Trial record 1 of 1 for:
61186372NSC2007
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (COCOON)
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| ClinicalTrials.gov Identifier: NCT06120140 |
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Recruitment Status :
Recruiting
First Posted : November 7, 2023
Last Update Posted : April 25, 2024
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Drug: Amivantamab Drug: Lazertinib Drug: Doxycycline Drug: Minocycline Drug: Clindamycin Drug: Chlorhexidine Other: Noncomedogenic skin moisturizer | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivantamab + Lazertinib |
| Actual Study Start Date : | February 16, 2024 |
| Estimated Primary Completion Date : | July 3, 2025 |
| Estimated Study Completion Date : | March 31, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
Drug Information
available for:
Amivantamab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A: Enhanced Dermatologic Management
Participants will receive enhanced dermatologic management to reduce dermatologic toxicities in skin and nail with oral doxycycline tablet or minocycline capsule (100 milligrams [mg] twice daily for 12 weeks), clindamycin 1 percent (%) topical lotion, chlorhexidine 4% topical solution, and noncomedogenic skin moisturizer (once daily, sufficient quantity to cover skin) during background anticancer treatment of advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) with amivantamab (1050 mg for body weight less than [<] 80 kilograms [kg] and 1400 mg for body weight greater than or equal to [>=] 80 kg as intravenous [IV] infusion, once weekly for the first 4 weeks and then once every 2 weeks) and lazertinib (240 mg, tablet, once daily) until documented disease progression using Response Evaluation Criteria in Solid Tumors [RECIST] version [v] 1.1).
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Drug: Amivantamab
Amivantamab will be administered as intravenous (IV) infusion.
Other Name: JNJ-61186372 Drug: Lazertinib Lazertinib tablet will be administered orally.
Other Name: JNJ-73841937 Drug: Doxycycline Doxycycline tablet will be administered orally. Drug: Minocycline Minocycline capsule will be administered orally. Drug: Clindamycin Clindamycin lotion will be used as topical application on the scalp. Drug: 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. |
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Active Comparator: Arm B: Standard-of-Care Dermatologic Management
Participants will receive standard care for dermatologic management according to local practice to reduce dermatologic toxicities in skin and nail during background anticancer treatment of advanced or metastatic EGFR-mutated NSCLC with amivantamab plus lazertinib.
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Drug: Amivantamab
Amivantamab will be administered as intravenous (IV) infusion.
Other Name: JNJ-61186372 Drug: Lazertinib Lazertinib tablet will be administered orally.
Other Name: JNJ-73841937 |
Primary Outcome Measures :
- 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 [ Time Frame: Up to 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.
Secondary Outcome Measures :
- Number of Participants With DAEIs by Severity Based on NCI CTCAE v 5.0 [ Time Frame: Up to 12 weeks after initiation of anticancer treatment ]Number of participants with DAEIs by severity based on NCI CTCAE v 5.0 will be reported.
- Number of Participants With Grade >=2 DAEIs Within 6 Months After Initiation of Anticancer Treatment Based on NCI CTCAE v 5.0 [ Time Frame: Up to 6 months after initiation of anticancer treatment ]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.
- Time to First Occurrence of Grade >=2 DAEI [ Time Frame: Up to 12 months ]Time to first occurrence of Grade >=2 DAEI will be reported.
- Number of Participants With Paronychia by Severity Based on NCI CTCAE v 5.0 [ Time Frame: Up to 6 months after initiation of anticancer treatment ]Number of participants with paronychia by severity based on NCI CTCAE v 5.0 will be reported.
- Number of Participants With Scalp Rash by Severity Based on NCI CTCAE v 5.0 [ Time Frame: Up to 12 months after initiation of anticancer treatment ]Number of participants with scalp rash by severity based on NCI CTCAE v 5.0 will be reported.
- Change From Baseline in Skindex Symptoms Domain Score up to 12 Months [ Time Frame: Baseline, up to Month 12 ]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.
- Change From Baseline in Patient's Global Impression-Severity (PGI-S) Rash up to 12 Months [ Time Frame: Baseline, up to Month 12 ]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.
- 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 [ Time Frame: Baseline, up to Month 12 ]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.
- Percentage of Participants With Dose Reductions, Dose Interruptions, and Dose Discontinuations of Anticancer Treatment due to DAEIs [ Time Frame: Up to 12 months ]Percentage of participants with dose reductions, dose interruptions, and dose discontinuations of anticancer treatment due to DAEIs will be reported.
- Relative Dose Intensity (RDI) of Anticancer Treatment [ Time Frame: Up to 12 months ]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.
- Percentage of Participants With Venous Thromboembolism (VTE) Adverse Events (AEs) by Severity Based on NCI CTCAE v 5.0 [ Time Frame: Up to 12 months ]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.
- Percentage of Participants With Adverse Events (AEs) by Severity Based on NCI CTCAE v 5.0 [ Time Frame: Up to 12 months ]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.
- Progression Free Survival (PFS) [ Time Frame: Up to 12 months ]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.
- Overall Response Rate (ORR) [ Time Frame: Up to 12 months ]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.
- Duration of Response (DoR) [ Time Frame: Up to 12 months ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06120140
Contacts
| Contact: Study Contact | 844-434-4210 | Participate-In-This-Study@its.jnj.com |
Locations
Show 41 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT06120140 |
| Other Study ID Numbers: |
61186372NSC2007 2023-505863-35-00 ( Registry Identifier: EUCT number ) 61186372NSC2007 ( Other Identifier: Janssen Research & Development, LLC ) |
| First Posted: | November 7, 2023 Key Record Dates |
| Last Update Posted: | April 25, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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 |
| URL: | https://www.janssen.com/clinical-trials/transparency |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Chlorhexidine Doxycycline Minocycline Clindamycin Clindamycin palmitate |
Clindamycin phosphate Amivantamab-vmjw Lazertinib Anti-Infective Agents, Local Anti-Infective Agents Disinfectants Anti-Bacterial Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Antineoplastic Agents, Immunological |