Clinical trial · Interventional
A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer
A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer
NCT04025879CI-TRIAL-00124041active not recruitingPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
- interventionNames
- Biological: Nivolumab
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Paclitaxel
- Drug: Pemetrexed
- Drug: Docetaxel
- type
- PLACEBO_COMPARATOR
- label
- Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
- interventionNames
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Paclitaxel
- Drug: Pemetrexed
- Drug: Placebo
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Event-Free Survival (EFS) by BICR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with suspected or histologically confirmed Stage IIA (\> 4 cm) to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable * No brain metastasis * Treatment-naive for NSCLC (no prior systemic anti-cancer treatment) * Ability to provide surgical or biopsy tumor tissue for biomarkers * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 Exclusion Criteria: * Participants with an active, known or suspected autoimmune disease * Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) * Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC * Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol-defined inclusion/exclusion criteria apply
References
Publications (6)
- DERIVEDCascone T, Awad MM, Spicer JD, He J, Lu S, Tanaka F, Cornelissen R, Petruzelka LB, Gao Y, Pujol JL, Ito H, de Oliveira Muniz Koch L, Ciuleanu TE, Wu L, Bohnet S, Watanabe Y, Taube JM, Deutsch JS, Erdmann CC, Meadows-Shropshire S, Neely J, Ip V, Hung YH, Sathyanarayana P, Bhatia S, Chu K, Blum SI, Lucherini S, Eddy N, Yadav A, Provencio M. Biomarkers of nivolumab benefit in resectable non-small cell lung cancer. Nature. 2026 Aug 12. doi: 10.1038/s41586-026-10925-6. Online ahead of print. PMID 42587156
- DERIVEDProvencio M, Awad MM, Spicer JD, Janssens A, Moiseyenko F, Gao Y, Watanabe Y, Alexandru A, Guisier F, Frost N, Franke F, Hiltermann TJN, He J, Tanaka F, Lu S, Coronado Erdmann C, Sathyanarayana P, Tran P, Devas V, Cascone T. Clinical outcomes with perioperative nivolumab by nodal status in patients with stage III resectable NSCLC: phase 3 CheckMate 77T exploratory analysis. Nat Cancer. 2026 Jan;7(1):169-181. doi: 10.1038/s43018-025-01104-z. Epub 2026 Jan 8. PMID 41507539
- DERIVEDTanaka F, Watanabe Y, Sugawara S, Okami J, Muto S, Okada M, Horio Y, Tsuboi M, Sato Y, Takamochi K, Horinouchi H, Tambo Y, Seike M, Okishio K, Coronado Erdmann C, Sathyanarayana P, Meadows-Shropshire S, Ito H. Perioperative Nivolumab in Resectable Non-Small Cell Lung Cancer: A Subanalysis of Japanese Patients From CheckMate 77T. Cancer Sci. 2026 Mar;117(3):759-768. doi: 10.1111/cas.70300. Epub 2025 Dec 23. PMID 41431434
- DERIVEDCascone T, Awad MM, Spicer JD, He J, Lu S, Sepesi B, Tanaka F, Taube JM, Cornelissen R, Havel L, Karaseva N, Kuzdzal J, Petruzelka LB, Wu L, Pujol JL, Ito H, Ciuleanu TE, de Oliveira Muniz Koch L, Janssens A, Alexandru A, Bohnet S, Moiseyenko FV, Gao Y, Watanabe Y, Coronado Erdmann C, Sathyanarayana P, Meadows-Shropshire S, Blum SI, Provencio Pulla M; CheckMate 77T Investigators. Perioperative Nivolumab in Resectable Lung Cancer. N Engl J Med. 2024 May 16;390(19):1756-1769. doi: 10.1056/NEJMoa2311926. PMID 38749033
- DERIVEDLeal TA, Ramalingam SS. Neoadjuvant therapy gains FDA approval in non-small cell lung cancer. Cell Rep Med. 2022 Jul 19;3(7):100691. doi: 10.1016/j.xcrm.2022.100691.