Back to search
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-small-Cell Lung
Clinicaltrials.gov:
EU CTIS:
#2023-505065-91-00
EudraCT:
J&J ID:
#CR109264
Other:
#61186372NSC2002
Interested in this trial?
Subscribe or share this trial
Trials at a glance
Status
Enrolling
Condition
Carcinoma, Non-small-Cell Lung
Trial type
Interventional
Trial phase
Phase 2
Investigational
product
product
Amivantamab
Carboplatin
Direct Oral Anticoagulant (DOAC)
Lazertinib
Low Molecular Weight Heparin (LMWH)
Pemetrexed
Age
18+ years old
Biological sex
All
Placebo?
No
Trial start date
November 11, 2022
Trial end date
August 18, 2028
CT.gov ID
#NCT05498428
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).
Primary outcome measures
- All Cohorts Except Cohort 4: Objective Response Rate (ORR) Based on Investigator Assessment (INV)
- Cohort 4: Number of Participants with Adverse Events (AEs)
- Cohort 4: Number of Participants with AEs by Severity
- Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values
- Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values by Severity
Secondary outcome measures
- All Cohorts Except Cohort 4: Number of Participants with AEs
- All Cohorts Except Cohort 4: Number of Participants with AEs by Severity
- All Cohorts Except Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values
- All Cohorts Except Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values by Severity
- All Cohorts Except Cohort 4: ORR Based on Independent Central Review (ICR)
- All Cohorts Except Cohort 4: Duration of Response (DoR) Based on Investigator Assessment (INV)
- All Cohorts Except Cohort 4: Time to Response (TTR) Based on INV
- All Cohorts Except Cohort 4: Clinical Benefit Rate (CBR)
- All Cohorts Except Cohort 4: Progression-free Survival (PFS)
- All Cohorts Except Cohort 4: Overall Survival (OS)
- All Cohorts Except Cohort 4: Number of Participants with Venous Thromboembolic Events (VTE)
- All Cohorts Except Cohort 4: Number of Participants with Venous Thromboembolic Events (VTE) by Severity
- All Cohorts Except Cohort 4: Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough) of Amivantamab
- Cohort 4: Cancer Therapy Satisfaction as Assessed by Modified Therapy Administration Satisfaction Questionnaire - Intravenous (TASQ-IV)
- Cohort 4: Cancer Therapy Satisfaction as Assessed by Modified Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC)
- Cohort 4: Patient-reported Status as Assessed by Patient Global Impression of Change (PGIC) Scale Score
- Cohort 4: Patient-reported Status as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
Access detailed information on the trial:
Clinical trials information
© Johnson & Johnson and its affiliates 2026
