Clinical trial NCT04205812: Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
Official title: A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Metastatic Squamous Non-Small Cell Lung Cancer
Metastatic Nonsquamous Non-Small Cell Lung Cancer
Keywords: Metastatic
non-small cell lung cancer
nonsquamous
squamous
PD-1
PD-L1
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2019-12-19
Enrollment: 583
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8).
* No prior systemic treatment for the advanced/metastatic NSCLC
* Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biopsy
* Measurable disease per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least 3 months.
* Willingness to avoid pregnancy or fathering children.
* Adequate organ function as indicated by protocol-specified laboratory values. - Has been fully vaccinated against SARS-CoV-2 or is willing and able to be fully vaccinated against SARS-CoV-2 during the study by starting the vaccination process during screening.

Exclusion Criteria:

* Clinically significant cardiac disease within 6 months of start of study treatment.
* Any major surgery within 3 weeks of the first dose of study treatment.
* Thoracic radiation therapy of \> 30 Gy within 6 months of the first dose of study treatment.
* History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receive cisplatin, paclitaxel, or nab-paclitaxel.
* Untreated central nervous system metastases and/or carcinomatous meningitis.
* Evidence or history of interstitial lung disease or noninfectious pneumonitis that required systemic steroids.
* Active infection requiring systemic therapy or active tuberculosis. Note: If required by country or local regulations to be tested for COVID-19 during screening, a participant should be excluded if they have a positive test result for SARS CoV-2 infection until both the retesting result is negative and clinical recovery is obtained.
* Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
* Has contraindications to chemotherapy agents used in the study.
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose of study treatment.
* Has received a live vaccine within 30 days before the first dose of study treatment (and until 90 days after last dose of study drug).

Note: While based on approved SARS-CoV-2 vaccines available worldwide, many vaccines are not live (mRNA and adenovirus vaccines do not contain live virus), if a live vaccine against SARS-CoV-2 is the only available option, prior consultation with the medical monitor should be obtained.

• Has known active HBV or HCV (testing must be performed to determine eligibility)

Primary outcomes:
measure: Overall Survival
timeFrame: up to 39.1 months
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: up to 35.8 months
measure: Objective Response Rate
timeFrame: up to 35.78 months
measure: Duration of Response
timeFrame: up to 34.3 months
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the Randomized Treatment Period
timeFrame: up to approximately 39 months
measure: Number of Participants Who Discontinued Study Drug Due to TEAEs in the Randomized Treatment Period
timeFrame: up to approximately 39 months
measure: Number of Participants With Any TEAE in the Monotherapy Treatment Period
timeFrame: up to approximately 27 months
measure: Number of Participants Who Discontinued Study Drug Due to TEAEs in the Monotherapy Treatment Period
timeFrame: up to approximately 27 months
measure: Cmax of Retifanlimab
timeFrame: Cycle 1 Day 1: predose and end of infusion (EOI). Cycle 2 Day 1: predose. Cycle 4 Day 1: predose and EOI. Cycles 6, 8, and beyond Day 1: predose (every 4 cycles thereafter) and end of treatment visit or 30-day safety follow-up visit
measure: AUC of Retifanlimab
timeFrame: Cycle 1 Day 1: predose and end of infusion (EOI). Cycle 2 Day 1: predose. Cycle 4 Day 1: predose and EOI. Cycles 6, 8, and beyond Day 1: predose (every 4 cycles thereafter) and end of treatment visit or 30-day safety follow-up visit
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
city: Barretos
country: Brazil
facility: Fundacao Pio Xii Hospital de Cancer de Barretos
city: Caxias Do Sul
country: Brazil
facility: Incan - Instituto Do Cancer - Hospital Pompeia
city: Fortaleza
country: Brazil
facility: Centro Regional Integrado de Oncologia
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica E Oncologia
city: Itajai
country: Brazil
facility: Clinica de Neoplasias Litoral Ltda
city: Londrina
country: Brazil
facility: Hospital Do Cancer de Londrina
city: Passo Fundo
country: Brazil
facility: Instituto Mederi de Pesquisa E Saude
city: Porto Alegre
country: Brazil
facility: Hgb - Hospital Giovanni Battista - Mae de Deus Center
city: Rio de Janeiro
country: Brazil
facility: Inca - Instituto Nacional de Cancer
city: S?O Paulo
country: Brazil
facility: Sao Camilo Oncologia
city: Santo Andre
country: Brazil
facility: Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
city: Sao Jose
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
city: Sofia
country: Bulgaria
facility: Mc Women'S Health-Nadezhda Eood
city: Sofia
country: Bulgaria
facility: Acibadem Cityclinica Mhat Tokuda
city: Sofia
country: Bulgaria
facility: Umhat Sv. Ivan Rilski Ead
city: Sofia
country: Bulgaria
facility: Mhat Serdika Eood
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment Central Onco Hospital Ood
city: Varna
country: Bulgaria
facility: Shatod Dr Marko Marko - Varna Ltd
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital Sun Yat-Sen University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Hangzhou Cancer Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hefei
country: China
facility: University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
city: Jinan
country: China
facility: Jinan Central Hospital
city: Linyi
country: China
facility: Linyi Cancer Hospital
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Tianjing
country: China
facility: General Hospital of Tianjin
city: Urumqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical University
city: Zhengzhou
country: China
facility: Henan Cancer Hostipal
city: Zhengzhou
country: China
facility: Henan Provincial Peoples Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc
city: Ostrava - Vitkovice
country: Czechia
facility: Nemocnice Agel Ostrava - Vitkovice A.S
city: Praha 5
country: Czechia
facility: Fakultni Nemocnice V Motole
city: Batumi
country: Georgia
facility: High Technology Hospital Medcenter
city: Kutaisi
country: Georgia
facility: Jsc Evex Hospitals
city: Tbilisi
country: Georgia
facility: Archangel St. Michael Multi Profile Clinical Hospital
city: Tbilisi
country: Georgia
facility: Israel-Georgian Medical Research Clinic Helsicore
city: Tbilisi
country: Georgia
facility: New Hospitals
city: Tbilisi
country: Georgia
facility: Medulla Chemotherapy and Immunotherapy Clinic
city: Tbilisi
country: Georgia
facility: Tbilisi State Medical University First University Clinic
city: Tbilisi
country: Georgia
facility: High Technology Medical Center, University Clinic
city: Tbilisi
country: Georgia
facility: Institute of Clinical Oncology Ltd
city: Tbilisi
country: Georgia
facility: Cancer Research Center Ltd
city: Budapest
country: Hungary
facility: Orszagos Koranyi Tbc Es Pulmonological Intezet
city: Kecskemet
country: Hungary
facility: Bacs Kiskun Megyei Oktatokorhaz
city: Kepala Batas
country: Malaysia
facility: Advanced Medical and Dental Institute Husm
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Petaling Jaya
country: Malaysia
facility: Beacon Hospital Sdn Bhd
city: Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang
city: Putrajaya
country: Malaysia
facility: Institut Kanser Negara - National Cancer Institute
city: Cebu City
country: Philippines
facility: Cebu Doctors University Hospital
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
city: Iloilo City
country: Philippines
facility: West Visayas State University Medical Center
city: Makati City
country: Philippines
facility: Makati Medical Center
city: Makati
country: Philippines
facility: Makati Medical Center
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Muntinlupa
country: Philippines
facility: Asian Hospital and Medical Center
city: Pasig City
country: Philippines
facility: The Medical City
city: Quezon City
country: Philippines
facility: St. Lukes Medical Center
city: Biala Podlaska
country: Poland
facility: Ko-Med Centra Kliniczne Biala Podlaska
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
city: Poznan
country: Poland
facility: Przychodnia Med-Polonia Sp. Z O.O.
city: Baia Mare
country: Romania
facility: S.C Oncopremium Team S.R.L
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
city: Cluj-napoca
country: Romania
facility: Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Constanta
city: Timisoara
country: Romania
facility: S C Oncocenter Oncologie Medicala S R L
city: Timisoara
country: Romania
facility: Oncomed Srl
city: Arkhangelsk
country: Russian Federation
facility: Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary
city: Kursk
country: Russian Federation
facility: Rbih Kursk Regional Clinical Oncology Dispensary of Kursk Region Healthcare Committee
city: Moscow
country: Russian Federation
facility: Federal State Institution "Russian Cancer Research Center Named After N.N. Blokhin" Rams
city: Nizniy Novgorod
country: Russian Federation
facility: Llc Tonus
city: Novosibirsk
country: Russian Federation
facility: Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary
city: Omsk
country: Russian Federation
facility: Bhi of Omsk Region Clinical Oncology Dispensary
city: Saint-petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
city: Saint-petersburg
country: Russian Federation
facility: N.N. Petrov Research Institute of Oncology
city: St Petersburg
country: Russian Federation
facility: N.N. Petrov Research Institute of Oncology
city: Volgograd
country: Russian Federation
facility: Sbhi Volgograd Regional Onclogy Dispensary
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska Kosa
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrad
country: Serbia
facility: Oncomed-System
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Sremska Kamenica
country: Serbia
facility: Institute For Pulmonary Diseases of Vojvodina
city: Cape Town
country: South Africa
facility: Cape Town Oncology Trials (Pty) Ltd
city: Cape Town
country: South Africa
facility: Cancercare Rondebosch Oncology Centre
city: Johannesburg
country: South Africa
facility: Wits Clinical Research
city: Johannesburg
country: South Africa
facility: Sandton Oncology Centre
city: Pretoria
country: South Africa
facility: University of Pretoria Oncology Department
city: Pretoria
country: South Africa
facility: Mary Potter Oncology Centre
city: Adana
country: Turkey
facility: Acibadem Adana Hospital
city: Adana
country: Turkey
facility: Adana Sehir Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital
city: Ankara
country: Turkey
facility: Memorial Ankara Hospital
city: Ankara
country: Turkey
facility: Yildirim Beyazit University Ankara Ataturk Training and Research Hospital
city: Antalya
country: Turkey
facility: Memorial Antalya Hastanesi
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi
city: Gaziantep
country: Turkey
facility: Gaziantep University Gaziantep Oncology Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Bakirkoy Dr Sadi Konuk Teaching and Research Hospital
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty
city: Izmir
country: Turkey
facility: Izmir Medicalpark Hospital
city: Konya
country: Turkey
facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
city: Malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal Tip Merkezi
city: Dnipro
country: Ukraine
facility: Multifield Clinical Hospital No 4
city: Ivano-frankivsk
country: Ukraine
facility: Ci Carpathian Clinical Oncological Center
city: Kharkiv
country: Ukraine
facility: Communal Non-Profit Enterprise Regional Center of Oncology
city: Kharkiv
country: Ukraine
facility: V.T.Zaycev Institute of General and Urgent Surgery of National Academy Medical Sciences of Ukraine
city: Kherson
country: Ukraine
facility: Kherson Regional Oncologic Dispensary
city: Kropyvnytskyi
country: Ukraine
facility: Pp Ppc Acinus Medical and Diagnostic Centre
city: Kryvyi Rih
country: Ukraine
facility: Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncological Center
city: Kyiv
country: Ukraine
facility: Medical Center Asklepion Llc
city: Kyiv
country: Ukraine
facility: Ci of Krc Kyiv Regional Oncologic Dispensary
city: Lutsk
country: Ukraine
facility: Volyn Regional Oncological Dispensary
city: Sumy
country: Ukraine
facility: Rmi Sumy Regional Clinical Oncology Dispensary
city: Uzhgorod
country: Ukraine
facility: Cne Ccch of Uzh Cc Oncological Center
city: Zaporizhzhia
country: Ukraine
facility: Medical Center Oncolife Llc
city: Can Tho
country: Vietnam
facility: Can Tho Oncology Hospital
city: Hanoi
country: Vietnam
facility: 103 Military Hospital
city: Hanoi
country: Vietnam
facility: Bach Mai Hospital
city: Hanoi
country: Vietnam
facility: Hanoi Oncology Hospital
city: Hanoi
country: Vietnam
facility: National Cancer Hospital
city: Hanoi
country: Vietnam
facility: National Lung Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Hcmc Oncology Hospital
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: