Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer

Metastatic Squamous Non-Small Cell Lung Cancer Clinical Trial

— POD1UM-304  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04205812
• Other study ID #: INCMGA 0012-304
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 11, 2020
• Est. completion date: April 15, 2025

Study information

• Verified date: May 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 583
• Est. completion date: April 15, 2025
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Nonsquamous Non-Small Cell Lung Cancer
• Metastatic Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• Retifanlimab
INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
• Placebo
Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
• Pemetrexed
Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle.
• Cisplatin
Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
• Carboplatin
Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
• Paclitaxel
Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
• nab-Paclitaxel
nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Vietnam,  Brazil,  Bulgaria,  China,  Czechia,  Georgia,  Hungary,  Malaysia,  Philippines,  Poland,  Romania,  Russian Federation,  Serbia,  South Africa,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	Defined as the time from randomization until death due to any cause.	Approximately 4.5 years.
Secondary	Progression-free survival (PFS)	Defined as the time from randomization until disease progression by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by blinded independent central review (BICR) or death due to any cause.	Approximately 4.5 years
Secondary	Objective response rate (ORR)	Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1 based on BICR.	Approximately 4.5 years.
Secondary	Duration of response (DOR)	Defined as the time from the earliest date of documented response until earliest date of disease progression (per RECIST v1.1 based on BICR) or death from any cause, whichever comes first.	Approximately 4.5 years.
Secondary	Number of treatment-emergent adverse events	Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.	Approximately 4.5 years.
Secondary	Cmax of INCMGA00012 when administered with chemotherapy	Maximum observed plasma or serum concentration.	Approximately 4.5 years.
Secondary	AUC of INCMGA00012 when administered with chemotherapy	Area under the plasma or serum concentration curve.	Up to approximately 4.5 years.