Lung CancerPhase 2NCT05092412

Low-dose Radiotherapy Combined With Durvalumab, Chemotherapy(EP) in the Treatment of ES-SCLC

A Phase 2 study testing Low-dose radiotherapy, Durvalumab and Etoposide, and cisplatin/carboplatin in people with Lung Cancer and Extensive-stage Small-cell Lung Cancer, run by You Lu at 3 sites in China.

Active, not recruiting

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

Official record

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Trial summary

The purpose of this study was to evaluate the efficacy of low-dose radiotherapy (LDRT) combined with durvalumab, etoposide, and cisplatin/carboplatin in the first-line treatment of extensive-stage small cell lung cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Extensive-stage Small-cell Lung Cancer, Durvalumab
What is being tested?: Low-dose radiotherapy, Durvalumab and Etoposide, and cisplatin/carboplatin
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 3 sitesChina
Study dates: 2 Mar 2022to 30 Jun 2027
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

At the time of screening, male or female participants were ≥18 years old.
Before carrying out any research program related procedures (including screening evaluation), obtain written informed consent and any locally required authorization from the participant or his legal representative.
Extensive-stage disease confirmed by histology or cytology (American Joint Committee on Cancer (8th edition) stage IV SCLC [any T, any N and M1a/b/c]), or due to multiple lung nodules with a wide range Or the size of the tumor/nodule is too large to be included in a tolerable radiotherapy plan for stage T3-4 disease.
Participants with brain metastases must be asymptomatic or stable with steroids and anticonvulsants for at least 1 month before study treatment. Participants with suspected brain metastases during screening should undergo brain CT/MRI before enrollment in the study.
The participant must be considered suitable for platinum-based chemotherapy as the first-line treatment for extensive-stage small cell lung cancer. Chemotherapy must include either cisplatin or carboplatin, combined with etoposide.
The participant must be considered suitable for thoracic radiotherapy as the first-line treatment for extensive-stage small cell lung cancer.

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Life expectancy on the first day of study treatment was ≥12 weeks.
At the time of enrollment, the World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) physical status score was 0 or 1.
Weight>30 kg.
According to the requirements of RECIST1.1 guidelines, at least one lesion (never received radiotherapy before), accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline shows that its longest diameter is ≥10mm (except for lymph nodes, Its short axis must be ≥15 mm); and the lesion is suitable for repeated and accurate measurement.
Have not been exposed to immune-mediated therapies in the past, including but not limited to other anti-PD-1, anti-PD-L1 and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, except for therapeutic anti-tumor vaccines.
With sufficient organ and bone marrow function, it needs to be measured 28 days before receiving treatment, which is defined as follows:
Hemoglobin ≥9 g/dL. Absolute neutrophil count ≥ 1.5 × 109/L (granulocyte colony stimulating factor is not allowed during screening).
Platelet count ≥75 × 109/L. Serum bilirubin ≤1.5 × upper limit of normal (ULN). It is not applicable to participants diagnosed with Gilbert syndrome. These participants are allowed to enter into the group through consultation with the investigators.
For participants without liver metastasis: ALT and AST ≤2.5 × ULN. The ALT and AST of participants with liver metastases are ≤5 × ULN.
Measured or calculated creatinine clearance rate: According to the Cockcroft-Gault formula (using actual body weight) or a 24-hour urine test, participants receiving cisplatin therapy >60mL/min, and participants receiving carboplatin therapy >45mL/min.
The female participant has evidence of postmenopausal status, or the urine or serum pregnancy test result of the premenopausal female participant is negative. Women who stop menopause for 12 months without other medical reasons are considered menopausal. The specific requirements for age are as follows:
For female participants <50 years of age who had amenorrhea for 12 months or more after discontinuing exogenous hormone therapy and whose luteinizing hormone and follicle-stimulating hormone levels were in the postmenopausal range or who had undergone sterilization (bilateral oophorectomy or hysterectomy) were considered postmenopausal.
For female participants ≥50 years of age, if all exogenous hormone treatments are stopped and the menopause is 12 months or more, or radiotherapy-induced ovariectomy and the last menstruation occurred more than 1 year ago, or chemotherapy-induced menopause and the last menstruation is more than 1 year , Or have undergone surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy), who can be considered a postmenopausal woman.

Who cannot join

Participate in the design and execution of the study (applicable to researchers and/or members of the research center).
Have previously received the distribution of experimental drug (IP) in this study.
Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
Etoposide-platinum (carboplatin or cisplatin)-based chemotherapy is medically contraindicated.
Have a history of chest radiotherapy or plan to undergo intensive chest radiotherapy before systemic treatment. Radiotherapy outside the chest (eg, bone metastases) for the purpose of palliative care is allowed, but it must be completed before the first administration of the study drug.
Simultaneously carry out any chemotherapy, biological products or hormone therapy for cancer treatment. The use of hormone therapy for non-cancer related conditions (eg, hormone replacement therapy) is acceptable.

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Major surgery (defined by the investigator) within 28 days before the first IP administration. Note: Local surgery on isolated lesions for the purpose of palliative care is acceptable.
History of allogeneic organ transplantation.
Paraneoplastic syndromes (PNS) with autoimmune properties requiring systemic treatment (systemic steroids or immunosuppressive agents) or clinical symptoms suggesting that PNS is aggravated.
Active or previously recorded autoimmune diseases or inflammatory diseases (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [except diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome [granulomatous vasculitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). For this standard, the following exceptions:
Participants with vitiligo or hair loss. Participants with hypothyroidism (eg after Hashimoto syndrome) and stable disease after receiving hormone replacement therapy.
Any chronic skin disease that does not require systemic treatment. Participants without active disease in the past 5 years can be included in the study after discussion with the investigators.
Participants with celiac disease who can be controlled by diet alone.
Uncontrolled concurrent diseases, including but not limited to: persistent or active infections, interstitial lung disease, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmia, concomitant Severe chronic gastrointestinal disease with diarrhea, or psychiatric/social problem conditions that may limit compliance with research requirements, cause a significant increase in the risk of AEs, or affect the participant's ability to provide written informed consent.
A history of another type of primary malignant tumor, except for the following conditions:
Malignant tumors that are treated for the purpose of curing, have no known active disease ≥5 years before the first administration of IP, and have a low potential for recurrence risk.
Adequately treated non-melanoma skin cancer or malignant freckle-like nevus without evidence of disease.
Carcinoma in situ with adequate treatment and no evidence of disease.
History of leptomeningeal carcinoma.
History of active primary immunodeficiency.
Active infections, including tuberculosis (clinical evaluation, including clinical history, physical examination, imaging findings and tuberculosis examination in line with local clinical practice), hepatitis B (known positive for HBV surface antigen [HbsAg]), hepatitis C or human immunity Defective virus (HIV 1/2 antibody positive). Participants who have previously suffered from HBV infection or who have been cured (defined as the presence of hepatitis B core IgG antibodies and the absence of HBsAg) are eligible. Participants who are positive for HCV antibodies are only eligible if they are negative for HCV RNA polymerase chain reaction.
Immunosuppressive drugs were being used when durvalumab was first administered; Or use of immunosuppressive drugs in the 14 days prior to initial use of durvalumab. There are exceptions to this criterion:
Intranasal, inhaled, topical steroid therapy or local injection of steroid drugs (eg, intra-articular injection).
Systemic corticosteroid therapy that does not exceed 10 mg of prednisone per day or its equivalent physiological dose.
Steroids used as pre-medication for allergic reactions (for example, medication before CT scan). Steroid pretherapy for chemotherapy is acceptable.
Vaccine live attenuated vaccine within 30 days before the first dose of IP. Note: After enrollment, participants cannot receive live vaccines during IP treatment and within 30 days after the last dose of IP.
Pregnant or lactating female participants, or male or female participants with reproductive potential who are unwilling to take effective birth control measures during screening to 90 days after the last dosing of durvalumab monotherapy.
Known to have allergic or hypersensitivity reactions to duvalvumab, etoposide, carboplatin, cisplatin or any of its excipients.
Have participated in the clinical research of durvalumab and/or other anti-tumor drugs in the past, regardless of the allocation of treatment groups.

Trial locations and contacts

3 sites in 1 country.

China3 sites

West China Hospital Sichuan University
Chengdu, Sichuan, 610044
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003

Other trials in China

About this study

Official title: A First-line Multi-center, Single-arm Exploratory Study Using Low-dose Radiotherapy (LDRT) Combined With Durvalumab (MEDI4736), Etoposide, and Cisplatin/Carboplatin for Patients With Extensive-stage Small Cell Lung Cancer

Read the detailed description

This study will enrol 30 subjects at 3 sites in China. Subjects who fulfil all the inclusion criteria and none of the exclusion criteria will be enrolled and receive treatment with Durvalumab and EP for 4 cycles. Durvalumab will be administered at a dose of 1500 mg every 3 weeks (Q3W) with first-line chemotherapy and will continue to be administered as monotherapy every 4 weeks(Q4W) post-chemotherapy until progressive disease. The LDRT deals with primary tumour in a 15 Gy of 5 fractions over five days, starting from Day 1 in the first cycle. Subjects will attend safety follow up 12 weeks ±14 days after last dose of Durvalumab. The primary endpoint is mPFS.

Conditions: Lung Cancer, Extensive-stage Small-cell Lung Cancer, Durvalumab
Being tested: Low-dose radiotherapy, Durvalumab, Etoposide, and cisplatin/carboplatin
Keywords: ES-SCLC, Durva, LDRT
Medical subject headings: Lung Neoplasms, Small Cell Lung Carcinoma

What participants receive

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

Low-dose radiotherapyRadiation
The LDRT deals with primary tumour in a 15 Gy of 5fractions over five days, starting from Day 1 in the first cycle.
DurvalumabDrug
Durvalumab 1500 mg intravenous infusion, started to be used simultaneously with chemotherapy at week 0 and continued after chemotherapy.
Etoposide, and cisplatin/carboplatinDrug
Starting from week 0, the dose of etoposide + carboplatin or cisplatin in the study will not exceed the dose for specific indications in the product instructions (etoposide [80 to 100mg/m2] via intravenous infusion and carboplatin [ The area under the curve (AUC) is 5-6] by intravenous infusion or cisplatin [75-80 mg/m2] by intravenous infusion), using up to 4 cycles. The choice of platinum drugs is at the discretion of the investigator.

Study groups in NCT05092412
Study group	Role	What they receive
Low-dose radiotherapy combined with durvalumab, etoposide, and cisplatin/carboplatin	Experimental	Not described Receives: Radiation: Low-dose radiotherapy; Drug: Durvalumab; Drug: Etoposide, and cisplatin/carboplatin

What is being measured

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

Progression-free survival (PFS)
The time from the date of first dosing of durvalumab to the first appearance of objective disease progression (according to RECIST1.1) or death from any cause (if it occurs before disease progression).
Measured: up to 2 years

Secondary outcomes (3)

median overall survival（mOS）
Time from the date of first dosing of durvalumab to death from any cause.
Measured: up to 2 years
Objective response rate (ORR)
According to the evaluation criteria of RECIST1.1.
Measured: up to 2 years
6-month progression-free survival rate / 12-month progression-free survival rate (PFS6/12)
The proportion of patients who are still alive and have no disease progression 6 months/12 months after the first dose of Durvalumab.
Measured: 1 years

Timeline

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

2 Mar 202230 Jun 2027

First posted25 Oct 2021
Study start2 Mar 2022
Primary completion6 Feb 2023
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (34)Papers the sponsor has linked to this study.
Other trials for 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05092412
Sponsor's protocol ID: ESR-20-20849
Status last verified: May 2026
First submitted: 13 Oct 2021
Last updated: 8 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Puglisi M, Dolly S, Faria A, Myerson JS, Popat S, O'Brien ME. Treatment options for small cell lung cancer - do we have more choice? Br J Cancer. 2010 Feb 16;102(4):629-38. doi: 10.1038/sj.bjc.6605527. Epub 2010 Jan 26.
PubMed 20104223
Peifer M, Fernandez-Cuesta L, Sos ML, George J, Seidel D, Kasper LH, Plenker D, Leenders F, Sun R, Zander T, Menon R, Koker M, Dahmen I, Muller C, Di Cerbo V, Schildhaus HU, Altmuller J, Baessmann I, Becker C, de Wilde B, Vandesompele J, Bohm D, Ansen S, Gabler F, Wilkening I, Heynck S, Heuckmann JM, Lu X, Carter SL, Cibulskis K, Banerji S, Getz G, Park KS, Rauh D, Grutter C, Fischer M, Pasqualucci L, Wright G, Wainer Z, Russell P, Petersen I, Chen Y, Stoelben E, Ludwig C, Schnabel P, Hoffmann H, Muley T, Brockmann M, Engel-Riedel W, Muscarella LA, Fazio VM, Groen H, Timens W, Sietsma H, Thunnissen E, Smit E, Heideman DA, Snijders PJ, Cappuzzo F, Ligorio C, Damiani S, Field J, Solberg S, Brustugun OT, Lund-Iversen M, Sanger J, Clement JH, Soltermann A, Moch H, Weder W, Solomon B, Soria JC, Validire P, Besse B, Brambilla E, Brambilla C, Lantuejoul S, Lorimier P, Schneider PM, Hallek M, Pao W, Meyerson M, Sage J, Shendure J, Schneider R, Buttner R, Wolf J, Nurnberg P, Perner S, Heukamp LC, Brindle PK, Haas S, Thomas RK. Integrative genome analyses identify key somatic driver mutations of small-cell lung cancer. Nat Genet. 2012 Oct;44(10):1104-10. doi: 10.1038/ng.2396. Epub 2012 Sep 2.
PubMed 22941188
Pignon JP, Arriagada R, Ihde DC, Johnson DH, Perry MC, Souhami RL, Brodin O, Joss RA, Kies MS, Lebeau B, et al. A meta-analysis of thoracic radiotherapy for small-cell lung cancer. N Engl J Med. 1992 Dec 3;327(23):1618-24. doi: 10.1056/NEJM199212033272302.
PubMed 1331787
Roth BJ, Johnson DH, Einhorn LH, Schacter LP, Cherng NC, Cohen HJ, Crawford J, Randolph JA, Goodlow JL, Broun GO, et al. Randomized study of cyclophosphamide, doxorubicin, and vincristine versus etoposide and cisplatin versus alternation of these two regimens in extensive small-cell lung cancer: a phase III trial of the Southeastern Cancer Study Group. J Clin Oncol. 1992 Feb;10(2):282-91. doi: 10.1200/JCO.1992.10.2.282.
PubMed 1310103
Rossi A, Di Maio M, Chiodini P, Rudd RM, Okamoto H, Skarlos DV, Fruh M, Qian W, Tamura T, Samantas E, Shibata T, Perrone F, Gallo C, Gridelli C, Martelli O, Lee SM. Carboplatin- or cisplatin-based chemotherapy in first-line treatment of small-cell lung cancer: the COCIS meta-analysis of individual patient data. J Clin Oncol. 2012 May 10;30(14):1692-8. doi: 10.1200/JCO.2011.40.4905. Epub 2012 Apr 2.
PubMed 22473169
Clark R, Ihde DC. Small-cell lung cancer: treatment progress and prospects. Oncology (Williston Park). 1998 May;12(5):647-58; discussion 661-3.
PubMed 9597676
Slotman BJ, van Tinteren H, Praag JO, Knegjens JL, El Sharouni SY, Hatton M, Keijser A, Faivre-Finn C, Senan S. Use of thoracic radiotherapy for extensive stage small-cell lung cancer: a phase 3 randomised controlled trial. Lancet. 2015 Jan 3;385(9962):36-42. doi: 10.1016/S0140-6736(14)61085-0. Epub 2014 Sep 14.
PubMed 25230595
Reck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D. Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2016 Nov 1;34(31):3740-3748. doi: 10.1200/JCO.2016.67.6601.
PubMed 27458307
Dunn GP, Old LJ, Schreiber RD. The three Es of cancer immunoediting. Annu Rev Immunol. 2004;22:329-60. doi: 10.1146/annurev.immunol.22.012703.104803.
PubMed 15032581
Keir ME, Butte MJ, Freeman GJ, Sharpe AH. PD-1 and its ligands in tolerance and immunity. Annu Rev Immunol. 2008;26:677-704. doi: 10.1146/annurev.immunol.26.021607.090331.
PubMed 18173375
Butte MJ, Keir ME, Phamduy TB, Sharpe AH, Freeman GJ. Programmed death-1 ligand 1 interacts specifically with the B7-1 costimulatory molecule to inhibit T cell responses. Immunity. 2007 Jul;27(1):111-22. doi: 10.1016/j.immuni.2007.05.016. Epub 2007 Jul 12.
PubMed 17629517
Zou W, Chen L. Inhibitory B7-family molecules in the tumour microenvironment. Nat Rev Immunol. 2008 Jun;8(6):467-77. doi: 10.1038/nri2326.
PubMed 18500231
Paterson AM, Brown KE, Keir ME, Vanguri VK, Riella LV, Chandraker A, Sayegh MH, Blazar BR, Freeman GJ, Sharpe AH. The programmed death-1 ligand 1:B7-1 pathway restrains diabetogenic effector T cells in vivo. J Immunol. 2011 Aug 1;187(3):1097-105. doi: 10.4049/jimmunol.1003496. Epub 2011 Jun 22.
PubMed 21697456
Stewart R, Morrow M, Hammond SA, Mulgrew K, Marcus D, Poon E, Watkins A, Mullins S, Chodorge M, Andrews J, Bannister D, Dick E, Crawford N, Parmentier J, Alimzhanov M, Babcook JS, Foltz IN, Buchanan A, Bedian V, Wilkinson RW, McCourt M. Identification and Characterization of MEDI4736, an Antagonistic Anti-PD-L1 Monoclonal Antibody. Cancer Immunol Res. 2015 Sep;3(9):1052-62. doi: 10.1158/2326-6066.CIR-14-0191. Epub 2015 May 5.
PubMed 25943534
Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.
PubMed 22658128

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?

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A First-line Multi-center, Single-arm Exploratory Study Using Low-dose Radiotherapy (LDRT) Combined With Durvalumab (MEDI4736), Etoposide, and Cisplatin/Carboplatin for Patients With Extensive-stage Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05092412
Acronym / sponsor ID: ESR-20-20849
Conditions: Lung Cancer, Extensive-stage Small-cell Lung Cancer, Durvalumab
Keywords: ES-SCLC, Durva, LDRT
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 30 participants (actual)
Lead sponsor: You LuUniversity, hospital or other
Collaborators: AstraZeneca
Study start: 2 Mar 2022 (actual)
Primary completion: 6 Feb 2023 (actual)
Study completion: 30 Jun 2027 (estimated)
First posted: 25 Oct 2021 (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
Low-dose radiotherapy combined with durvalumab, etoposide, and cisplatin/carboplatin	Experimental	Radiation: Low-dose radiotherapy, Drug: Durvalumab, Drug: Etoposide, and cisplatin/carboplatin

Who may qualify

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

Key inclusion criteria (19 listed)

At the time of screening, male or female participants were ≥18 years old.
Before carrying out any research program related procedures (including screening evaluation), obtain written informed consent and any locally required authorization from the participant or his legal representative.
Extensive-stage disease confirmed by histology or cytology (American Joint Committee on Cancer (8th edition) stage IV SCLC [any T, any N and M1a/b/c]), or due to multiple lung nodules with a wide range Or the size of the tumor/nodule is too large to be included in a tolerable radiotherapy plan for stage T3-4 disease.
Participants with brain metastases must be asymptomatic or stable with steroids and anticonvulsants for at least 1 month before study treatment. Participants with suspected brain metastases during screening should undergo brain CT/MRI before enrollment in the study.
The participant must be considered suitable for platinum-based chemotherapy as the first-line treatment for extensive-stage small cell lung cancer. Chemotherapy must include either cisplatin or carboplatin, combined with etoposide.

Key exclusion criteria (29 listed)

Participate in the design and execution of the study (applicable to researchers and/or members of the research center).
Have previously received the distribution of experimental drug (IP) in this study.
Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
Etoposide-platinum (carboplatin or cisplatin)-based chemotherapy is medically contraindicated.
Have a history of chest radiotherapy or plan to undergo intensive chest radiotherapy before systemic treatment. Radiotherapy outside the chest (eg, bone metastases) for the purpose of palliative care is allowed, but it must be completed before the first administration of the study drug.

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
Low-dose radiotherapyThe LDRT deals with primary tumour in a 15 Gy of 5fractions over five days, starting from Day 1 in the first cycle.	Radiation	Low-dose radiotherapy combined with durvalumab, etoposide, and cisplatin/carboplatin
DurvalumabDurvalumab 1500 mg intravenous infusion, started to be used simultaneously with chemotherapy at week 0 and continued after chemotherapy.	Drug	Low-dose radiotherapy combined with durvalumab, etoposide, and cisplatin/carboplatin
Etoposide, and cisplatin/carboplatinStarting from week 0, the dose of etoposide + carboplatin or cisplatin in the study will not exceed the dose for specific indications in the product instructions (etoposide [80 to 100mg/m2] via intravenous infusion and carboplatin [ The area under the curve (AUC) is 5-6] by intravenous infusion or cisplatin [75-80 mg/m2] by intravenous infusion), using up to 4 cycles. The choice of platinum drugs is at the discretion of the investigator.	Drug	Low-dose radiotherapy combined with durvalumab, etoposide, and cisplatin/carboplatin

Primary outcome

Progression-free survival (PFS)
Time frame: up to 2 years
The time from the date of first dosing of durvalumab to the first appearance of objective disease progression (according to RECIST1.1) or death from any cause (if it occurs before disease progression).

3 secondary outcomes

median overall survival（mOS）
Time frame: up to 2 years
Objective response rate (ORR)
Time frame: up to 2 years
6-month progression-free survival rate / 12-month progression-free survival rate (PFS6/12)
Time frame: 1 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 8 May 2026.
Background: PubMed 20104223Puglisi M, Dolly S, Faria A, Myerson JS, Popat S, O'Brien ME. Treatment options for small cell lung cancer - do we have more choice? Br J Cancer. 2010 Feb 16;102(4):629-38. doi: 10.1038/sj.bjc.6605527. Epub 2010 Jan 26.
Background: PubMed 22941188Peifer M, Fernandez-Cuesta L, Sos ML, George J, Seidel D, Kasper LH, Plenker D, Leenders F, Sun R, Zander T, Menon R, Koker M, Dahmen I, Muller C, Di Cerbo V, Schildhaus HU, Altmuller J, Baessmann I, Becker C, de Wilde B, Vandesompele J, Bohm D, Ansen S, Gabler F, Wilkening I, Heynck S, Heuckmann JM, Lu X, Carter SL, Cibulskis K, Banerji S, Getz G, Park KS, Rauh D, Grutter C, Fischer M, Pasqualucci L, Wright G, Wainer Z, Russell P, Petersen I, Chen Y, Stoelben E, Ludwig C, Schnabel P, Hoffmann H, Muley T, Brockmann M, Engel-Riedel W, Muscarella LA, Fazio VM, Groen H, Timens W, Sietsma H, Thunnissen E, Smit E, Heideman DA, Snijders PJ, Cappuzzo F, Ligorio C, Damiani S, Field J, Solberg S, Brustugun OT, Lund-Iversen M, Sanger J, Clement JH, Soltermann A, Moch H, Weder W, Solomon B, Soria JC, Validire P, Besse B, Brambilla E, Brambilla C, Lantuejoul S, Lorimier P, Schneider PM, Hallek M, Pao W, Meyerson M, Sage J, Shendure J, Schneider R, Buttner R, Wolf J, Nurnberg P, Perner S, Heukamp LC, Brindle PK, Haas S, Thomas RK. Integrative genome analyses identify key somatic driver mutations of small-cell lung cancer. Nat Genet. 2012 Oct;44(10):1104-10. doi: 10.1038/ng.2396. Epub 2012 Sep 2.
Background: PubMed 1331787Pignon JP, Arriagada R, Ihde DC, Johnson DH, Perry MC, Souhami RL, Brodin O, Joss RA, Kies MS, Lebeau B, et al. A meta-analysis of thoracic radiotherapy for small-cell lung cancer. N Engl J Med. 1992 Dec 3;327(23):1618-24. doi: 10.1056/NEJM199212033272302.
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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.

You Lu, MD study chair

West China Hospital

Yan Zhang, MD principal investigator

West China Hospital

Yue Xie, MM study director

Chongqing University Cancer Hospital

3 sites 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 19 inclusion and 29 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 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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: up to 2 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 NCT05092412, which also lists 34 linked publications.

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 8 May 2026.