A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-s

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

Last Updated August 24, 2024

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CR109323

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 1

1
Sites
22 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:

More...

DETAILS

LOCATIONS

Locations in:

United States, Brazil, South Korea, Malaysia, Türkiye, Italy, Poland

Country (7)	City or Province (22)	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

Geo Locations

33.80307, -118.07256

45.52345, -122.67621

38.84622, -77.30637

-23.5475, -46.63611

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

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