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A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer (PolyDamas)

Last Updated   April 25, 2025

Want to learn how to participate in this trial?

CR109323

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 1
    1
  • Sites
    41 Sites
  • Status
    Recruiting

SUMMARY

The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and cetrelimab combination therapy in participants with 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 characterized on the basis of epidermal growth factor receptor (EGFR) and Programmed-cell death Ligand (PD-L)1 status, in the Phase 2 (expansion).

CONDITIONS

  • Carcinoma, Non-Small-Cell Lung

ELIGIBILITY


Inclusion Criteria:

* 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;1. 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 2. 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
* 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
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1


Exclusion Criteria:

* 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
* 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
* Has an active autoimmune disease or a documented history of autoimmune disease that requires systemic steroids or immunosuppressive agents
* 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


Inclusion Criteria:

* 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 st

More...

DETAILS

LOCATIONS

Locations in:
United States, Brazil, South Korea, Malaysia, Türkiye, Italy, Poland, Spain, United Kingdom
Country (9) City or Province (41) Status
United States Los Alamitos Cancer and Blood Specialty Clinic
RECRUITING
United States Portland Providence Portland Medical Center
RECRUITING
United States Portland Providence Oncology and Hematology Care Clinic Westside
RECRUITING
United States Fairfax Virginia Cancer Specialists
RECRUITING
Brazil Sao Paulo Fundacao Antonio Prudente A C Camargo Cancer Center
RECRUITING
South Korea Seoul Seoul National University Hospital
RECRUITING
South Korea Seoul Severance Hospital Yonsei University Health System
RECRUITING
South Korea Seoul Samsung Medical Center
RECRUITING
Malaysia Kuala Lumpur University Malaya Medical Centre
RECRUITING
Malaysia Kuching Hospital Umum Sarawak
RECRUITING
Türkiye Ankara Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
RECRUITING
United States Duarte City of Hope
RECRUITING
United States Irvine City of Hope Orange County Lennar Foundation Cancer Center
RECRUITING
Brazil Barretos Fundacao Pio XII
RECRUITING
Brazil Belo Horizonte Cetus Oncologia
RECRUITING
Brazil Curitiba CIONC Centro Integrado de Oncologia de Curitiba
RECRUITING
Italy Milano European Institute of Oncology
RECRUITING
Italy Verona Centro Ricerche Cliniche di Verona S r l
RECRUITING
Poland Lublin INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o
RECRUITING
Türkiye Cankaya Ankara Bilkent City Hospital
COMPLETED
Türkiye Istanbul Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
RECRUITING
Türkiye Sakarya Sakarya University Training and Research Hospital
RECRUITING
United States Houston MD Anderson Cancer Center
RECRUITING
Brazil Belo Horizonte PERSONAL Oncologia de Precisao e Personalizada
RECRUITING
Brazil Londrina Hospital do Cancer de Londrina
RECRUITING
Brazil Porto Alegre Hospital Nossa Senhora da Conceicao S A
RECRUITING
Brazil Salvador Hospital Santa Izabel Santa Casa de Misericordia da Bahia
RECRUITING
Italy Milano ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Italy Orbassano Aou San Luigi Gonzaga
RECRUITING
Poland Poznan Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
RECRUITING
Poland Warszawa Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
RECRUITING
Spain Alicante Hosp. Gral. Univ. de Alicante
RECRUITING
Spain Barcelona Hosp Univ Vall D Hebron
RECRUITING
Spain Barcelona Hosp. Univ. Quiron Dexeus
RECRUITING
Spain Madrid Hosp. Univ. 12 de Octubre
RECRUITING
Spain Sevilla Hosp. Virgen Macarena
RECRUITING
Spain Valencia Instituto Valenciano de Oncologia
RECRUITING
Türkiye Ankara Ankara Bilkent City Hospital
RECRUITING
United Kingdom London Imperial College London and Imperial College Healthcare NHS Trust
RECRUITING
United Kingdom Newcastle Freeman Hospital
RECRUITING
United Kingdom Sutton Royal Marsden Hospital
RECRUITING
Show More
Geo Locations

33.80307, -118.07256

45.52345, -122.67621

45.52345, -122.67621

38.84622, -77.30637

-23.5475, -46.63611

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

3.1412, 101.68653

1.54999, 110.33333

39.91987, 32.85427

34.13945, -117.97729

33.66946, -117.82311

-20.55722, -48.56778

-19.92083, -43.93778

-25.42778, -49.27306

45.46427, 9.18951

45.4299, 10.98444

51.25, 22.56667

39.9179, 32.86268

41.01384, 28.94966

40.788855, 30.405954

29.76328, -95.36327

-19.92083, -43.93778

-23.31028, -51.16278

-30.03306, -51.23

-12.97111, -38.51083

45.46427, 9.18951

45.00547, 7.53813

52.40692, 16.92993

52.22977, 21.01178

38.34517, -0.48149

41.38879, 2.15899

41.38879, 2.15899

40.4165, -3.70256

37.38283, -5.97317

39.46975, -0.37739

39.91987, 32.85427

51.50853, -0.12574

54.97328, -1.61396

51.35, -0.2

x
50

Indicates 50+ sites in this region: click to zoom in.

10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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