Clinical Trial 21028

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04538664

Phase: Phase III
Principal Investigator: Haura, Eric

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Overview

Study Title

A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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.

Objective

To compare the efficacy, as demonstrated by PFS, in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone, to further assess the clinical benefit achieved with amivantamab in combination with chemotherapy, versus chemotherapy alone and to assess the safety in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone.

Treatments

Therapies

Chemotherapy (NOS); Immunotherapy

Medications

Alimta (Pemetrexed); Amivantamab (); JNJ-61186372 (Amivantamab); Not Applicable (); Paraplatin (carboplatin); Pemetrexed (); carboplatin ()

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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