A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

NCT06532032 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 61186372PANSC2003
• Study Type: interventional
• Target: 12
• Locations: 4 countries
• Sites: 15

Brief Summary

The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and docetaxel combination therapy in participants with metastatic non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection); and to evaluate the antitumor effect of the combination at the selected RP2CD in participants with NSCLC without oncogenic driver mutations with disease progression on platinum-based chemotherapy and immune checkpoint inhibitor, in the Phase 2 (expansion).

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (3)

• Phase 1: Number of Participants with Adverse events (AEs) by Severity

  An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

  Up to 1 year 4 months

• Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)

  DLTs are specific adverse events and are defined as any of following: Any high grade (Grade 3, 4 or 5) non-hematologic toxicity with exceptions such as: Grade 3 fever resolved in \<=48 hours, anorexia; Grade 3 nausea, vomiting or diarrhea, or constipation Grade 3 fatigue; rash that improves to Grade \<; transient electrolyte abnormalities; symptoms of IRRs that are attributable to amivantamab or docetaxel; Tumor flare; hematologic toxicity (Grade 4 anemia or neutropenia, Febrile neutropenia; Grade 3 or 4 thrombocytopenia associated with bleeding or requiring transfusion); pulmonary toxicity (confirmed any grade pulmonary toxicity, including pneumonitis or interstitial lung disease \[ILD\]), liver enzyme elevation (ALT or AST elevation\>=Grade 3 persisting \>=7 days); or treatment delay greater than (\>) 28 days due to unresolved toxicity.

  Up to 21 days

• Phase 2: Objective Response Rate (ORR)

  ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  Up to 1 year 4 months

Secondary Outcomes (6)

• Phase 1 and Phase 2: Number of Participants with AEs by Severity

  Up to 1 year 4 months

• Phase 1 and Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Parameters

  Up to 1 year 4 months

• Phase 2 : Duration of Response (DoR)

  Up to 1 year 4 months

• Phase 2: Disease Control Rate (DCR)

  Up to 1 year 4 months

• Phase 2: Progression Free Survival (PFS)

  Up to 1 year 4 months

Study Arms (2)

Phase 1 (Combination Dose Selection)

EXPERIMENTAL

Participants will receive amivantamab intravenous (IV) infusion administered based on body weight from Cycle 1 Day 1, Day 2, and subsequent doses on Days 8 and 15, and then on Day 1 of each 21-day treatment cycle. Docetaxel will be administered on Day 2 of Cycle 1 (before Day 2 amivantamab infusion) and then on Day 1 of each 21-day treatment cycle, thereafter. Doses will be escalated or de-escalated based on the dose limiting toxicities (DLTs) and the recommended Phase 2 combination dose (RP2CD) will be determined. Participants will continue study treatment until disease progression, unacceptable toxicity, or until another criterion for discontinuation of study treatment is met.

Drug: Amivantamab; Drug: Docetaxel

Phase 2 (Dose Expansion)

EXPERIMENTAL

Participants will receive amivantamab in combination with docetaxel in 2 cohorts (Cohort A \[adenocarcinoma\] and Cohort B \[squamous\]) at the RP2CD determined in Phase 1. Participants will continue study treatment until disease progression, unacceptable toxicity, or until another criterion for discontinuation of study treatment is met.

Drug: Amivantamab; Drug: Docetaxel

Interventions

Amivantamab DRUG

Amivantamab will be administered as IV infusion.

Also known as: JNJ-61186372

Phase 1 (Combination Dose Selection); Phase 2 (Dose Expansion)

Docetaxel DRUG

Docetaxel will be administered as IV infusion.

Also known as: TAXOTERE

Phase 1 (Combination Dose Selection); Phase 2 (Dose Expansion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must have histologically or cytologically confirmed NSCLC and must have metastatic NSCLC at the time of enrollment
• Participant must have at least 1 measurable lesion, according to RECIST v1.1, that has not been previously irradiated
• May have brain metastases only if previously definitively treated, and participant is clinically stable and asymptomatic for \>2 weeks and is off or receiving low-dose corticosteroid treatment (\<=10 mg prednisone or equivalent) for at least 2 weeks prior to start of study treatment
• May have a prior malignancy (other than the disease under study) if the natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
• Have an ECOG performance status of 0 or 1

You may not qualify if:

• For Phase 2 only: Participant has known oncogenic driver mutations (EGFR, MET, HER2, ALK, ROS1, NTRK, BRAF, RET, or KRAS) as detected by local testing or by central ctDNA testing
• Participant has received radiotherapy for palliative purposes less than 14 days prior to the first dose of study treatment
• Participant has: a.(Or has a history of) leptomeningeal disease (carcinomatous meningitis); b. Spinal cord compression not definitively treated with surgery or radiation.
• Medical history of (non-infectious) ILD/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening- Participant has history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia) or has known allergies, hypersensitivity, or intolerance to: a. amivantamab or amivantamab excipients (refer to the amivantamab IB); b.docetaxel, docetaxel excipients or to other drugs formulated with polysorbate and paclitaxel

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (15)

UCI Health Irvine Hospital

Irvine, California, 92612, United States

Location

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

Location

University of California Irvine Medical Center Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Oncology Hematology Associates

Springfield, Missouri, 65807, United States

Location

Hunterdon Hematology Oncology

Flemington, New Jersey, 08822, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

Kaohsiung Medical University Hospital

Kaohsiung City, 80708, Taiwan

Location

Chi Mei Medical Center Liu Ying

Liou Ying Township, 736, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 10043, Taiwan

Location

Taipei Medical University

Taipei, 110, Taiwan

Location

Ankara Bilkent Sehir Hastanesi

Çankaya, 06800, Turkey (Türkiye)

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

The Royal Marsden NHS Trust

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

amivantamab; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Janssen Research &Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: July 23, 2024
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): June 9, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

TU (1); US (6); TW (6); GB (2)