Recruiting NCT06667076

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Phase II Interventional Carcinoma, Non-Small-Cell Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Amivantamab, Lazertinib, Chemotherapy: Pemetrexed, Chemotherapy: Carboplatin.
Who it may be relevant to: Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Belgium, Finland, France, Germany +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Overview

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Interventions

Drug Amivantamab
Amivantamab will be administered.
Drug Lazertinib
Lazertinib tablet will be administered.
Drug Chemotherapy: Pemetrexed
Pemetrexed will be administered.
Drug Chemotherapy: Carboplatin
Carboplatin will be administered.

Primary outcome measures

Progression Free Survival (PFS) [Time frame: Up to 4 Years and 6 months]

Secondary outcome measures (11)

Number of Participants Reporting Dose Reductions, Interruptions, and Discontinuations [Time frame: Up to 4 Years and 6 months]
Number of Participants With Venous Thromboembolic Events (VTEs) [Time frame: Up to 4 Years and 6 months]
Number of Participants With Dermatologic Adverse Events (AEs) [Time frame: Up to 4 Years and 6 months]
Number of Participants with AEs by Severity [Time frame: Up to 4 Years and 6 months]
Overall Survival (OS) [Time frame: Up to 4 Years and 6 months]
Overall Response Rate (ORR) [Time frame: Up to 4 Years and 6 months]
Clinical Benefit Rate (CBR) [Time frame: Up to 4 Years and 6 months]
Duration of Response (DOR) [Time frame: Up to 4 Years and 6 months]
Time to Treatment Discontinuation (TTTD) [Time frame: Up to 4 Years and 6 months]
Time to Subsequent Therapy (TTST) [Time frame: Up to 4 Years and 6 months]
Time to Symptomatic Progression (TTSP) [Time frame: Up to 4 Years and 6 months]

Eligibility criteria

Inclusion criteria

Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended
Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia \[any grade\], grade <=2 peripheral neuropathy, or grade <=2 hypothyroidism stable on hormone replacement)
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion criteria

Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis
Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)
Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study
Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment