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| ID | Type | Description | Link |
|---|---|---|---|
| 61186372PANSC2003 | Other Identifier | Janssen Research & Development, LLC |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amivantamab | Drug | Amivantamab will be administered as IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 and Phase 2: Number of Participants with 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 NCI-CTCAE 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research &Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCI Health Irvine Hospital | Irvine | California | 92612 | United States | ||
| Cancer and Blood Specialty Clinic |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Docetaxel | Drug | Docetaxel will be administered as IV infusion. |
|
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| Up to 1 year 4 months |
| Phase 1 and Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Parameters | Number of participants with abnormalities in clinical laboratory parameters (serum chemistry, hematology, coagulation, serology, and urinalysis) will be reported. | Up to 1 year 4 months |
| Phase 2 : Duration of Response (DoR) | DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death from any case, whichever comes first, for participants who have PR or CR. | Up to 1 year 4 months |
| Phase 2: Disease Control Rate (DCR) | DCR is defined as the percentage of participants who achieve a PR, CR, or stable disease using RECIST version 1.1. | Up to 1 year 4 months |
| Phase 2: Progression Free Survival (PFS) | PFS is defined as the time from first dose date until the date of disease progression or death, whichever comes first, based on investigator assessment using RECIST version 1.1. | Up to 1 year 4 months |
| Phase 2: Overall Survival (OS) | OS is defined as the time from the date of administration of the first study treatment until the date of death due to any cause. | Up to 1 year 4 months |
| Los Alamitos |
| California |
| 90720 |
| United States |
| University of California Irvine Medical Center Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| Oncology Hematology Associates | Springfield | Missouri | 65807 | United States |
| Hunterdon Hematology Oncology | Flemington | New Jersey | 08822 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Changhua Christian Hospital | Changhua | 500 | Taiwan |
| Kaohsiung Medical University Hospital | Kaohsiung City | 80708 | Taiwan |
| Chi Mei Medical Center Liu Ying | Liou Ying Township | 736 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | 10043 | Taiwan |
| Taipei Medical University | Taipei | 110 | Taiwan |
| Ankara Bilkent Sehir Hastanesi | Çankaya | 06800 | Turkey (Türkiye) |
| Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7TF | United Kingdom |
| The Royal Marsden NHS Trust | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000718215 | amivantamab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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