Clinical trial for Metastatic NSCLC - Non-Small Cell Lung Cancer
Official title Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.
ClinicalTrials.gov ID: NCT07392658
What this study is testing
What is Amivantamab?
Amivantamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for metastatic nsclc - non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To assess safety and efficacy of amivantamab plus monochemotherapy in terms of ORR, PFS and OS in subjects with EGFR exon20 insertion mutations metastatic non-small cell lung cancer unfit for platinum-based chemotherapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Written informed consent;
- Male or female patient aged ≥18 years;
- Histologically or cytologically confirmed stage IV or recurrent non-squamous NSCLC harboring EGFR exon20 insertion mutation;
- No prior systemic treatment;
- Unfit for platinum-based chemotherapy; Unfit for platinum is defined by a glomerular filtration rate (GFR) value less than 50 ml/min/BSA (body...
You likely can't join if
- Uncontrolled infectious liver disease;
- Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) Note: participants with a prior history of HBV demonstrated by positive...
- Positive hepatitis C antibody (anti-HCV). Note: participants with a prior history of HCV, who have completed antiviral treatment and have...
- Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following: Receiving ART that may interfere with study...
- Uncontrolled (persistent) hypertension: systolic blood pressure \>160 mm Hg; diastolic blood pressure \>100 mm Hg.
- Congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF (any NYHA class; refer to...
See the full eligibility criteria
- Written informed consent;
- Male or female patient aged ≥18 years;
- Histologically or cytologically confirmed stage IV or recurrent non-squamous NSCLC harboring EGFR exon20 insertion mutation;
- No prior systemic treatment;
- Unfit for platinum-based chemotherapy; Unfit for platinum is defined by a glomerular filtration rate (GFR) value less than 50 ml/min/BSA (body surface area) 1.73 m2 (or a CCR value of \<50 ml/min) or age 80 years...
- At least one radiological measurable disease according to RECIST criteria version 1.1;
- Patients with brain metastases are eligible if they are asymptomatic and stable (i.e. without evidence of progression by imaging for at least two weeks prior to the first dose of trial treatment and without...
- Performance status 0-2 (ECOG PS);
- Patient compliance to trial procedures;
- Adequate bone marrow function (ANC ≥ 1.5x109/L, platelets ≥75x109/L, haemoglobin \>9 g/dl);
- Adequate liver function (Total bilirubin ≤1.5 x ULN; people with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits, transaminases no more than 3xULN/\<5xULN in presence of liver metastases);
- Normal level of alkaline phosphatase and Serum creatinine \ 45 mL/min as measured or calculated; refer to Appendix --Cockcroft-Gault Formula for Estimated creatinine clearance 12 Patients should be using adequate...
- 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 in section 9.6...
- Uncontrolled infectious liver disease;
- Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) Note: participants with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a...
- Positive hepatitis C antibody (anti-HCV). 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...
- Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following: Receiving ART that may interfere with study treatment (consult sponsor for review of medication prior to enrollment) CD4...
- Uncontrolled (persistent) hypertension: systolic blood pressure \>160 mm Hg; diastolic blood pressure \>100 mm Hg.
- Congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF (any NYHA class; refer to Appendix 6: New York Heart Association Criteria) within 6 months of...
- Participant has an uncontrolled illness, including but not limited to: Uncontrolled diabetes Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required...
- Absence of measurable lesions;
- Concomitant radiotherapy;
- Previous treatment with any EGFR Exon20ins-targeted TKIs;
- Symptomatic or immediately requiring therapy for brain metastases or carcinomatous meningitis. people with asymptomatic and stable or treated brain metastases may participate;
- Participant has concurrent or prior malignancy other than the disease under study. The following exceptions require consultation with the Medical Monitor:
- Non-muscle invasive bladder cancer (NMIBC) treated within the last 24 months that is considered completely cured.
- Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.
- Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.
- Participant had major surgery excluding placement of vascular access or tumor biopsy, or had significant traumatic injury within 4 weeks before randomization, or will not have fully recovered from surgery, or has...
- History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia...
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV);
- Pregnancy or lactating female;
- Other serious illness or medical condition potentially interfering with the study.
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Roma (RM), Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, Roma (RM), Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.