RecruitingNCT05498428PALOMA-2Updated Sep 28, 2026

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

A Phase 2 interventional study of Amivantamab and Lazertinib in Carcinoma, Non-small-Cell Lung, sponsored by Janssen Research & Development, LLC. Recruiting at 110 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 520
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

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).

Conditions studied

Carcinoma, Non-small-Cell Lung

Browse trials for

Carcinoma, Non-Small-Cell Lung 6,478

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC) that is not amenable to curative therapy including surgical resection or chemoradiation. Additional Cohort specific disease requirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2: EGFR Exon 20ins mutation. Cohorts 1,5,and6: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohort 2: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohorts 3and3b: Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second-line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Cohort 4: Participants need to currently be on an amivantamab IV Q2W regimen (1,050 mg or 1,400 mg depending on weight) for at least 8 weeks, as part of standard of care, an expanded access program, or as a rollover from a long-term extension, without any amivantamab dose reduction. Cohort 7: Participants must have progressed on or after the combination of amivantamab and lazertinib as the most recent line of treatment. The combination of amivantamab and lazertinib must have been administered as the first-line treatment for locally advanced or metastatic disease. Cohort 2, 3, 3b, and 7 only: Squamous NSCLC are excluded. EGFR mutation must have been identified as determined by Food and Drug Administration (FDA) approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US). A copy of the initial test report documenting the EGFR mutation must be included in the participant records and a deidentified copy must also be submitted to the sponsor
All cohorts except Cohort 4: Participants must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the only target lesion has been previously irradiated, it must show signs of disease progression since radiation was completed If only 1 non-irradiated measurable lesion exists, which undergoes a biopsy and is acceptable as a target lesion, the baseline tumor assessment scans should be performed at least 14 days after the biopsy
May have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
Have adequate organ (renal, hepatic, hematological, coagulation and cardiac) functions
Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1
Cohort 6: Must be eligible for, and agree to comply with, the use of prophylactic anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of study treatment
A participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Participants with child bearing potential should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility

Exclusion criteria

Exclusion Criteria:

Participant has a medical history of interstitial lung disease (ILD), including drug induced ILD or radiation pneumonitis
Participant has a history of hypersensitivity to any excipients of the investigational products to be used in their enrollment cohort
Participant has received a live or live attenuated vaccine within 3 months before Cycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines against Coronavirus disease 19 (COVID-19) are not exclusionary
For all cohorts (with regimens potentially including lazertinib): Participant is currently receiving medications or herbal supplements known to be potent Cytochrome (CYP3A4/5) inducers and is unable to stop use for an appropriate washout period prior to Cycle 1 Day 1
Other clinically active liver disease of infectious origin
Participant has a history of clinically significant cardiovascular disease including, but not limited to: a) All cohorts: diagnosis of deep vein thrombosis or pulmonary embolism within 1 month prior to the first dose of study treatment(s), or any of the following within 6 months prior to the first dose of study treatment(s): myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as non-obstructive catheter-associated clots, are not exclusionary; b) All cohorts (with regimens potentially including lazertinib): Participant has a significant genetic predisposition to venous thromboembolic events (VTE; such as Factor V Leiden); c) All cohorts (with regimens potentially including lazertinib): Participant has a prior history of VTE and is not on appropriate therapeutic anticoagulation as per NCCN or local guidelines; d) prolonged corrected QT interval by Fridericia (QTcF) interval greater than (>) 480 milliseconds (msec) or clinically significant cardiac arrhythmia or electrophysiologic disease (example, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate); e) uncontrolled (persistent) hypertension: systolic blood pressure >160 millimeter(s) of mercury (mmHg); diastolic blood pressure >100 mmHg; f) Congestive heart failure defined as NYHA class III-IV or hospitalization for congestive heart failure (CHF) (any New York Heart Association [NYHA] class) within 6 months of treatment initiation at Cycle 1/day 1 (C1D1); g) pericarditis/clinically significant pericardial effusion; h) myocarditis; i) baseline left ventricular ejection fraction (LVEF) below the institution's lower limit of normal at screening, as assessed by echocardiogram or multigated acquisition (MUGA) scan
Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have received definitive radiation or surgical treatment for symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at least 2 weeks before Screening are eligible, provided they have been either off corticosteroid treatment or are receiving low-dose corticosteroid treatment (less than or equal to [\<=] 10 milligrams per day [mg/day] prednisone or equivalent) for at least 2 weeks prior to treatment allocation

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 520 participants (estimated)

Study arms

Experimental
Cohort 1(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q2W) + Lazertinib
Participants with treatment-naive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) exon 19 deletion (exon19del) or exon 21 leucine 858 to arginine substitution (exon 21 L858R) mutation, will receive amivantamab SC-CF injection, 1600 milligrams (mg) or 2240 mg if body weight is greater than or equal to (\>=) 80 kilograms (kg), on Cycle 1 Days 1, 8, 15, and 22 and on Days 1 and 15 of each subsequent 28-day cycle, starting with Cycle 2, along with lazertinib 240 mg orally once daily. Eligible participants will be given an option to enter long-term extension (LTE) phase and may continue to receive access to study treatment(s) within the study by transferring to the Drug Access (DA)-LTE Phase.
Drug: Amivantamab · Drug: Lazertinib
Experimental
Cohort 2(Exon20 NSCLC,1L, Previously Untreated): Amivantamab (Q3W) + Chemotherapy
Participants with treatment-naive locally advanced or metastatic NSCLC harboring an EGFR exon20ins mutation will receive Amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is \>=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is \>=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle, starting with Cycle 2 along with pemetrexed 500 milligrams per meter square (mg/m\^2) as intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and IV infusion carboplatin area under the concentration-time curve 5 milligrams per milliliters (mg/mL) per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Drug: Amivantamab · Drug: Carboplatin · Drug: Pemetrexed
Experimental
Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+Chemotherapy
Participants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after treatment with a third-generation EGFR TKI (osimertinib), will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is \>=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is \>=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m\^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression. Lazertinib 240 mg orally once daily starting Cycle 5 Day 1 when carboplatin is complete or sooner if carboplatin discontinued earlier than Cycle 4. Eligible participants will be given an option to enter LTE phase and DA-LTE Phase.
Drug: Amivantamab · Drug: Lazertinib · Drug: Carboplatin · Drug: Pemetrexed
Experimental
Cohort 3b(Exon19del/Exon21 L858R NSCLC, 2L, Post Osimertinib): Amivantamab (Q3W)+Chemotherapy
Participants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after treatment with a third-generation EGFR TKI (osimertinib), will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is \>=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is \>=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m\^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Drug: Amivantamab · Drug: Carboplatin · Drug: Pemetrexed
Experimental
Cohort 4(Previously Treated with Amivantamab IV): Switch from Amivantamab IV to SC-CF (Q2W)
Participants who were previously on amivantamab IV once every 2 weeks (Q2W) regimen as part of standard of care, for at least 8 weeks, either as monotherapy or combination with lazertinib, will receive amivantamab SC-CF injection 1600 mg and 2240 mg if body weight is greater than or equal to 80 kg. Participants who continue to benefit from study treatments, as determined by their investigator, may shift to the drug access (DA)-LTE phase.
Drug: Amivantamab · Drug: Lazertinib
Experimental
Cohort 5(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q4W) + Lazertinib
Participants with treatment-naïve locally advanced or metastatic NSCLC harboring an EGFR Exon19del or Exon 21 L858R mutation will receive amivantamab SC-CF induction with 1,600 mg (or 2,240 mg if BW \>=80 kg) on Cycle 1 Days 1, 8, 15, and 22, starting with Cycle 2 on Day 1 of each next 28-day cycle, amivantamab SC-CF (160 mg/mL co-formulated with rHuPH20) by manual injection at 3,520 mg (or 4,640 mg if BW \>=80 kg); along with lazertinib 240 mg by mouth once daily from Cycle 1 Day 1. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Drug: Amivantamab · Drug: Lazertinib
Experimental
Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+Anticoagulant
Participants with treatment-naive locally advanced or metastatic NSCLC harboring an EGFR Exon19del or Exon 21 L858R mutation treated will receive will receive amivantamab SC-CF injection, 1600 milligrams (mg) and 2240 mg if body weight is greater than or equal to (\>=) 80 kilograms (kg), on Cycle 1 Days 1, 8, 15, and 22 and on Days 1 and 15 of each subsequent 28-day cycle, starting with Cycle 2, along with lazertinib 240 mg orally once daily from Cycle 1 Day 1. Participants will additionally take prophylactic anticoagulation with a direct oral anticoagulant (DOAC) or a low molecular weight heparin (LMWH) for the first four months of study treatment (from Day 1 through Day 120) with the combination of amivantamab and lazertinib. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Drug: Amivantamab · Drug: Lazertinib · Drug: Direct Oral Anticoagulant (DOAC) · Drug: Low Molecular Weight Heparin (LMWH)
Experimental
Cohort 7(Exon19del/Exon21 L858R NSCLC,2L,Post Amivantamab+Lazertinib):Amivantamab(Q3W)+Chemotherapy
Participants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after the combination of amivantamab and lazertinib will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is \>=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is \>=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m\^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Drug: Amivantamab · Drug: Carboplatin · Drug: Pemetrexed

Interventions

DrugAmivantamab
Amivantamab will be administered subcutaneously by manual injection.
Also known as: JNJ-61186372
DrugLazertinib
Lazertinib will be administered as an oral tablet.
Also known as: JNJ-73841937; YH25448
DrugCarboplatin
Carboplatin will be administrated by IV infusion.
DrugPemetrexed
Pemetrexed will be administered by IV infusion.
DrugDirect Oral Anticoagulant (DOAC)
DOAC will be administered orally.
DrugLow Molecular Weight Heparin (LMWH)
LMWH will be administered subcutaneously.

What researchers measure

Primary outcomes

All Cohorts Except Cohort 4: Objective Response Rate (ORR) Based on Investigator Assessment (INV)
ORR based on INV will be reported. ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by investigator.
Time frame: Up to 1 year 6 months
Cohort 4: Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Time frame: Up to approximately 4 years and 9 months
Cohort 4: Number of Participants with AEs by Severity
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Up to approximately 4 years and 9 months
Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values
Number of participants with abnormalities in clinical laboratory values (which includes serum chemistry, hematology, coagulation, urinalysis, and serology) will be reported.
Time frame: Up to approximately 4 years and 9 months
Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values by Severity
Number of participants with laboratory values abnormalities which includes serum chemistry, hematology, coagulation, urinalysis, and serology) by severity will be reported. Severity of laboratory values abnormalities will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Up to approximately 4 years and 9 months

Secondary outcomes

All Cohorts Except Cohort 4: Number of Participants with AEs
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Number of Participants with AEs by Severity
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values
Number of participants with abnormalities in clinical laboratory values (which includes serum chemistry, hematology, coagulation, urinalysis, and serology) will be reported.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values by Severity
Number of participants with abnormalities in clinical laboratory values which includes serum chemistry, hematology, coagulation, urinalysis, and serology) by severity will be reported. Severity of laboratory values abnormalities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: ORR Based on Independent Central Review (ICR)
ORR based on ICR will be reported. The ORR is defined as the percentage of participants who achieve a CR or PR, based on RECIST version 1.1, as confirmed by ICR.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Duration of Response (DoR) Based on Investigator Assessment (INV)
DoR based on INV is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Time to Response (TTR) Based on INV
TTR (that is, time to first response) based on INV is defined as the time from the first dose of study treatment to the date of first documentation of a response (PR or CR) prior to any disease progression and subsequent anticancer therapy, based on RECIST version 1.1., for participants who have PR or CR as their best response.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants achieving CR or PR, or durable standard deviation (SD) of a duration of at least 11 weeks as defined by RECIST version 1.1.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Progression-free Survival (PFS)
The PFS is defined as the time from the first dose of study treatment until the date of objective disease progression or death, whichever comes first, based on RECIST version 1.1.
Time frame: Up to 3 years
All Cohorts Except Cohort 4: Overall Survival (OS)
The OS is defined as the time from the first dose of study treatment until the date of death due to any cause.
Time frame: Up to approximately 4 years
All Cohorts Except Cohort 4: Number of Participants with Venous Thromboembolic Events (VTE)
Number of participants with adverse events of VTE (pulmonary embolism and deep vein thrombosis) will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Number of Participants with Venous Thromboembolic Events (VTE) by Severity
Number of participants with adverse events of VTE (pulmonary embolism and deep vein thrombosis) by severity will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death).
Time frame: Up to 1 year 6 months
All Cohorts Except Cohort 4: Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough) of Amivantamab
Ctrough is defined as the serum concentration of amivantamab immediately prior to the next drug administration.
Time frame: Cycle 2 Day 1 of 28-day cycle
Cohort 4: Cancer Therapy Satisfaction as Assessed by Modified Therapy Administration Satisfaction Questionnaire - Intravenous (TASQ-IV)
Patient-reported outcome (PRO): Cancer therapy satisfaction will be assessed using the modified TASQ-IV. The modified TASQ is a 12-item questionnaire measuring the impact of each mode of treatment administration on five domains: physical impact, psychological impact, impact on activities of daily living, convenience, and satisfaction. Each of the domain/scale scores is scored on a 1-100 scale, where 0 is worst and 100 is best.
Time frame: Up to 1 year 6 months
Cohort 4: Cancer Therapy Satisfaction as Assessed by Modified Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC)
PRO: Cancer therapy satisfaction will be assessed using the modified TASQ-SC. The modified TASQ is a 12-item questionnaire measuring the impact of each mode of treatment administration on five domains: physical impact, psychological impact, impact on activities of daily living, convenience, and satisfaction. Each of the domain/scale scores is scored on a 1-100 scale, where 0 is worst and 100 is best.
Time frame: Up to 1 year 6 months
Cohort 4: Patient-reported Status as Assessed by Patient Global Impression of Change (PGIC) Scale Score
Patient-reported status as assessed by PGIC scale score will be reported. The PGIC is an assessment of the participant's overall sense of whether there has been a change since starting treatment. The PGIC is a 7-point response scale. Participants will be asked to rate their current fatigue as compared to when they started the study, using the following 7-point scale: 1 = Much better, 2 = Moderately better, 3 = A little better, 4 = No change, 5 = A little worse, 6 = Moderately worse, and 7 = Much worse.
Time frame: Up to 1 year 6 months
Cohort 4: Patient-reported Status as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
Patient-reported status as assessed by PGIS scale score will be reported. The PGIS is an assessment of lung cancer severity at a given point in time. The PGIS is a 5-point response scale. Participants will be asked to rate their fatigue over the past 7 days using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe.
Time frame: Up to 1 year 6 months

Study locations

82 of 110 sites recruiting

University of California at San Diego
La Jolla, California 92093, United States
Recruiting
University of California Irvine
Orange, California 92868, United States
Recruiting
Stanford Cancer Institute
Stanford, California 94305, United States
Recruiting
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C., District of Columbia 20016, United States
Recruiting
Baptist Lynn Cancer Institute
Boca Raton, Florida 33486, United States
Completed
Mount Sinai Medical Center
Miami Beach, Florida 33140, United States
Recruiting
AdventHealth
Orlando, Florida 32804, United States
Recruiting
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida 33612, United States
Completed
University of Kansas Cancer Center
Westwood, Kansas 66205, United States
Recruiting
Sidney Kimmel Cancer Center - Bayview Campus
Baltimore, Maryland 21224, United States
Recruiting
Boston Medical Center
Boston, Massachusetts 02118, United States
Recruiting
Washington University School Of Medicine
St Louis, Missouri 63110, United States
Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601, United States
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901, United States
Recruiting
Hematology-Oncology Associates of CNY
East Syracuse, New York 13057, United States
Completed
Novant Health 1
Charlotte, North Carolina 28204, United States
Completed
Novant Health
Winston-Salem, North Carolina 27106, United States
Completed
Cleveland Clinic 1
Cleveland, Ohio 44111, United States
Completed
Cleveland Clinic
Cleveland, Ohio 44195, United States
Completed
Cleveland Clinic 2
Mayfield Heights, Ohio 44124, United States
Completed
Cleveland Clinic 3
Warrensville Heights, Ohio 44122, United States
Completed
The Huntsman Cancer Institute
Salt Lake City, Utah 84112, United States
Completed
Virginia Cancer Specialists
Fairfax, Virginia 22031, United States
Recruiting
Providence Regional Cancer Partnership
Everett, Washington 98201, United States
Completed
Virginia Mason Medical Center
Seattle, Washington 98101, United States
Completed
Swedish Cancer Institute
Seattle, Washington 98104, United States
Recruiting
Fundacao Pio XII
Barretos, 14784-400, Brazil
Recruiting
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte, 30130 090, Brazil
Recruiting
Hospital do Cancer de Londrina
Londrina, 86015 520, Brazil
Recruiting
Hospital Moinhos de Vento
Porto Alegre, 90035-001, Brazil
Recruiting
IDOR - Regional Rio de Janeiro
Rio de Janeiro, 22281 100, Brazil
Recruiting
IDOR - Regional Bahia
Salvador, 41253-190, Brazil
Recruiting
Hospital Alemao Oswaldo Cruz
São Paulo, 01327 001, Brazil
Recruiting
Impar Servicos Hospitalares SA Hospital Nove de Julho
São Paulo, 01409-001, Brazil
Completed
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01509 900, Brazil
Recruiting
Affiliated Hospital of Hebei University
Baoding, 071051, China
Completed
Jilin cancer hospital
Changchun, 130000, China
Recruiting
Sichuan Cancer Hospital
Chengdu, 610041, China
Recruiting
West China Hospital Sichuan University
Chengdu, 610047, China
Recruiting
The First Affiliated Hospital of PLA Army Medical University
Chongqing, 400038, China
Recruiting
The First Affiliated Hospital Sun Yat sen University
Guangzhou, 510060, China
Recruiting
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, 310003, China
Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310016, China
Recruiting
Harbin medical university cancer hospital
Harbin, 150000, China
Recruiting
Huizhou Municipal Central Hospital
Huizhou, 516001, China
Recruiting
Liuzhou people's Hospital
Liuzhou, 545006, China
Completed
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Recruiting
Tianjin Medical University General Hospital
Tianjin, 300052, China
Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Recruiting
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430022, China
Recruiting
Hospital of Jiangnan University
Wuxi, 214122, China
Completed
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061, China
Recruiting
Yantai Yuhuangding Hospital
Yantai, 264000, China
Completed
Centre Francois Baclesse
Caen, 14076, France
Recruiting
Centre Georges-François Leclerc
Dijon, 21079, France
Completed
Institut de Cancérologie du Gard
Nîmes, 30029, France
Recruiting
Institut Curie
Paris, 75248, France
Recruiting
Institut de cancerologie de l'ouest
Saint-Herblain, 44805, France
Recruiting
Gustave Roussy
Villejuif, 94800, France
Recruiting
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Completed
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Recruiting
LungenClinic Grosshansdorf GmbH
Grosshandorf, 22927, Germany
Recruiting
Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
Recruiting
Klinikum Würzburg Mitte gGmbH Standort Missioklinik
Würzburg, 97074, Germany
Recruiting
Rambam Medical Center
Haifa, 3109601, Israel
Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Recruiting
Meir Medical Center
Kfar Saba, 44281, Israel
Completed
Rabin Medical Center
Petah Tikva, 4941492, Israel
Recruiting
Sheba Medical Center
Ramat Gan, 52621, Israel
Recruiting
Policlinico Hospital San Martino- IRCCS for Oncology
Genova, 16132, Italy
Recruiting
Ospedale San Raffaele
Milan, 20132, Italy
Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Recruiting
Azienda Ospedaliera San Gerardo
Monza, 20090, Italy
Recruiting
Azienda Ospedaliera Specialistica dei Colli
Naples, 80131, Italy
Recruiting
National Hospital Organization Himeji Medical Center
Himeji, 670-8520, Japan
Active, not recruiting
Saiseikai Matsusaka Municipal Hospital
Matsusaka, 515 8544, Japan
Active, not recruiting
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Active, not recruiting
Shizuoka Cancer Center
Shizuoka, 411 8777, Japan
Active, not recruiting
The Cancer Institute Hospital of JFCR
Tokyo, 135 8550, Japan
Active, not recruiting
Wakayama Medical University Hospital
Wakayama, 641 8510, Japan
Active, not recruiting
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Recruiting
Hospital Tengku Ampuan Afzan
Kuantan, 25100, Malaysia
Recruiting
Hospital Umum Sarawak
Kuching, 93586, Malaysia
Recruiting
Beacon Hospital Sdn Bhd
Petaling Jaya, 46050, Malaysia
Recruiting
National Cancer Center
Goyang-si, 10408, South Korea
Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Recruiting
Seoul National University Hospital
Seoul, 03080, South Korea
Recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Recruiting
Asan Medical Center
Seoul, 05505, South Korea
Completed
Hosp Univ A Coruna
A Coruña, 15006, Spain
Recruiting
General University Hospital of Alicantet
Alicante, 03010, Spain
Recruiting
Hosp. Del Mar
Barcelona, 08003, Spain
Recruiting
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Recruiting
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Recruiting
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, 8908, Spain
Recruiting
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007, Spain
Recruiting
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Recruiting
Hosp. Univ. La Paz
Madrid, 28046, Spain
Recruiting
Hosp Regional Univ de Malaga
Málaga, 29010, Spain
Recruiting

Showing the first 100 of 110 sites across 12 countries.

References and documents

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT05498428
Lead sponsor: Janssen Research & Development, LLC
Responsible party: Sponsor
First posted: Aug 12, 2022
Start date: Nov 11, 2022
Primary completion: Aug 17, 2027 (estimated)
Completion: Aug 18, 2028 (estimated)
Last update: Sep 28, 2026

Study contacts

Study Contact

Contact

Participate-In-This-Study1@its.jnj.com

844-434-4210

Janssen Research & Development, LLC Clinical Trial

study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carcinoma, Non-Small-Cell Lung→

Other studies from this sponsor

Janssen Research & Development, LLC

Start the discussion