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Immunotherapy plus chemo shows promise for rare lung cancer

NCT ID NCT05470595

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 II trial is testing whether adding the immunotherapy drug atezolizumab to standard chemotherapy (platinum and etoposide) can help people with advanced large-cell neuroendocrine lung cancer live longer. About 67 participants who have not had prior systemic treatment will receive the combination for four cycles, followed by atezolizumab alone. The study measures overall survival, tumor response, and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Atezolizumab (an immunotherapy drug) combined with standard chemotherapy (platinum and etoposide)
What this could lead to
If successful, this could offer a new, more effective treatment option for people with advanced large-cell neuroendocrine lung cancer, potentially improving survival and disease control.
What could go wrong
This is a mid-stage trial with only 67 participants and no comparison group, so results may not be definitive. Immunotherapy can cause immune-related side effects, and the cancer may still progress.

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 67 people

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

Started

Jan 2022

Expected to finish

Jan 2029

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: 1. Written informed consent 2. Patients with locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung (LCNEC) without curative treatment options (patients with mixed histology are eligible if LCNEC is the predominant histology i.e. ≥50%) 3. Previously untreated with systemic therapy (note: patients relapsing after curative radio chemotherapy or adjuvant chemotherapy are eligible if relapse occurs ≥6 months after discontinuation of curative treatment) 4. Planned treatment with Carboplatin or Cisplatin and Etoposide (SoC) 5. ECOG performance status: 0-2 6. age ≥18 years 7. measurable disease according to RECIST v1.1 8. adequate organ function defined as: 1. ALAT/ASAT ≤2.5x ULN or ≤3.5x ULN in case of liver metastases 2. Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases 3. Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault \>60 ml/min 4. Neutrophils ≥1 Gpt/l, Platelets \>50 Gpt/l unless caused by bone marrow carcinosis Exclusion Criteria: 1. Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks) 2. Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment) 3. Severe uncontrolled infection 4. Prior treatment with either Atezolizumab or other immune checkpoint inhibitor 5. Any prior treatment for metastatic disease

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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 München-Gauting

    Gauting, 82131, Germany

  • Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik

    Berlin, 10117, Germany

  • Evangelische Lungenklinik

    Berlin, 12125, Germany

  • Klinikum der J.W. Goethe Universität, Medizinische Klinik II

    Frankfurt am Main, 60590, Germany

  • Klinikum der Johannes Gutenberg Universität, III. Med. Klinik und Poliklinik

    Mainz, 55131, Germany

  • Klinikum der Universität zu Köln, Klinik I für Innere Medizin

    Cologne, 50937, Germany

  • Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH

    Halle, 06110, Germany

  • LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927, Germany

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376, Germany

  • Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH

    Hemer, 58675, Germany

  • Pius Hospital, Klinik für Hämatologie und Onkologie

    Oldenburg, 26121, Germany

  • Rems-Murr-Klinikum Winnenden, Klinik für Hämatologie, Onkologie und Palliativmedizin

    Winnenden, 71364, Germany

  • Robert-Bosch-Krankenhaus GmbH

    Stuttgart, 70376, Germany

  • Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg

    Heidelberg, 69126, Germany

  • Universitätsklinikum Dresden, Medizinische Klinik 1

    Dresden, 01307, Germany

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