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Age: 18Years +
All Genders
ID07230691

Observational Study of Clinical Outcomes in EGFR-Mutated Advanced Non-Small Cell Lung Cancer Patients Treated with Amivantamab-Containing Regimens Under Routine Clinical Practice

Led by Janssen Research & Development, LLC · Updated on 2026-06-05

380

Participants Needed

70

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the outcomes of treatments containing amivantamab for people with advanced non-small cell lung cancer NSCLC that have specific mutations in the epidermal growth factor receptor EGFR gene. This research focuses on patients with common EGFR mutations, including exon 19 deletions or exon 21 L858R substitutions, to understand how these regimens perform in real-world medical practice. The study aims to capture clinical and health-related results for this serious lung cancer type, particularly when it has spread to other parts of the body. The study observes two groups of participants receiving amivantamab-based treatments as part of their standard care. One group includes patients treated with amivantamab combined with carboplatin and pemetrexed after previous therapy has failed. The other group involves participants receiving amivantamab with lazertinib as their first-line therapy. No study drugs are provided instead, researchers collect data from routine clinical visits, tracking how patients are treated according to usual medical practice. Participants are monitored for up to about 60 months to gather information on how long they continue treatment, progression-free survival, overall survival, and time to next treatment. Researchers also record adverse events, dose changes, use of other medications, and quality of life using specific questionnaires. This long-term observation helps to understand treatment impact and safety in everyday clinical settings without additional interventions or procedures beyond standard care.

CONDITIONS

Brief Title

A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-World Setting

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant has a confirmed diagnosis of common EGFR-mutated non-small cell lung cancer (exon 19 deletions or exon 21 L858R substitution)
  • Eligible for an amivantamab-containing regimen according to treating physician and local approved indications
  • Participant or legal representative must sign informed consent allowing data verification
  • Planned initiation of amivantamab-containing regimen for the first time within 4 weeks of data collection start
  • Decision to use amivantamab-containing regimen made before enrollment and separate from study inclusion decision
Not Eligible

You will not qualify if you...

  • Receiving active systemic anticancer treatment for advanced NSCLC not included in approved amivantamab combination regimen at treatment start (one cycle of platinum-based chemotherapy allowed before amivantamab in first-line therapy)
  • Prior amivantamab treatment in clinical trial or compassionate use
  • Receiving biosimilar or non-original biologic agents instead of amivantamab
  • Any conditions listed as contraindications in the summary of product characteristics for amivantamab or agents required in the treatment regimen (lazertinib, platinum, pemetrexed)

Research Team

S

Study Contact

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