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Immunotherapy combo shows promise against tough lung cancer

NCT ID NCT04602533

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding the immunotherapy drug durvalumab (Imfinzi) to standard chemotherapy and radiation can help people with limited-stage small cell lung cancer live longer without their cancer growing. About 105 participants will receive either the standard treatment alone or the standard treatment plus durvalumab, followed by maintenance durvalumab. The study aims to see if the combination improves progression-free survival at 18 months.

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 with etoposide) and radiation therapy
What this could lead to
If successful, this could offer a new standard treatment that delays cancer progression in patients with limited-stage small cell lung cancer.
What could go wrong
This is a mid-stage trial with only 105 participants, so results may not apply to all patients. Adding durvalumab may increase side effects like immune-related inflammation.

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

105 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Dec 2026

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: * Signed and dated informed consent of the subject must be available before start of any specific trial procedures * Male or female ≥ 18 years * Histological confirmed limited disease small cell lung cancer (stage 2 and 3; T1a-4, N1-3, M0 according UICC8 criteria; if primarius is not eligible as RECIST1.1 target lesion (in cases with T1a and T1b) at least one lymph node must meet RECIST1.1 criteria for target lesion (≥15 mm short axis)) * Availability of tumor tissue or fresh tumor material for translational research by central lab testing * ECOG PS 0 - 1 * At least one measurable lesion according RECIST 1.1 * Body weight \> 30 kg * Adequate normal organ function 1. Hemoglobin ≥ 9.0 g/dL 2. Absolute neutrophil count (ANC) ≥ 1.5 x109/L 3. Platelet count ≥ 100 x109/L 4. AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal 5. Serum Bilirubin ≤ 1.5 x institutional upper limit of normal 6. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min for Carboplatin, ≥ 60 mL/min for Cisplatin, calculated by the Cockcroft-Gault formula * Life expectancy of at least 12 weeks in the discretion of the investigator * Ability of subject to understand nature, importance and individual consequences of clinical trial Exclusion Criteria: * Extensive disease small cell lung cancer (Tx, Nx, M1; stage IV) * Major surgical process within 28 day prior first dose of IMP and/or Radiochemotherapy * History of allogenic organ transplantation * Active or prior documented autoimmune or inflammatory disorder (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: 1. Patients with vitiligo or alopecia 2. Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement 3. Patients with any chronic skin condition that not required systemic therapy 4. Patients without active disease in the last 5 years may be included but only after consultation with the study physician 5. Patients with celiac disease controlled by diet alone * Uncontrolled intercurrent illness (i.e. active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, serious chronic gastrointestinal conditions (i.e. diarrhea), psychiatric illness) * History of another primary malignancy in the last 5 years, except adequately treated nonmelanoma skin cancer, adequately treated carcinoma in situ (without evidence of disease) * History of leptomeningeal carcinomatosis, or brain metastases * Known HIV positive and/or 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.The following are exceptions to this criterion: 1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) 2. Systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or its equivalent 3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) * Receipt of live attenuated vaccine within 30 days prior to the first dose of IMP * Participation in another clinical trial with an investigational product within the last 30 days (unless during follow-up period of an interventional study) * Known hypersensitivity to one of the ingredients * Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial * Pregnancy, lactation and contraception 1. Women who are pregnant, nursing or who plan to become pregnant while in the trial 2. Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at informed consent, for the duration of drug treatment and for the drug out washout period (90 days after last dose of Durvalumab and/or 6 months after last dose of cisplatin/carboplatin and etoposide). * Patients who are legally institutionalized

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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.

Contacts and locations

Locations

  • Asklepios Fachkliniken Muenchen Gauting

    München Gauting, Bavaria, 82131, Germany

  • Asklepios Klinikum Hamburg

    Hamburg, 21075, Germany

  • Helios Kliniken Erfurt

    Erfurt, Thuringia, 99089, Germany

  • Johannes Wesling Klinikum Minden

    Minden, North Rhine-Westphalia, 32429, Germany

  • KEM GmbH

    Essen, North Rhine-Westphalia, 45136, Germany

  • Klinikum Ernst von Bergmann

    Potsdam, Brandenburg, 14467, Germany

  • Klinikum Kassel GmbH-Klinik für Onkologie und Hämatologie

    Kassel, Hesse, 34125, Germany

  • Klinikverbund Allgäu gGmbH

    Immenstadt im Allgäu, Bavaria, 87509, Germany

  • Lungenklinik Hemer

    Hemer, North Rhine-Westphalia, 58675, Germany

  • Lungenklinik Köln-Merheim

    Cologne, North Rhine-Westphalia, 51109, Germany

  • Sana-Klinikum Offenbach

    Offenbach, Hesse, 63069, Germany

  • Universitätsklinikum Aachen

    Aachen, North Rhine-Westphalia, 52074, Germany

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitätsklinikum Gießen Marburg

    Giessen, Hesse, 35392, Germany

  • Universitätsmedizin Rostock

    Rostock, Mecklenburg-Vorpommern, 18059, Germany

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