Large Cell Neuroendocrine Carcinoma of the LungPhase 2LCNEC-ALPINENCT05470595
A Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung
A Phase 2 study testing Atezolizumab in people with Large Cell Neuroendocrine Carcinoma of the Lung, run by Technische Universität Dresden at 15 sites in Germany.
Trial summary
This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Cell Neuroendocrine Carcinoma of the Lung
- What is being tested?
- Atezolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 15 sitesGermany
- Study dates
- 18 Jan 2022to 31 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- 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%)
- 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)
- Planned treatment with Carboplatin or Cisplatin and Etoposide (SoC)
- ECOG performance status: 0-2
- age ≥18 years
Show all 12Show fewer
- measurable disease according to RECIST v1.1
- adequate organ function defined as:
- ALAT/ASAT ≤2.5x ULN or ≤3.5x ULN in case of liver metastases
- Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases
- Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault >60 ml/min
- Neutrophils ≥1 Gpt/l, Platelets >50 Gpt/l unless caused by bone marrow carcinosis
Who cannot join
- Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks)
- Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment)
- Severe uncontrolled infection
- Prior treatment with either Atezolizumab or other immune checkpoint inhibitor
- Any prior treatment for metastatic disease
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Germany15 sites
Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik
Berlin, 10117
Evangelische Lungenklinik
Berlin, 12125
Klinikum der Universität zu Köln, Klinik I für Innere Medizin
Cologne, 50937
Universitätsklinikum Dresden, Medizinische Klinik 1
Dresden, 01307
Klinikum der J.W. Goethe Universität, Medizinische Klinik II
Frankfurt am Main, 60590
Asklepios Fachkliniken München-Gauting
Gauting, 82131
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Halle, 06110
Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg
Heidelberg, 69126
Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
Hemer, 58675
Lungenfachklinik Immenhausen
Immenhausen, 34376
Klinikum der Johannes Gutenberg Universität, III. Med. Klinik und Poliklinik
Mainz, 55131
Pius Hospital, Klinik für Hämatologie und Onkologie
Oldenburg, 26121
Robert-Bosch-Krankenhaus GmbH
Stuttgart, 70376
Rems-Murr-Klinikum Winnenden, Klinik für Hämatologie, Onkologie und Palliativmedizin
Winnenden, 71364
About this study
Official title: A Phase II, Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung
This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
- Being tested
- Atezolizumab
- Keywords
- Lung Cancer, LCNEC, Neuroendocrine Carcinoma
- Medical subject headings
- Lung Neoplasms, Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Atezolizumab (IMP) will be added to Platinum/Etoposide (Standard-of-Care). Four cycles of combined immunochemotherapy 3qw will be followed by maintenance with atezolizumab monotherapy until progression.
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab/Platinum/Etoposide | Experimental | Atezolizumab/Platinum/Etoposide Platinum will be cisplatin or carboplatin at the investigators discretion. Receives: Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
To assess the efficacy of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC as measured by overall survival.
Measured: appr. 72 months
Secondary outcomes (10)
Objective Response Rate (ORR)
According to RECIST v1.1 as assessed by local investigator.
Measured: appr. 72 months
Immune Objective Response Rate (iORR)
According to iRECIST as assessed by local investigator.
Measured: appr. 72 months
Disease Control Rate (DCR)
According to RECIST v1.1 as assessed by local investigator.
Measured: appr. 72 months
Progression Free Survival (PFS)
Measured: appr. 72 months
Immune Progression Free Survival (iPFS)
Measured: appr. 72 months
Duration of Response (DoR)
Measured: appr. 72 months
Progression Free Survival (PFS) rate at one year
Measured: 1 year
Immune Progression Free Survival (iPFS) rate at one year
Measured: 1 year
Overall survival at one year
Measured: 1 year
Incidence, intensity, seriousness, relationship to Atezolizumab, and outcome of adverse events graded according to NCI CTCAE (v5.0).
Measured: appr. 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start18 Jan 2022
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Large Cell Neuroendocrine Carcinoma of the LungStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Martin Wermke, Prof. Dr., Principal investigator, Technische Universität Dresden (TUD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470595
- Sponsor's protocol ID
- TUD-ALPINE-077
- Other IDs
- 2024-515902-15-00, 2020-002683-31
- Acronym
- LCNEC-ALPINE
- Status last verified
- Apr 2026
- First submitted
- 13 Jul 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Montfort A, Perol D, Lupo-Mansuet A, Greillier L, Gautier J, Decroisette C, Chabaud S, Arpin D, Odier L. Development of an externally controlled trial from a single-arm study to assess first-line immunochemotherapy in advanced large cell neuroendocrine lung carcinomas: a study protocol from the FIRST-NEC GFPC 01-2022 trial. BMJ Open. 2026 Jul 29;16(7):e118897. doi: 10.1136/bmjopen-2026-118897.
PubMed 42526918
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung
- ClinicalTrials.gov ID
- NCT05470595
- Acronym / sponsor ID
- LCNEC-ALPINE / TUD-ALPINE-077
- Keywords
- Lung Cancer, LCNEC, Neuroendocrine Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab/Platinum/Etoposide | Experimental | Drug: AtezolizumabAtezolizumab/Platinum/Etoposide Platinum will be cisplatin or carboplatin at the investigators discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent
- 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%)
- 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)
- Planned treatment with Carboplatin or Cisplatin and Etoposide (SoC)
- ECOG performance status: 0-2
Key exclusion criteria (5 listed)
- Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks)
- Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment)
- Severe uncontrolled infection
- Prior treatment with either Atezolizumab or other immune checkpoint inhibitor
- Any prior treatment for metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAtezolizumab (IMP) will be added to Platinum/Etoposide (Standard-of-Care). Four cycles of combined immunochemotherapy 3qw will be followed by maintenance with atezolizumab monotherapy until progression. | Drug | Atezolizumab/Platinum/Etoposide |
Primary outcome
Overall survival
Time frame: appr. 72 months
To assess the efficacy of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC as measured by overall survival.
10 secondary outcomes
Objective Response Rate (ORR)
Time frame: appr. 72 months
Immune Objective Response Rate (iORR)
Time frame: appr. 72 months
Disease Control Rate (DCR)
Time frame: appr. 72 months
Progression Free Survival (PFS)
Time frame: appr. 72 months
Immune Progression Free Survival (iPFS)
Time frame: appr. 72 months
Duration of Response (DoR)
Time frame: appr. 72 months
Progression Free Survival (PFS) rate at one year
Time frame: 1 year
Immune Progression Free Survival (iPFS) rate at one year
Time frame: 1 year
Overall survival at one year
Time frame: 1 year
Incidence, intensity, seriousness, relationship to Atezolizumab, and outcome of adverse events graded according to NCI CTCAE (v5.0).
Time frame: appr. 72 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Derived from this study: PubMed 42526918De Montfort A, Perol D, Lupo-Mansuet A, Greillier L, Gautier J, Decroisette C, Chabaud S, Arpin D, Odier L. Development of an externally controlled trial from a single-arm study to assess first-line immunochemotherapy in advanced large cell neuroendocrine lung carcinomas: a study protocol from the FIRST-NEC GFPC 01-2022 trial. BMJ Open. 2026 Jul 29;16(7):e118897. doi: 10.1136/bmjopen-2026-118897.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Wermke, Prof. Dr. principal investigator
Technische Universität Dresden (TUD)
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab in people with Large Cell Neuroendocrine Carcinoma of the Lung, run by Technische Universität Dresden at 15 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: appr. 72 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05470595, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.