ACASUNLIMAB for Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Participant has histologically or cytologically confirmed metastatic NSCLC (stage IV with known subtype)."}
• {"criterion_text":"- Participant has progressed radiographically on or after receiving: - One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy concomitantly) in the metastatic disease setting; OR - No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy sequentially, irrespective of the order) in the metastatic disease setting."}
• {"criterion_text":"- Participant must have positive tumor PD-L1 expression (tumor cells ≥1%) determined prospectively on a tumor sample from the metastatic setting at a sponsor-designated central laboratory."}
• {"criterion_text":"- Participant has measurable disease according to RECIST v1.1 as assessed by the investigator at baseline."}
• {"criterion_text":"- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days of Cycle 1 Day 1."}
• {"criterion_text":"- Participant has a life expectancy of ≥3 months."}
• {"criterion_text":"- Participant must have adequate organ and bone marrow function, per laboratory test results, within 7 days of trial treatment."}

Exclusion criteria

• {"criterion_text":"- Documentation of known targetable epidermal growth factor receptor (EGFR) sensitizing mutations, anaplastic lymphoma kinase (ALK), RET proto-oncogene (RET), ROS proto-oncogene 1; receptor tyrosine kinase (ROS1) rearrangement, Kirsten rat sarcoma virus (KRAS), B-Raf proto-oncogene (BRAF) mutations, and MET proto-oncogene; receptor tyrosine kinase (MET) exon 14 skipping mutations/MET amplification. NOTE: MET amplification testing is optional based on local availability of the test. – Participants with known KRAS/BRAF mutations are eligible for the trial if they do not have access to approved targeted therapies."}
• {"criterion_text":"- Participants with newly identified or known unstable or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis."}
• {"criterion_text":"- Prior treatment with docetaxel for NSCLC."}
• {"criterion_text":"- Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, autologous cell immunotherapy, or any unapproved immunotherapy."}
• {"criterion_text":"- Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment."}
• {"criterion_text":"- Note: Other protocol-defined inclusion and exclusion criteria may apply."}

Primary endpoints

• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Confirmed objective response rate (ORR)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Duration of response (DoR)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of participants with adverse events (AEs)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to treatment discontinuation due to AE","definition_or_measurement_approach":""}
• {"endpoint_text":"- Plasma concentration of acasunlimab","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of participants with anti-drug antibodies (ADAs) to acasunlimab","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change from baseline in Functional Assessment of Cancer Therapy item GP5 (FACIT-GP5, version 4) score","definition_or_measurement_approach":""}
• {"endpoint_text":"- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)","definition_or_measurement_approach":""}

Methods

• Social media and online advertising (banner ads, social media clinical-trial posts) targeted to potential participants (patient-facing digital channels) — country-specific language versions provided.
• Physician referral letters and physician referral brochures directed at HCPs to refer eligible patients.
• Patient brochures, flyers and posters for distribution at sites and clinics (site posters and patient-facing printed materials) in country/language variants.
• Patient advocacy group outreach (Patient Advocacy Group Letters) to engage patient organisations.
• Community engagement slides and materials for outreach events.
• Digital patient brochure, landing pages and eConsent materials including participant-facing screenshots and video storyboard (eConsent platform) enabling remote/ digital consent and information provision.
• Use of third-party recruitment vendors and digital workflows (Massive Bio and other patient recruitment vendors) to support identification and referral of patients.
• Site-based recruitment via trial sites and standard clinical referrals.

Primary sponsor

Full Name

Genmab A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

IQVIA Limited

Responsibilities

Trial Feasibility, Patient Recruitment and Retention, e-consent, regulatory and operational support

Name

PPD Development LP

Responsibilities

Soluble Target testing

Name

Almac Clinical Services Limited

Responsibilities

IP Packaging & Labeling, Distribution, Reconciliation

Name

Fortrea Development Limited / Fortrea Inc.

Responsibilities

Pharmacovigilance

Third parties

• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Patient questionnaire (eCOA)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Trial Feasibility, Patient Recruitment and Retention, e-consent, regulatory/operational support (multiple study activities listed)","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Exploratory IHC testing on tumor biopsy","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical Imaging","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Fortrea Development Limited","duties_or_roles":"Pharmacovigilance; other responsibilities","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Genmab B.V.","duties_or_roles":"Laboratory analysis: ADA (Neutralizing Ab) testing.","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"Regulatory Applications in Greece (IQVIA office in Athens, Greece).","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"IP Packaging & Labeling, Distribution, Reconciliation","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"Role code listed (code 3) — duties not further specified in CTIS metadata","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Massive Bio Inc.","duties_or_roles":"Patient recruitment vendor","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Pharmacovigilance; other responsibilities","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Soluble Target testing","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Role code listed (code 7) — responsibilities related to data systems","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"PK and ADA sample testing","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"Role code listed (code 4) — duties related to laboratory services","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical Imaging (duplicate entry for imaging-related duties)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"ctDNA testing","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Sample logistics, Result Management, PDL1 analysis.","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Genmab US Inc.","duties_or_roles":"Immune phenotyping (PBMC) testing","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Hangzhou Tigermed Consulting Co. Ltd.","duties_or_roles":"Statistical Programming, Biostatistics","organisation_type":"Pharmaceutical company"}