Non-small Cell Lung Cancer (NSCLC)Phase 2NEOMUNNCT03197467
Neoadjuvant Anti PD-1 Immunotherapy in Resectable Non-small Cell Lung Cancer
A Phase 2 study testing Pembrolizumab in people with Non-small Cell Lung Cancer (NSCLC), run by AIO-Studien-gGmbH at 1 site in Germany.
Trial summary
NEOMUN is designed as an open-label, single arm, prospective, monocenter, phase II study of pembrolizumab in a neoadjuvant setting in patients with non-small cell lung cancer of Stage II/IIIA suitable for curative intent surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jun 2018to 5 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Cooperation and willingness to complete all aspects of the study
- Signed and dated written informed consent must be given prior to study inclusion
- Histological or cytological confirmed NSCLC
- Clinical stage II-IIIA according to the TNM classification, 7th edition:
- stage IIIa: T1/T2 N2 (IIIa1-3 Robinson classification)
- Adequate disease staging by PET/CT and brain MRI
Show all 21Show fewer
- At least 1 measurable lesion according to RECIST 1.1
- Age ≥ 18 years
- ECOG performance status 0 - 1
- Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
- Adequate bone marrow function, liver and renal function:
- Absolute neutrophil count ≥ 1.5 x 109/L
- Thrombocytes ≥ 100 x 109/L
- Hemoglobin ≥ 9 g/dL without transfusion or EPO dependency (within 7 days of assessment)
- INR < 1.4 ULN and PTT < 40 seconds during the last 7 days before therapy
- Bilirubin < 1.5 x upper limit of normal
- AST (GOT) and ALT (GPT) < 2.5 x ULN
- Albumin >2.5 mg/dL
- Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤1.5 X upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
- Adequate lung and cardiac function for intended lung resection according to German S3 guideline
Who cannot join
- Anticancer treatment during the last 30 days prior to start of treatment, including systemic therapy, radiotherapy or major surgery
- Participation in a clinical trial within the last 30 days prior to study treatment
- History of allogeneic tissue/solid organ transplant
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Evidence of interstitial lung disease.
- cT4 tumor
Show all 23Show fewer
- Symptomatic acute cardiovascular or cerebrovascular disease
- Known active HBV, HCV or HIV infection
- Has any other active infection requiring systemic therapy.
- Patients with active tuberculosis
- Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor [TNFR] family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
- A diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Patient has had a prior monoclonal antibody within 4 weeks prior to study Day 1
- Patient has had prior chemotherapy, targeted small molecule therapy, or radiation therapy in history.
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.
- Has received a live vaccine within 30 days prior to the first dose of trial treatment. [Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines are live attenuated vaccines, and are not allowed.]
- Has known hypersensitivity to pembrolizumab or any of the constituents of the product.
- Other active malignancy requiring treatment Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Lactating or pregnant women, women of child-bearing potential who do not agree to the usage of highly effective contraception methods (allowed methods of contraception, meaning methods with a rate of failure of less than 1% per year are implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner). Women of childbearing potential must have a negative pregnancy test (serum β-hCG) at Screening.
- Any psychiatric illness that would affect the patient's ability to understand the demands of the clinical trial
- Patient has already been recruited in this trial
- Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
- Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Anti PD-1 Immunotherapy in Resectable Non-small Cell Lung Cancer [NEOMUN]
NEOMUN is designed as an open-label, single arm, prospective, monocenter, phase II study of pembrolizumab in a neoadjuvant setting in patients with non-small cell lung cancer of Stage II/IIIA suitable for curative intent surgery.
Read the detailed description
The study is designed as an open-label, single arm, prospective, monocenter, phase II study of pembrolizumab in a neoadjuvant setting in patients with resectable NSCLC stage II/IIIA suitable for curative intent surgery, taking place in Germany. Planned sample size is N=30.
Investigational drug is Pembrolizumab at fixed dose, given 200 mg q3w i.v. for 2 cycles. After completion of immunotherapy lobectomy/ bilobectomy with curative intent is scheduled.
Primary objectives are to assess feasibility and safety of a neoadjuvant application of pembrolizumab and to assess antitumor activity of pembrolizumab with regard to clinical and pathologic tumor response. Secondary objective is to assess the impact of neoadjuvant pembrolizumab on patient disease free and overall survival. Exploratory objective is o explore potential predictive biomarkers for pembrolizumab efficacy (immune cell imaging).
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Pembrolizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab | Experimental | Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Treated in Compliance With Protocol
The definition for this endpoint was neoadjuvant pembrolizumab treatment followed by successful curative intent tumor resection.
Measured: From screening until surgery, ca. 6-8 weeks
Tumor Response According to RECIST 1.1 Criteria
Radiologic tumor assessments were performed at screening and pre-surgery.
Measured: From screening until pre-surgery radiologic assessment, ca. 6-8 weeks
Tumor Response Evaluation - Pathologic Response
Pathologic regression grading according to Junker criteria.
The following grades are defined:
Grade I No tumor regression or only spontaneous tumor regression in the sections of the primary tumor and mediastinal lymph nodes.
Grade IIa Morphological signs of therapy-induced tumor regression in the sections of the primary tumor and/or mediastinal lymph nodes: More than 10% vital tumor tissue
Grade IIb Morphological signs of therapy-induced tumor regression: Less than 10% vital tumor tissue
Grade III Complete tumor regression, no evidence of vital tumor in the sections of the primary tumor and/or mediastinal lymph nodes.
Regression grades IIb and III suggest a good response to neoadjuvant therapy.
Reference: Junker K, Langner K, Klinke F, Bosse U, Thomas M. Grading of tumor regression in non-small cell lung cancer : morphology and prognosis. Chest 2001; 120:1584-91.
Measured: From screening until surgery, ca. 6-8 weeks
Tumor Response Evaluation - Δ Tumor Size
Δ tumor size was defined as the difference [mm] between longest diameter at baseline and pre-surgery.
Measured: From screening until pre-surgery radiologic assessment, ca. 6-8 weeks
Tumor Response - Δ PET Activity
Δ PET activity (standardized uptake value [SUV]). This method uses radiolabeled tracer 82-deoxy-2-[18F]fluoro-D-glucose, FDG) during PET imaging of the tumor and accumulation of radiolabeled FDG measured by the PET scanner. Accumulation of FDG relative to normal tissue is related to the proliferative activity of malignant tissue and to the number of viable tumor cells. The endpoint is based on per-patient changes in tumor maximal standardized uptake value during PET examinations of the tumor before the start of treatment and after 2 cycles of neoadjuvant immunotherapy, i.e. between screening and shortly before surgery. Reduction of proliferative activity or of the number of viable tumor cells results in negative values.
Measured: From screening until pre-surgery radiologic assessment, ca. 6-8 weeks
Secondary outcomes (5)
Disease-free Survival at 6 Months
Probability of disease-free survival (DFS) was calculated using Kaplan-Meier statistics from date of surgery to the date until tumor recurrence or death. Follow-up was until 24 months after last-patient-out.
Measured: 6 months after surgery, i.e. circa 8 months after treatment start
Disease-free Survival at 12 Months
Probability of disease-free survival (DFS) was calculated from date of surgery until tumor recurrence or death using Kaplan-Meier statistics. Follow-up was until 24 months after last-patient-out.
Measured: 12 months after surgery, i.e. circa 14 months after treatment start
Overall Survival at 12 Months
Probability of overall survival (OS) was calculated from date of surgery until date of death using Kaplan-Meier statistics. Follow-up was until 24 months after last-patient-out.
Measured: 12 months after surgery, i.e. circa 14 months after treatment start
Overall Survival at 18 Months
Probability of overall survival (OS) was calculated from date of surgery until date of death using Kaplan-Meier statistics. Follow-up was until 24 months after last-patient-out.
Measured: 18 months after surgery, i.e. circa 20 months after treatment start
Overall Survival at 24 Months
Probability of overall survival (OS) was calculated from date of surgery until date of death using Kaplan-Meier statistics. Follow-up was until 24 months after last-patient-out.
Measured: 24 months after surgery, i.e. circa 26 months after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start18 Jun 2018
- Primary completion30 Oct 2021
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIO-Studien-gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Martin E. Eichhorn, PD Dr. med., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197467
- Sponsor's protocol ID
- 0316-ASG
- Other IDs
- 2016-002170-13, MISP 52887, 2016
- Acronym
- NEOMUN
- Status last verified
- Apr 2025
- First submitted
- 21 Jun 2017
- Last updated
- 4 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi Y, Li J, Chen M, Liu H, Ma D, Lin Y, Wang M, Xu Y. Sarcoidosis-like reaction after neoadjuvant pembrolizumab combined with chemotherapy mimicking disease progression of NSCLC induced encouraging discovery of pathological complete response. Thorac Cancer. 2021 Dec;12(24):3433-3436. doi: 10.1111/1759-7714.14228. Epub 2021 Nov 11.
PubMed 34761878Eichhorn F, Klotz LV, Kriegsmann M, Bischoff H, Schneider MA, Muley T, Kriegsmann K, Haberkorn U, Heussel CP, Savai R, Zoernig I, Jaeger D, Thomas M, Hoffmann H, Winter H, Eichhorn ME. Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. Lung Cancer. 2021 Mar;153:150-157. doi: 10.1016/j.lungcan.2021.01.018. Epub 2021 Jan 21.
PubMed 33529989Eichhorn F, Klotz LV, Bischoff H, Thomas M, Lasitschka F, Winter H, Hoffmann H, Eichhorn ME. Neoadjuvant anti-programmed Death-1 immunotherapy by Pembrolizumab in resectable nodal positive stage II/IIIa non-small-cell lung cancer (NSCLC): the NEOMUN trial. BMC Cancer. 2019 May 2;19(1):413. doi: 10.1186/s12885-019-5624-2.
PubMed 31046714
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Anti PD-1 Immunotherapy in Resectable Non-small Cell Lung Cancer [NEOMUN]
- ClinicalTrials.gov ID
- NCT03197467
- Acronym / sponsor ID
- NEOMUN / 0316-ASG
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AIO-Studien-gGmbHUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Posted 4 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
NEOMUN is designed as an open-label, single arm, prospective, monocenter, phase II study of pembrolizumab in a neoadjuvant setting in patients with non-small cell lung cancer of Stage II/IIIA suitable for curative intent surgery.
Detailed description
The study is designed as an open-label, single arm, prospective, monocenter, phase II study of pembrolizumab in a neoadjuvant setting in patients with resectable NSCLC stage II/IIIA suitable for curative intent surgery, taking place in Germany. Planned sample size is N=30.
Investigational drug is Pembrolizumab at fixed dose, given 200 mg q3w i.v. for 2 cycles. After completion of immunotherapy lobectomy/ bilobectomy with curative intent is scheduled.
Primary objectives are to assess feasibility and safety of a neoadjuvant application of pembrolizumab and to assess antitumor activity of pembrolizumab with regard to clinical and pathologic tumor response. Secondary objective is to assess the impact of neoadjuvant pembrolizumab on patient disease free and overall survival. Exploratory objective is o explore potential predictive biomarkers for pembrolizumab efficacy (immune cell imaging).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab | Experimental | Drug: PembrolizumabPembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Cooperation and willingness to complete all aspects of the study
- Signed and dated written informed consent must be given prior to study inclusion
- Histological or cytological confirmed NSCLC
- Clinical stage II-IIIA according to the TNM classification, 7th edition:
- stage IIIa: T1/T2 N2 (IIIa1-3 Robinson classification)
Key exclusion criteria (23 listed)
- Anticancer treatment during the last 30 days prior to start of treatment, including systemic therapy, radiotherapy or major surgery
- Participation in a clinical trial within the last 30 days prior to study treatment
- History of allogeneic tissue/solid organ transplant
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Evidence of interstitial lung 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 |
|---|---|---|
| PembrolizumabPembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles | Drug | Pembrolizumab |
Primary outcome
Number of Patients Treated in Compliance With Protocol
Time frame: From screening until surgery, ca. 6-8 weeks
The definition for this endpoint was neoadjuvant pembrolizumab treatment followed by successful curative intent tumor resection.
Tumor Response According to RECIST 1.1 Criteria
Time frame: From screening until pre-surgery radiologic assessment, ca. 6-8 weeks
Radiologic tumor assessments were performed at screening and pre-surgery.
Tumor Response Evaluation - Pathologic Response
Time frame: From screening until surgery, ca. 6-8 weeks
Pathologic regression grading according to Junker criteria. The following grades are defined: Grade I No tumor regression or only spontaneous tumor regression in the sections of the primary tumor and mediastinal lymph nodes. Grade IIa Morphological signs of therapy-induced tumor regression in the sections of the primary tumor and/or mediastinal lymph nodes: More than 10% vital tumor tissue Grade IIb Morphological signs of therapy-induced tumor regression: Less than 10% vital tumor tissue Grade III Complete tumor regression, no evidence of vital tumor in the sections of the primary tumor and/or mediastinal lymph nodes. Regression grades IIb and III suggest a good response to neoadjuvant therapy. Reference: Junker K, Langner K, Klinke F, Bosse U, Thomas M. Grading of tumor regression in non-small cell lung cancer : morphology and prognosis. Chest 2001; 120:1584-91.
Tumor Response Evaluation - Δ Tumor Size
Time frame: From screening until pre-surgery radiologic assessment, ca. 6-8 weeks
Δ tumor size was defined as the difference [mm] between longest diameter at baseline and pre-surgery.
Tumor Response - Δ PET Activity
Time frame: From screening until pre-surgery radiologic assessment, ca. 6-8 weeks
Δ PET activity (standardized uptake value [SUV]). This method uses radiolabeled tracer 82-deoxy-2-[18F]fluoro-D-glucose, FDG) during PET imaging of the tumor and accumulation of radiolabeled FDG measured by the PET scanner. Accumulation of FDG relative to normal tissue is related to the proliferative activity of malignant tissue and to the number of viable tumor cells. The endpoint is based on per-patient changes in tumor maximal standardized uptake value during PET examinations of the tumor before the start of treatment and after 2 cycles of neoadjuvant immunotherapy, i.e. between screening and shortly before surgery. Reduction of proliferative activity or of the number of viable tumor cells results in negative values.
5 secondary outcomes
Disease-free Survival at 6 Months
Time frame: 6 months after surgery, i.e. circa 8 months after treatment start
Disease-free Survival at 12 Months
Time frame: 12 months after surgery, i.e. circa 14 months after treatment start
Overall Survival at 12 Months
Time frame: 12 months after surgery, i.e. circa 14 months after treatment start
Overall Survival at 18 Months
Time frame: 18 months after surgery, i.e. circa 20 months after treatment start
Overall Survival at 24 Months
Time frame: 24 months after surgery, i.e. circa 26 months after treatment start
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34761878Shi Y, Li J, Chen M, Liu H, Ma D, Lin Y, Wang M, Xu Y. Sarcoidosis-like reaction after neoadjuvant pembrolizumab combined with chemotherapy mimicking disease progression of NSCLC induced encouraging discovery of pathological complete response. Thorac Cancer. 2021 Dec;12(24):3433-3436. doi: 10.1111/1759-7714.14228. Epub 2021 Nov 11.
- Derived from this study: PubMed 33529989Eichhorn F, Klotz LV, Kriegsmann M, Bischoff H, Schneider MA, Muley T, Kriegsmann K, Haberkorn U, Heussel CP, Savai R, Zoernig I, Jaeger D, Thomas M, Hoffmann H, Winter H, Eichhorn ME. Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. Lung Cancer. 2021 Mar;153:150-157. doi: 10.1016/j.lungcan.2021.01.018. Epub 2021 Jan 21.
- Derived from this study: PubMed 31046714Eichhorn F, Klotz LV, Bischoff H, Thomas M, Lasitschka F, Winter H, Hoffmann H, Eichhorn ME. Neoadjuvant anti-programmed Death-1 immunotherapy by Pembrolizumab in resectable nodal positive stage II/IIIa non-small-cell lung cancer (NSCLC): the NEOMUN trial. BMC Cancer. 2019 May 2;19(1):413. doi: 10.1186/s12885-019-5624-2.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
Understanding the Feasibility of a Co-designed Pre-radiotherapy Exercise Programme - A Single-arm Study
Lung Cancer
RecruitingPhase 2
Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I
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 E. Eichhorn, PD Dr. med. principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Non-small Cell Lung Cancer (NSCLC), run by AIO-Studien-gGmbH at 1 site 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 21 inclusion and 23 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: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Treated in Compliance With Protocol (time frame: From screening until surgery, ca. 6-8 weeks). The study lists 5 primary outcomes in all. 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 NCT03197467, which also lists 3 linked publications.
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 4 Apr 2025.