A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy Compared With Carboplatin-Pemetrexed in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

  • STATUS
    Recruiting
  • End date
    Nov 8, 2024
  • participants needed
    300
  • sponsor
    Janssen Research & Development, LLC
Updated on 22 September 2021
measurable disease
growth factor
pemetrexed
carboplatin
epidermal growth factor receptor
EGFR
cancer chemotherapy
epidermal growth factor
lung carcinoma

Summary

The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.

Description

Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent [%] of cancer deaths); NSCLC accounts for 80% to 85% of lung cancers. Amivantamab (JNJ-61186372) is a low fucose, fully human immunoglobulin G1 (IgG1)-based bispecific antibody directed against epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) tyrosine kinase receptors that is being developed for the treatment of solid tumors. The hypothesis is that amivantamab, when given in combination with standard of care carboplatin-pemetrexed chemotherapy, will prolong PFS compared with carboplatin-pemetrexed in patients with locally advanced or metastatic NSCLC characterized by EGFR Exon 20ins activating mutations. The study will include a Screening phase (28 days), a Treatment phase (from Cycle 1 Day 1 [21-day cycle] till end of treatment [30 days after last dose]) and a Follow up phase (from the end of treatment visit and until the end of study, death, loss to follow-up, or withdrawal of consent from participation in the study, whichever comes first). An independent data monitoring committee (IDMC) will be commissioned for the periodic review of safety and tolerability data, as well as planned efficacy analyses. Efficacy assessments will include disease assessment, symptomatic progression and patient-reported outcome. Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status and clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis). The total duration of the study is up to 48 months.

Details
Condition Non-Small Cell Lung Cancer
Treatment carboplatin, Pemetrexed, Amivantamab
Clinical Study IdentifierNCT04538664
SponsorJanssen Research & Development, LLC
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation
Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream
A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study

Exclusion Criteria

Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance)
Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible)
Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation
Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis
Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid
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