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

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

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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.

Study ID CR108905 61186372LUC4001 NCT04599712
Fase N/A
Enrollment -
Study type Expanded Access
Has expanded access -

Locations

Finland
  • DUMMY, Dummy, Finland

Design info

- - - -

Drug

  • 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.

Condition

Lung Cancer, Lung, Metastatic Cancer, metastatic
  • Metastatic Non-Small Cell Lung Cancer

Eligibility

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
  • Gender: all
  • Age: 18
  • Healthy volunteers: -
  • Therapy type: -
  • Therapy Specification: -

Contact information

Local contact information

Overall contact

  • Lastname overall: Janssen Research & Development, LLC Clinical Trial
  • Role: Study Director
  • Affiliation: Janssen Research & Development, LLC
  • NordicNect: No
Verification date 2025-06-01
Study first submitted 2020-10-19
Study first posted 2020-10-23
Last update submitted 2025-06-12
Last update posted 2025-06-13

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