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Clinical Trials List

Protocol Number61186372NSC3001
NCT Number(ClinicalTrials.gov Identfier)NCT04538664
Active

2020-11-01 - 2026-06-30

Phase III

Not yet recruiting5

Recruiting1

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Johnson & Johnson

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

NSCLC

Objectives

Primary: To compare the efficacy, as demonstrated by PFS, in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone. PFS (using RECIST v1.1 guidelines), as assessed by blinded independent central review Key Secondary： To further assess the clinical benefit achieved with amivantamab in combination with chemotherapy, versus chemotherapy alone. - Objective response rate - Overall survival

Test Drug

JNJ-61186372(Amivantamab)

Active Ingredient

Amivantamab

Dosage Form

vial

Dosage

50 mg/ml

Endpoints

Primary:
To compare the efficacy, as demonstrated by PFS, in participants treated with
amivantamab in combination with chemotherapy, versus chemotherapy alone.
- PFS (using RECIST v1.1 guidelines), as assessed by blinded independent central review

Inclution Criteria

Main inclusion criteria:
Each potential participant must satisfy all of the following criteria to be enrolled in the study:
1.
Participant must be ≥18 years of age (or the legal consent in jurisdiction which the study is taking place)
2.
Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous NSCLC with documented primary EGFR Exon 20ins activating mutation (a copy of the mutation analysis must be submitted during screening) performed by a Clinical Laboratory Improvement Amendments (CLIA)-certified (US sites) or an accredited (outside of the US) local laboratory.
3.
Participant must have measurable disease according to RECIST v1.1. If only one measurable lesion exists, it may be used for the screening biopsy (if required for submission of tumor tissue) if the baseline tumor assessment scans are performed ≥14 days after the biopsy.
4.
Participant must have ECOG performance status 0 or 1.
5.
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.
6.
Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion or platelet transfusion within 7 days prior to the date of the laboratory test.

Exclusion Criteria

1.
Participant has received any prior systemic treatment for locally advanced or metastatic disease, with the following exceptions:
• Prior adjuvant or neoadjuvant platinum-based doublet chemotherapy is allowed, if completed at least 12 months prior to signing the study ICF.
• Localized radiotherapy to the lung must be completed at least 6 months prior to randomization. Palliative radiation to other sites must be completed at least 7 days prior to randomization. See Section 8.1 for information regarding irradiated target lesions.
• Prior monotherapy with an approved EGFR TKI (gefitinib, erlotinib, afatinib, or osimertinib) as non-standard first-line therapy for the treatment of locally advanced or metastatic disease is allowed, if: 1) treatment duration did not exceed 8 weeks; 2) lack of disease response was documented (radiographically) by an increase in tumor burden; 3) associated toxicities have resolved to baseline; and 4) the EGFR TKI was discontinued at least 2 weeks or 4 half-lives prior to randomization, whichever is longer. Prior therapy with investigational EGFR TKI agents targeting Exon20ins mutations, including TAK788 or poziotinib, is not allowed.
2.
Participant has evidence of synchronous NSCLC with an EGFR mutation other than EGFR Exon 20ins.
3.
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). If brain metastases are diagnosed on Screening imaging, the participant may be rescreened for eligibility after definitive treatment.
4.
Participant has a history of leptomeningeal disease.
5.
Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation.

The Estimated Number of Participants

  • Taiwan

    17 participants

  • Global

    300 participants

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