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A Study of Lazertinib and Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05388669
Collaborator
(none)
640
Enrollment
118
Locations
4
Arms
23.9
Anticipated Duration (Months)
5.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lazertinib
  • Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
  • Drug: Amivantamab Intravenous
  • Device: Amivantamab SC-CF On-Body Delivery System (OBDS)
 Phase 3

Detailed Description

Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer. Amivantamab is a low-fucose, fully human immunoglobulin (IgG)1-based bispecific antibody directed against EGFR and mesenchymal-epithelial transition (MET) tyrosine kinase receptors. Lazertinib is an oral, highly potent, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The study will include screening phase (up to 28 days), a treatment phase (from randomization until the end of treatment visit), and a follow-up phase for both parts (from end of treatment visit until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first). Safety will be assessed by physical examinations, vital signs, electrocardiograms, echocardiograms, ophthalmologic assessments, laboratory tests, adverse event (AE) frequency and severity (by Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) monitoring, and concomitant medication use. The total duration of the study will be up to 1 year and 11 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
640 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Administered Via Manual Injection Compared With Intravenous Amivantamab or Amivantamab Subcutaneous On Body Delivery System in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy
Anticipated Study Start Date :
Aug 5, 2022
Anticipated Primary Completion Date :
Jan 24, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: Arm A1: Lazertinib with Amivantamab SC-CF

Lazertinib 240 mg will be administered orally once daily. Participants will receive Amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 milligrams (mg)/ 2240 mg depending on the body weight by manual injection.

Drug: Lazertinib
Lazertinib tablets will be administered orally.
Other Names:
  • JNJ-73841937
  • YH25448

    • Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
    Amivantamab injection will be administered subcutaneously by manual injection
    Other Names:
  • JNJ-61186372

    		•
    Experimental: Part 1: Arm B1: Lazertinib with Amivantamab Intravenous (IV) Infusion

    Lazertinib 240 mg will be administered orally once. Participants will receive amivantamab, 1050 mg or 1400 mg depending on the body weight as an IV infusion.

    Drug: Lazertinib
    Lazertinib tablets will be administered orally.
    Other Names:
  • JNJ-73841937
  • YH25448

    • Drug: Amivantamab Intravenous
    Amivantamab will be administered by IV infusion
    Other Names:
  • JNJ-61186372

    		•
    Experimental: Part 2: Arm A2: Lazertinib with Amivantamab SC-CF

    Lazertinib 240 mg will be administered orally once daily. Participants will receive amivantamab SC-CF, 1600 mg or 2240 depending on the body weight mg by manual injection.

    Drug: Lazertinib
    Lazertinib tablets will be administered orally.
    Other Names:
  • JNJ-73841937
  • YH25448

    • Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
    Amivantamab injection will be administered subcutaneously by manual injection
    Other Names:
  • JNJ-61186372

    		•
    Experimental: Part B2: Arm B2: Lazertinib with Amivantamab SC-CF OBDS

    Lazertinib 240 mg will be administered orally once daily. Participants will receive amivantamab SC-CF On-Body Delivery System (OBDS), 1600 mg or 2240 mg depending on the body weight by manual injection.

    Drug: Lazertinib
    Lazertinib tablets will be administered orally.
    Other Names:
  • JNJ-73841937
  • YH25448

    • Device: Amivantamab SC-CF On-Body Delivery System (OBDS)
    Amivantamab will be administered by subcutaneously by OBDS
    Other Names:
  • JNJ-61186372

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Part 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1 [Cycle 4 Day 1 (28 days cycle)]

      Ctrough is the observed serum concentration of Amivantamab at steady state on Cycle 4 Day 1 immediately prior to the next drug administration.

    2. Part 1: Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab of Cycle 2 [Cycle 2 Day 1 to Cycle 2 Day 15 (28 days cycle)]

      AUC(Day 1-15) defined as area under the concentration time curve from Day 1 to Day 15, will be reported will be reported in Cycle 2.

    3. Part 2: Maximum Serum Concentration (Cmax) of Amivantamab After Cycle 1 Day 1 [After Cycle 1 Day 1 (28 days cycle)]

      Cmax is defined as maximum serum concentration of Amivantamab, will be reported after Cycle 1 Day 1.

    4. Part 2: Area Under the Concentration Time Curve from Day 1 to Day 8 (AUC[Day 1-8]) of Amivantamab of Cycle 1 [From Cycle 1 Day 1 to Cycle 1 Day 8 (28 days cycle)]

      AUC(Day 1-8) defined as area under the concentration time curve from Day 1 to Day 8, will be reported in Cycle 1.

    Secondary Outcome Measures

    1. Part 1 and Part 2: Objective Response Rate (ORR) [Up to 1 year 11 months]

      ORR is defined as the percentage of participants who achieve either a CR or PR as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.1).

    2. Part 1 and Part 2: Progression-Free Survival (PFS) [Up to 1 year 11 months]

      PFS is defined as the time from randomization until the date of objective disease progression or death, whichever comes first, based on RECIST version 1.1.

    3. Part 1 and Part 2: Duration of Response (DOR) [Up to 1 year 11 months]

      The DoR 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.

    4. Part 1 and Part 2: Time to Response. [Up to 1 year 11 months]

      Time to response (that is time to first response) is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression and subsequent anticancer therapy, as defined by BICR using RECIST version 1.1., for participants who have PR or CR as their best response.

    5. Part 1 and Part 2: Number of Participants With Adverse Events (AEs) [Up to 1 year 11 months]

      An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention.

    6. Part 1 and Part 2: Number of Participants with AEs by Severity [Up to 1 year 11 months]

      Severity 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.

    7. Part 1 and Part 2: Number of Participants with Clinical Laboratory Abnormalities [Up to 1 year 11 months]

      Number of participants with clinical laboratory abnormalities (serum Chemistry, hematology, coagulation and urinalysis) will be reported.

    8. Part 1 and Part 2: Number of Participants Infusion Related Reactions (IRRs) [Up to 1 year 11 months]

      Number of participants with IRRs will be reported.

    9. Part 1 and Part 2: Number of Participants with Infusion Related Reactions (IRRs) by Severity [Up to 1 year 11 months]

      Number of participants with IRRs by severity will be reported.

    10. Part 1: Observed Serum Concentration (Ctrough) of Amivantamab on Cycle 2 Day 1 [Cycle 2 Day 1 (28 days cycle)]

      The Ctrough is the observed serum concentration of Amivantamab on Cycle 2 Day 1 (Part 1 only) immediately prior to the next drug administration.

    11. Part 1: Model-Predicted Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab at Steady State of Cycle 4 [From Cycle 4 Day 1 to Cycle 4 Day 15 (28 days cycle)]

      Model-predicted AUC(Day 1-15) defined as area under the concentration time curve from Day 1 to Day 15, will be reported in Cycle 4 (Part 1 only).

    12. Part 2: Observed Serum Concentration (Ctrough) of Amivantamab on Cycle 4 Day 1 [Cycle 4 Day 1 (28 days cycle)]

      Ctrough is the observed serum concentration of Amivantamab on Cycle 4 Day 1 (Part 2 only) immediately prior to the next drug administration.

    13. Part 1 and Part 2: Percentage of Participants with Presence of Anti-amivantamab Antibodies and Anti-rHuPH20 Antibodies [Up to 1 year 11 months]

      Percentage of participants with presence of anti-amivantamab antibody anti-rHuPH20 antibodies will be reported.

    14. Part 1 and Part 2: Percentage of Participants with Cancer Therapy Satisfaction as Assessed by Therapy Administration Satisfaction Questionnaire (TASQ) [Up to 1 year 11 months]

      Percentage of participants with cancer therapy satisfaction in will be assessed using the modified TASQ. The modified TASQ is an 11-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.

    15. Part 1 and Part 2: Change from Baseline in TASQ as Assessed Over Time [Up to 1 year 11 months]

      Change from baseline in TASQ as assessed Over time will be reported. The modified TASQ is an 11-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.

    16. Part 1 and Part 2: Participant Chair Time [Up to 1 year 11 months]

      Participant chair time will be assessed by time and motion analysis.

    17. Part 1 and Part 2: Duration of Treatment Administration [Up to 1 year 11 months]

      Duration of treatment administration will be assessed by time and motion analysis.

    18. Part 1 and Part 2: Active HCP Time For Drug Preparation, Treatment Administration and Posttreatment Monitoring. [Up to 1 year 11 months]

      Active health care professional time for drug preparation, treatment administration, and posttreatment monitoring will be assessed by time and motion analysis.

    19. Part 1 and Part 2: Participant Time in Treatment Room [Up to 1 year 11 months]

      Participant time in treatment room will be assessed by time and motion analysis.

    20. Part 1 and Part 2: Rate of Successful Injections with Amivantamab SC-CF OBDS [Up to 1 year 11 months]

      Rate of successful injections with amivantamab SC-CF OBDS at each amivantamab SC-CF administration will be reported.

    21. Part 2: Ease of use and Satisfaction with Amivantamab SC-CF OBDS as Assessed by Ease of use and Satisfaction Questionnaire [Cycle 2 Day 1 (28 days cycle)]

      Ease of use and Satisfaction is 8-items questionnaire to access the satisfaction and ease of use of OBDS. The questionnaire is constructed as five-point Likert rating scales. HCPs that cared for participants are asked to rate agreement with the statements, ranging from 1=strongly disagree to 5=strongly agree on Cycle 2 Day 1 (Part 2 only).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an 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 Started [US]) or an accredited local laboratory (sites outside of the US)

    • Have progressed on or after osimertinib and platinum-based chemotherapy (irrespective of order). a) Osimertinib must have been administered as the first epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with osimertinib or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease

    • Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1

    • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

    • Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade less than or equal to (<=) 2 peripheral neuropathy, and Grade <=2 hypothyroidism stable on hormone replacement)

    Exclusion Criteria:

    • Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors

    • Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization

    • Participant has symptomatic or progressive brain metastases

    • Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation

    • Participant has uncontrolled tumor-related pain

    • Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114
    2 University of Mississippi Medical Center Jackson Mississippi United States 39213
    3 Cleveland Clinic Cleveland Ohio United States 44195
    4 Providence Portland Medical Center Portland Oregon United States 97213
    5 Medical University of South Carolina Charleston South Carolina United States 29425
    6 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    7 Swedish Cancer Institute Seattle Washington United States 98104
    8 Centro Oncológico Korben Ciudad Autonoma de Buenos Aires Argentina C1426AGE
    9 Fundacao Pio Xii - Hospital De Cancer De Barretos Barretos Brazil 147844
    10 Cetus Oncologia Belo Horizonte Brazil 30110-017
    11 CIONC - Centro Integrado de Oncologia de Curitiba Curitiba Brazil 80810-050
    12 Ynova Pesquisa Clinica Florianopolis Brazil 88020-210
    13 Fundação São Francisco Xavier Ipatinga Brazil 35162 189
    14 UPCO Unidade de Pesquisa Clinica em Oncologia Pelotas Brazil 96020 080
    15 Hospital de Clínicas de Porto Alegre Porto Alegre Brazil 90035-903
    16 Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul Porto Alegre Brazil 90610-000
    17 Hospital sao lucas Rio de Janeiro Brazil 22061-080
    18 Oncoclínicas Rio De Janeiro Brazil 22250-905
    19 Núcleo de Oncologia da Bahia Salvador Brazil 40170-110
    20 CEPHO - Faculdade de Medicina do ABC Santo André Brazil 09060-650
    21 Hospital Nove de Julho São Paulo Brazil 01409-002
    22 Núcleo de Pesquisa São Camilo São Paulo Brazil 04014-002
    23 Onco Star SP Oncologia Ltda São Paulo Brazil 04543-000
    24 Hospital Israelita Albert Einstein São Paulo Brazil 05651-901
    25 The Ottawa Hospital Cancer Centre Ottawa Ontario Canada K1H 8L6
    26 Princess Margaret Hospital Toronto Ontario Canada M5G 1Z5
    27 Beijing Shijitan Hospital, Capital Medical University Beijing China 100038
    28 Beijing Friendship Hospital, Capital Medical University Beijing China 100050
    29 Beijing Cancer Hospital Beijing China 100142
    30 Peking University Third Hospital Beijing China 100191
    31 Beijing Chest hospital, Capital medical university Beijing China 101149
    32 Cancer Hospital Chinese Academy of Medical Sciences Beijing China 200240
    33 Jilin cancer hospital Changchun China 130012
    34 The First People's Hospital Of Changzhou Changzhou China 213004
    35 Sichuan Cancer Hospital Chengdu China 610041
    36 West China Hospital, Sichuan University Chengdu China 610047
    37 Chongqing University Cancer Hospital Chongqing China 400030
    38 Southwest Hospital ChongQing China 400038
    39 First Affiliated Hospital of Gannan Medical University Ganzhou China 341000
    40 The First Affiliated Hospital, Sun Yat-sen University Guang Zhou China 510080
    41 Sun Yat-Sen Memorial Hospital Sun Yat-sen University Guangzhou China 510120
    42 Zhejiang Cancer Hospital Hang Zhou China 310022
    43 The Second Affiliated Hospital of Zhejiang University College of Medicine Hangzhou China 310009
    44 Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou China 310016
    45 Harbin medical university cancer hospital Harbin China 150081
    46 Huizhou Municipal Central Hospital Huizhou China 516001
    47 Liuzhou people&#39;s Hospital Liuzhou China 545026
    48 Fudan University Shanghai Cancer Center Shanghai China 200032
    49 Shengjing Hospital of China Medical University Shenyang China 110004
    50 Shenzhen university General Hospital Shenzhen China 518020
    51 Shenzhen university General Hospital Shenzhen China 518055
    52 Tianjin Medical University Cancer Institute and Hospital Tianjin China 300060
    53 Union Hospital Tongji Medical College of Huazhong University of Science and Technology Wuhan China 430022
    54 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an China 710061
    55 Yantai Yuhuangding Hospital Yantai China 264000
    56 Henan Cancer Hospital Zhengzhou China 450008
    57 CHU Grenoble La Tronche France 38700
    58 Institute Coeur Poumon Lille France 59000
    59 CHU de Limoges, Hopital Dupuytren Limoges France 87000
    60 Hopital Nord Marseille Cedex 20 France 13915
    61 Institut Regional du Cancer de Montpellier Val d'Aurelle Montpellier France 34090
    62 CHU Bordeaux Pessac France 33604
    63 Samson Assuta Ashdod University Hospital Ashdod Israel 7747629
    64 Rambam Medical Center Haifa Israel 3109601
    65 Meir Medical Center Kfar Saba Israel 44281
    66 Rabin Medical Center Petah-Tikva Israel 49100
    67 Assuta MC Tel Aviv-Yafo Israel 6971028
    68 Assaf Harofeh Medical Center Zerifin Israel 73100
    69 Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II Bari Italy 70124
    70 A.O.U Sant'Orsola-Malpighi Bologna Italy 40138
    71 European Institute of Oncology Milano Italy 20141
    72 Istituto Oncologico Veneto - IRCCS Padova Italy 35128
    73 Ospedale S. Maria Delle Croci Ravenna Italy 48121
    74 A.O. San Camillo Forlanini Roma Italy 00152
    75 Istituto Nazionale Tumori Regina Elena Rome Italy 00144
    76 Istituto Clinico Humanitas Rozzano Italy 20089
    77 Prince Court Medical Centre Kuala Lumpur Malaysia 50450
    78 Pantai Hospital Kuala Lumpur Kuala Lumpur Malaysia 59100
    79 University Malaya Medical Centre Kuala Lumpur Malaysia 59100
    80 Hospital Umum Sarawak Kuching Malaysia 93586
    81 Beacon Hospital Sdn. Bhd. Petaling Jaya Malaysia 46050
    82 Sunway Medical Centre Petaling Jaya Malaysia 47500
    83 Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy Bydgoszcz Poland 85-796
    84 Krakowski Szpital Specjalityczny im. Jana Pawla II Krakow Poland 31-202
    85 Mazowieckie Centrum Leczenia Chorob Pluc Otwock Poland 05-400
    86 Private Specialist Hospitals - MedPolonia Poznan Poland 60-693
    87 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Warszawa Poland 02-781
    88 Hosp. Univ. A Coruña A Coruña Spain 15006
    89 Hosp. Gral. Univ. de Alicante Alicante Spain 03010
    90 Hosp. Univ. Vall D Hebron Barcelona Spain 08035
    91 Hosp. Clinic I Provincial de Barcelona Barcelona Spain 08036
    92 Hosp. Univ. Quiron Dexeus Barcelona Spain 8028
    93 Hosp. Reina Sofia Córdoba Spain 14004
    94 Hosp. Univ. Insular de Gran Canaria Las Palmas de Gran Canaria Spain 35016
    95 Hosp. Univ. Lucus Augusti Lugo Spain 27003
    96 Hosp. Gral. Univ. Gregorio Marañon Madrid Spain 28009
    97 Hosp. Univ. La Paz Madrid Spain 28046
    98 Hosp. Univ. Pta. de Hierro Majadahonda Majadahonda Spain 28222
    99 Hosp. Regional Univ. de Malaga Malaga Spain 29010
    100 Hosp. Univ. Central de Asturias Oviedo Spain 33006
    101 Hosp. Univ. Son Espases Palma de Mallorca Spain 07120
    102 Hosp. Virgen Del Rocio Sevilla Spain 41013
    103 Hosp. Univ. I Politecni La Fe Valencia Spain 46026
    104 Chang Kung Memorial Hospital Kaohsiung City Taiwan 833
    105 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 80756
    106 Chung Shan Medical University Hospital Taichung Taiwan 403
    107 National Cheng Kung University Hospital Tainan Taiwan 70403
    108 Linkou Chang Gung Memorial Hospital Taoyuan City Taiwan 33382
    109 Adana City Hospital Adana Turkey 01060
    110 Adana Baskent Yuregir Hospital Adana Turkey 01120
    111 Memorial Ankara Hastanesi Ankara Turkey 06520
    112 Ankara Bilkent City Hospital Ankara Turkey 06590
    113 Trakya University Medical Faculty Edirne Turkey 22030
    114 Istanbul University Cerrahpasa Medical Faculty Istanbul Turkey 34098
    115 Acıbadem Maslak Hospital Istanbul Turkey 34457
    116 Dokuz Eylul University Medical Faculty İzmir Turkey 35330
    117 Izmir Medical Park Hospital Izmir Turkey 35575
    118 Medical Park Samsun Hastanesi Samsun Turkey 55200

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT05388669
    Other Study ID Numbers:
    • CR109211
    • 2022-000525-25
    • 61186372NSC3004
    First Posted:
    May 24, 2022
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Amivantamab-vmjw
    Lazertinib
    Antibodies, Bispecific

    Study Results

    No Results Posted as of May 24, 2022