Extensive-stage Small-cell Lung CancerPhase 1NCT05403723

Adaptive SBRT Plus Chemoimmunotherapy for ES-SCLC

A Phase 1 study testing Durvalumab 50 MG/1 ML Intravenous Solution, Etoposide Injection and Cisplatin in people with Extensive-stage Small-cell Lung Cancer, run by University of Maryland, Baltimore at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

This is trial studying the safety of adaptive stereotactic body radiotherapy (SBRT) combined with durvalumab immunotherapy, platinum chemotherapy, and etoposide chemotherapy in platinum refractory extensive stage small cell lung cancer (SCLC). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Extensive-stage Small-cell Lung Cancer
What is being tested?: Durvalumab 50 MG/1 ML Intravenous Solution, Etoposide Injection and Cisplatin
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 30 Jan 2027to Aug 2028
Phase: Phase 1
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

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
Age > 18 years at time of study entry
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Body weight >30 kg
Adequate normal organ and marrow function as defined below:
Hemoglobin ≥10.0 g/dL

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Absolute neutrophil count (ANC) ≥1.5 × 109 /L
Platelet count ≥100 × 109/L
Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN
Creatinine WNL or if >ULN, then measured creatinine clearance (CL) >50 mL/min or calculated creatinine CL>50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
Males:
Creatinine CL (mL/min) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)
Females:
Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Confirmed histologic or cytologic diagnosis of small cell lung cancer
No prior treatment for ES-SCLC (patients who received not more than one cycle of chemotherapy ± durvalumab as SOC prior to enrolment may be allowed on study at the discretion of the study sponsor)
Extensive stage disease at diagnosis
Measurable disease per Recist 1.1
Female Patients must either be of non-reproductive potential (i.e., post-menopausal by history: ≥50 years old and no menses for 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.

Who cannot join

Participation in another clinical study with an investigational product during the last 4 weeks prior to first dose of IP
Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
Any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis.
Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study PI/Sponsor
Major surgical procedure within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.

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History of allogenic organ transplantation.
Active or prior documented autoimmune or inflammatory disorders (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
Any chronic skin condition that does not require 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, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
History of another primary malignancy except for
Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated carcinoma in situ without evidence of disease
History of leptomeningeal carcinomatosis
Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 2-5 minutes apart)
History of active primary immunodeficiency
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 of durvalumab. 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 to exceed <<10 mg/day>> of prednisone or its equivalent
Steroids as premedication for chemotherapy or hypersensitivity reactions (e.g., CT scan premedication)
Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control (see Table 6) from screening to 90 days after the last dose of durvalumab monotherapy.
Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) and interstitial lung disease
Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
Symptomatic or uncontrolled brain metastases requiring treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids. (Patients with small untreated but asymptomatic brain lesions are eligible).
Patients with uncontrolled seizures.
Previous treatment with definitive chemoradiation for LS-SCLC

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: A Phase 1b Trial of Adaptive Stereotactic Body Radiotherapy in Combination With Durvalumab (MEDI4736), Platinum, and Etoposide in Extensive Stage Small Cell Lung Cancer

Read the detailed description

This is a phase Ib, open-label, single-arm study in newly diagnosed patients with extensive stage SCLC, to test the safety of the adaptive addition of SBRT to combination therapy with durvalumab, platinum, and etoposide. Approximately 50 patients with ES-SCLC will be enrolled in this study in order to identify 20 patients with platinum refractory disease who do not show evidence of early response to chemoimmunotherapy. Eligible patients will complete 2 cycles of study treatment with durvalumab, platinum (cisplatin or carboplatin per investigator choice), and etoposide. Patients will then undergo standard of care restaging imaging. Those patients who have a partial or complete response will continue with combination systemic therapy, without additional intervention.

In patients with less than a partial response (stable disease or progressive disease), SBRT will be given prior to cycle 3 of systemic therapy. The radiotherapy will be given in 5 fractions of 6 Gy to the primary tumor site. See study schema. Patients who undergo SBRT will resume systemic therapy within 2 weeks of completing SBRT and the interval between cycle 2 and cycle 3 should not exceed 6 weeks. Subsequent restaging imaging will continue as per standard of care. All patients will continue maintenance therapy with durvalumab until confirmed progressive disease.

Conditions: Extensive-stage Small-cell Lung Cancer
Being tested: Durvalumab 50 MG/1 ML Intravenous Solution, Etoposide Injection, Cisplatin, Carboplatin, Stereotactic Body Radiotherapy
Keywords: Lung Cancer, Chemoimmunotherapy, Stereotactic Body Radiotherapy, Durvalumab, Platinum, Etoposide
Medical subject headings: Small Cell Lung Carcinoma, Lung Neoplasms

What participants receive

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

Durvalumab 50 MG/1 ML Intravenous SolutionDrug
Durvalumab (1500 mg durvalumab via IV infusion) in combination with platinum doublet chemotherapy will be administered to patients once every 3 weeks for up to 4 cycles plus SBRT (platinum resistant group) or without SBRT (platinum sensitive group). Each 3-week of chemoimmunotherapy interval is considered a cycle. Patients with platinum sensitive disease will receive the combination of durvalumab and chemotherapy (total of four cycles) while those with platinum resistant SCLC will receive SBRT and continue to receive up to two additional cycles of treatment with durvalumab along with platinum/etoposide (not to exceed a total of four6 cycles of chemoimmunotherapy including 2 cycles obtained prior to SBRT). Following completion of 4-6 cycles of combination therapy, patients in both groups will continue with maintenance durvalumab (1500 mg) in q4w cycles until disease progression.
Etoposide InjectionDrug
A platinum/etoposide doublet will be administered according to institutional standards. Platinum-etoposide will consist of etoposide 80-100 mg/m2 on days 1-3 of each cycle along with a choice of either carboplatin area under the curve 5-6 mg/mL per min or cisplatin 75-80 mg/m2 (administered on day 1 of each cycle).
CisplatinDrug
Also called Platinum
A platinum/etoposide doublet will be administered according to institutional standards. Platinum-etoposide will consist of etoposide 80-100 mg/m2 on days 1-3 of each cycle along with a choice of either carboplatin area under the curve 5-6 mg/mL per min or cisplatin 75-80 mg/m2 (administered on day 1 of each cycle).
CarboplatinDrug
Also called Platinum
A platinum/etoposide doublet will be administered according to institutional standards. Platinum-etoposide will consist of etoposide 80-100 mg/m2 on days 1-3 of each cycle along with a choice of either carboplatin area under the curve 5-6 mg/mL per min or cisplatin 75-80 mg/m2 (administered on day 1 of each cycle).
Stereotactic Body RadiotherapyDevice
Also called SBRT
Patients will receive palliative radiation to the primary tumor site up to 30 Gy for 1 week given as 5 daily fractions of 6 Gy each or 27 Gy as 3 fractions of 9 Gy administered every other day.

Study groups in NCT05403723
Study group	Role	What they receive
Single Treatment Arm	Experimental	Eligible patients will complete 2 cycles of study treatment with durvalumab, platinum (cisplatin or carboplatin per investigator choice), and etoposide. Patients will then undergo standard of care restaging imaging. Those patients who have a partial or complete response will continue with combination systemic therapy, without additional intervention. In patients with less than a partial response (stable disease or progressive disease), SBRT will be given prior to cycle 3 of systemic therapy. The radiotherapy will be given in 5 fractions of 6 Gy to the primary tumor site. See study schema. Patients who undergo SBRT will resume systemic therapy within 2 weeks of completing SBRT and the interval between cycle 2 and cycle 3 should not exceed 6 weeks. Subsequent restaging imaging will continue as per standard of care. All patients will continue maintenance therapy with durvalumab until confirmed progressive disease. Receives: Drug: Durvalumab 50 MG/1 ML Intravenous Solution; Drug: Etoposide Injection; Drug: Cisplatin; Drug: Carboplatin; Device: Stereotactic Body Radiotherapy

What is being measured

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

Incidence of treatment-related adverse events (AEs)
Number of patients that experience Adverse Events (AEs) assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse Events will be described by Type, Category, including only most severe Grade experienced by a single patient.
Measured: Up to 2.5 years

Secondary outcomes (1)

Objective Response Rate (ORR)
Proportion of patients with objective response (Complete Response (CR) + Partial Response (PR)) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR) is defined as: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is defined as: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to 2.5 years

Timeline

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

30 Jan 2027Aug 2028

First posted3 Jun 2022
Study start30 Jan 2027 (estimated)
Primary completionFeb 2028 (estimated)
Study completionAug 2028 (estimated)

Why it stopped: PI changed institution. Not yet approved at current location.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Extensive-stage 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: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05403723
Sponsor's protocol ID: 2464GCCC_HP-00110765
Status last verified: Sep 2026
First submitted: 28 May 2022
Last updated: 14 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b Trial of Adaptive Stereotactic Body Radiotherapy in Combination With Durvalumab (MEDI4736), Platinum, and Etoposide in Extensive Stage Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05403723
Acronym / sponsor ID: 2464GCCC_HP-00110765
Conditions: Extensive-stage Small-cell Lung Cancer
Keywords: Lung Cancer, Chemoimmunotherapy, Stereotactic Body Radiotherapy, Durvalumab, Platinum, Etoposide
Phase: Phase 1
Study type: Interventional
Recruitment status: SuspendedReason stopped: PI changed institution. Not yet approved at current location.
Enrolment: 50 participants (estimated)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: AstraZeneca
Study start: 30 Jan 2027 (estimated)
Primary completion: Feb 2028 (estimated)
Study completion: Aug 2028 (estimated)
First posted: 3 Jun 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Treatment Arm	Experimental	Drug: Durvalumab 50 MG/1 ML Intravenous Solution, Drug: Etoposide Injection, Drug: Cisplatin, Drug: Carboplatin, Device: Stereotactic Body RadiotherapyEligible patients will complete 2 cycles of study treatment with durvalumab, platinum (cisplatin or carboplatin per investigator choice), and etoposide. Patients will then undergo standard of care restaging imaging. Those patients who have a partial or complete response will continue with combination systemic therapy, without additional intervention. In patients with less than a partial response (stable disease or progressive disease), SBRT will be given prior to cycle 3 of systemic therapy. The radiotherapy will be given in 5 fractions of 6 Gy to the primary tumor site. See study schema. Patients who undergo SBRT will resume systemic therapy within 2 weeks of completing SBRT and the interval between cycle 2 and cycle 3 should not exceed 6 weeks. Subsequent restaging imaging will continue as per standard of care. All patients will continue maintenance therapy with durvalumab until confirmed progressive disease.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
Age > 18 years at time of study entry
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Body weight >30 kg
Adequate normal organ and marrow function as defined below:

Key exclusion criteria (36 listed)

Participation in another clinical study with an investigational product during the last 4 weeks prior to first dose of IP
Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
Any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
Major surgical procedure within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
History of allogenic organ transplantation.

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
Durvalumab 50 MG/1 ML Intravenous SolutionDurvalumab (1500 mg durvalumab via IV infusion) in combination with platinum doublet chemotherapy will be administered to patients once every 3 weeks for up to 4 cycles plus SBRT (platinum resistant group) or without SBRT (platinum sensitive group). Each 3-week of chemoimmunotherapy interval is considered a cycle. Patients with platinum sensitive disease will receive the combination of durvalumab and chemotherapy (total of four cycles) while those with platinum resistant SCLC will receive SBRT and continue to receive up to two additional cycles of treatment with durvalumab along with platinum/etoposide (not to exceed a total of four6 cycles of chemoimmunotherapy including 2 cycles obtained prior to SBRT). Following completion of 4-6 cycles of combination therapy, patients in both groups will continue with maintenance durvalumab (1500 mg) in q4w cycles until disease progression.	Drug	Single Treatment Arm
Etoposide InjectionA platinum/etoposide doublet will be administered according to institutional standards. Platinum-etoposide will consist of etoposide 80-100 mg/m2 on days 1-3 of each cycle along with a choice of either carboplatin area under the curve 5-6 mg/mL per min or cisplatin 75-80 mg/m2 (administered on day 1 of each cycle).	Drug	Single Treatment Arm
CisplatinAlso: PlatinumA platinum/etoposide doublet will be administered according to institutional standards. Platinum-etoposide will consist of etoposide 80-100 mg/m2 on days 1-3 of each cycle along with a choice of either carboplatin area under the curve 5-6 mg/mL per min or cisplatin 75-80 mg/m2 (administered on day 1 of each cycle).	Drug	Single Treatment Arm
CarboplatinAlso: PlatinumA platinum/etoposide doublet will be administered according to institutional standards. Platinum-etoposide will consist of etoposide 80-100 mg/m2 on days 1-3 of each cycle along with a choice of either carboplatin area under the curve 5-6 mg/mL per min or cisplatin 75-80 mg/m2 (administered on day 1 of each cycle).	Drug	Single Treatment Arm
Stereotactic Body RadiotherapyAlso: SBRTPatients will receive palliative radiation to the primary tumor site up to 30 Gy for 1 week given as 5 daily fractions of 6 Gy each or 27 Gy as 3 fractions of 9 Gy administered every other day.	Device	Single Treatment Arm

Primary outcome

Incidence of treatment-related adverse events (AEs)
Time frame: Up to 2.5 years
Number of patients that experience Adverse Events (AEs) assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse Events will be described by Type, Category, including only most severe Grade experienced by a single patient.

1 secondary outcome

Objective Response Rate (ORR)
Time frame: Up to 2.5 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 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.

Taofeek Owonikoko, MD, PhD principal investigator

University of Maryland, Baltimore

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

Questions about this trial

What is this clinical trial studying?

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 21 inclusion and 36 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: paused, as of the sponsor's last update on 14 Sep 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Incidence of treatment-related adverse events (AEs) (time frame: Up to 2.5 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 NCT05403723.

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 14 Sep 2026.