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AzTrials

Lung Cancer (NSCLC)Phase 2NEOpredict-EGFNCT06784791

Preoperative Amivantamab or Amivantamab and Carboplatin/Pemetrexed Treatment in Patients With Resectable Non-small-cell Lung Cancer Harboring Oncogenic EGFR Mutations (NEOpredict-EGFR)

A Phase 2 study testing Amivantamab Intravenous and Carboplatin/Pemetrexed in people with Lung Cancer (NSCLC), run by University Hospital, Essen at 4 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The primary objective of this study is to determine the feasibility of four weeks of preoperative antibody therapy with amivantamab. Amivantamab will be administered as monotherapy (stage 1), and combined with carboplatin/pemetrexed chemotherapy (stage 2). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer (NSCLC)
What is being tested?
Amivantamab Intravenous and Carboplatin/Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
4 sitesin 3 countries
Study dates
6 Nov 2024to 31 Dec 2027
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

  • Patients with histologically (core biopsy) or cytologically (e.g., bronchoscopy-guided biopsy) confirmed non-small-cell lung cancer (NSCLC) eligible for anatomic resection, with the following specifications:
  • Clinical stages I B, II or selected stage III A (T3 N1, T4 with satellite nodule in the same lung N0/N1, selected T1a-T2b N2 cases considered suitable for primary surgical approach by the multidisciplinary tumor board) according to UICC 8th edition
  • Confirmation of an oncogenic EGFR mutation (EGFR p.L858R, EGFR exon 19 in-frame deletion, EGFR exon 20 in-frame insertions, EGFR p.S768I, EGFR p.L861Q, EGFR p.G719x - additional EGFR mutations with clinically validated oncogenicity and susceptibility to amivantamab may be eligible following discussion and approval by the coordinating investigator in his capacity as sponsor representative) by validated assaytechnology (e.g., diagnostic NGS or PCR-based genotyping, adhering to quality standards defined by the nNGM Lung Cancer biomarker standard operating procedure (version 007 or higher) in Germany, or equivalent in Belgium and the Netherlands) in a pretreatment biopsy (primary tumor or lymph node metastasis)
  • Males and females, ages >= 18 years, inclusive
  • A participant of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of study treatment and must agree to further serum or urine pregnancy testing during the study.
  • A participant must be (as defined in Appendix IV: Contraceptive Guidance and Collection of Pregnancy Information) either of the following:
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  • Not of childbearing potential
  • Of child-bearing potential and practicing true abstinence during the entire period of the study, including up to 6 months after the last dose of study treatment is given
  • Of childbearing potential and practicing 2 methods of contraception, including 1 highly effective user independent method and a second method (examples of highly effective methods of contraception are located in Appendix IV: Contraceptive Guidance and Collection of Pregnancy Information).Participant must agree to continue contraception throughout the study and through 6 months after the last dose of study treatment.
  • Note: If the childbearing potential changes after start of the study (e.g., participant of childbearing potential who is not heterosexually active becomes active, premenarchal participant experiences menarche) the participant must begin birth control, as described above
  • A participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment.
  • A participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 6 months after receiving the last dose of study treatment. A participant who is sexually active with a partner of childbearing potential must agree to use a condom with spermicidal foam/gel/film/cream/suppository and their partner must also be practicing a highly effective method of contraception (i.e., established use of oral, injected, or implanted hormonal methods of contraception; placement of an intrauterine device [IUD] or intrauterine hormone-releasing system [IUS]). If the participant is vasectomized, they must still use a condom (with or without spermicide) for prevention of passage of exposure through ejaculation, but their partner is not required to use contraception.
  • A participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment.
  • Participant must be willing and able to adhere to the lifestyle restrictions specified in this protocol.
  • ECOG performance status ≤ 1
  • Exclusion of extensive mediastinal lymph node metastases (multilevel N2, N3) by PET/CT and/or invasive mediastinal lymph node staging by EBUS-TBNA and/or staging mediastinoscopy as performed by institutional guidelines.
  • Exclusion of distant metastases by standard of care imaging studies, which include but are not limited to PET/CT or PET/MRI, or CT or MRI of thorax, abdomen including pelvic region, and bone scan. Asymptomatic brain metastases will be excluded by MRI or contrastenhanced CT as indicated by institutional guidelines and patient factors.
  • Measurable target tumor (pre RECIST 1.1) prior to preoperative study therapy using standard imaging techniques.
  • Sufficient pulmonary function (ppFEV1>30%, ppDLCO>30%) to undergo curative lung cancer surgery. Exercise tests should be performed in all patients with FEV1 or DLCO <60% of normal. In case of cardiopulmonary exercise testing, the following basic cut-off values for VO2-peak should be considered: >75% predicted or >20 mL·kg-1·min-1 qualify for pneumonectomy; <35% predicted or <10 mL·kg-1·min-1 indicate high risk for any resection. There is insufficient evidence to recommend specific cut-off values for lobectomy or segmentectomy.
  • Adequate hematological, hepatic and renal function parameters:
  • Leukocytes ≥ 2,000/mm³, platelets ≥ 100,000/mm³, absolute neutrophil count (ANC) ≥ 1,500/μL, hemoglobin ≥ 9 g/dL (stage 1) or 10 g/dL (stage 2)
  • Anti-platelet therapy (such as but not limited to clopidogrel) should be discontinued pre-operatively according to local standards. If this therapy cannot be interrupted due to severe cardiovascular comorbidity, patient is ineligible for the trial
  • Adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the upper limit of normal (ULN) (unless receiving anticoagulation therapy). Patients receiving warfarin/phenprocoumon or direct oral anticoagulants are to be bridged according to local standards and have achieved stable coagulation profile prior to surgery
  • Serum creatinine ≤ 1.5 x upper limit of normal and creatinine clearance >45 mL/min as measured or calculated by Cockcroft- Gault formula for estimated creatinine clearance (Appendix VII)
  • Bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.0 x upper limit of normal, alkaline phosphatase ≤ 6 x upper limit of normal. Subjects with Gilbert's syndrome can be enrolled if conjugated bilirubin is within normal limits
  • Sufficient cardiac left ventricular defined as LVEF ≥ 50% documented either by echocardiography or MUGA (echocardiography preferred, MUGA not used in German sites) within 6 months before first administration of study drug.
  • Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures.

Who cannot join

  • Lung cancer entity and stage other than defined by the inclusion criteria.
  • Absence of a predictive oncogenic EGFR mutation (EGFR p.L858R, EGFR exon 19 in-frame deletion, EGFR exon 20 in-frame insertions, EGFR p.S768I, EGFR p.L861Q, EGFR p.G719x - additional EGFR mutations with clinically validated oncogenicity and susceptibility to amivantamab may be eligible following discussion and approval by the coordinating investigator in his capacity as sponsor representative) in apretreatment biopsy (primary tumor or metastasis).
  • Active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug- or radiation-induced ILD/pneumonitis.
  • Subjects with a condition requiring continuous systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted.
  • Subjects who have undergone organ transplant or allogeneic stem cell transplantation.
  • ppFEV1<30%, ppDLCO<30%, ppVO2max < 10 ml/min/kg or other criteria of functional inoperability per local guidelines.
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  • History of uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
  • Myocardial infarction (MI), NSTEMI, coronary artery bypass grafting, or stroke/transient ischemic attack (TIA) within the 6 months prior to consent
  • Uncontrolled angina within the 3 months prior to consent
  • Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
  • Prolonged corrected QTc interval by Fridericia's > 470 msec
  • Uncontrolled persistent hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg)
  • Clinically significant deep vein thrombosis or pulmonary embolism within 1 month prior to study treatment (clinically nonsignificant thrombosis or incidental, asymptomatic pulmonary embolism are not exclusionary)
  • Pulmonary hypertension (sPAP >35 mmHg; only measured if clinically indicated and/or mandated per local guidelines)
  • History of other clinically significant cardiovascular disease (i.e., cardiomyopathy, congestive heart failure with New York Heart Association [NYHA] functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion etc.).
  • Cardiovascular or pulmonary disease-related requirement for daily supplemental oxygen.
  • History of two or more myocardial infarctions or two or more coronary revascularization procedures.
  • Patients with active neurological disease should be excluded.
  • Active malignancy or a prior malignancy within the past 3 years. Patients with the following conditions are not excluded from participation:
  • o Patients with adequately resected skin cancer (melanoma or non-melanoma), cervical carcinoma in-situ, intestinal polyps not containing invasive cancer, treated breast carcinoma in-situ or bladder carcinoma in-situ that are considered completely cured, and patients with isolated elevation in prostate-specific antigen or low risk prostate cancer managed with active surveillance or watchful waiting in the absence of radiographic evidence of metastatic prostate cancer.
  • Known history of positive test for human immunodeficiency virus (HIV- 1 and HIV-2) or known acquired immunodeficiency syndrome (AIDS). NOTE: Testing for HIV-1 and HIV-2 must be performed at screening.
  • Positive test result for hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg).
  • o Note: participants with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at screening (i) a negative HBsAg and (ii) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.
  • Positive hepatitis C antibody (anti-HCV).
  • o Note: participants with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.
  • History of other clinically active infectious liver disease
  • Uncontrolled diabetes mellitus
  • Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week prior to starting study treatment] or diagnosed or suspected viral infection.
  • Psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements.
  • Any ophthalmologic condition that is clinically unstable.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of amivantamab, carboplatin or pemetrexed, or may affect the interpretation of the results, or may render the patient at high risk from treatment complications.
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of study medication.
  • Serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment
  • The patient has undergone major surgery within 28 days prior to enrollment except staging mediastinoscopy, diagnostic VATS or implantation of a venous port-system, or has not recovered from prior surgery.
  • Any other concurrent preoperative antineoplastic treatment including irradiation
  • Pregnant women
  • Breastfeeding women
  • Insufficient cardiac left ventricular function defined as LVEF<50% by echocardiography (outside Germany: or MUGA scan)
  • A confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
  • Subjects with history of severe or life-threatining (grade 3 or 4) infusion-related reactions to prior antibody therapy or immune therapy
  • Prior treatment with amivantamab or any EGFR tyrosine kinase inhibitor
  • Participation in another interventional clinical study within the last 3 months prior to inclusion or simultaneous participation in other interventional clinical studies
  • Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety.
  • Any contraindications against amivantamab (stages 1 and 2), carboplatin or pemetrexed (stage 2)

Trial locations and contacts

4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Martin Schuler, Prof. Dr. med. contact

+492017232011

neopredictEGFR.umesz@uk-essen.de

4 sites in 3 countries

Germany2 sites, 2 recruiting

  • West German Cancer Center, Department of Medical Oncology, University Hospital Essen

    Essen, Germany, 45147

    Martin Schuler, Prof. Dr. med., +49 (0) 201 723 -2000, martin.schuler@uk-essen.de

    Recruiting

  • Thoraxklinik Heidelberg gGmbH, Studienzentrum Thoraxonkologie

    Heidelberg, Baden-Wurttemberg, 69126

    Helge Bischoff, Dr., +49 (0) 6221 396-1301, Helge.bischoff@med.uni-heidelberg.de

    Recruiting

Other trials in Germany

Belgium1 site, 1 recruiting

  • Jessa Ziekenhuis, Department of Pneumology

    Hasselt, 3500

    Kristof Cuppens, Dr., +32 (0) 11 33 55 11, Kristof.Cuppens@jessazh.be

    Recruiting

Other trials in Belgium

Netherlands1 site, 1 recruiting

  • Erasmus Universitair Medisch Centrum Rotterdam Department of Pulmonary Medicine

    Rotterdam, 3015 GD

    Anne-Marie C. Dingemans, Prof. Dr., a.dingemans@erasmusmc.nl

    Recruiting

Other trials in Netherlands

About this study

The primary objective of this study is to determine the feasibility of four weeks of preoperative antibody therapy with amivantamab. Amivantamab will be administered as monotherapy (stage 1), and combined with carboplatin/pemetrexed chemotherapy (stage 2). Study treatment is followed by standard of care surgery, and (if clinically indicated) standard of care adjuvant therapy (chemotherapy, radiotherapy, EGFR tyrosine kinase inhibitor therapy) in patients with early stage or locally advanced non-small-cell lung cancer harboring oncogenic EGFR mutations who are eligible for curative resection.

Being tested
Amivantamab Intravenous, Carboplatin/Pemetrexed
Keywords
NSCLC, Lung cancer, non-small-cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Amivantamab IntravenousDrug

    Also called Chemotherapy

    Stage 1: Pre-operative amivantamab monotherapy Stage 2: Pre-operative amivantamab treatment plus chemotherapy (carboplatin/pemetrexed)

  • Carboplatin/PemetrexedDrug

    Stage 2: Pre-operative amivantamab plus chemotherapy (carboplatin/pemetrexed)

Study groups in NCT06784791
Study groupRoleWhat they receive
Pre-operative amivantamab monotherapyExperimentalPatients in stage 1 will receive 1 cycle (28 days) of pre-operative amivantamab monotherapy, splitted on 5 treatment days. Dosing will be weight-adapted.
Receives: Drug: Amivantamab Intravenous
Amivantamab + chemotherapyExperimentalPatients in stage 2 will receive 1 cycle (28 days) of pre-operative amivantamab monotherapy, splitted on 5 treatment days (dosing will be weight-adapted) plus additional chemotherapy (carboplatin/pemetrexed) on day 1.
Receives: Drug: Amivantamab Intravenous; Drug: Carboplatin/Pemetrexed

What is being measured

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

  1. Feasibility of one cycle of preoperative amivantamab therapy

    The primary objective of this study is to determine the feasibility of four weeks of preoperative antibody therapy with amivantamab. Amivantamab will be administered as monotherapy (stage 1), and combined with carboplatin/pemetrexed chemotherapy (stage 2). Study treatment is followed by standard of care surgery, and (if clinically indicated) standard of care adjuvant therapy (chemotherapy, radiotherapy, EGFR tyrosine kinase inhibitor therapy) in patients with early stage or locally advanced non-small-cell lung cancer harboring oncogenic EGFR mutations who are eligible for curative resection.

    Measured: 28 days pre-operative treatment

Secondary outcomes (1)

  1. Characterization of residual tumor cells (if present) and immune cell infiltrate in resected tumors and lymph nodes

    Secondary objectives are to characterize residual tumor cells (if present) and the immune cell infiltrate in resected tumors and lymph nodes following preoperative treatment with amivantamab (stage 1), and amivantamab plus carboplatin/pemetrexed (stage 2).

    Measured: through study completion, an average of 1 year

Timeline

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

  1. First posted20 Jan 2025
  2. Study start6 Nov 2024
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Dec 2027 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Multicenter, international, open-label, two-stage design, non-randomized
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06784791
Sponsor's protocol ID
NEOpredict-EGFR
Other IDs
2023-505662-28-00, 2023
Acronym
NEOpredict-EGF
Status last verified
Aug 2025
First submitted
4 Dec 2024
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amivantamab Intravenous and Carboplatin/Pemetrexed in people with Lung Cancer (NSCLC), run by University Hospital, Essen at 4 sites in 3 countries.

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 27 inclusion and 44 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 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany, Belgium, Netherlands. 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 Martin Schuler, Prof. Dr. med. (+492017232011, neopredictEGFR.umesz@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of one cycle of preoperative amivantamab therapy (time frame: 28 days pre-operative treatment). 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 NCT06784791.

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 29 Aug 2025.

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