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Non-Small Cell Lung Cancer MetastaticPhase 4ANTELOPENCT05689671

Pemetrexed-free vs. Pemetrexed-based Immunochemotherapy in Metastatic TTF-1 Negative Lung Adenocarcinoma

A Phase 4 study testing Atezolizumab, Nab paclitaxel and Carboplatin in people with Non-Small Cell Lung Cancer Metastatic, run by Nikolaj Frost MD at 36 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is an open-label randomized, controlled, multicenter, phase II trial with two arms. Patients with metastatic TTF-1 negative, treatment-naive lung adenocarcinoma without actionable genomic alterations are randomized in a 1:1 manner to investigate the efficiency of atezolizumab, carboplatin and nab-paclitaxel (Arm… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer Metastatic
What is being tested?
Atezolizumab, Nab paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
36 sitesGermany
Study dates
6 Dec 2023to Oct 2026
Phase
Phase 4
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

  • Patient has provided written informed consent
  • Patient* 18 years or older at time of signing the informed consent form
  • Histologically or cytologically confirmed metastatic stage IV non-squamous NSCLC
  • Negative local testing for TTF-1
  • Negative molecular testing for EGFR mutations and ALK rearrangements (tested locally). Exception: In specific individual cases, treatment can be initiated prior to receiving molecular diagnostics after consulting with the sponsor, if the local principal investigator assesses the likelihood of an EGFR mutation or ALK fusion to be negligible. However, this should only be done in exceptional cases if the patient has particularly high demand for treatment. If it is subsequently found that patients are positive for EGFR mutations and/or ALK rearrangements, they must be withdrawn from the study immediately and must not receive any further study medication. Instead, patients should receive adequate SOC therapy outside the study.
  • Awaiting results for molecular testing remains standard procedure for patient inclusion.
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  • PD-L1 tumor proportion score (TPS) < 50%, tested locally by QUiP®-certified immunohistochemistry
  • ECOG performance status ≤ 1
  • Measurable lesions according to RECIST v1.1
  • Life expectancy ≥ 12 weeks
  • Adequate hepatic, renal and bone marrow function
  • Hemoglobin ≥ 8.0 g/dL
  • Absolute neutrophil count ≥ 1.5 x 109/L
  • Platelets ≥ 100 x 109/L
  • Calculated creatine clearance ≥ 50 mL/min as determined by the Cockcroft-Gault equation and/or creatinin ≤ 1,5x upper limit of normal (ULN)
  • Serum bilirubin ≤ 1.5 x institutional ULN
  • AST/ ALT and alkaline phosphatase ≤ 2.5 x ULN
  • International normalized ratio (INR)/ Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants
  • The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
  • Female patients who are considered as woman of childbearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year during the treatment as well as up to 6 months after the last dose of study treatment. Male patients who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year during the treatment as well as at least 6 months after the last dose of IMP. Female patients who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic male patients do not require contraception

Who cannot join

  • Mixed histologies (small-cell and non-small cell or non-squamous and squamous; patients exhibiting the latter expression pattern may be eligible if the non-squamous part predominates)
  • Patients having received:
  • Systemic treatment for metastatic or locally advanced disease
  • prior PD-1/PD-L1 immunotherapies (prior treatment with CD137 agonists or immune checkpoint blockade therapies, including, but not limited to, anti-cytotoxic T lymphocyte associated protein 4 [anti-CTLA-4], anti T cell immunoreceptor with Ig and tyrosine-based inhibition motif domains [anti-TIGIT], anti-PD-1 and anti-PD-L1 therapeutic antibodies)
  • Symptomatic, neurologically unstable CNS metastases or requiring increasing doses of steroids to manage CNS symptoms within 2 weeks prior to study entry (maximal acceptable dose must be ≤ 10 mg of prednisolone). Patients with asymptomatic, incidentally detected CNS metastases may be enrolled. Palliative radiotherapy for asymptomatic brain metastases (and any other, non-brain metastases, e.g. bone metastases) may be conducted after study entry.
  • Leptomeningeal disease
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  • History of interstitial lung disease
  • Severe infection within 2 weeks prior to study entry. Clinical signs must have been resolved to CTCAE grade ≤ 1
  • Active infection with hepatitis B or C virus (HBV, HCV), human immunodeficiency virus (HIV) or Mycobacterium tuberculosis
  • Known additional malignancies other than NSCLC, either untreated or having required active treatment within the past 3 years
  • Significant cardiovascular disease (≥ NYHA 3)
  • Active or prior documented autoimmune or inflammatory disorders (including but not limited to diverticulitis [with the exception of diverticulosis], celiac disease, systemic lupus erythematosus, Sarcoidosis, or Wegener's syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis). The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism (e.g., following Hashimoto's disease) stable on hormone replacement
  • Patients with controlled Type I diabetes mellitus on an insulin regimen
  • Any chronic skin condition that does not require systemic therapy
  • Patients without active disease in the last 5 years may be included but only after consultation with the study physician
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of atezolizumab/pembrolizumab. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication)
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
  • Live vaccine within 30 days prior to first dose of trial treatment
  • Known allergy or hypersensitivity to any component of the chemotherapy regimen or to atezolizumab or pembrolizumab or any constituents of the products
  • Any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.
  • Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

Germany36 sites

  • Klinikum St. Marien

    Amberg, 92224

  • Universitätsklinikum Augsburg

    Augsburg, 86156

  • MVZ Taunus GmbH

    Bad Homburg, 61352

  • Evangelische Lungenklinik Krankenhausbetriebs gGmbH

    Berlin, 13125

  • Evangelische Lungenklinik

    Berlin, 13125

  • Charité Universitätsmedizin

    Berlin, 13353

  • Helios Klinikum Emil von Behring

    Berlin, 14165

  • Klinikum Bielefeld

    Bielefeld, 33604

  • Kliniken der Stadt Köln GmbH

    Cologne, 51109

  • Technische Universität Dresden Medizinische Fakultät Carl Gustav Carus

    Dresden, 01307

  • Universitätsklinikum Essen

    Essen, 45122

  • KEM Evang. Kliniken Essen-Mitte

    Essen, 45136

  • Klinikum Esslingen GmbH

    Esslingen am Neckar, 73730

  • Krankenhaus Nordwest

    Frankfurt, 60488

  • Universitätsklinikum Frankfurt am Main

    Frankfurt am Main, 60590

  • Asklepios Klinik Gauting GmbH

    Gauting, 82131

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • LungenClinic Großhansdorf GmbH

    Großhansdorf, 22927

  • Asklepios Klinkum Hamburg

    Hamburg, 21075

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126

  • Lungenklinik Hemer

    Hemer, 58675

  • Thoraxzentrum Ruhrgebiet Ev. Krankenhaus Herne

    Herne, 44651

  • Helios Klinikum Krefeld

    Krefeld, 47805

  • ÜBAG- Medizinisches Versorgungszentrum Dr. Vehling-Kaiser GmbH

    Landshut, 84036

  • Klinikum Lippe GmbH

    Lemgo, 32657

  • UKSH, Campus Lübeck

    Lübeck, 23538

  • Klinikum Ludwigsburg

    Ludwigsburg, 71640

  • Medizinische Fakultät Mannheim der Universität Heidelberg

    Mannheim, 68167

  • LMU Klinikum

    München, 80336

  • Unversitätsklinikum Münster

    Münster, 48149

  • Überörtliche Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster, 48153

  • Pius Hospital

    Oldenburg, 26121

  • MVZ für Hämatologie und Onkologie Ravensburg GmbH

    Ravensburg, 88212

  • Barmherzige Brüder Krankenhaus Regensburg

    Regensburg, 93049

  • Elblandkliniken Stiftung & Co. KG Elblandklinikum Riesa

    Riesa, 01589

  • Klinikum Stuttgart

    Stuttgart, 70174

Other trials in Germany

About this study

Official title: Atezolizumab/Carboplatin/Nab-Paclitaxel vs. Pembrolizumab/Platinum/Pemetrexed in Metastatic TTF-1 Negative Lung Adenocarcinoma

This is an open-label randomized, controlled, multicenter, phase II trial with two arms. Patients with metastatic TTF-1 negative, treatment-naive lung adenocarcinoma without actionable genomic alterations are randomized in a 1:1 manner to investigate the efficiency of atezolizumab, carboplatin and nab-paclitaxel (Arm A) versus pembrolizumab, cis-/carboplatin and pemetrexed (Arm B) as first-line treatment.

Read the detailed description

Thyroid transcription factor 1 (TTF-1) is expressed in the majority of lung adenocarcinoma and has a clear prognostic value. Pemetrexed-based immunochemotherapy is a standard of care for advanced lung adenocarcinoma. However, real-world data suggest that TTF-1 negative patients might derive superior outcome using pemetrexed-free regimens. The aim of this study is to compare a pemetrexed-free (Arm A) vs. a pemetrexed-based immunochemotherapy (Arm B) as first-line treatment for metastatic TTF-1 negative lung adenocarcinoma without actionable genomic alterations.

Keywords
NSCLC, checkpoint inhibitors, immunochemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05689671
Study groupRoleWhat they receive
Pemetrexed-free Immunochemotherapy (Arm A)ExperimentalAtezolizumab 1200 mg q3w, carboplatin AUC 5-6 q3w, nab-paclitaxel 100 mg/m2 qw (administered for 4 cycles with subsequent maintenance with atezolizumab monotherapy 1200 mg q3w until loss of clinical benefit or occurrence of unacceptable toxicity)
Receives: Drug: Atezolizumab; Drug: Nab paclitaxel; Drug: Carboplatin
Pemetrexed-based Immunochemotherapy (Arm B)Active comparatorPembrolizumab 200 mg q3w, cisplatin 75 mg/m2 q3w OR carboplatin AUC 5-6 (each) q3w, pemetrexed 500 mg/m2 q3w (administered for 4 cycles with subsequent maintenance with pembrolizumab 200 mg AND pemetrexed 500 mg/m2 (each) q3w until loss of clinical benefit or occurrence of unacceptable toxicity)
Receives: Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    time from randomization to the date of death due to any case

    Measured: 30 months

Secondary outcomes (7)

  1. Objectice Response Rate (ORR)

    proportion of subjects with best response of complete or partial response (CR \& PR) according to RECIST v1.1

    Measured: 30 months

  2. Progression-Free Survival (PFS)

    time from randomization until progression defined by RECIST v1.1 or death due to any cause

    Measured: 30 months

  3. One-Year Overall Survival Rate

    percentage of patients alive at 12 months after randomization

    Measured: 30 months

  4. Time to Next Treatment or Death (TNTD)

    time from initial study randomization to the start of next subsequent treatment or death, whichever occurs first

    Measured: 30 months

  5. Progression-Free Survival 2 (PFS2)

    time from initial study randomization to second disease progression or death from any cause to assess efficacy post-trial-treatment anti-cancer therapy

    Measured: 30 months

  6. Health-related quality of life 1 (HRQoL)

    assessed with the QoL questionnaire QLQ-C30 on general health conditions in lung cancer patients using numeric scales ranging from 1-4. Lower numbers indicate no, higher numbers high agreement.

    Measured: Assessed after randomization at cycle 1 day 1, after completion of cycle 4 (each cycle is 21 days) of the chemoimmunotherapy and at progressive disease (if occurring within the maximum time frame of 30 months)

  7. Health-related quality of life 2 (HRQoL)

    assessed with the lung cancer symptom-specific QoL questionnaire QLQ-LC13 using numeric scales ranging from 1-4. Lower numbers indicate no, higher numbers high agreement.

    Measured: Assessed after randomization at cycle 1 day 1, after completion of cycle 4 (each cycle is 21 days) of the chemoimmunotherapy and at progressive disease (if occurring within the maximum time frame of 30 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2023
  2. Study start6 Dec 2023
  3. Primary completion5 Mar 2026
  4. Study completionOct 2026 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05689671
Sponsor's protocol ID
SAP131705
Other IDs
2022-002990-27, AIO-TRK-0122
Acronym
ANTELOPE
Status last verified
Mar 2026
First submitted
30 Nov 2022
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Frost N, Zhamurashvili T, von Laffert M, Klauschen F, Ruwwe-Glosenkamp C, Raspe M, Brunn M, Ochsenreither S, Temmesfeld-Wollbruck B, Suttorp N, Grohe C, Witzenrath M. Pemetrexed-Based Chemotherapy Is Inferior to Pemetrexed-Free Regimens in Thyroid Transcription Factor 1 (TTF-1)-Negative, EGFR/ALK-Negative Lung Adenocarcinoma: A Propensity Score Matched Pairs Analysis. Clin Lung Cancer. 2020 Nov;21(6):e607-e621. doi: 10.1016/j.cllc.2020.05.014. Epub 2020 May 22.

    PubMed 32620471

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atezolizumab, Nab paclitaxel and Carboplatin in people with Non-Small Cell Lung Cancer Metastatic, run by Nikolaj Frost MD at 36 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 20 inclusion and 26 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 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 (OS) (time frame: 30 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 NCT05689671, 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 10 Mar 2026.

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