## Protocol Section
### Identification Module
**NCT ID:** NCT06430866

**Acronym:** Eucalyptus

**Brief Title:** Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)

**Official Title:** A Randomized, Double-blind Study to Compare the Pharmacokinetics Between ABP 234 and Keytruda® (Pembrolizumab) in Participants With Early-stage Non-squamous Non-small Cell Lung Cancer as Adjuvant Treatment Following Resection and Platinum-based Chemotherapy

#### Organization Study ID Info
**ID:** 20230127
#### Organization
**Class:** INDUSTRY
**Full Name:** Amgen
### Status Module
#### Completion Date
**Date:** 2026-10-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-17

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-15
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Amgen

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.

### Conditions Module

**Conditions:**

- Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)

**Keywords:**

- NSCLC

- Keytruda

- Pembrolizumab

- ABP 234

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 154

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive ABP 234 every 3 weeks (Q3W) for up to 12 months.

**Intervention Names:**

- Drug: ABP 234

**Label:** ABP 234

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive pembrolizumab Q3W for up to 12 months.

**Intervention Names:**

- Drug: Pembrolizumab

**Label:** Pembrolizumab

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ABP 234

**Description:** Administered by intravenous (IV) injection.

**Name:** ABP 234

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Pembrolizumab

**Description:** Administered by IV injection.

**Name:** Pembrolizumab

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose

**Time Frame:** 21 days

**Measure:** AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss)

**Time Frame:** Weeks 16-19

#### Secondary Outcomes

**Measure:** Maximum Observed Serum Concentration (Cmax) Following the First Dose (Cmax_dose1)

**Time Frame:** Up to 65 weeks

**Measure:** Time to Maximum Serum Concentration (Tmax) Following the First Dose (Tmax_dose1)

**Time Frame:** Up to 65 weeks

**Measure:** Cmax at Steady State (Cmax_ss)

**Time Frame:** Weeks 16-19

**Measure:** Tmax at Steady State (Tmax_ss)

**Time Frame:** Weeks 16-19

**Measure:** Trough Serum Concentrations (Ctrough) at Pre-dose of Week 4 (Ctrough_w4)

**Time Frame:** Week 4 pre-dose

**Measure:** Ctrough at Stead State (Ctrough_ss)

**Time Frame:** Weeks 16 and 19 pre-dose

**Measure:** Number of Participants with Treatment-emergent Adverse Events

**Time Frame:** Up to 16 months

**Measure:** Number of Participants with Treatment-emergent Serious Adverse Events

**Time Frame:** Up to 16 months

**Measure:** Number of Participants with Treatment-emergent Adverse Events of Interest (EOIs)

**Time Frame:** Up to 16 months

**Measure:** Number of Participants with Andit-drug Antibodies

**Time Frame:** Baseline and weeks 4, 7, 16, 19, 22, 28, 40, 52, and 65

**Measure:** Disease-free Survival

**Time Frame:** Up to 65 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Males and females ≥ 18 years of age.
* Pathological diagnosis of non-squamous NSCLC.
* Stage IB (T2 ≥ 4 cm), II, or IIIA NSCLC after complete surgical resection and received platinum-based chemotherapy.
* For programmed death-ligand 1 (PD-L1) testing, tumor tissue from the resected site of disease must be sent, received, and analyzed for biomarkers.
* Treated with platinum-based chemotherapy:

  1. Chemotherapy must have begun within 12 weeks after the resection surgery.
  2. The last chemotherapy dose must have been completed at least 3 weeks and no more than 12 weeks before the participant is randomized.
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
* Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS-1 negative.
* Have adequate organ function as indicated by laboratory values.
* Absence of severe comorbidities that in the opinion of the investigator might hamper participation in the study and/or treatment administration.
* Participants must sign approved informed consent form (ICF).

Exclusion Criteria:

* Evidence of disease.
* Prior treatment with anti-programmed cell death protein 1 and anti-PD-L1/2 modulating agents in adjuvant setting.
* History or presence of immune-mediated disorders.
* Participants with type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll.
* Participant has positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C (HCV).
* Medical conditions requiring systemic immunosuppression.
* History of any other malignancy other than NSCLC within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, etc.
* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis virus, current alcohol abuse or cirrhosis.
* Surgery or chemotherapy-related toxicity not resolved to grade 1 with the exception of grade ≤ 2 alopecia, fatigue, neuropathy, and lack of appetite/nausea.
* Woman of childbearing potential who is pregnant or is breast feeding.
* Woman of childbearing potential who is not consenting to use highly effective methods of birth control.
* Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control.
* Participant has known hypersensitivity to monoclonal antibodies or to any of the excipients of the investigational product (IP).
* Active cardiac disease or history of cardiac dysfunction, that in the judgment of the investigator would place the participant at additional risk when participating in the study.
* Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current neumonitis/interstitial lung disease.
* Live vaccine therapy within 4 weeks prior to IP administration.
* Participation in another investigational drug study within 30 days prior to IP administration.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** medinfo@amgen.com

**Name:** Amgen Call Center

**Phone:** 866-572-6436

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Amgen

**Name:** MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

**Description:** De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

**URL:** http://www.amgen.com/datasharing

### References Module

#### See Also Links

**Label:** AmgenTrials clinical trials website

**URL:** http://www.amgentrials.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: HIGH

- As Found: Non-Small Cell Lung Cancer

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Cancer

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000002289

- Term: Carcinoma, Non-Small-Cell Lung

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000082082

- Term: Immune Checkpoint Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M349416

- Name: Pembrolizumab

- Relevance: HIGH

- As Found: Blind

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000582435

- Term: Pembrolizumab

### Misc Info Module

- Version Holder: 2024-05-31
