A Clinical Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Conditions
- EGFR Exon 20ins-mutated Locally Advanced or Metastatic Non-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-000633-40-HU
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
1.Participant must be =18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
2.Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous NSCLC with documented primary EGFR Exon 20ins activating mutation (a copy of the mutation analysis must be submitted during screening) performed by a Clinical Laboratory Improvement Amendments (CLIA) certified (US sites) or an accredited (outside of the US) local laboratory.
3.Participant must have measurable disease according to RECIST v1.1. If only one measurable lesion exists, it may be used for the screening biopsy (if required for submission of tumor tissue) if the baseline tumor assessment scans are performed =14 days after the biopsy.
4.Participant must have ECOG performance status 0 or 1.
5.Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream.
6.Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion or platelet transfusion within 7 days prior to the date of the laboratory test.
•Hemoglobin =10 g/dL
•Absolute neutrophil count =1.5x109/L, without use of granulocyte colony stimulating factor (G-CSF) within 10 days prior to the date of the test
•Platelets =100x109/L
•ALT and aspartate aminotransferase (AST) =3×upper limit of normal (ULN)
•Total bilirubin =1.5xULN (participants with Gilbert’s syndrome can enroll if conjugated bilirubin is within normal limits)
•Creatinine clearance >50 mL/min as measured or calculated by Cockroft Gault formula
7.Participant must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
8.A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
9.A female participant must be (as defined in Appendix 4: Contraceptive and Barrier Guidance) either of the following:
a.Not of childbearing potential
b.Of childbearing 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;
•have a sole partner who is vasectomized;
•or practicing 2 highly effective methods of contraception, including 1 user independent method and a second method (examples of highly effective methods of contraception are located in Appendix 4: Contraceptive and Barrier Guidance).
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 (eg, woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) the woman must begin 2 highly effective methods of birth control, as described above.
10.A female 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.
11.A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to
1. Participant has received any prior systemic treatment for locally advanced or metastatic disease, with following exceptions noted in section 5.2 of the protocol
2. Participant has evidence of synchronous NSCLC with an EGFR mutation other than EGFR Exon 20ins.
3. Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible). If brain metastases are diagnosed on Screening imaging, the participant may be rescreened for eligibility after definitive treatment.
4. Participant has a history of leptomeningeal disease.
5. Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation.
6. Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy [eg, bone metastases or metastases causing nerve impingement] should be treated prior to Screening).
7. Participant has a medical history of ILD, including drug-induced ILD, or radiation pneumonitis.
8. Participant has an active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Exceptions noted in section 5.2. of the protocol.
9. Participant has a history of clinically significant cardiovascular disease. Examples noted in section 5.2 of the protocol.
10. Participant has at Screening:
• Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg)
• Positive hepatitis C (hepatitis C virus [HCV]) antibody (anti-HCV)
• Other clinically active infectious liver disease
11. Participant is known to be positive for human immunodeficiency virus (HIV)
• Not receiving highly active antiretroviral therapy (ART)
• Had a change in antiretroviral therapy within 6 months of the start of screening
• Receiving antiretroviral therapy that may interfere with study treatment (consult Sponsor for review of medication prior to enrollment)
• CD4 count <350 at screening
• AIDS-defining opportunistic infection within 6 months of start of screening
• Not agreeing to start ART and be on ART>4 weeks plus having HIV viral load <400 copies/mL at end of 4-week period (to ensure ART is tolerated and HIV controlled).
12. Participant has an uncontrolled illness, including but not limited to the following:
• Diabetes
• Ongoing or active bacterial infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week before randomization]), symptomatic viral infection, or any other clinically significant infection
• Active bleeding diathesis
• Impaired oxygenation requiring supplemental oxygen
• Psychiatric illness/social situation that would limit compliance with study requirements
13. Participant had major surgery (eg, requiring general anesthesia) or significant traumatic injury within 4 weeks of randomization, will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study.
Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate.
14. Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent2,5). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid.
15. Participant has a
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method