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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

NCT04538664

Active Not RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Amivantamab, Pemetrexed, Carboplatin, Pemetrexed

Countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (232)

Duarte, California, United States
Orange, California, United States
Santa Monica, California, United States
Washington D.C., District of Columbia, United States
Tampa, Florida, United States
Athens, Georgia, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
East Brunswick, New Jersey, United States
New York, New York, United States
New York, New York, United States
Portland, Oregon, United States
Sioux Falls, South Dakota, United States
Tyler, Texas, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Salem, Virginia, United States
Camperdown, Australia
Kogarah, Australia
Malvern, Australia
Nedlands, Australia
Leuven, Belgium
Roeselare, Belgium
Yvoir, Belgium
Barretos, Brazil
Belo Horizonte, Brazil
Florianópolis, Brazil
Ijuí, Brazil
Natal, Brazil
Pelotas, Brazil
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