Clinical trial · Interventional
Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Nonsquamous Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
| Metastatic Squamous Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| nab-Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Retifanlimab | Drug | Retifanlimab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- INCMGA00012 + chemotherapy (nonsquamous NSCLC)
- description
- INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.
- interventionNames
- Drug: Retifanlimab
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
- type
- ACTIVE_COMPARATOR
- label
- Placebo + chemotherapy (nonsquamous NSCLC)
- description
- 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.
- interventionNames
- Drug: Placebo
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDLu 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. PMID 40983066