NSCLC Stage IIPhase 2iRePNCT04865250
Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel in Resectable Non-squamous NSCLC
A Phase 2 study testing Atezolizumab 1200 mg abs day 1 q22 (iv) in people with NSCLC Stage II and NSCLC, Stage IIIA, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Exploratory study evaluating the potential of immune signature profiling for predicting response in patients with resectable Stage II, IIIA and select IIIB (T3N2 only) non-squamous Non-Small Cell Lung Cancer (NSCLC) to neoadjuvant ATEZOLIZUMAB plus Carboplatin/nab Paclitaxel Atezolizumab is given as intravenous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage II, NSCLC, Stage IIIA, NSCLC Stage IIIB
- What is being tested?
- Atezolizumab 1200 mg abs day 1 q22 (iv)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jan 2021to 30 Dec 2026
- 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
- Informed consent, patients age ≥ 18-year-old including, signed and dated
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically confirmed NSCLC of non-squamous histology, cStage II, IIIA or select IIIB (T3N2 only); for T-status ≤ T3 allowed; for N2 patients only IIIa1-3 Robinson classification allowed
- Deemed surgically resectable with curative intent by an attending thoracic surgeon after adequate staging including PET-CT (positron emission tomography)
- Adequate lung and cardiac function for intended lung resection according to German S3 regulation
- Radiologically measurable disease as defined by response evaluation criteria in solid tumors RECIST v1.1
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- Sufficient availability of the tissue sample from primary tumor before start of neoadjuvant treatment
- Females of child-bearing potential must agree to use, and be able to comply with, effective contraception (</=1% failure rate annually) without interruption, 28 days prior to starting therapy (including dose interruptions), and while on study medication or for a period of 120 days after the last dose of study medication
- Females must have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy.
- Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following treatment discontinuation, even if he has undergone a successful vasectomy.
- adequate renal, hepatic, and bone marrow function as defined below
- Absolute neutrophil count (ANC) > 1500/μl
- Platelet count ≥ 100000/μl
- Hemoglobin ≥ 9 g/dl (can be post-transfusion)
- International normalized ratio (INR) ≤ 1.4 in patients not receiving anticoagulation; for patients receiving respective anticoagulation an INR ≤3.0 allowed
- Activated partial thromboplastin time (aPTT) ≤ 1.5 times upper limit of normal (ULN) in patients not receiving anticoagulation; for patients receiving respective anticoagulation a PTT ≤2.5 ULN allowed
- Bilirubin < 1.5 times ULN (for patients with known Gilbert disease Bilirubin ≤ 3 times ULN allowed)
- ALT and AST < 2.5 times ULN
- Creatinine ≤ 1.5 ULN or calculated creatinine clearance > 60 ml/min for subjects with creatinine levels > 1.5 ULN; for patients meeting the criterion of creatinine ≤ 1.5 ULN also a calculated creatinine clearance of > 30 ml/min is mandatory
Who cannot join
- Illness or condition that may interfere with a patient's capacity to understand, follow, and/or comply with study procedures
- Treatment in any other clinical trial within 30 days before screening.
- NSCLC Stage cT4
- NSCLC stage cN3 or cN2 IIIA4 (bulky or fixed multi-station N2 disease) according to Robinson classification
- NSCLC of squamous cell histology
- Any prior therapy for lung cancer (including systemic therapy, radiotherapy or major surgery)
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- Malignancies other than NSCLC within 5 years prior to study inclusion with the exception of malignancies with a negligible risk of metastasis or death (5-year OS > 90%) like localized prostate cancer, ductal carcinoma in situ, adequately treated carcinoma in situ of the cervix, Stage I uterine cancer or non-melanoma skin carcinoma
- History of allogeneic tissue / solid organ transplant or allogeneic stem cell transplantation
- Patients with active hepatitis B or C infections or a history of HIV infection
- Pregnant or lactating women
- Active autoimmune disease or history of severe autoimmune disease or immunodeficiency or a syndrome that requires systemic steroids or immunosuppressive agents
- The following exceptions are granted:
- patients with vitiligo, eczema, lichen simplex or resolved childhood asthma/atopy
- subjects requiring intermittent use of bronchodilatators or local steroid injections
- patients with hypothyroidism stable on hormone replacement
- Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, and anti-tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to Cycle 1, Day 1 (except low-dose steroids for adrenal failure or emesis prophylaxis)
- History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia, drug-induced pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan
- Prior treatment with cluster of differentiation 137 (CD137) agonist or immune checkpoint blockade therapies, anti-programmed-death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
- Live vaccine within 30 days prior to first dose of trial treatment
- Cerebrovascular accident within the past 6 months
- Severe infection or significant traumatic injury within the past 4 weeks
- Clinically significant history of cardiovascular disease, including any of the following:
- Myocardial infarction or unstable angina within the past 6 months
- New York Heart Association class II, III-IV congestive heart failure
- Poorly controlled cardiac arrhythmia despite medication, except rate-controlled atrial fibrillation
- Known allergy or hypersensitivity to any component of the chemotherapy regimen Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities, as well as patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Thoraxklinik Heidelberg gGmbH
Heidelberg, BaWü, 69126
Martin Eichhorn, PD Dr. med.
About this study
Official title: Exploratory Study Evaluating the Potential of Immune Signature Profiling for Predicting Response in Patients With Resectable Stage II, IIIA and Select IIIB (T3N2 Only) Non-squamous Non-Small Cell Lung Cancer (NSCLC) to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel
Exploratory study evaluating the potential of immune signature profiling for predicting response in patients with resectable Stage II, IIIA and select IIIB (T3N2 only) non-squamous Non-Small Cell Lung Cancer (NSCLC) to neoadjuvant ATEZOLIZUMAB plus Carboplatin/nab Paclitaxel
Atezolizumab is given as intravenous infusion at a fixed dose of 1200 mg, day 1 of each 21-day cycle (every 3 weeks) for 3 cycles during the neoadjuvant treatment phase, Carboplatin at an initial dose of AUC (area under curve) 5 mg/mL/min, intravenously day 1 of each 21-day cycle for 3 cycles during the neoadjuvant treatment Phase, and Nab-Paclitaxel (Abraxane) at 100 mg/m2, intravenously day 1, 8 and 15 of each 21-day cycle for 3 cycles during the neoadjuvant treatment phase. Surgery after the 3rd cycle Atezolizumab / Carboplatin / Nab-Paclitaxel is standard procedure.
Read the detailed description
In early stages of non-small cell lung cancer (NSCLC), surgical treatment with curative intent is the treatment of choice. Adjuvant chemotherapy is standard of care for fully resected stage II, IIIA, or select IIIB [T3N2] NSCLC to improve survival outcome as compared to surgery alone. Neoadjuvant platinum-based chemotherapy has become a widely accepted alternative therapy. Chemotherapy regimens used in the adjuvant and neoadjuvant settings consist of platinum-based doublets. With the successful development of cancer immunotherapy in advanced NSCLC, several (neo)adjuvant studies of anti-PD-1/PD-L1 inhibitors are currently being conducted in resectable early-stage NSCLC.
The IREP study explores neoadjuvant immunochemotherapy with three cycles of atezolizumab, carboplatin and nab-paclitaxel in patients with histologically confirmed and resectable non-squamous NSCLC Stage II, IIIA or select IIIB (T3N2 only). The primary endpoint of the study is the Major Pathologic Response (MPR) rate (≤10% residual viable tumor cells) at surgery. Secondary endpoints include EFS and OS, safety endpoints as well as analyses of molecular and immunological biomarkers that are predictive of response to the neoadjuvant immunochemotherapy treatment.
Atezolizumab is given as intravenous infusion at a fixed dose of 1200 mg day 1, carboplatin at an initial dose of AUC 5 mg/mL/min intravenously day 1 and nab-paclitaxel at 100 mg/m2 intravenously day 1, 8 and 15 of each 21-day cycle (every 3 weeks) for 3 cycles during the neoadjuvant treatment phase. Subsequent surgery is standard procedure with standard lobectomy / bi-lobectomy with systematic lymph node dissection.
- Conditions
- NSCLC Stage II, NSCLC, Stage IIIA, NSCLC Stage IIIB
- Being tested
- Atezolizumab 1200 mg abs day 1 q22 (iv)
- 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.
Atezolizumab 1200 mg abs day 1 q22 (iv)Drug
Also called Carboplatin AUC5 day 1 q22 (iv), Nab-Paclitaxel 100 mg/m2 day 1,8,15 q22
Immune checkpoint blockade antibody ATEZOLIZUMAB directed against PD-L1 (Programmed death-ligand 1); Carboplatin; Nab-Paclitaxel (iv)
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | ATEZOLIZUMAB; Carboplatin; Nab-Paclitaxel Receives: Drug: Atezolizumab 1200 mg abs day 1 q22 (iv) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to neoadjuvant immunochemotherapy with ATEZOLIZUMAB, Carboplatin and nab-Paclitaxel
determined by Major Pathologic Response (MPR) (≤10% residual viable tumor cells) (pathologic regression grading according to Junker criteria) rate
Measured: up to 5 months (after 9 weeks of neoadjuvant immunochemotherapy (3 cycles with 21 days per cycle) + surgery (4-8 additional weeks after completion of neoadjuvant immunochemotherapy)
Secondary outcomes (5)
Response rate according to RECIST 1.1 criteria
determined by Δ tumor size and Δ lymph node size
Measured: pre-surgery after completion of neoadjuvant immunochemotherapy
Response rate as determined by Δ PETactivity
determined by standardized uptake value [SUV] (standard uptake value)
Measured: pre-surgery after completion of neoadjuvant immunochemotherapy
Event-free survival (EFS)
time to any of the following events, whichever occurs first: progression of disease prior to surgery as defined by RECIST v1.1, local or distant disease recurrence, or death due to any cause
Measured: up to 29 months after study inclusion; calculated from start of 1st cycle of neoadjuvant treatment, thus including three 21 day cycles+surgery, follow-up for 24 months after end of treatment visit; end of treatment visit takes place 6 weeks after surgery
Overall survival (OS)
time to death due to any cause
Measured: up to 29 months after study inclusion; calculated from start of 1st cycle of neoadjuvant treatment, thus including three 21 day cycles+surgery, follow-up for 24 months after end of treatment visit; end of treatment visit takes place 6 weeks after surgery
Number of patients attaining surgery as planned
number of patients attaining surgery divided by the total number of patients included
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start7 Jan 2021
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IIStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- Model description
- Exploratory, open-label, non-randomized, single treatment, phase II study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Dietmar Hopp Stiftung
- Responsible party
- Principal investigator, Dirk Jäger, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865250
- Sponsor's protocol ID
- iReP
- Acronym
- iReP
- Status last verified
- May 2024
- First submitted
- 8 Mar 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study Evaluating the Potential of Immune Signature Profiling for Predicting Response in Patients With Resectable Stage II, IIIA and Select IIIB (T3N2 Only) Non-squamous Non-Small Cell Lung Cancer (NSCLC) to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel
- ClinicalTrials.gov ID
- NCT04865250
- Acronym / sponsor ID
- iReP / iReP
- Conditions
- NSCLC Stage II, NSCLC, Stage IIIA, NSCLC Stage IIIB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Dietmar Hopp Stiftung
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Apr 2021 (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.
Exploratory study evaluating the potential of immune signature profiling for predicting response in patients with resectable Stage II, IIIA and select IIIB (T3N2 only) non-squamous Non-Small Cell Lung Cancer (NSCLC) to neoadjuvant ATEZOLIZUMAB plus Carboplatin/nab Paclitaxel
Atezolizumab is given as intravenous infusion at a fixed dose of 1200 mg, day 1 of each 21-day cycle (every 3 weeks) for 3 cycles during the neoadjuvant treatment phase, Carboplatin at an initial dose of AUC (area under curve) 5 mg/mL/min, intravenously day 1 of each 21-day cycle for 3 cycles during the neoadjuvant treatment Phase, and Nab-Paclitaxel (Abraxane) at 100 mg/m2, intravenously day 1, 8 and 15 of each 21-day cycle for 3 cycles during the neoadjuvant treatment phase. Surgery after the 3rd cycle Atezolizumab / Carboplatin / Nab-Paclitaxel is standard procedure.
Detailed description
In early stages of non-small cell lung cancer (NSCLC), surgical treatment with curative intent is the treatment of choice. Adjuvant chemotherapy is standard of care for fully resected stage II, IIIA, or select IIIB [T3N2] NSCLC to improve survival outcome as compared to surgery alone. Neoadjuvant platinum-based chemotherapy has become a widely accepted alternative therapy. Chemotherapy regimens used in the adjuvant and neoadjuvant settings consist of platinum-based doublets. With the successful development of cancer immunotherapy in advanced NSCLC, several (neo)adjuvant studies of anti-PD-1/PD-L1 inhibitors are currently being conducted in resectable early-stage NSCLC.
The IREP study explores neoadjuvant immunochemotherapy with three cycles of atezolizumab, carboplatin and nab-paclitaxel in patients with histologically confirmed and resectable non-squamous NSCLC Stage II, IIIA or select IIIB (T3N2 only). The primary endpoint of the study is the Major Pathologic Response (MPR) rate (≤10% residual viable tumor cells) at surgery. Secondary endpoints include EFS and OS, safety endpoints as well as analyses of molecular and immunological biomarkers that are predictive of response to the neoadjuvant immunochemotherapy treatment.
Atezolizumab is given as intravenous infusion at a fixed dose of 1200 mg day 1, carboplatin at an initial dose of AUC 5 mg/mL/min intravenously day 1 and nab-paclitaxel at 100 mg/m2 intravenously day 1, 8 and 15 of each 21-day cycle (every 3 weeks) for 3 cycles during the neoadjuvant treatment phase. Subsequent surgery is standard procedure with standard lobectomy / bi-lobectomy with systematic lymph node dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exploratory, open-label, non-randomized, single treatment, phase II study
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: Atezolizumab 1200 mg abs day 1 q22 (iv)ATEZOLIZUMAB; Carboplatin; Nab-Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Informed consent, patients age ≥ 18-year-old including, signed and dated
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically confirmed NSCLC of non-squamous histology, cStage II, IIIA or select IIIB (T3N2 only); for T-status ≤ T3 allowed; for N2 patients only IIIa1-3 Robinson classification allowed
- Deemed surgically resectable with curative intent by an attending thoracic surgeon after adequate staging including PET-CT (positron emission tomography)
- Adequate lung and cardiac function for intended lung resection according to German S3 regulation
Key exclusion criteria (26 listed)
- Illness or condition that may interfere with a patient's capacity to understand, follow, and/or comply with study procedures
- Treatment in any other clinical trial within 30 days before screening.
- NSCLC Stage cT4
- NSCLC stage cN3 or cN2 IIIA4 (bulky or fixed multi-station N2 disease) according to Robinson classification
- NSCLC of squamous cell histology
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 |
|---|---|---|
| Atezolizumab 1200 mg abs day 1 q22 (iv)Also: Carboplatin AUC5 day 1 q22 (iv), Nab-Paclitaxel 100 mg/m2 day 1,8,15 q22Immune checkpoint blockade antibody ATEZOLIZUMAB directed against PD-L1 (Programmed death-ligand 1); Carboplatin; Nab-Paclitaxel (iv) | Drug | treatment |
Primary outcome
Response to neoadjuvant immunochemotherapy with ATEZOLIZUMAB, Carboplatin and nab-Paclitaxel
Time frame: up to 5 months (after 9 weeks of neoadjuvant immunochemotherapy (3 cycles with 21 days per cycle) + surgery (4-8 additional weeks after completion of neoadjuvant immunochemotherapy)
determined by Major Pathologic Response (MPR) (≤10% residual viable tumor cells) (pathologic regression grading according to Junker criteria) rate
5 secondary outcomes
Response rate according to RECIST 1.1 criteria
Time frame: pre-surgery after completion of neoadjuvant immunochemotherapy
Response rate as determined by Δ PETactivity
Time frame: pre-surgery after completion of neoadjuvant immunochemotherapy
Event-free survival (EFS)
Time frame: up to 29 months after study inclusion; calculated from start of 1st cycle of neoadjuvant treatment, thus including three 21 day cycles+surgery, follow-up for 24 months after end of treatment visit; end of treatment visit takes place 6 weeks after surgery
Overall survival (OS)
Time frame: up to 29 months after study inclusion; calculated from start of 1st cycle of neoadjuvant treatment, thus including three 21 day cycles+surgery, follow-up for 24 months after end of treatment visit; end of treatment visit takes place 6 weeks after surgery
Number of patients attaining surgery as planned
Time frame: up to 5 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 16 May 2024.
- Individual participant dataSharing planned: No
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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.
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 Atezolizumab 1200 mg abs day 1 q22 (iv) in people with NSCLC Stage II and NSCLC, Stage IIIA, run by University Hospital Heidelberg 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 19 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: looking for participants now, as of the sponsor's last update on 16 May 2024. 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?
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?
Contact Dirk Jäger, Prof. med. (+49 6221 56 7229, Dirk.Jaeger@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to neoadjuvant immunochemotherapy with ATEZOLIZUMAB, Carboplatin and nab-Paclitaxel (time frame: up to 5 months (after 9 weeks of neoadjuvant immunochemotherapy (3 cycles with 21 days per cycle) + surgery (4-8 additional weeks after completion of neoadjuvant immunochemotherapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.