---
title: Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
nct_id: NCT04205812
overall_status: ACTIVE_NOT_RECRUITING
phase: PHASE3
sponsor: Incyte Corporation
study_type: INTERVENTIONAL
primary_condition: Metastatic Squamous Non-Small Cell Lung Cancer
countries: United States, Brazil, Bulgaria, China, Czechia, Georgia, Hungary, Malaysia, Philippines, Poland, Romania, Russia, Serbia, South Africa, Turkey (Türkiye), Ukraine, Vietnam
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04205812.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04205812"
ct_last_update_post_date: 2026-03-31
last_seen_at: "2026-05-12T07:16:16.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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)

**NCT ID:** [NCT04205812](https://clinicaltrials.gov/study/NCT04205812)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 583
- **Lead Sponsor:** Incyte Corporation
- **Conditions:** Metastatic Squamous Non-Small Cell Lung Cancer, Metastatic Nonsquamous Non-Small Cell Lung Cancer
- **Start Date:** 2020-09-11
- **Completion Date:** 2026-08-28
- **CT.gov Last Update:** 2026-03-31

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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)
```

## Arms

- **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.

## Interventions

- **Retifanlimab** (DRUG) — INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
- **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.

## Primary Outcomes

- **Overall Survival** _(time frame: up to 39.1 months)_ — Overall survival was defined as the time between the date of randomization and the date of death due to any cause.

## Secondary Outcomes

- **Progression-free Survival (PFS)** _(time frame: up to 35.8 months)_
- **Objective Response Rate** _(time frame: up to 35.78 months)_
- **Duration of Response** _(time frame: up to 34.3 months)_
- **Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the Randomized Treatment Period** _(time frame: up to approximately 39 months)_
- **Number of Participants Who Discontinued Study Drug Due to TEAEs in the Randomized Treatment Period** _(time frame: up to approximately 39 months)_
- **Number of Participants With Any TEAE in the Monotherapy Treatment Period** _(time frame: up to approximately 27 months)_
- **Number of Participants Who Discontinued Study Drug Due to TEAEs in the Monotherapy Treatment Period** _(time frame: up to approximately 27 months)_
- **Cmax1 of Retifanlimab When Administered With Chemotherapy** _(time frame: Cycle 1 Day 1: pre-infusion and immediately after infusion)_
- **AUC1 of Retifanlimab When Administered With Chemotherapy** _(time frame: Cycle 1 Day 1: pre-infusion and immediately after infusion)_
- **Cmaxss of Retifanlimab When Administered With Chemotherapy** _(time frame: 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** _(time frame: 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.)_

## Locations (140)

- Pacific Cancer Medical Center, Anaheim, California, United States
- Innovative Clinical Research Institute, Whittier, California, United States
- Reading Hospital and Medical Center, Reading, Pennsylvania, United States
- 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, Ijuí, Brazil
- Clinica de Neoplasias Litoral Ltda, Itajaí, 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 André, Brazil
- Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto, São José, Brazil
- Mc Women'S Health-Nadezhda Eood, Sofia, Bulgaria
- Acibadem Cityclinica Mhat Tokuda, Sofia, Bulgaria
- Umhat Sv. Ivan Rilski Ead, Sofia, Bulgaria
- Mhat Serdika Eood, Sofia, Bulgaria
- Multiprofile Hospital For Active Treatment Central Onco Hospital Ood, Sofia, Bulgaria
- Shatod Dr Marko Marko - Varna Ltd, Varna, Bulgaria
- Hunan Cancer Hospital, Changsha, China
- The First Affiliated Hospital Sun Yat-Sen University, Guangzhou, China
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou, China
- Hangzhou Cancer Hospital, Hangzhou, China
- The First Affiliated Hospital of Zhejiang University, Hangzhou, China
- Zhejiang Cancer Hospital, Hangzhou, China
- Harbin Medical University Cancer Hospital, Harbin, China
- University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital), Hefei, China
- The Second Hospital of Anhui Medical University, 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, Ürümqi, China
- Henan Cancer Hostipal, Zhengzhou, China
- Henan Provincial Peoples Hospital, Zhengzhou, China
- The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
- University Hospital Hradec Kralove, Hradec Králové, Czechia
- Fakultni Nemocnice Olomouc, Olomouc, Czechia
- Nemocnice Agel Ostrava - Vitkovice A.S, Ostrava - Vitkovice, Czechia
- Fakultni Nemocnice V Motole, Prague, Czechia
- High Technology Hospital Medcenter, Batumi, Georgia
- Jsc Evex Hospitals, Kutaisi, Georgia
- Archangel St. Michael Multi Profile Clinical Hospital, Tbilisi, Georgia
- Israel-Georgian Medical Research Clinic Helsicore, Tbilisi, Georgia
- New Hospitals, Tbilisi, Georgia
- Medulla Chemotherapy and Immunotherapy Clinic, Tbilisi, Georgia
- Tbilisi State Medical University First University Clinic, Tbilisi, Georgia
- High Technology Medical Center, University Clinic, Tbilisi, Georgia
- Institute of Clinical Oncology Ltd, Tbilisi, Georgia
- Cancer Research Center Ltd, Tbilisi, Georgia
- Orszagos Koranyi Tbc Es Pulmonological Intezet, Budapest, Hungary
- Bacs Kiskun Megyei Oktatokorhaz, Kecskemét, Hungary
- 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, Malaysia
- Cebu Doctors University Hospital, Cebu City, Philippines
- Asian Hospital and Medical Center, City of Muntinlupa, 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
- The Medical City, Pasig, Philippines
- St. Lukes Medical Center, Quezon City, Philippines
- Ko-Med Centra Kliniczne Biala Podlaska, Biała 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, Poland
- 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, Constanța, Romania
- S C Oncocenter Oncologie Medicala S R L, Timișoara, Romania
- Oncomed Srl, Timișoara, Romania
- Sbih of Arkhangelsk Region Arkhangelsk Clinical Oncological Dispensary, Arkhangelsk, Russia
- Rbih Kursk Regional Clinical Oncology Dispensary of Kursk Region Healthcare Committee, Kursk, Russia
- Federal State Institution "Russian Cancer Research Center Named After N.N. Blokhin" Rams, Moscow, Russia
- Llc Tonus, Nizniy Novgorod, Russia
- Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary, Novosibirsk, Russia
- Bhi of Omsk Region Clinical Oncology Dispensary, Omsk, Russia
- Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia
- N.N. Petrov Research Institute of Oncology, Saint Petersburg, Russia
- Sbhi Volgograd Regional Onclogy Dispensary, Volgograd, Russia
- Clinical Center of Serbia, Belgrade, Serbia
- Clinical Center Bezanijska Kosa, Belgrade, Serbia
- Clinical Center of Serbia, Belgrade, Serbia
- Oncomed-System, Belgrade, Serbia
- Institute For Pulmonary Diseases of Vojvodina, Kamenitz, Serbia
- Clinical Center Kragujevac, Kragujevac, Serbia
- Cape Town Oncology Trials (Pty) Ltd, Cape Town, South Africa
- Cancercare Rondebosch Oncology Centre, Cape Town, South Africa
- Wits Clinical Research, Johannesburg, South Africa
- Sandton Oncology Centre, Johannesburg, South Africa
- University of Pretoria Oncology Department, Pretoria, South Africa
- Mary Potter Oncology Centre, Pretoria, South Africa
- Acibadem Adana Hospital, Adana, Turkey (Türkiye)
- Adana Sehir Hastanesi, Adana, Turkey (Türkiye)
- Hacettepe Universitesi Tip Fakultesi Hastanesi, Ankara, Turkey (Türkiye)
- Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital, Ankara, Turkey (Türkiye)
- Memorial Ankara Hospital, Ankara, Turkey (Türkiye)
- Yildirim Beyazit University Ankara Ataturk Training and Research Hospital, Ankara, Turkey (Türkiye)
- Memorial Antalya Hastanesi, Antalya, Turkey (Türkiye)
- Trakya Universitesi Tip Fakultesi, Edirne, Turkey (Türkiye)
- Gaziantep University Gaziantep Oncology Hospital, Gaziantep, Turkey (Türkiye)
- Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty, Istanbul, Turkey (Türkiye)
- Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Istanbul, Turkey (Türkiye)
- Medipol University Medical Faculty, Istanbul, Turkey (Türkiye)
- Izmir Medicalpark Hospital, Izmir, Turkey (Türkiye)
- Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi, Konya, Turkey (Türkiye)
- Inonu Universitesi Turgut Ozal Tip Merkezi, Malatya, Turkey (Türkiye)
- 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
- Kyiv City Clinical Oncological Center, Kyiv, Ukraine
- Medical Center Asklepion Llc, Kyiv, Ukraine
- Ci of Krc Kyiv Regional Oncologic Dispensary, Kyiv, Ukraine
- Volyn Regional Oncological Dispensary, Lutsk, Ukraine
- Rmi Sumy Regional Clinical Oncology Dispensary, Sumy, Ukraine
- Cne Ccch of Uzh Cc Oncological Center, Uzhhorod, Ukraine
- Medical Center Oncolife Llc, Zaporizhzhia, Ukraine
- 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, Vietnam

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pacific cancer medical center|anaheim|california|united states` — added _(2026-05-12)_
- `locations.innovative clinical research institute|whittier|california|united states` — added _(2026-05-12)_
- `locations.reading hospital and medical center|reading|pennsylvania|united states` — added _(2026-05-12)_
- `locations.fundacao pio xii hospital de cancer de barretos|barretos||brazil` — added _(2026-05-12)_
- `locations.incan - instituto do cancer - hospital pompeia|caxias do sul||brazil` — added _(2026-05-12)_
- `locations.centro regional integrado de oncologia|fortaleza||brazil` — added _(2026-05-12)_
- `locations.oncosite - centro de pesquisa clinica e oncologia|ijuí||brazil` — added _(2026-05-12)_
- `locations.clinica de neoplasias litoral ltda|itajaí||brazil` — added _(2026-05-12)_
- `locations.hospital do cancer de londrina|londrina||brazil` — added _(2026-05-12)_
- `locations.instituto mederi de pesquisa e saude|passo fundo||brazil` — added _(2026-05-12)_
- `locations.hgb - hospital giovanni battista - mae de deus center|porto alegre||brazil` — added _(2026-05-12)_
- `locations.inca - instituto nacional de cancer|rio de janeiro||brazil` — added _(2026-05-12)_
- `locations.sao camilo oncologia|s?o paulo||brazil` — added _(2026-05-12)_
- `locations.cepho - centro de estudos e pesquisas de hematologia e oncologia|santo andré||brazil` — added _(2026-05-12)_
- `locations.fundacao faculdade regional de medicina de sao jose do rio preto|são josé||brazil` — added _(2026-05-12)_
- `locations.mc women's health-nadezhda eood|sofia||bulgaria` — added _(2026-05-12)_
- `locations.acibadem cityclinica mhat tokuda|sofia||bulgaria` — added _(2026-05-12)_
- `locations.umhat sv. ivan rilski ead|sofia||bulgaria` — added _(2026-05-12)_
- `locations.mhat serdika eood|sofia||bulgaria` — added _(2026-05-12)_
- `locations.multiprofile hospital for active treatment central onco hospital ood|sofia||bulgaria` — added _(2026-05-12)_
- `locations.shatod dr marko marko - varna ltd|varna||bulgaria` — added _(2026-05-12)_
- `locations.hunan cancer hospital|changsha||china` — added _(2026-05-12)_
- `locations.the first affiliated hospital sun yat-sen university|guangzhou||china` — added _(2026-05-12)_
- `locations.sir run run shaw hospital zhejiang university school of medicine|hangzhou||china` — added _(2026-05-12)_
- `locations.hangzhou cancer hospital|hangzhou||china` — added _(2026-05-12)_
- `locations.the first affiliated hospital of zhejiang university|hangzhou||china` — added _(2026-05-12)_
- `locations.zhejiang cancer hospital|hangzhou||china` — added _(2026-05-12)_
- `locations.harbin medical university cancer hospital|harbin||china` — added _(2026-05-12)_
- `locations.university of science and technology of china-first affiliated hospital (anhui provincial hospital)|hefei||china` — added _(2026-05-12)_
- `locations.the second hospital of anhui medical university|hefei||china` — added _(2026-05-12)_
- `locations.jinan central hospital|jinan||china` — added _(2026-05-12)_
- `locations.linyi cancer hospital|linyi||china` — added _(2026-05-12)_
- `locations.the second affiliated hospital of nanchang university|nanchang||china` — added _(2026-05-12)_
- `locations.the first affiliated hospital of guangxi medical university|nanning||china` — added _(2026-05-12)_
- `locations.shanghai chest hospital|shanghai||china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04205812*  
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