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

Part of paid clinical trials in Duarte, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04538664
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amivantamab — DRUG
    Amivantamab will be administered as an IV infusion at a dose of 1400 mg (1750 mg if body weight is \>=80 kilogram \[kg\]) by once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is \>=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 and will continue the same treatment in OLE phase then in LTE phase.
  • Pemetrexed — DRUG
    Pemetrexed will be administered as 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm A and will continue the same treatment in OLE phase then in LTE phase.
  • Carboplatin — DRUG
    Carboplatin will be administered as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle.
  • Pemetrexed — DRUG
    Pemetrexed will be administered as 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm B and will continue the same treatment in OLE phase then in LTE phase.

Study Details

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.

Key Dates

Start date
Oct 13, 2020
Status verified
Jun 2026
Primary completion
May 3, 2023
Completion
Aug 2, 2027

Study Design

Enrollment
308 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Amivantamab + Chemotherapy
    Participants will receive pemetrexed 500 milligram per meter square (mg/m\^2) intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. Carboplatin area under the concentration-time curve 5 milligram per milliliter (mg/mL) per minute (AUC 5) will be administered as IV infusion on Day 1 of each 21 day cycle, for up to 4 cycles. Participants will receive amivantamab 1400 mg (1750 mg if body weight is \>=80 kilogram \[kg\]) by IV infusion once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is \>=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3. Following the primary analysis for efficacy, the study will transition to an OLE phase and participants will continue to receive the amivantamab plus chemotherapy in OLE phase. Participants who completed OLE period will enter LTE period and continue to receive same treatment.
  • Experimental: Arm B: Chemotherapy Alone
    Participants will receive pemetrexed 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. Carboplatin AUC 5 IV infusion will be administered on Day 1 of each 21-day cycle for up to 4 cycles. Following the primary analysis for efficacy, the study will transition to an OLE phase and participants will either continue to receive the chemotherapy or cross over to amivantamab in OLE phase. Participants who completed OLE period will enter LTE period and continue to receive same treatment.

Primary Outcome Measure

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: From randomization to either disease progression or death whichever occurs first (up to 29 months) ]

Locations (17)

FacilityCityStateZIPSite coordinators
City of Hope 2DuarteCalifornia91010-
University of California IrvineOrangeCalifornia92868-
UCLASanta MonicaCalifornia90404-
Georgetown University HospitalWashington D.C.District of Columbia20007-
H. Lee Moffitt Cancer & Research InstituteTampaFlorida33612-
University Cancer And Blood Center LLCAthensGeorgia30607-
Henry Ford HospitalDetroitMichigan48202-
Washington University Medical CenterSt LouisMissouri63110-
Regional Cancer Care Associates LLCEast BrunswickNew Jersey08816-
Columbia University Medical CenterNew YorkNew York10032-
Langone Health at NYC University, NYU School of MedicineNew YorkNew York10016-
Providence Portland Medical CenterPortlandOregon97213-
Sanford HealthSioux FallsSouth Dakota57104-
Texas Oncology PaTylerTexas75702-
Utah Cancer SpecialistsSalt Lake CityUtah84106-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Blue Ridge Cancer CareSalemVirginia24153-

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By research site
City of Hope 2· Duarte, CAUniversity of California Irvine· Orange, CAUCLA· Santa Monica, CAGeorgetown University Hospital· Washington D.C., DCH. Lee Moffitt Cancer & Research Institute· Tampa, FLUniversity Cancer And Blood Center LLC· Athens, GA

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