pre-screening with fulfillment of all inclusion and exclusion criteria of pre-screening. Pre-screening must have tested positive for homologous recombination deficiency as defined in this protocol at central testing. [...]
- Patients must not have radiographic or clinic disease progression while on induction therapy and/or prior to start of study treatment.
- Patients must have received 4 cycles (21-day cycles) of induction with carboplatin or cisplatin, etoposide and durvalumab completed within 1 to 14 days prior to initiation of study treatment on C5D1. Patients must have received durvalumab at minimum three times during the four induction cycles.
- Adequate organ and marrow function
Who cannot join
- Induction therapy other than carboplatin/cisplatin, etoposide and durvalumab. (The administration of one induction cycle without durvalumab is permitted.)
- Radiographic or clinical evidence of progressive disease.
- Negative HRD result in a previous pre-screening in this trial.
- [...]
- Patients with symptomatic uncontrolled central nervous system (CNS) metastases.
- Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
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- History of leptomeningeal carcinomatosis.
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy. Exceptions are:
- Alopecia (any Grade)
- Vitiligo (any Grade)
- Hypothyroidism stable on hormone replacement (Grade ≤2)
- Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or olaparib may be included only after consultation with the Sponsor.
- ...
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
About this study
Official title: A Multicenter Phase II Trial of Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in Homologous Recombination Deficiency (HRD) Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC)
Maintenance durvalumab (MEDI4736) and olaparib (AZD2281) after standard 1st line treatment (carboplatin/ cisplatin, etoposide, durvalumab) in HRD positive extensive disease (ED) small-cell lung cancer (SCLC)
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- Durvalumab, Olaparib
- 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.
DurvalumabDrug
Also called MEDI4736, IMFINZI
1500 mg i.v. Q4W
OlaparibDrug
Also called AZD2281, LYNPARZA
300 mg BID orally
| Study group | Role | What they receive |
|---|---|---|
| Combination of olaparib and durvalumab after four cycles of standard 1st line treatment | Experimental | Study treatment (olaparib and durvalumab) starts with the initiation of maintenance therapy and is administered at a 28-day cycle until progression, unacceptable toxicity, or discontinuation for other reasons.
Induction therapy (four cycles of carboplatin/cisplatin, etoposide, durvalumab (the administration of one induction cycle without durvalumab is permitted)) is administered as part of standard of care. Receives: Drug: Durvalumab; Drug: Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS according to investigator-assessed RECIST 1.1 from start of maintenance therapy
Measured: Approximately two years (from First patient in (FSI) to Last patient last visit (LSLV))
Secondary outcomes (2)
Incidence, severity and grading of adverse events (AE) and seriouse adverse events (SAE).
Grading is based on CTCAE Version 5
Measured: Approximately two years (from FSI to LSLV)
ORR of maintenance.
Grading is based on RECIST 1.1
Measured: Approximately two years (from FSI to LSLV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start9 Oct 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 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 CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Prof. Dr. Juergen Wolf, University of Cologne
- Investigators
- Jürgen Wolf, MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419179
- Sponsor's protocol ID
- Uni-Koeln-5159
- Other IDs
- 2024-512373-27-00
- Acronym
- GUIDANCE
- Status last verified
- May 2025
- First submitted
- 3 May 2024
- Last updated
- 20 May 2025
- 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 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Trial of Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in Homologous Recombination Deficiency (HRD) Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC)
- ClinicalTrials.gov ID
- NCT06419179
- Acronym / sponsor ID
- GUIDANCE / Uni-Koeln-5159
- Conditions
- Small Cell Lung Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 May 2024 (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.
Maintenance durvalumab (MEDI4736) and olaparib (AZD2281) after standard 1st line treatment (carboplatin/ cisplatin, etoposide, durvalumab) in HRD positive extensive disease (ED) small-cell lung cancer (SCLC)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination of olaparib and durvalumab after four cycles of standard 1st line treatment | Experimental | Drug: Durvalumab, Drug: OlaparibStudy treatment (olaparib and durvalumab) starts with the initiation of maintenance therapy and is administered at a 28-day cycle until progression, unacceptable toxicity, or discontinuation for other reasons. Induction therapy (four cycles of carboplatin/cisplatin, etoposide, durvalumab (the administration of one induction cycle without durvalumab is permitted)) is administered as part of standard of care. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Newly diagnosed, histologically documented advanced or metastatic small-cell lung cancer (UICC stage III which is not amenable to curative radiochemotherapy or stage IV). [...]
- Either de novo biopsies collected as part of routine clinical practice or archival tumor samples (taken ≤6 months prior to screening) are acceptable.
- Planned or ongoing treatment with carboplatin/cisplatin, etoposide, durvalumab as 1st-line SoC. Pre-screening must begin no later than the start of the 3rd cycle to allow sufficient time for molecular analyses. [...]
- Available radiographic chest and abdominal CT or MRI scans performed up to 42 days before initial first line treatment with carboplatin/cisplatin, etoposide and durvalumab.
- At least one measurable site of disease as defined by RECIST v1.1 criteria.
Key exclusion criteria (14 listed)
- Induction therapy other than carboplatin/cisplatin, etoposide and durvalumab. (The administration of one induction cycle without durvalumab is permitted.)
- Radiographic or clinical evidence of progressive disease.
- Negative HRD result in a previous pre-screening in this trial.
- [...]
- Patients with symptomatic uncontrolled central nervous system (CNS) metastases.
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: MEDI4736, IMFINZI1500 mg i.v. Q4W | Drug | Combination of olaparib and durvalumab after four cycles of standard 1st line treatment |
| OlaparibAlso: AZD2281, LYNPARZA300 mg BID orally | Drug | Combination of olaparib and durvalumab after four cycles of standard 1st line treatment |
Primary outcome
Progression-free survival (PFS)
Time frame: Approximately two years (from First patient in (FSI) to Last patient last visit (LSLV))
PFS according to investigator-assessed RECIST 1.1 from start of maintenance therapy
2 secondary outcomes
Incidence, severity and grading of adverse events (AE) and seriouse adverse events (SAE).
Time frame: Approximately two years (from FSI to LSLV)
ORR of maintenance.
Time frame: Approximately two years (from FSI to LSLV)
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 20 May 2025.
- 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.
Jürgen Wolf, MD principal investigator
University Hospital of Cologne
1 site 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 and Olaparib in people with Small Cell Lung Carcinoma, run by University of Cologne at 1 site 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 10 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 20 May 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 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: Approximately two years (from First patient in (FSI) to Last patient last visit (LSLV))). 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 20 May 2025.