Immunotherapy plus chemo shows promise for rare lung cancer
NCT ID NCT05470595
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
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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 67 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Jan 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. 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
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Asklepios Fachkliniken München-Gauting
Gauting, 82131, Germany
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Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik
Berlin, 10117, Germany
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Evangelische Lungenklinik
Berlin, 12125, Germany
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Klinikum der J.W. Goethe Universität, Medizinische Klinik II
Frankfurt am Main, 60590, Germany
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Klinikum der Johannes Gutenberg Universität, III. Med. Klinik und Poliklinik
Mainz, 55131, Germany
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Klinikum der Universität zu Köln, Klinik I für Innere Medizin
Cologne, 50937, Germany
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Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Halle, 06110, Germany
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LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927, Germany
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Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
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Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
Hemer, 58675, Germany
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Pius Hospital, Klinik für Hämatologie und Onkologie
Oldenburg, 26121, Germany
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Rems-Murr-Klinikum Winnenden, Klinik für Hämatologie, Onkologie und Palliativmedizin
Winnenden, 71364, Germany
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Robert-Bosch-Krankenhaus GmbH
Stuttgart, 70376, Germany
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Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg
Heidelberg, 69126, Germany
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Universitätsklinikum Dresden, Medizinische Klinik 1
Dresden, 01307, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Immunotherapy combo targets rare, aggressive lung cancer
- New drug cocktail aims to tame rare lung cancer
- Triple-Drug cocktail takes aim at rare, aggressive cancers
- Engineered immune cells take aim at tough lung cancer
- Radioactive drug targets tough lung cancers in early trial
- New hope for Chemo-Resistant lung cancers?