Metastatic Non-Small Cell Lung Cancer: Amivantamab and Lazertinib in Combination with Platinum-Based Chemotherapy

Summary

This study focuses on patients who have EGFR-mutated advanced or metastatic non-small cell lung cancer (NSCLC). The purpose of the study is to determine whether amivantamab and lazertinib added to standard-of-care chemotherapy (carboplatin and pemetrexed) is safe and effective for treating individuals with NSCLC, specifically in patients with a gene abnormality called EGFR Exon 19 deletion or Exon 21 L858R substitution (types of EFGR mutations) who have received prior treatment for their cancer. EGFR (epidermal growth factor receptor) is a protein present on the surface of both healthy cells and cancer cells. When damaged, as can occur in lung cancer, EGFR doesn’t work as it should and the cells grow too fast. Researchers will evaluate the effects on lung cancer and any side effects caused by amivantamab and lazertinib in combination with chemotherapy or amivantamab with chemotherapy or chemotherapy alone. Participants will be randomly assigned to 1 of 3 groups. Specifically, they will have a: 40% chance of receiving amivantamab plus lazertinib added to carboplatin and pemetrexed; 40% chance of receiving carboplatin and pemetrexed; and 20% chance of receiving amivantamab added to carboplatin and pemetrexed.


Inclusion Criteria

  • Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated
  • Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), characterized at or after the time of locally advanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation
  • A participant 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 than10 milligrams (mg) prednisone or equivalent daily for the treatment of intracranial disease
  • Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
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Study Location(s)

Cedars-Sinai Cancer at SOCC : Amy Oppenheim

More about this Clinical Trial

Full Title

61186372NSC3002: A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination with Platinum-Based Chemotherapy Compared with Platinum-Based Chemotherapy in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure

Details
Disease Type/Condition

Lung

Principal Investigator

Reckamp, Karen

Co-Investigators

Alain Mita, Ronald Natale, Sukhmani Padda

Age Group

Adult

Phase

III

IRB Number

STUDY00001986

ClinicalTrials.gov ID

NCT04988295

Key Eligibility
ClinicalTrials.gov

Contact
Name

Amy Oppenheim

Phone
+1 310-423-3713
Email
amy.oppenheim@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Lung

Principal Investigator

Reckamp, Karen

Age Group

Adult

Phase

III

IRB Number

61186372NSC3002

ClinicalTrials.gov ID

NCT04988295

Key Eligibility
ClinicalTrials.gov

Contact
Name

Amy Oppenheim

Phone
+1 310-423-3713
Email
amy.oppenheim@cshs.org
Want to join the study or
learn more?