New hope for small cell lung cancer: immunotherapy after surgery
NCT ID NCT07149363
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether adding the immunotherapy drug durvalumab to standard chemotherapy after surgery can help prevent small cell lung cancer from coming back. About 65 adults who had their cancer completely removed will receive the combination for 12 weeks, then durvalumab alone for another 36 weeks. The study compares their outcomes to historical data from patients who only got chemotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- durvalumab (Imfinzi) plus chemotherapy (cisplatin or carboplatin and etoposide)
- What this could lead to
- If successful, this could offer a new standard treatment after surgery for limited-stage small cell lung cancer, potentially delaying or preventing cancer return.
- What could go wrong
- This is a small, early-phase trial (65 people) comparing results to past data, not a direct control group. Immunotherapy can cause immune-related side effects, and the benefit over chemo alone is not yet proven.
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 65 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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Feb 2031
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: * Age ≥ 18 years. * Body weight \>30 kg. * Must have a life expectancy of at least 12 weeks. * Must have histologically or cytologically confirmed diagnosis of pathologic T1-T2 N0-1 M0 small-cell lung cancer per the American Joint Committee on Cancer staging system, 8th edition. * Have completely resected (wedge resection, segmentectomy, lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy) small-cell lung cancer within 78 days of enrollment. * Complete mediastinal lymph node dissection (MLND) or systematic mediastinal lymph node sampling is required. * No prior systemic therapies, for small cell lung cancer. * Post-operative radiation for the resected small cell lung cancer is acceptable per treating physician in the setting of N1 disease, but no other prior radiation for small cell lung cancer. * ECOG performance status 0-1. Exclusion Criteria: * Patients who are receiving any other investigational agents. * Concurrent enrollment in another clinical study involving investigational treatment directed to treatment of patients with small cell lung cancer. * Prior treatment with durvalumab. * 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. * Superficial bladder cancer without active disease after treatment. * Low grade prostate cancer without indication for active treatment. * Adequately treated carcinoma in situ without evidence of disease. * Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months. * Patients with hemoptysis in excess of 2.5 mL within 2 weeks prior to the first dose of study medication. * Patients requiring concomitant therapy with phenytoin, phenobarbital, or carbamazepine.
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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
3 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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Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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University of Illinois Chicago
RECRUITINGChicago, Illinois, 60612, United States
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University of Virginia Comprehensive Cancer Center
RECRUITINGCharlottesville, Virginia, 22908, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can armored CAR t cells take down Hard-to-Treat neuroendocrine cancers?
- Engineered immune cells take aim at stubborn lung cancer
- Could a hidden nerve condition be more common in lung cancer than we think?
- Can a gentler drug trio tame small cell lung cancer in older patients?
- Experimental combo aims to tackle Treatment-Resistant cancers