AMIVANTAMAB for Metastatic non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- 1. Participant must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) (any histology), and must have metastatic NSCLC at the time of enrollment: Phase 1 (Combination Dose Selection) Cohort; Metastatic NSCLC progressed on or after standard of care systemic anti-cancer therapy and participant is declining other systemic treatment options, if any; A. Participants without known mutations must have had disease progression on, or have intolerance to, prior platinum-based chemotherapy and PD-(L)1-targeted immunotherapy given concurrently or sequentially, OR B. Participants with NSCLC characterized by known driver mutations must have had disease progression on, or have intolerance to, appropriate targeted therapies as per local standard of care. Participants may have received prior therapy with amivantamab as long as discontinuation was not due to toxicity. Participants with EGFR mutation must not have had an anti-PD-1/PD-L1 therapy, Phase 2 Expansion Cohorts; Cohort A: Participant's tumor must have an EGFR exon19del or L858R mutation, as determined by local molecular testing, Cohort B: Participants must have tumors lacking known primary driver mutations and must have PD-L1 expression of greater than or equal to (>=)50 percentage (%), per local testing, and are treatment-naïve in the metastatic setting\n- 2. Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, that has not been previously irradiated\n- 3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1"}

Exclusion criteria

• {"criterion_text":"- 1. Participant has an uncontrolled illness, including but not limited to: a. Uncontrolled diabetes, b. Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week prior to starting study treatment] or diagnosed or suspected viral infection), c. Active bleeding diathesis, d. Impaired oxygenation requiring continuous oxygen supplementation, e. Psychiatric illness or any other circumstances (including social circumstances) that would limit compliance with study requirements\n- 2. Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening\n- 3. Has an active autoimmune disease or a documented history of autoimmune disease that requires systemic steroids or immunosuppressive agents\n- 4. Participant has received radiotherapy for palliative purposes less than 14 days prior to the first dose of study treatment\n- 5. Participant has a. (or has a history of) leptomeningeal disease (carcinomatous meningitis), b. spinal cord compression not definitively treated with surgery or radiation"}

Primary endpoints

• {"endpoint_text":"- 1. Incidence and severity of AEs, including dose limiting toxicities (DLTs)","definition_or_measurement_approach":"Incidence and severity of adverse events (AEs) including assessment of dose limiting toxicities (DLTs) as reported during the study (safety/tolerability measures)."}
• {"endpoint_text":"- 2. Objective response rate (ORR) according to RECIST v1.1 by investigator review; confirmatory analysis may be performed using blinded independent central review (BICR)","definition_or_measurement_approach":"Objective response rate measured per RECIST v1.1 by investigator review; confirmatory analysis may be performed using blinded independent central review (BICR)."}

Poland

Earliest CTIS Part Ii Submission Date

24-06-2024

Latest Decision Or Authorization Date

21-11-2025

Processing Time Days

515

Number Of Sites

3

Number Of Participants

6

Italy

Earliest CTIS Part Ii Submission Date

10-06-2024

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

653

Number Of Sites

3

Number Of Participants

8

Spain

Earliest CTIS Part Ii Submission Date

14-05-2024

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

664

Number Of Sites

6

Number Of Participants

12

Primary sponsor

Full Name

Janssen - Cilag International

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Sponsor duties: code 6 (specific responsibilities not detailed in supplied JSON)

Name

Almac Clinical Technologies LLC

Responsibilities

screening and enrolling patients

Name

Altasciences Compagnie Inc.

Responsibilities

role indicated (sponsor duty code 4); specific responsibilities not detailed

Third parties

• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Sponsor duties: code 6 (role code present in record; specific role text not provided)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Sample management; other sponsor duty code 4 (additional role code present)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"screening and enrolling patients; other sponsor duty code 3","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"sponsor duty code 4 (role code present; specific role text not provided)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Smithers PDS LLC","duties_or_roles":"PK and immunogenicity","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"ctDNA samples","organisation_type":"Laboratory/Research/Testing facility"}