The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pre-Approval Access With Amivantamab (JNJ-61186372) in Participants With Metastatic Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04599712
Expanded Access Status : Approved for marketing
First Posted : October 23, 2020
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this expanded access program (EAP) is to provide amivantamab for the treatment of participants with metastatic non-small cell lung cancer who have epidermal growth factor receptor exon 20 insertion mutations, and whose disease has progressed during or after current standard of care platinum-based chemotherapy. This intermediate EAP may be considered for individuals with serious/life-threatening diseases or conditions, where there are no alternative treatments or where individuals have progressed following standard of care.

Condition or disease Intervention/treatment
Metastatic Non-Small Cell Lung Cancer Drug: Amivantamab

Study Design
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Pre-Approval Access With Amivantamab in Patients With Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations Who Have Failed Platinum-Based Chemotherapy

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Amivantamab

Interventions
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: Amivantamab
    Amivantamab will be administered intravenously at the recommended doses based on weight (1050 milligram [mg] or 1400 mg) once weekly for the first 4 week cycle (1 cycle equals to 28 days), then every 2 weeks thereafter.
    Other Name: JNJ-61186372
Eligibility Criteria
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Has histologically or cytologically confirmed unresectable or metastatic non-small cell lung (NSCLC) cancer with an epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins), not amenable to curative therapy
  • Has completed prior treatment with platinum-based chemotherapy. In the case of platinum ineligible participants, the participant may qualify if previously treated with an alternative treatment (example, an investigational or approved EGFR Exon 20 targeted tyrosine kinase inhibitor [TKI], or see guidelines such as those from national comprehensive cancer network [NCCN] or European society for medical oncology [ESMO] for alternative non-platinum-based treatments)
  • Life expectancy is projected to be greater than or equal to (>=) 3 months with adequate hepatic, renal, pulmonary and cardiac function (physician assessed)

Exclusion Criteria:

  • Has medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis requiring treatment with prolonged steroids or other immune suppressive agents within the last 3 months
  • Has leptomeningeal disease that is active or symptomatic
  • Symptomatic, unstable or untreated brain metastases (need to be resolved prior to participating in the program)
  • Known allergies, hypersensitivity, or intolerance to amivantamab or its excipients or to other monoclonal antibodies
  • Is pregnant or breastfeeding
Contacts and Locations
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

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): NCT04599712


Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Layout table for investigator information
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04599712    
Other Study ID Numbers: CR108905
61186372LUC4001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Amivantamab-vmjw
Antineoplastic Agents, Immunological
Antineoplastic Agents