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Carcinoma, Non-Small-Cell LungPhase 1/2PolyDamasNCT05908734

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

A Phase 1/2 study testing Cetrelimab and Amivantamab in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 44 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Cetrelimab and Amivantamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
44 sitesin 9 countries
Study dates
18 May 2023to 31 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

44 sites in 9 countries.

44 sites in 9 countries

Brazil8 sites

  • Fundacao Pio XII

    Barretos, 14784 400

  • Cetus Oncologia

    Belo Horizonte, 30110 022

  • PERSONAL Oncologia de Precisao e Personalizada

    Belo Horizonte, 30130 090

  • CIONC Centro Integrado de Oncologia de Curitiba

    Curitiba, 80810 050

  • Hospital do Cancer de Londrina

    Londrina, 86015 520

  • Hospital Nossa Senhora da Conceicao S A

    Porto Alegre, 91350 200

  • Hospital Santa Izabel Santa Casa de Misericordia da Bahia

    Salvador, 40050-410

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

Other trials in Brazil

Turkey (Türkiye)8 sites

  • Adana City Hospital

    Adana, 01170

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara, 06200

  • Ankara Bilkent Sehir Hastanesi 1

    Ankara, 06800

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

  • Bakirkoy Sadi Konuk Training and Research Hospital

    Istanbul, 34147

  • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • Medicana International Izmir

    Izmir, 35170

  • Sakarya Universitesi Egitim Ve Arastırma Hastanesi

    Sakarya, 54100

Other trials in Turkey (Türkiye)

United States7 sites

  • City of Hope

    Duarte, California, 91010

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Oncology and Hematology Care Clinic Westside

    Portland, Oregon, 97225

Other trials in United States

Spain6 sites

  • Hosp. Gral. Univ. de Alicante

    Alicante, 03010

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 8028

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Virgen Macarena

    Seville, 41009

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

Italy4 sites

  • European Institute of Oncology

    Milan, 20141

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Aou San Luigi Gonzaga

    Orbassano, 10043

  • Centro Ricerche Cliniche di Verona S r l

    Verona, 37134

Other trials in Italy

Poland3 sites

  • INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o

    Lublin, 20 609

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow

    Poznan, 60 569

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02 781

Other trials in Poland

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

United Kingdom3 sites

  • Imperial College London and Imperial College Healthcare NHS Trust

    London, W6 8RF

  • Freeman Hospital

    Newcastle, NE7 7DN

  • Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Malaysia2 sites

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Umum Sarawak

    Kuching, 93586

Other trials in Malaysia

About this study

Official title: A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer

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).

Being tested
Cetrelimab, Amivantamab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CetrelimabDrug

    Also called JNJ-63723283

    Cetrelimab will be administered as IV infusion.

  • AmivantamabDrug

    Also called JNJ-61186372

    Amivantamab will be administered as IV infusion.

Study groups in NCT05908734
Study groupRoleWhat they receive
Phase 1 (Combination Dose Selection)ExperimentalParticipants will receive amivantamab low dose or high dose intravenous (IV) infusion based on body weight from Cycle 1 Day 1, Day 2, and subsequently Day 8, Day 15, and Day 22 and then every 2 weeks from Cycle 2 in combination with cetrelimab IV infusion from Cycle 1 Day 2 (after the Day 2 infusion of amivantamab). Cetrelimab treatment duration will be limited to a maximum of 24 months. Doses will be escalated or de-escalated based on the dose limiting toxicities (DLTs) and the recommended Phase 2 combination dose (RP2CD) will be determined by the study evaluation team (SET). Participants who continue to benefit from study treatment(s), as determined by their investigator, may continue to receive access to study treatment(s) within the study by transferring to a long term extension (LTE) phase.
Receives: Drug: Cetrelimab; Drug: Amivantamab
Phase 2 (Dose Expansion)ExperimentalParticipants will receive amivantamab in combination with cetrelimab in Cohorts A and B at the RP2CD determined by the SET in Phase 1. Participants will continue study treatment until disease progression, unacceptable toxicity, or until another criterion for discontinuation of study treatment is met. Cetrelimab treatment duration will be limited to a maximum of 24 months. Participants who continue to benefit from study treatment(s), as determined by their investigator, may continue to receive access to study treatment(s) within the study by transferring to an LTE phase.
Receives: Drug: Cetrelimab; Drug: Amivantamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Number of Participants with Adverse events (AEs) by Severity

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

    Measured: Up to 2 years 3 months

  2. Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)

    The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, hematological toxicity, pulmonary toxicity, liver enzyme elevation, treatment delay greater than (>) 28 days due to unresolved toxicity, or immune-related toxicity requiring the use of therapies in excess of corticosteroids.

    Measured: Up to Cycle 1 (Day 1 through Day 28)

  3. Phase 2: Objective Response Rate

    ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as per investigator assessment.

    Measured: Up to 2 years 3 months

Secondary outcomes (6)

  1. Phase 1 and Phase 2: Number of Participants with AEs by Severity

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

    Measured: Up to 2 years 3 months

  2. Phase 1 and Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Parameters

    Number of participants with abnormalities in clinical laboratory parameters (serum chemistry, hematology, coagulation, serology, and urinalysis) will be reported.

    Measured: Up to 2 years 3 months

  3. Phase 2 : Duration of Response (DoR)

    DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death from any case, whichever comes first, for participants who have PR or CR. If a participant does not progress following a response, then his/her duration of response will be censored at the date of last evaluable disease assessment. Participants who started a subsequent anticancer therapy in the absence of progression will be censored at the last disease assessment before or on the start of subsequent therapy.

    Measured: Up to 2 years 3 months

  4. Phase 2: Disease Control Rate (DCR)

    DCR is defined as the percentage of participants who achieve a PR, CR, or stable disease using RECIST version 1.1 by investigator review.

    Measured: Up to 2 years 3 months

  5. Phase 2: Progression Free Survival (PFS)

    PFS is defined as the time from first dose date until the date of disease progression or death, whichever comes first, based on investigator assessment using RECIST version 1.1. Participants who have not progressed or have not died at the time of analysis will be censored at the time of their last evaluable RECIST v1.1 assessment.

    Measured: Up to 2 years 3 months

  6. Phase 2: Overall Survival (OS)

    OS is defined as the time from the date of administration of the first study treatment until the date of death due to any cause. Any participant not known to have died at the time of analysis will be censored based on the last recorded date on which the participant was known to be alive.

    Measured: Up to 2 years 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2023
  2. Study start18 May 2023
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05908734
Sponsor's protocol ID
CR109323
Other IDs
61186372PANSC2002, 2022-501452-29-00
Acronym
PolyDamas
Status last verified
Nov 2026
First submitted
6 Jun 2023
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cetrelimab and Amivantamab in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 44 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Brazil, Turkey (Türkiye), United States, Spain, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Number of Participants with Adverse events (AEs) by Severity (time frame: Up to 2 years 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05908734.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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