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New hope for small cell lung cancer: immunotherapy after surgery

NCT ID NCT07149363

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 65 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • University of Illinois Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Virginia Comprehensive Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

More trials for these conditions

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