Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06120140
Other study ID # 61186372NSC2007
Secondary ID 2023-505863-35-0
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 16, 2024
Est. completion date March 31, 2026

Study information

Verified date June 2024
Source Janssen Research & Development, LLC
Contact Study Contact
Phone 844-434-4210
Email Participate-In-This-Study@its.jnj.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether enhanced dermatologic management can reduce incidence of grade greater than or equal to (>=) 2 dermatologic adverse events of interest (DAEIs) when compared with standard-of-care skin management in participants with locally advanced or metastatic stage IIIB/C-IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) treated first-line with amivantamab and lazertinib.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date March 31, 2026
Est. primary completion date July 3, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment-naive and not amenable to curative therapy including surgical resection or (chemo) radiation. Adjuvant or neoadjuvant therapy for Stage I or Stage II disease is allowed if administered more than 12 months prior to the development of locally advanced or metastatic disease - Have a tumor that harbors an epidermal growth factor receptor (EGFR) exon 19del or exon 21 L858R substitution, as detected by an Food and Drug Administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the United States) or an accredited local laboratory (sites outside of the United States) in accordance with site standard of care - Participants with a history of brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization, and the participant can be receiving no greater than 10 milligram (mg) prednisone or equivalent daily for the treatment of intracranial disease - Can have prior or concurrent second malignancy (other than the disease under study)which natural history or treatment is unlikely to interfere with any study endpoints, safety, or the efficacy of the study treatment(s) - Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 Exclusion Criteria: - History of uncontrolled illness, including but not limited to uncontrolled diabetes; ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week prior to starting background anticancer treatment] or diagnosed or suspected viral infection); active bleeding diathesis; impaired oxygenation requiring continuous oxygen supplementation; refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of background anticancer treatment or doxycycline/minocycline; psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements; any ophthalmologic condition that is clinically unstable; pre-existing skin condition that would prevent adequate evaluations of dermatologic toxicity, as determined by the investigator - Medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis - Known allergy, hypersensitivity, or intolerance to the excipients of amivantamab, lazertinib, or to tetracyclines, doxycycline, minocycline, or their excipients or to any component of the enhanced dermatologic management - Participant has received any prior systemic treatment at any time for locally advanced stage III or metastatic stage IV disease (adjuvant or neoadjuvant therapy for stage I or II disease is allowed if administered more than 12 months prior to the development of locally advanced or metastatic disease) - Participant has an active or past medical history of leptomeningeal disease

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Amivantamab
Amivantamab will be administered as intravenous (IV) infusion.
Lazertinib
Lazertinib tablet will be administered orally.
Doxycycline
Doxycycline tablet will be administered orally.
Minocycline
Minocycline capsule will be administered orally.
Clindamycin
Clindamycin lotion will be used as topical application on the scalp.
Chlorhexidine
Chlorhexidine solution will be used as topical application on hands and feet.
Other:
Noncomedogenic skin moisturizer
Noncomedogenic skin moisturizer will be used as topical application.

Locations

Country Name City State
Argentina Hospital Italiano de Buenos Aires Buenos Aires
Argentina IADT Instituto Argentino de Diagnostico y Tratamiento Caba
Argentina Centro Medico Austral Capital Federal
Argentina Hospital Italiano de La Plata La Plata
Argentina Hospital Privado de la Comunidad Mar del Plata
Brazil Fundacao Doutor Amaral Carvalho Jaú
Brazil Fundacao Antonio Prudente A C Camargo Cancer Center Sao Paulo
Brazil Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia Vitoria
China Changzhou No 2 Peoples Hospital Changzhou
China West China Hospital Chengdou
China Sichuan Cancer Hospital Chengdu
China The First Affiliated Hospital Sun Yat sen University Guang Zhou
China Huizhou Municipal Central Hospital Huizhou
China Fudan University Shanghai Cancer Center ShangHai
France Hopital Nord Marseille Cedex 20
France Hopital PASTEUR Nice
France Institut Curie Paris
Germany Universitaetsklinikum der RWTH Aachen Aachen
Germany Kliniken Essen-Mitte Essen
Germany Universitaetsklinikum Giessen und Marburg GmbH Giessen
Germany Thoraxklinik am Universitatsklinikum Heidelberg Heidelberg
Germany Klinikum Kassel GmbH Kassel
Korea, Republic of Chungbuk National University Hospital Cheongju-si
Korea, Republic of Gachon University Gil Hospital Incheon
Korea, Republic of Severance Hospital Yonsei University Health System Seoul
Malaysia Hospital Pulau Pinang Georgetown
Malaysia University Malaya Medical Centre Kuala Lumpur
Malaysia Hospital Tengku Ampuan Afzan Kuantan
Malaysia Hospital Umum Sarawak Kuching
Spain Hosp. Univ. A Coruna A Coruna
Spain Hosp. Gral. Univ. de Alicante Alicante
Spain Hosp. Univ. Quiron Dexeus Barcelona
Spain Hosp. Univ. Vall D Hebron Barcelona
Spain Hosp. Univ. de Jaen Jaen
Spain Hosp. Univ. Lucus Augusti Lugo
Spain Hosp. Gral. Univ. Gregorio Maranon Madrid
Spain Hosp. Regional Univ. de Malaga Malaga
Spain Hosp. Ntra. Sra. de Valme Sevilla
Taiwan National Taiwan University Hospital Hsin Chu Branch Hsin Chu
Taiwan Chang Kung Memorial Hospital Kaohsiung City
Taiwan Taichung Veterans General Hospital Taichung City
Taiwan National Taiwan University Hospital Taipei
Taiwan Linkou Chang Gung Memorial Hospital Taoyuan City
Turkey Adana City Hospital Adana
Turkey Ankara Bilkent City Hospital Ankara
Turkey Gazi University Hospital Ankara
Turkey Gulhane Training and Research Hospital Ankara
Turkey I A U VM Medical Park Florya Hastanesi Istanbul
Turkey Ege University Medical Faculty Izmir
Turkey Ondokuz Mayis University Samsun
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States City of Hope Duarte California
United States Virginia Cancer Specialists Fairfax Virginia
United States Hunterdon Hematology Oncology Flemington New Jersey
United States Hope and Healing Care Hinsdale Illinois
United States City of Hope Huntington Beach Huntington Beach California
United States City of Hope Orange County Lennar Foundation Cancer Center Irvine California
United States City of Hope Long Beach Elm Long Beach California
United States Cancer and Blood Specialty Clinic Los Alamitos California
United States Keck Hospital of USC Los Angeles California
United States USC Norris Oncology Hematology Newport Beach Newport Beach California
United States Renown Regional Medical Center Reno Nevada
United States Valley Medical Center Renton Washington
United States City of Hope South Pasadena South Pasadena California
United States Oncology Hematology Associates Springfield Missouri
United States Gundersen Health System W. Salem Wisconsin
United States Clinical Research Alliance, Inc. Westbury New York
United States Regional Medical Oncology Center Wilson North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  China,  France,  Germany,  Korea, Republic of,  Malaysia,  Spain,  Taiwan,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Grade Greater Than or Equal to (>=) 2 Dermatologic Adverse Events of Interest (DAEIs) Within 12 Weeks After Initiation of Anticancer Treatment Number of participants with Grade >= 2 DAEIs within 12 weeks after initiation of anticancer treatment based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 will be reported. DAEIs includes rash, dermatitis acneiform, pruritus, skin fissures, acne, folliculitis, erythema, eczema, rash maculo-papular, skin exfoliation, skin lesion, skin irritation, dermatitis, rash erythematous, rash macular, rash popular, rash pruritic, rash pustular, dermatitis contact, dermatitis exfoliative generalized, drug eruption, dyshidrotic eczema, eczema asteatotic and paronychia. As per NCI CTCAE v 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. Up to 12 weeks after initiation of anticancer treatment
Secondary Number of Participants With DAEIs by Severity Based on NCI CTCAE v 5.0 Number of participants with DAEIs by severity based on NCI CTCAE v 5.0 will be reported. Up to 12 weeks after initiation of anticancer treatment
Secondary Number of Participants With Grade >=2 DAEIs Within 6 Months After Initiation of Anticancer Treatment Based on NCI CTCAE v 5.0 Number of participants with Grade >=2 DAEIs within 6 months after initiation of anticancer treatment based on NCI CTCAE v 5.0 will be reported. Up to 6 months after initiation of anticancer treatment
Secondary Time to First Occurrence of Grade >=2 DAEI Time to first occurrence of Grade >=2 DAEI will be reported. Up to 12 months
Secondary Number of Participants With Paronychia by Severity Based on NCI CTCAE v 5.0 Number of participants with paronychia by severity based on NCI CTCAE v 5.0 will be reported. Up to 6 months after initiation of anticancer treatment
Secondary Number of Participants With Scalp Rash by Severity Based on NCI CTCAE v 5.0 Number of participants with scalp rash by severity based on NCI CTCAE v 5.0 will be reported. Up to 12 months after initiation of anticancer treatment
Secondary Change From Baseline in Skindex Symptoms Domain Score up to 12 Months Change from baseline in skindex symptoms domain score up to 12 months will be reported. The score of quality of life will be assessed using the Skindex-16 questionnaire. Skindex-16 is used for participants to rate skin conditions. Baseline, up to Month 12
Secondary Change From Baseline in Patient's Global Impression-Severity (PGI-S) Rash up to 12 Months Change from baseline in PGI-S rash up to 12 months will be reported. Participant quality of life will be evaluated using PGI-S Rash. PGI-S is a single-item questionnaire assessing participants disease severity on a 7-point response scale. Baseline, up to Month 12
Secondary Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score up to 12 Months Change from baseline in EORTC-QLQ-C30 score up to 12 months will be reported. EORTC-QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. Baseline, up to Month 12
Secondary Percentage of Participants With Dose Reductions, Dose Interruptions, and Dose Discontinuations of Anticancer Treatment due to DAEIs Percentage of participants with dose reductions, dose interruptions, and dose discontinuations of anticancer treatment due to DAEIs will be reported. Up to 12 months
Secondary Relative Dose Intensity (RDI) of Anticancer Treatment Relative dose intensity of anticancer treatment will be reported. The relative dose intensity is defined as the ratio of total actually received dose versus total prescribed dose. Up to 12 months
Secondary Percentage of Participants With Venous Thromboembolism (VTE) Adverse Events (AEs) by Severity Based on NCI CTCAE v 5.0 Percentage of participants with VTE AEs (pulmonary embolism and deep vein thrombosis) by severity based on NCI CTCAE v 5.0 will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Up to 12 months
Secondary Percentage of Participants With Adverse Events (AEs) by Severity Based on NCI CTCAE v 5.0 Percentage of participants with AEs by severity based on NCI CTCAE v 5.0 will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Up to 12 months
Secondary Progression Free Survival (PFS) PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause, whichever occurs first. Up to 12 months
Secondary Overall Response Rate (ORR) ORR is defined as the percentage of participants who achieve a partial response (PR) or better response using RECIST v1.1 as assessed by the investigator. Up to 12 months
Secondary Duration of Response (DoR) DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the RECIST v1.1 response criteria. Up to 12 months
See also
  Status Clinical Trial Phase
Completed NCT04879849 - A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers Phase 1
Completed NCT04426825 - A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer Phase 2
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT02864394 - Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033) Phase 3
Completed NCT02810457 - Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer Phase 3
Recruiting NCT04592523 - A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
Recruiting NCT04838548 - A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer Phase 2
Recruiting NCT04077463 - A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer Phase 1
Recruiting NCT04603807 - A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases Phase 3
Recruiting NCT05167604 - Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
Completed NCT04948411 - Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
Active, not recruiting NCT04487080 - A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Phase 3
Not yet recruiting NCT04255836 - Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC) Phase 2
Completed NCT01953913 - Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation Phase 3
Recruiting NCT05715229 - Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy Phase 2
Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
Suspended NCT05421936 - Osimertinib for NSCLC With Uncommon EGFR Mutations
Completed NCT02847377 - A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC N/A
Completed NCT04427072 - Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation Phase 3
Recruiting NCT04823377 - Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. N/A