New combo aims to boost survival in aggressive lung cancer
NCT ID NCT07055581
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial is testing whether adding the immunotherapy drug durvalumab to standard chemotherapy and radiation can help people with limited-stage small-cell lung cancer live longer without their cancer returning. About 100 participants will receive durvalumab plus chemo before radiation, then durvalumab alone for up to two years. The study is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Durvalumab (an immunotherapy drug) combined with chemotherapy (etoposide and cisplatin or carboplatin) and radiation therapy
- What this could lead to
- If successful, this could offer a new treatment option that improves how long people with limited-stage small-cell lung cancer live without their cancer getting worse.
- What could go wrong
- This is an early phase II study with only 100 participants and no comparison group, so results are uncertain. Immunotherapy can cause immune-related side effects like lung inflammation or colitis.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1.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. * 2.Histologically or cytologically confirmed small cell lung cancer * 3.Limited-stage, defined as stage I-III SCLC (T any, N any, M0). Patients who are Stage I or II must be medically inoperable as determined by investigator. * 4.Age \> 18 years. * 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * 6.Adequate normal organ and marrow function. * 7.Must have a life expectancy of at least 12 week. * 8.At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to enrollment. Exclusion Criteria: * 1.Patients with extensive disease small-cell lung cancer. * 2.Patients who previously received radiotherapy to the thorax or chemotherapy for small cell lung cancer. * 3.Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology. Patients with mixed histology tumors with predominant SCLC histology are allowed. * 4.Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values. * 5.Any concurrent chemotherapy other than study treatment, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. * 6.History of allogenic organ transplantation. * 7.Active or prior documented autoimmune or inflammatory disorders. * 8.Uncontrolled intercurrent illness. * 9.History of leptomeningeal carcinomatosis. * 10.Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart) * 11.History of active primary immunodeficiency * 12.Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of antiHBc and absence of HBsAg) and with undetectable HBV DNA (\< 10 IU/ml or under the limit of detection per local lab standard) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. * 13.Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. * 14.Prior treatment in a previous durvalumab clinical study. * 15.Known allergy or hypersensitivity to IP or any excipient.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital
RECRUITINGZhengzhou, Henan, 450008, China
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Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430030, China
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