TriangleNCT04025879 · CITED IN SOURCE DOCUMENTS
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
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-08-26
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Event-Free Survival (EFS) by BICR
Overall Survival (OS)
Pathologic Complete Response (pCR) Rate
Major Pathological Response (MPR) Rate
The Number of Participants With Adverse Events (AEs)
The Number of Participants With Serious Adverse Events (SAEs)
The Number of Participants With Select Adverse Events (AEs)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Biological: Nivolumab
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Paclitaxel
- Drug: Pemetrexed
- Drug: Docetaxel
- label
- Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
- type
- EXPERIMENTAL
- intervention Names
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Paclitaxel
- Drug: Pemetrexed
- Drug: Placebo
- Drug: Docetaxel
- label
- Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
- type
- PLACEBO_COMPARATOR
- interventions
- arm Group Labels
- Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
- description
- Specified dose on specified days
- name
- Nivolumab
- other Names
- Opdivo, BMS936558
- type
- BIOLOGICAL
- arm Group Labels
- Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
- Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
- description
- Specified dose on specified days
- name
- Carboplatin
- type
- DRUG
- arm Group Labels
- Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
- Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
- description
- Specified dose on specified days
- name
- Cisplatin
- type
- DRUG
- arm Group Labels
- Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
- Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
- description
- Specified dose on specified days
- name
- Paclitaxel
- type
- DRUG
- arm Group Labels
- Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
- Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
- description
- Specified dose on specified days
- name
- Pemetrexed
- type
- DRUG
- arm Group Labels
- Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
- description
- Specified dose on specified days
- name
- Placebo
- type
- DRUG
- arm Group Labels
- Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
- Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
- description
- Specified dose on specified days
- name
- Docetaxel
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- DOUBLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 461
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- The length of time from randomization to any of the following events: progression of disease or worsening of disease precluding surgery, if surgery is attempted but gross resection is abandoned due to unresectable tumor or worsening of disease, progression or recurrence of disease after surgery, progression or recurrence of disease without surgery, or death due to any cause. Progression/recurrence will be assessed by BICR per RECIST 1.1. Participants who do not undergo surgery for reason other than progression will be considered to have an event at RECIST 1.1 progression or death
- measure
- Event-Free Survival (EFS) by BICR
- time Frame
- From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months)
- secondary Outcomes
- description
- OS is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive.
- measure
- Overall Survival (OS)
- time Frame
- From randomization and the date of death due to any cause.
- description
- Pathologic complete response (pCR) rate is defined as the percentage of randomized participants with absence of residual viable tumor in lung and lymph nodes as evaluated by blinded independent pathology review (BIPR).
- measure
- Pathologic Complete Response (pCR) Rate
- time Frame
- From randomization up to approximately 44 months
- description
- Major pathological response (MPR) rate is defined as the percentage of randomized participants with ≤10% residual viable tumor in lung and lymph nodes as evaluated by blinded independent pathology review (BIPR).
- measure
- Major Pathological Response (MPR) Rate
- time Frame
- From randomization up to approximately 44 months
- description
- An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
- measure
- The Number of Participants With Adverse Events (AEs)
- time Frame
- From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
- description
- Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
- measure
- The Number of Participants With Serious Adverse Events (SAEs)
- time Frame
- From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
- description
- An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Select AEs include endocrinopathies, diarrhea/colitis, hepatitis, pneumonitis, interstitial nephritis, and rash. Multiple event terms that may describe each of these were grouped into endocrine, GI, hepatic, pulmonary, renal, and skin select AE categories, respectively. Hypersensitivity/infusion reactions were analyzed along with the select AE categories.
- measure
- The Number of Participants With Select Adverse Events (AEs)
- time Frame
- From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
Full study description
- brief Summary
- 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.
Source references
- references
- citation
- Cascone 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
- type
- DERIVED
- citation
- Provencio 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
- type
- DERIVED
- citation
- Tanaka 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
- type
- DERIVED
- citation
- Cascone 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
- type
- DERIVED
- citation
- Leal 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.
- pmid
- 35858590
- type
- DERIVED
- citation
- Hong WX, Sagiv-Barfi I, Czerwinski DK, Sallets A, Levy R. Neoadjuvant Intratumoral Immunotherapy with TLR9 Activation and Anti-OX40 Antibody Eradicates Metastatic Cancer. Cancer Res. 2022 Apr 1;82(7):1396-1408. doi: 10.1158/0008-5472.CAN-21-1382.
- pmid
- 35135810
- type
- DERIVED
- see Also Links
- label
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Source notices and limitations
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Preserved source evidence · Not medical advice