Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501987-16-00 | Registry Identifier | EU CT Number | |
| 2019-003372-39 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCMGA00012 + chemotherapy (nonsquamous NSCLC) | Experimental | INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression. |
|
| Placebo + chemotherapy (nonsquamous NSCLC) | Active Comparator | Placebo with pemetrexed + cisplatin OR carboplatin followed by placebo plus pemetrexed until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease. |
|
| INCMGA00012 + chemotherapy (squamous NSCLC) | Experimental | INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression. |
|
| Placebo + chemotherapy (squamous NSCLC) | Active Comparator | Placebo with carboplatin + paclitaxel OR nab-paclitaxel followed by placebo until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retifanlimab | Drug | INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was defined as the time between the date of randomization and the date of death due to any cause. | up to 39.1 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS was defined as the length of time from the date of randomization until the earliest date of 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, if occurring sooner than progression. | up to 35.8 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Cancer Medical Center | Anaheim | California | 92801 | United States | ||
| Innovative Clinical Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40983066 | Derived | Lu S, Vynnychenko O, Kulyaba Y, Kuchava V, Ibrahim A, Moiseenko F, Arslan C, Nguyen DT, Petrovic M, Cicin I, Bibichadze K, Cil T, Shi J, Olmez OF, Gogishvili M, Artac M, Nguyen HG, Cornfeld M, Tian C, Munteanu MC, Sette CVM, Bondarenko I; POD1UM-304 Study Team. Retifanlimab versus placebo in combination with platinum-based chemotherapy in patients with first-line non-squamous or squamous metastatic non-small-cell lung cancer (POD1UM-304): a phase 3, multiregional, placebo-controlled, double-blind, randomised study. Lancet Respir Med. 2025 Dec;13(12):1096-1107. doi: 10.1016/S2213-2600(25)00209-7. Epub 2025 Sep 19. |
| Label | URL |
|---|---|
| Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer | View source |
Not provided
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
This study was conducted in Bulgaria, Brazil, China, Czech Republic, Georgia, Malaysia, Philippines, Poland, Romania, Russia, Serbia, Turkey, Ukraine, United States, Vietnam, and South Africa. Data collected through 15 December 2023 have been included in this results summary.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Chemotherapy | Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 [D1]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m^2) + either cisplatin 75 mg/m^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m^2 (on D1) or nab-paclitaxel 100 mg/m^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. Participants who experienced progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by blinded independent central review (BICR) had the opportunity to receive retifanlimab 375 mg IV Q3W for up to approximately 2 years (or up to 35 cycles [21-day cycles]) in the optional monotherapy treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized Treatment Period |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 18, 2022 | Dec 13, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles. |
|
| Pemetrexed | Drug | Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle. |
|
| Cisplatin | Drug | Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles. |
|
| Carboplatin | Drug | Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles. |
|
| Paclitaxel | Drug | Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles. |
|
| nab-Paclitaxel | Drug | nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles. |
|
| Objective Response Rate | Objective response rate was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 based on BICR at any post-Baseline visit until the first progressive disease or new anticancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. | up to 35.78 months |
| Duration of Response | Duration of response was defined as the time from the earliest date of documented response until the earliest date of disease progression or death from any cause, whichever comes first, per RECIST v1.1 based on BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. | up to 34.3 months |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the Randomized Treatment Period | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded. | up to approximately 39 months |
| Number of Participants Who Discontinued Study Drug Due to TEAEs in the Randomized Treatment Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded. | up to approximately 39 months |
| Number of Participants With Any TEAE in the Monotherapy Treatment Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded. | up to approximately 27 months |
| Number of Participants Who Discontinued Study Drug Due to TEAEs in the Monotherapy Treatment Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded. | up to approximately 27 months |
| Cmax1 of Retifanlimab When Administered With Chemotherapy | Cmax1 was defined as the first-dose maximum serum concentration of retifanlimab. | Cycle 1 Day 1: pre-infusion and immediately after infusion |
| AUC1 of Retifanlimab When Administered With Chemotherapy | AUC1 was defined as the first-dose area under the serum concentration versus time curve. | Cycle 1 Day 1: pre-infusion and immediately after infusion |
| Cmaxss of Retifanlimab When Administered With Chemotherapy | Cmaxss was defined as the maximum serum concentration of retifanlimab at steady state. | Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit. |
| AUCss of Retifanlimab When Administered With Chemotherapy | AUCss was defined as the area under the serum concentration versus time curve at steady state. | Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit. |
| Whittier |
| California |
| 90603 |
| United States |
| Reading Hospital and Medical Center | Reading | Pennsylvania | 19612 | United States |
| Fundacao Pio Xii Hospital de Cancer de Barretos | Barretos | 14784-400 | Brazil |
| Incan - Instituto Do Cancer - Hospital Pompeia | Caxias do Sul | 95010-005 | Brazil |
| Centro Regional Integrado de Oncologia | Fortaleza | 60336-045 | Brazil |
| Oncosite - Centro de Pesquisa Clinica E Oncologia | Ijuí | 98700-000 | Brazil |
| Clinica de Neoplasias Litoral Ltda | Itajaí | 88301-220 | Brazil |
| Hospital Do Cancer de Londrina | Londrina | 86015-520 | Brazil |
| Instituto Mederi de Pesquisa E Saude | Passo Fundo | 99010-120 | Brazil |
| Hgb - Hospital Giovanni Battista - Mae de Deus Center | Porto Alegre | 90470-340 | Brazil |
| Inca - Instituto Nacional de Cancer | Rio de Janeiro | 20230-130 | Brazil |
| Sao Camilo Oncologia | S?O Paulo | 03102-002 | Brazil |
| Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia | Santo André | 09060-870 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto | São José | 15090-000 | Brazil |
| Mc Women'S Health-Nadezhda Eood | Sofia | 01330 | Bulgaria |
| Acibadem Cityclinica Mhat Tokuda | Sofia | 01407 | Bulgaria |
| Umhat Sv. Ivan Rilski Ead | Sofia | 01431 | Bulgaria |
| Mhat Serdika Eood | Sofia | 01632 | Bulgaria |
| Multiprofile Hospital For Active Treatment Central Onco Hospital Ood | Sofia | 01797 | Bulgaria |
| Shatod Dr Marko Marko - Varna Ltd | Varna | 09002 | Bulgaria |
| Hunan Cancer Hospital | Changsha | 410013 | China |
| The First Affiliated Hospital Sun Yat-Sen University | Guangzhou | 510080 | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | 310001 | China |
| Hangzhou Cancer Hospital | Hangzhou | 310002 | China |
| The First Affiliated Hospital of Zhejiang University | Hangzhou | 310003 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital) | Hefei | 230001 | China |
| The Second Hospital of Anhui Medical University | Hefei | 230601 | China |
| Jinan Central Hospital | Jinan | 250013 | China |
| Linyi Cancer Hospital | Linyi | 276001 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | 330006 | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | 530021 | China |
| Shanghai Chest Hospital | Shanghai | 200030 | China |
| General Hospital of Tianjin | Tianjing | 300052 | China |
| The Affiliated Cancer Hospital of Xinjiang Medical University | Ürümqi | 830000 | China |
| Henan Cancer Hostipal | Zhengzhou | 450003 | China |
| Henan Provincial Peoples Hospital | Zhengzhou | 450003 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | 450052 | China |
| University Hospital Hradec Kralove | Hradec Králové | 50333 | Czechia |
| Fakultni Nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Nemocnice Agel Ostrava - Vitkovice A.S | Ostrava - Vitkovice | 703 84 | Czechia |
| Fakultni Nemocnice V Motole | Prague | 150 06 | Czechia |
| High Technology Hospital Medcenter | Batumi | 06000 | Georgia |
| Jsc Evex Hospitals | Kutaisi | 04600 | Georgia |
| Archangel St. Michael Multi Profile Clinical Hospital | Tbilisi | 00102 | Georgia |
| Israel-Georgian Medical Research Clinic Helsicore | Tbilisi | 00112 | Georgia |
| New Hospitals | Tbilisi | 00114 | Georgia |
| Medulla Chemotherapy and Immunotherapy Clinic | Tbilisi | 00141 | Georgia |
| Tbilisi State Medical University First University Clinic | Tbilisi | 00141 | Georgia |
| High Technology Medical Center, University Clinic | Tbilisi | 00144 | Georgia |
| Institute of Clinical Oncology Ltd | Tbilisi | 00159 | Georgia |
| Cancer Research Center Ltd | Tbilisi | 00177 | Georgia |
| Orszagos Koranyi Tbc Es Pulmonological Intezet | Budapest | 01121 | Hungary |
| Bacs Kiskun Megyei Oktatokorhaz | Kecskemét | 06000 | Hungary |
| Advanced Medical and Dental Institute Husm | Kepala Batas | 13200 | Malaysia |
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| Hospital Tengku Ampuan Afzan | Kuantan | 25100 | Malaysia |
| Sarawak General Hospital | Kuching | 93586 | Malaysia |
| Beacon Hospital Sdn Bhd | Petaling Jaya | 46050 | Malaysia |
| Hospital Pulau Pinang | Pulau Pinang | 10990 | Malaysia |
| Institut Kanser Negara - National Cancer Institute | Putrajaya | 62250 | Malaysia |
| Cebu Doctors University Hospital | Cebu City | 06000 | Philippines |
| Asian Hospital and Medical Center | City of Muntinlupa | 01781 | Philippines |
| Davao Doctors Hospital | Davao City | 08000 | Philippines |
| West Visayas State University Medical Center | Iloilo City | 05000 | Philippines |
| Makati Medical Center | Makati | 01229 | Philippines |
| Makati Medical Center | Makati City | 01229 | Philippines |
| Philippine General Hospital | Manila | 01000 | Philippines |
| The Medical City | Pasig | 01605 | Philippines |
| St. Lukes Medical Center | Quezon City | 01102 | Philippines |
| Ko-Med Centra Kliniczne Biala Podlaska | Biała Podlaska | 21-500 | Poland |
| Przychodnia Lekarska Komed | Konin | 62-500 | Poland |
| Centrum Medyczne Plejady | Krakow | 30-363 | Poland |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo-Akcyjna | Lodz | 90-242 | Poland |
| Przychodnia Med-Polonia Sp. Z O.O. | Poznan | 60-693 | Poland |
| S.C Oncopremium Team S.R.L | Baia Mare | 430295 | Romania |
| Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca | Cluj-Napoca | 400015 | Romania |
| Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca | Cluj-Napoca | 400132 | Romania |
| Spitalul Clinic Judetean de Urgenta Constanta | Constanța | 900591 | Romania |
| S C Oncocenter Oncologie Medicala S R L | Timișoara | 300166 | Romania |
| Oncomed Srl | Timișoara | 300239 | Romania |
| Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary | Arkhangelsk | 163045 | Russia |
| Rbih Kursk Regional Clinical Oncology Dispensary of Kursk Region Healthcare Committee | Kursk | 305035 | Russia |
| Federal State Institution "Russian Cancer Research Center Named After N.N. Blokhin" Rams | Moscow | 121309 | Russia |
| Llc Tonus | Nizniy Novgorod | 603089 | Russia |
| Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary | Novosibirsk | 630108 | Russia |
| Bhi of Omsk Region Clinical Oncology Dispensary | Omsk | 644013 | Russia |
| Pavlov First Saint Petersburg State Medical University | Saint Petersburg | 197022 | Russia |
| N.N. Petrov Research Institute of Oncology | Saint Petersburg | 197758 | Russia |
| Sbhi Volgograd Regional Onclogy Dispensary | Volgograd | 400138 | Russia |
| Clinical Center of Serbia | Belgrade | 11 000 | Serbia |
| Clinical Center Bezanijska Kosa | Belgrade | 11000 | Serbia |
| Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Oncomed-System | Belgrade | 11000 | Serbia |
| Institute For Pulmonary Diseases of Vojvodina | Kamenitz | 21204 | Serbia |
| Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| Cape Town Oncology Trials (Pty) Ltd | Cape Town | 07570 | South Africa |
| Cancercare Rondebosch Oncology Centre | Cape Town | 07700 | South Africa |
| Wits Clinical Research | Johannesburg | 02193 | South Africa |
| Sandton Oncology Centre | Johannesburg | 02196 | South Africa |
| University of Pretoria Oncology Department | Pretoria | 00002 | South Africa |
| Mary Potter Oncology Centre | Pretoria | 00181 | South Africa |
| Acibadem Adana Hospital | Adana | 01130 | Turkey (Türkiye) |
| Adana Sehir Hastanesi | Adana | 01230 | Turkey (Türkiye) |
| Hacettepe Universitesi Tip Fakultesi Hastanesi | Ankara | 06100 | Turkey (Türkiye) |
| Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital | Ankara | 06105 | Turkey (Türkiye) |
| Memorial Ankara Hospital | Ankara | 06520 | Turkey (Türkiye) |
| Yildirim Beyazit University Ankara Ataturk Training and Research Hospital | Ankara | 06800 | Turkey (Türkiye) |
| Memorial Antalya Hastanesi | Antalya | 07020 | Turkey (Türkiye) |
| Trakya Universitesi Tip Fakultesi | Edirne | 22030 | Turkey (Türkiye) |
| Gaziantep University Gaziantep Oncology Hospital | Gaziantep | 27310 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty | Istanbul | 34098 | Turkey (Türkiye) |
| Bakirkoy Dr Sadi Konuk Teaching and Research Hospital | Istanbul | 34147 | Turkey (Türkiye) |
| Medipol University Medical Faculty | Istanbul | 34214 | Turkey (Türkiye) |
| Izmir Medicalpark Hospital | Izmir | 35530 | Turkey (Türkiye) |
| Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi | Konya | 42080 | Turkey (Türkiye) |
| Inonu Universitesi Turgut Ozal Tip Merkezi | Malatya | 44280 | Turkey (Türkiye) |
| Multifield Clinical Hospital No 4 | Dnipro | 49102 | Ukraine |
| Ci Carpathian Clinical Oncological Center | Ivano-Frankivsk | 76018 | Ukraine |
| Communal Non-Profit Enterprise Regional Center of Oncology | Kharkiv | 61070 | Ukraine |
| V.T.Zaycev Institute of General and Urgent Surgery of National Academy Medical Sciences of Ukraine | Kharkiv | 61103 | Ukraine |
| Kherson Regional Oncologic Dispensary | Kherson | 73000 | Ukraine |
| Pp Ppc Acinus Medical and Diagnostic Centre | Kropyvnytskyi | 25006 | Ukraine |
| Mi Kryviy Rih Center of Dnipropetrovsk Regional Council | Kryvyi Rih | 50048 | Ukraine |
| Kyiv City Clinical Oncological Center | Kyiv | 03115 | Ukraine |
| Medical Center Asklepion Llc | Kyiv | 03126 | Ukraine |
| Ci of Krc Kyiv Regional Oncologic Dispensary | Kyiv | 04107 | Ukraine |
| Volyn Regional Oncological Dispensary | Lutsk | 43018 | Ukraine |
| Rmi Sumy Regional Clinical Oncology Dispensary | Sumy | 40022 | Ukraine |
| Cne Ccch of Uzh Cc Oncological Center | Uzhhorod | 88000 | Ukraine |
| Medical Center Oncolife Llc | Zaporizhzhia | 69059 | Ukraine |
| Can Tho Oncology Hospital | Can Tho | 00000 | Vietnam |
| 103 Military Hospital | Hanoi | 00000 | Vietnam |
| Bach Mai Hospital | Hanoi | 100000 | Vietnam |
| Hanoi Oncology Hospital | Hanoi | 100000 | Vietnam |
| National Cancer Hospital | Hanoi | 100000 | Vietnam |
| National Lung Hospital | Hanoi | 10000 | Vietnam |
| Hcmc Oncology Hospital | Ho Chi Minh City | 722681 | Vietnam |
| FG001 | Retifanlimab + Chemotherapy | Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m^2 + either cisplatin 75 mg/m^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m^2 (on D1) or nab-paclitaxel 100 mg/m^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Monotherapy Treatment Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Chemotherapy | Participants received placebo intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received placebo IV (on Day 1 [D1]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m^2) + either cisplatin 75 mg/m^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m^2 (on D1) or nab-paclitaxel 100 mg/m^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. Participants who experienced progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by blinded independent central review (BICR) had the opportunity to receive retifanlimab 375 mg IV Q3W for up to approximately 2 years (or up to 35 cycles [21-day cycles]) in the optional monotherapy treatment period. |
| BG001 | Retifanlimab + Chemotherapy | Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m^2 + either cisplatin 75 mg/m^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m^2 (on D1) or nab-paclitaxel 100 mg/m^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival | Overall survival was defined as the time between the date of randomization and the date of death due to any cause. | Median survival time in months was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley. Full Analysis Set: all participants to whom study treatment had been assigned by randomization. Participants were analyzed according to the treatment and strata they had been assigned to during the randomization procedure. | Posted | Median | 95% Confidence Interval | months | up to 39.1 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS was defined as the length of time from the date of randomization until the earliest date of 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, if occurring sooner than progression. | Full Analysis Set. Median PFS time was estimated using the Kaplan-Meier method. The confidence interval for median PFS time was calculated using the method of Brookmeyer and Crowley. | Posted | Median | 95% Confidence Interval | months | up to 35.8 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate | Objective response rate was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 based on BICR at any post-Baseline visit until the first progressive disease or new anticancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. | Full Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 35.78 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response was defined as the time from the earliest date of documented response until the earliest date of disease progression or death from any cause, whichever comes first, per RECIST v1.1 based on BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. | Full Analysis Set. Only those participants with a confirmed response were analyzed. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation. | Posted | Median | 95% Confidence Interval | months | up to 34.3 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the Randomized Treatment Period | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded. | Safety Population: all participants who received at least 1 dose of study treatment. Treatment groups for this population were determined by the actual treatment that the participant received regardless of treatment assignment at randomization. | Posted | Count of Participants | Participants | up to approximately 39 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Discontinued Study Drug Due to TEAEs in the Randomized Treatment Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded. | Safety Population | Posted | Count of Participants | Participants | up to approximately 39 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any TEAE in the Monotherapy Treatment Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded. | Monotherapy Analysis Set: all participants who were randomized to the placebo group and received at least 1 dose of placebo, who then transitioned and received at least 1 dose of retifanlimab | Posted | Count of Participants | Participants | up to approximately 27 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Discontinued Study Drug Due to TEAEs in the Monotherapy Treatment Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded. | Monotherapy Analysis Set | Posted | Count of Participants | Participants | up to approximately 27 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmax1 of Retifanlimab When Administered With Chemotherapy | Cmax1 was defined as the first-dose maximum serum concentration of retifanlimab. | Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of retifanlimab and provided at least 1 PK post-dose sample | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams per liter (mg/L) | Cycle 1 Day 1: pre-infusion and immediately after infusion |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC1 of Retifanlimab When Administered With Chemotherapy | AUC1 was defined as the first-dose area under the serum concentration versus time curve. | PK Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/L x day | Cycle 1 Day 1: pre-infusion and immediately after infusion |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmaxss of Retifanlimab When Administered With Chemotherapy | Cmaxss was defined as the maximum serum concentration of retifanlimab at steady state. | PK Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/L | Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUCss of Retifanlimab When Administered With Chemotherapy | AUCss was defined as the area under the serum concentration versus time curve at steady state. | PK Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/L x day | Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit. |
|
up to approximately 3.25 years
All-Cause Mortality was assessed for all randomized participants (Full Analysis Set). Adverse events were assessed for members of the Safety Population (participants who received at least 1 dose of study treatment) and the Monotherapy Analysis Set (participants who were randomized to the placebo group and received at least 1 dose of placebo, who then transitioned and received at least 1 dose of retifanlimab).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Retifanlimab + Chemotherapy | Participants received retifanlimab 375 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous non-small cell lung cancer (NSCLC) received retifanlimab 375 mg IV (on Day 1 [D1]) Q3W with pemetrexed 500 milligrams per meters squared (mg/m^2) + either cisplatin 75 mg/m^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m^2 (on D1) or nab-paclitaxel 100 mg/m^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. | 234 | 391 | 158 | 389 | 350 | 389 |
| EG001 | Placebo + Chemotherapy | Participants received placebo IV Q3W along with a standard-of-care chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received placebo IV (on D1) Q3W with pemetrexed 500 mg/m^2 + either cisplatin 75 mg/m^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by placebo IV Q3W + pemetrexed 500 mg/m^2 Q3W until progression. Participants with squamous NSCLC received placebo IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m^2 (on D1) or nab-paclitaxel 100 mg/m^2 (on D1, D8, D15) Q3W for 4 cycles followed by placebo IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. | 140 | 192 | 57 | 190 | 177 | 190 |
| EG002 | Randomized Treatment Period Total | Participants received retifanlimab 375 mg IV Q3W or matching placebo along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. | 374 | 583 | 215 | 579 | 527 | 579 |
| EG003 | Retifanlimab Monotherapy | Participants randomized to placebo plus a platinum-based chemotherapy who experienced progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by blinded independent central review (BICR) had the opportunity to receive retifanlimab 375 mg IV Q3W for up to approximately 2 years (or up to 35 cycles [21-day cycles]) in the optional monotherapy treatment period. | 42 | 59 | 12 | 59 | 44 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebral artery embolism | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Coronary artery insufficiency | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetes insipidus | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dilated cardiomyopathy | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypersensitivity pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Immune-mediated adrenal insufficiency | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Immune-mediated dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Organ failure | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Post-acute COVID-19 syndrome | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sacral pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Salmonella bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Vascular occlusion | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
|
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2023 | Dec 13, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black/African-American |
|
| Black/White biracial |
|
| Asian |
|
| Unknown |
|
| Retifanlimab + Chemotherapy |
Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m^2 + either cisplatin 75 mg/m^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m^2 (on D1) or nab-paclitaxel 100 mg/m^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. |
|
|
|
| OG001 | Retifanlimab + Chemotherapy | Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m^2 + either cisplatin 75 mg/m^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m^2 (on D1) or nab-paclitaxel 100 mg/m^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. |
|
|
|
| OG001 | Retifanlimab + Chemotherapy | Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m^2 + either cisplatin 75 mg/m^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m^2 (on D1) or nab-paclitaxel 100 mg/m^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. |
|
|
| OG001 | Retifanlimab + Chemotherapy | Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m^2 + either cisplatin 75 mg/m^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m^2 (on D1) or nab-paclitaxel 100 mg/m^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. |
|
|
| OG001 | Retifanlimab + Chemotherapy | Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m^2 + either cisplatin 75 mg/m^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m^2 (on D1) or nab-paclitaxel 100 mg/m^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination. |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m^2 + either cisplatin 75 mg/m^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m^2 (on D1) or nab-paclitaxel 100 mg/m^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination.
|
|
Participants received retifanlimab 375 mg IV Q3W along with a standard-of-care platinum-based chemotherapy regimen in the randomized treatment period. Participants with nonsquamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with pemetrexed 500 mg/m^2 + either cisplatin 75 mg/m^2 (on D1) Q3W or carboplatin AUC 5 (on D1) Q3W for 4 cycles (21-day cycles) followed by retifanlimab 375 mg IV Q3W + pemetrexed 500 mg/m^2 Q3W until progression. Participants with squamous NSCLC received retifanlimab 375 mg IV (on D1) Q3W with carboplatin AUC 6 (D1) + either paclitaxel 200 mg/m^2 (on D1) or nab-paclitaxel 100 mg/m^2 (on D1, D8, D15) Q3W for 4 cycles followed by retifanlimab 375 mg IV Q3W until progression. Treatment could continue for up to 2 years until unacceptable toxicity, disease progression, investigator's decision, pregnancy, withdrawal of consent, or study termination.
|
|